fbpx

The Digest

Pharma news roundup and Larvol updates

Contact Us
Category: Breast Cancer

Weekly Top News – Breast Cancer – November 11, 2019

November 11, 2019

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
EL1SSAR: A Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) – Nov 5, 2019 – P3; N=280; Not yet recruiting; Sponsor: Hoffmann-La Roche

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Second interim OS data from P3 SOPHIA trial (NCT02492711) in HER2+ metastatic breast cancer at SABCS (Dec 10- 14, 2019) (Macrogenics) – Nov 9, 2019 – Corporate Presentation 
[Screenshot]

 

llllllllll entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Launch in US for breast cancer in 2021 (Syndax) – Nov 11, 2019 – Q3 2019 Results
Launch US

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports third quarter 2019 financial results and provides clinical and business update (PRNewswire) – Nov 7, 2019 – P3, N=600; E2112 (NCT02115282); P1/2, N=132; AUGMENT-101 (NCT04065399); Sponsor: Syndax Pharmaceuticals; “Pipeline updates: (i) Entinostat: E2112 trial passed final interim OS analysis; trial continues, with final OS analysis expected in 2Q20; (ii) SNDX-5613: The Company expects to report initial clinical data from the…phase 1/2 open-label AUGMENT-101 trial…in 2020.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC at year end 2020 (Jones Trading) – Nov 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 68239157; Page no: 1; REPORT TITLE: “Infinity Pharmaceuticals, Inc.-3Q19 — Reiterating BUY & $3.50 PT. Mature phase 1b data potentially in mid/3Q20 likely to provide mechanistic insight; Phase 2 MARIO-3 data at YE20-10/31/2019 “; AUTHOR: Roy, Soumit, et al; DATE: 10/31/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) – Nov 5, 2019 – P1/2; N=220; Not yet recruiting; Sponsor: Dragonfly Therapeutics

 

Verzenio (abemaciclib) / Eli Lilly
COFEPRIS clears Eli Lilly’s onco drug Verzenio for Mexico market (GBI Health) – Nov 4, 2019 – “Eli Lilly last week announced the receipt of a marketing approval from Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) for its anti-cancer treatment Verzenio (abemaciclib). The oral drug is indicated as part of a first- or second-line combination therapy against hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to Present Immune Pharmacodynamic Data (IPD) Showing Immune Activation in Phase 2 Melanoma and Triple Negative Breast Cancer Study (GlobeNewswire, Biothera Pharmaceuticals, Inc.) – Nov 8, 2019 – P2, N=164; NCT02981303; Sponsor: Biothera; “In three previous mTNBC studies, CPI monotherapies resulted in a disease control rate of 7-10% (CR +PR+ SD >24 weeks), median overall survival (mOS) of 7-9 months and a 12-month OS of 37-40%. Primary data from the 44-patient Phase 2 study evaluating Imprime PGG and KEYTRUDA show a disease control rate of 25% (N= 11; 1 CR, 6 PR and 4 SD>24 weeks), mOS of 16.4 months and 12-month OS rate of 57.6%….Similar results were observed in the melanoma arm of the study, which tested the combination of Imprime PGG and KEYTRUDA in heavily CPI pre-treated melanoma patients (20 patients; 13/20 had ³2 prior CPI regimens and 17/20 had progressed on pembrolizumab). The disease control rate was 50% (1 CR and 9 SD as best response), 12-month OS rate was 45%.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Kisqali (ribociclib) / Novartis; veliparib (ABT-888) / AbbVie; Verzenio (abemaciclib) / Eli Lilly; Keytruda (pembrolizumab) / Merck (MSD); Zejula (niraparib) / GSK, J&J, Takeda
2019 Post European Society for Medical Oncology (ESMO) Report: Highlights from ESMO 2019 Congress – ResearchAndMarkets.com (Businesswire) – Nov 4, 2019 – “Conference highlights included new data from PARP inhibitors in ovarian cancer, such as Zejula, Lynparza and veliparib, as well as a follow-up update for KRAS-targeted drug AMG 510 for colorectal cancer, and CDK4/6-inhibitors, Kisqali and Verzenio, for breast cancer. Key pipeline updates for more established drugs were highly featured including Keytruda for non-small lung cancer and Kisqali for breast cancer.”

 

Nerlynx (neratinib) / Puma
CANbridge receives Hong Kong Department of Health market approval for Nerlynx (Businesswire) – Nov 5, 2019 – “CANbridge Pharmaceuticals Inc….announced that it received market approval from the Department of Health in Hong Kong for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early‑stage hormone receptor positive HER2-overexpressed/amplified breast cancer, and who completed adjuvant trastuzumab-based therapy less than one year ago.”

Read More …

Weekly Top News – Breast Cancer – November 4, 2019

November 4, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 regulatory estimate: Approval in Japan for breast cancer around Jan-Mar 2020 (Morgan Stanley) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68106862; Page no: 1; REPORT TITLE: “Pharmaceuticals: Japan week feedback: Daiichi Sankyo dominated discussion”; AUTHOR: Muraoka, Shinichiro, et al; DATE: 10/15/2019

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: PDUFA action date for HER2 positive metastatic breast cancer on April 29, 2020 (Daiichi Sankyo) – Nov 1, 2019 – Q2 FY 2019 Results 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Novartis’ breast cancer treatment wins regulator’s nod (Korea Biomedical Review) – Oct 31, 2019 – “Novartis Korea said that the Ministry of Food and Drug Safety has approved Kisqali, a kinase inhibitor, for the treatment of women with advanced or metastatic breast cancer…The ministry approved the drug based on clinical findings demonstrating clinical efficacy, such as the significant prolonged survival rate of Kisqali.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at SABCS (December 11, 2019) (Daiichi Sankyo) – Nov 1, 2019 – Q2 FY 2019 Results 
[Screenshot]

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics reports third quarter 2019 results and provides corporate update (Immunomedics Press Release) – Oct 30, 2019 – “TROPHY-U-01 reached target enrollment in cisplatin-eligible cohort of 100 patients…’we are on target to submit our Biologics License Application (BLA) for sacituzumab govitecan in late-stage metastatic triple-negative breast cancer (mTNBC) in patients who have received at least two prior therapies for metastatic disease to the FDA in late November or early December, 2019’…In the open-label, Trop-2-enriched multi-cohort Phase 2 TROPiCS-03 study (NCT03964727), the first patient with NSCLC has been dosed.”

 

capecitabine / Generic Mfg.
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer (clinicaltrials.gov) – Oct 28, 2019 – P3; N=1384; Completed; Sponsor: Spanish Breast Cancer Research Group; Active, not recruiting –> Completed; Trial completion date: Jan 2019 –> Apr 2019

 

eftilagimod alpha (IMP 321) / Immutep; Keytruda (pembrolizumab) / Merck (MSD)
Operational update (GlobeNewswire) – Oct 28, 2019 – “Significant eftilagimod alpha clinical data expected in coming months: AIPAC Phase II – data expected in Q1 calendar year 2020; TACTI-002 Phase II – data at SITC in Nov 2019 and in Q1 in 2020; TACTI-mel Phase I – final safety data expected in H1 2020; INSIGHT-004 Phase I – initial safety data expected in Q4 calendar year 2019.”

 

Zirabev (bevacizumab biosimilar) / Pfizer; Trazimera (trastuzumab biosimilar) / Pfizer
Pfizer announces launch dates for 2 more anticancer biosimilars: Ruxience and Trazimera (Center for Biosimilars) – Oct 29, 2019 – “…Ruxience will become commercially available in January 2020, and Trazimera will follow on February 15, 2020. The company previously confirmed that it plans to launch its biosimilar bevacizumab, Zirabev, on December 31, 2019.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
AstraZeneca wins expanded indication for anticancer treatment Lynparza (Korea Biomedical Review) – Oct 30, 2019 – “AstraZeneca said that it has received approval from the Ministry of Food and Drug Safety for an additional indication for a new tablet formulation of Lynparza, its poly ADP (adenosine diphosphate)-ribose polymerase (PARP) inhibitor, in treating ovarian and breast cancer. Until now, the Lynparza capsule was the only approved formulation in Korea.”

 

Ibrance (palbociclib) / Pfizer; Herceptin (trastuzumab) / Roche
PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (clinicaltrials.gov) – Oct 31, 2019 – P3; N=496; Recruiting; Sponsor: Alliance Foundation Trials, LLC.; Trial completion date: Aug 2024 –> Dec 2025; Trial primary completion date: Oct 2020 –> May 2021

Read More …

Weekly Top News – Breast Cancer – October 28, 2019

October 28, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in Japan for ovarian cancer, muscle-invasive urothelial cancer (adjuvant) and hepatocellular cancer in 2020 (Chugai) – Oct 25, 2019 – Q3 2019 Results: Regulatory submissions in Japan for early breast cancer and NSCLC (neoadjuvant) in 2021 
[Screenshot]

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi: P2 data from P1/2 BEGONIA trial (NCT03742102) for 1L metastatic TNBC in H2 2020 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P1/2 STUDY 1108 (NCT01693562) in advanced solid tumors in H2 2019 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Piqray: CHMP opinion in EU for breast cancer in H1 2020 (Novartis) – Oct 22, 2019 – Q3 2019 Results 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data from P3 DESTINY-Breast02 trial (NCT03523585) for pre-treated HER2 breast cancer in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive, unresectable and/or metastatic breast cancer in 2021 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data from P3 DESTINY-Breast04 trial (NCT03734029) for HER2-low, unresectable and/or metastatic breast cancer in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P2 DESTINY-Gastric01 trial (NCT03329690) for HER2-overexpressing advanced gastric cancer in H1 2020 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Kisqali: Regulatory submission for HR+, HER2(-) breast cancer (adjuvant) in 2023 or later (Novartis) – Oct 22, 2019 – Q3 2019 Results 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Acceptance of regulatory submission for pre-treated HER2 breast cancer (based on DESTINY-Breast02 trial) in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Acceptance of regulatory submission for HER2-positive/negative unresectable and/or metastatic breast cancer (based on DESTINY-Breast03, DESTINY-Breast04 trial) in 2021 or later 
[Screenshot]

 

margetuximab (MGAH 22) / MacroGenics
MacroGenics Announces Second Interim Overall Survival Data from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer (GlobeNewswire, MacroGenics, Inc.) – Oct 22, 2019 – P3, N=624; SOPHIA (NCT02492711); Sponsor: MacroGenics; “Among the approximately 85% of patients carrying a CD16A 158F allele, the median OS was prolonged by 4.3 months in the margetuximab arm compared to the trastuzumab arm (23.7 months versus 19.4 months; HR=0.793; 95% CI: 0.607-1.035; p=0.087). Among the approximately 15% of patients who were homozygous for the CD16A 158V allele, the trastuzumab arm performed better than the margetuximab arm. The final pre-specified OS analysis is planned after 385 events have accrued, which is projected to occur in 2020. The first sequential primary endpoint of progression-free survival (PFS) in the ITT population was achieved, with statistical significance as previously reported.”

 

Kisqali (ribociclib) / Novartis
Women living with metastatic breast cancer in British Columbia now have public access to Kisqali (Canada Newswire) – Oct 23, 2019 – “Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that British Columbia will now reimburse KISQALI® (ribociclib) for eligible patients in combination with an aromatase inhibitor (letrozole) under its provincial public drug program (complete British Columbia reimbursement criteria can be accessed here). For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body, such as the lungs, liver, bones or brain.”

 

Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, Teva
Celltrion launches Herzuma in Brazil (Korea Biomedical Review) – Oct 25, 2019 – “Celltrion Healthcare said that it has launched its anticancer antibody biosimilar Herzuma in Brazil…Brazil is a primary pharmaceutical market for the trastuzumab medicine worth about 270 billion won ($230 million)….company is preparing for direct sales of Herzuma, also in Colombia, Mexico, Chile, and Peru.”

Read More …

Weekly Top News – Breast Cancer – October 21, 2019

October 21, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
Trastuzumab deruxtecan granted FDA Priority Review for treatment of patients with HER2-positive metastatic breast cancer (AstraZeneca Press Release) – Oct 16, 2019 – “AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer, is set for the second quarter of 2020.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)
Olaparib Plus Pembrolizumab as Post-Induction Therapy in Triple Negative Breast Cancer Olaparib plusz pembrolizumab posztindukciós terápiaként tripla negatív emlőrákban (clinicaltrialsregister.eu) – Oct 17, 2019 – P2/3; N=317; Ongoing; Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc

 

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in US/EU for neoadjuvant HER2+ breast cancer in 2022 or later (Roche) – Oct 16, 2019 – Q3 2019 Results: Regulatory submissions in US/EU in combination with capecitabine or carboplatin/gemicitabine for TNBC in 2022 or later 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Piqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Kisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Zejula (niraparib) / GSK, J&J, Takeda
Clovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) – Oct 14, 2019 – “NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda regulatory estimate: Approval for TNBC in 2020 (J.P. Morgan) – Oct 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 68079155; Page no: 5; REPORT TITLE: “Merck & Co., Inc.: Does Keytruda concentration cap MRK’s multiple? We see shares as cheap on sotp basis”; AUTHOR: Schott, Christopher, et al; DATE: 10/10/2019

 

Perjeta (pertuzumab) / Roche; Tecentriq (atezolizumab) / Roche; Rozlytrek (entrectinib) / Roche
Roche reports very strong sales growth in the first nine months of 2019 – outlook raised (GlobeNewswire) – Oct 16, 2019 – “Pharmaceuticals Division sales up 12%, driven by high demand for recently launched medicines, mainly Ocrevus, Hemlibra, Tecentriq and Perjeta…New treatment options and diagnostic test approved in the third quarter….in the US Rozlytrek for lung cancer with a specific gene mutation and solid tumours carrying a certain gene fusion; in the EU three new indications for Tecentriq: for a certain type of breast cancer; for the initial treatment of non-small cell as well as small cell lung cancer”

 

Keytruda (pembrolizumab) / Merck (MSD); AE 37 / Generex
Generex Biotechnology announces merger with public vehicle for public trading of NuGenerex Immuno-Oncology (GlobeNewswire) – Oct 15, 2019 – “Generex has positioned its wholly-owned cancer subsidiary NuGenerex Immuno-Oncology to be merged with the public company, thereby completing the company’s go-public strategy to realize the value of the Ii-Key technology and AE37 immunotherapeutic vaccine program. NGIO is currently enrolling a Phase II trial to establish the recommended biologic dose for AE37 Peptide Vaccine in combination with Keytruda® (Pembrolizumab) that will enhance the tumor-specific immune response and demonstrate efficacy in patients with advanced triple-negative breast cancer (NSABP FB-14); the trial is currently screening and enrolling patients at multiple clinical research sites.”

 

Opdivo (nivolumab) / Ono Pharma, BMS; Keytruda (pembrolizumab) / Merck (MSD)
Uruguay to request inclusion of Opdivo, Keytruda into PAHO’s Strategic Fund (GBI Health) – Oct 14, 2019 – “According to Alicia Ferreira, head of Uruguay’s National Resources Fund (FNR), the country will call for the Pan American Health Organization (PAHO) to include Bristol-Myers Squibb (BMS)’s Opdivo (nivolumab) and Merck, Sharp & Dohme (MSD)’s Keytruda (pembrolizumab) into the Strategic Fund. The petition will be made at the next meeting of member countries, to which Janssen and MSD, the main manufacturers of Opdivo and Keytruda respectively, will be invited…The drugs, which have a monthly cost of about USD 13,000, will initially be used to treat melanoma, although their coverage will later be extended to include breast cancer and other tumors.”

Read More …

Weekly Top News – Breast Cancer – October 14, 2019

October 14, 2019

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax’s entinostat advances in late-stage breast cancer study (SeekingAlpha) – Oct 7, 2019 – “Syndax Pharmaceuticals…announces the fifth and final successful interim futility analysis of survival data in the Cancer Research Group-sponsored Phase 3 clinical trial, E2112, evaluating the combination of lead drug entinostat and exemestane (Pfizer’s Aromasin) in patients with advanced HR+/HER2- breast cancer. The study will continue until 410 of the 608 participants have died, currently expected to occur in Q2 2020. If all goes well, the company expects to file a U.S. marketing application in late 2020.”

 

Kisqali (ribociclib) / Novartis
Kisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Piqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Tecentriq (atezolizumab) / Roche
Roche’s atezolizumab is first breast cancer immunotherapy in Argentina (GBI Health) – Oct 12, 2019 – “Switzerland-based Roche has obtained an indication extension approval from Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) for its immuno-oncology product Tecentriq (atezolizumab) in combination with nab-paclitaxel or paclitaxel to treat triple negative breast cancer. The monoclonal antibody (mAb) was originally indicated against urothelial carcinoma (UC) and metastatic non-small cell lung cancer (NSCLC).”

 

triptorelin / Generic Mfg.; Xtandi (enzalutamide) / Pfizer, Astellas; pertuzumab/trastuzumab (RG6264) / Roche; Keytruda (pembrolizumab) / Merck (MSD)
SMC accepts lymphoma, lung cancer treatments in latest meeting (PharmaTimes) – Oct 8, 2019 – “In the latest Scottish Medicines Consortium (SMC) meeting, the committee has recommended four new medicines and rejected two…Among the positive opinions are Kite pharma’s Yescarta (axicabtagene ciloleucel), MSD’s cancer blockbuster Keytruda (pembrolizumab), Decapeptyl SR (triptorelin acetate)…Keytruda was approved for metastatic non-squamous non-small cell lung cancer (NSCLC), also through the PACE process…The committee also accepted Decapeptyl for the treatment of early stage breast cancer….On top of the four acceptances, the committee rejected Perjeta (pertuzumab) and Xtandi (enzalutamide) for the treatment of early stage breast cancer and prostate cancer, respectively.”

 

Zejula (niraparib) / GSK, J&J, Takeda
Clovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) – Oct 14, 2019 – “NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: CHF3,683M in 2023 (Deutsche Bank Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68025177; Page no: 2; REPORT TITLE: “Roche Holding ltd- Roche: ESMO feedback: IMpowering the Tecentriq brand”; AUTHOR: Parkes, Richard, et al; DATE: 09/30/2019

 

AVID100 / Formation Biologics
Forbius: phase 2 clinical data with tumor-selective anti-EGFR ADC AVID100 featured at AACR-NCI-EORTC and World ADC San Diego (Businesswire) – Oct 10, 2019 – “Forbius…will today present the first clinical data from its Phase 2 development program with novel, tumor-selective anti-EGFR ADC AVID100 at the 10th Annual World ADC in San Diego (Oct. 8 – 11). AVID100 clinical data will also be featured in an upcoming poster presentation at the AACR-NCI-EORTC meeting in Boston (Oct. 26 – 30).”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab sales projection: $300-400M peak for 3L HER2+ breast cancer setting (Cowen & Co) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67965816; Page no: 2377; REPORT TITLE: “Biotechnology quarterly”; AUTHOR: Cowen Biotechnology Team, et al; DATE: 09/16/2019

 

Ibrance (palbociclib) / Pfizer
Ibrance sales projection: $8.7B in 2023 (Infinata) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 1; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

Read More …

Weekly Top News – Breast Cancer – October 7, 2019

October 7, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Safety data consistent with known safety profile of Verzenio”; Metastatic breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in mid-2021 (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Verzenio (abemaciclib) / Eli Lilly
Health-related quality of life in MONARCH 3: Abemaciclib plus an aromatase inhibitor as initial therapy in women with HR-positive (HR +), HER2-negative (HER2) advanced breast cancer (DGHO 2019) – Sep 30, 2019 – Abstract #P1006; Pres time: Oct 14, 2019; 12:00 PM – 12:05 PM; Location: A6; P3; “Abemaciclib plus AI resulted in clinically meaningful and statistically significant changes in diarrhea, and clinically not meaningful differences in other symptom scores. Increased GI-related symptoms were consistent with the manageable, reversible AE profile. No clinically meaningful differences in global health status or functional scores were observed.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Abemaciclib + NSAI and Abemaciclib + fulvestrant showed significant PFS benefit in predominantly Chinese HR +/HER –advanced breast cancer patients”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019
P3 data
[Screenshot]

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Verzenio significantly extended life by 9.4 months”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Tecentriq (atezolizumab) / Roche
Tecentriq by Roche not approved on NHS for triple negative breast cancer (Pharmafield) – Oct 3, 2019 – “Draft guidance published by NICE does not recommend atezolizumab, Tecentriq by Roche, for treating people with a type of breast cancer that has spread to other parts of the body….Atezolizumab with nab-paclitaxel does not meet NICE’s Cancer Drugs Fund criteria because it does not have a plausible potential to be cost-effective and there is no clear evidence that further trial data would resolve the uncertainties associated with this appraisal.”

 

Ibrance (palbociclib) / Pfizer; Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
CDK4/6 inhibitor+fulvestrant combo nears getting benefit (Korea Biomedical Review) – Oct 2, 2019 – “The combination therapy of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and fulvestrant for advanced or metastatic breast cancer has taken the first step to receive insurance benefits. The Health Insurance Review and Assessment Service (HIRA)’s Cancer Drug Review Committee decided in September to grant reimbursement for Pfizer’s Ibrance (ingredient: palbociclib) plus fulvestrant and Lilly’s Verzenio (abemaciclib) plus fulvestrant, sources said on Monday.”

 

Tecentriq (atezolizumab) / Roche
A small molecule triple-negative breast cancer immunotherapy that targets the Liver-X-Receptor. (CRI-CIMT-EATI-AACR 2019) – Oct 4, 2019 – Abstract #A203; “There is only FDA-approved immunotherapy for TNBC, Atezolizumab for patients with high PD-L1 expression, which unfortunately only marginally improves patient survival (~2 months)…Lastly, through extracellular flux analysis and mitochondrial activity profiling we have determined that LXR activation severely disrupts mitochondrial function in CD8+ T-cells. Our discoveries implicate LXR as a central mediator of TNBC immune evasion and as a promising treatment target for the development of novel small molecule immunotherapies for TNBC.”

 

 

Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
Abemaciclib in combination with fulvestrant in patients with HR + / HER2- advanced breast cancer who had demonstrated primary or secondary resistance to previous endocrine therapy (DGHO 2019) – Sep 30, 2019 – Abstract #P1008; Pres time: Oct 14, 2019; 12:10 PM – 12:15 PM; Location: A6; P3; “Abemaciclib+F improved PFS and ORR with a generally tolerable safety profile in pts with HR+/HER2- ABC and primary/secondary ETR. Although pts with primary ETR typically have poor prognosis, the benefit from abemaciclib+F was maintained in this population. Previously presented at ESMO 2018, FPN 329P, Grischke E et al.”

 

Verzenio (abemaciclib) / Eli Lilly
Management of abemaciclib-associated adverse events in patients with HR + / HER2- advanced breast cancer: analysis of MONARCH studies (DGHO 2019) – Sep 30, 2019 – Abstract #P1007; Pres time: Oct 14, 2019; 12:05 PM – 12:10 PM; Location: A6; P2, P3; “Introduction: Abemaciclib is a CDK4/6 inhibitor dosed continuously, with demonstrated efficacy and an acceptable safety profile in patients (pts) with HR+/HER2- advanced breast cancer (ABC) alone (MONARCH 1, NCT02102490) or in combination with fulvestrant (MONARCH 2, NCT02107703) or non-steroidal aromatase inhibitors (MONARCH 3, NCT02246621). Abemaciclib dose adjustments and/or supportive medication were effective in managing AEs in pts with ABC in the MONARCH trials. Understanding the safety profile of abemaciclib can inform AE management and can extend time on treatment. Previously presented at ESMO 2018, FPN 339P, Rugo HS et al.”

Read More …

Weekly Top News – Breast Cancer – September 30, 2019

September 30, 2019

Tecentriq (atezolizumab) / Roche
Health Canada approves Tecentriq in combination with chemotherapy (nab-paclitaxel) as first immunotherapy treatment for aggressive form of breast cancer (Canada Newswire) – Sep 27, 2019 – “Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada under the Notice of Compliance with Conditions (NOC/c) policy has approved Tecentriq® (atezolizumab) in combination with chemotherapy (nab-paclitaxel) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%, and who have not received prior chemotherapy for metastatic disease. Tecentriq is the first and only approved cancer immunotherapy agent in Canada for first-line TNBC. This approval meets a significant unmet need for TNBC patients…This approval is based on results from the randomized Phase III IMpassion130 study.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio (abemaciclib) significantly extends life by a median of 9.4 months for women with HR+, HER2- advanced breast cancer in MONARCH 2 study (Eli Lilly Press Release) – Sep 29, 2019 – P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly; “Eli Lilly and Company…announced Verzenio® (abemaciclib) in combination with fulvestrant significantly extended life by a median of 9.4 months in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy (median of 46.7 months vs. median of 37.3 months with placebo plus fulvestrant; HR: 0.757; 95% CI: 0.606, 0.945; P = 0.0137). Results from the Phase 3 MONARCH 2 clinical trial, which included both pre/peri- and postmenopausal women, were consistent across subgroups.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) plus chemotherapy showed statistically significant increase in pathological complete response versus chemotherapy as neoadjuvant therapy in early-stage triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) – Sep 29, 2019 – P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck Sharp & Dohme Corp; “Merck…announced results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial in patients with early-stage triple-negative breast cancer (TNBC)…In the neoadjuvant phase, KEYTRUDA plus chemotherapy (n=401) resulted in a statistically significant increase in pathological complete response (pCR) versus chemotherapy (n=201), from 51.2% with neoadjuvant chemotherapy to 64.8% for neoadjuvant KEYTRUDA plus chemotherapy, in patients with early-stage TNBC (p=0.00055)….In the PD-L1 CPS ≥1 subgroup, the rates of pCR were 68.9% for neoadjuvant KEYTRUDA plus chemotherapy (n=334) versus 54.9% for neoadjuvant chemotherapy (n=164).”

 

Kisqali (ribociclib) / Novartis
Novartis Kisqali delivers consistently superior overall survival – MONALEESA-3 trial demonstrates more life for postmenopausal HR+/HER2- advanced breast cancer patients (Novartis Press Release) – Sep 29, 2019 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “Novartis today announced results from the MONALEESA-3 trial, which showed Kisqali® (ribociclib) achieved statistically significant improvement in overall survival (OS)…MONALEESA-3 evaluated efficacy and safety of Kisqali plus fulvestrant in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer….Median PFS in the first-line was also reached at this analysis and demonstrated that Kisqali in combination with fulvestrant has a median PFS of 33.6 months compared to 19.2 months in the placebo arm (HR=0.546; 95% CI: 0.415-0.718).”

 

Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)
Eisai announces data presentations on Keytruda (pembrolizumab) plus Lenvima (lenvatinib) investigational combination therapy and Halaven (eribulin) at ESMO 2019 (PRNewswire) – Sep 24, 2019 – P3, N=720; ENGOT-en9 (NCT03884101); Sponsor: Merck Sharp & Dohme Corp; P3, N=392; SELECT (NCT01321554); Sponsor: Eisai Inc; P3, N=694; LEAP-011 (NCT03898180); Sponsor: Merck Sharp & Dohme Corp; “Eisai today announced the presentation of new data and analyses via one oral proffered paper presentation, four poster discussions and seven poster presentations at the 2019 European Society for Medical Oncology (ESMO) Annual Meeting from September 27 – October 1 in Barcelona, Spain. Data to be presented include posters on the ongoing trials evaluating pembrolizumab plus lenvatinib…”

 

Tecentriq (atezolizumab) / Roche; sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics provides corporate update (GlobeNewswire) – Sep 28, 2019 – “The collaboration with Roche will evaluate the safety and efficacy of the combination of atezolizumab (Tecentriq®)…and sacituzumab govitecan, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC…. The open-label, multicenter, randomized Phase 1b/2 study will be conducted as part of MORPHEUS…. Roche will be responsible for conducting the randomized trial….Immunomedics and the GBG Forschungs-GmbH (GBG), Neu-Isenburg, Germany, have entered into a collaboration to develop sacituzumab govitecan as a treatment for newly-diagnosed breast cancer patients who do not achieve a pathological complete response (pCR) following standard neoadjuvant therapy…. The multinational, post-neoadjuvant Phase 3 SASCIA study developed by GBG will be conducted under the sponsorship of GBG.”

 

Cyramza (ramucirumab) / Eli Lilly; Tarceva (erlotinib) / Astellas, Roche; pemetrexed / Generic Mfg.; Verzenio (abemaciclib) / Eli Lilly; Keytruda (pembrolizumab) / Merck (MSD)
Lilly Oncology to present robust data across its growing portfolio at ESMO 2019 (Eli Lilly Press Release) – Sep 23, 2019 – P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly and Company; P1/2, N=970; LIBRETTO-001 (NCT03157128); Sponsor: Loxo Oncology, Inc; P3, N=543; RELAY (NCT02411448); Sponsor: Eli Lilly and Company; “Verzenio® (abemaciclib) Phase 3 data included in ESMO Presidential Symposium and Official Press Program: Positive overall survival results to be presented from MONARCH 2, evaluating Verzenio with fulvestrant for the treatment of women with HR+, HER2- advanced breast cancer whose cancer grew or spread following endocrine therapy; RET-altered thyroid cancer data for selpercatinib (LOXO-292) from the Phase 1/2 LIBRETTO-001 study to be featured in late-breaking oral presentation; Lung cancer highlights to include presentation of data from the Phase 3 CYRAMZA® (ramucirumab) RELAY trial and studies of the ALIMTA® (pemetrexed)-KEYTRUDA® (pembrolizumab)-platinum chemotherapy combination.”

 

Keytruda (pembrolizumab) / Merck (MSD); Opdivo (nivolumab) / Ono Pharma, BMS; Kadcyla (ado-trastuzumab emtansine) / Roche; Ibrance (palbociclib) / Pfizer
Flatiron Health announces research to be presented at European Society for Medical Oncology Congress 2019 (Businesswire) – Sep 26, 2019 – “Flatiron Health today announced 13 abstracts accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2019, which will be held September 27 – October 1, 2019, in Barcelona, Spain. The research, spanning multiple tumor types and areas of study, utilized Flatiron’s high-quality, real-world oncology datasets.”

 

Ibrance (palbociclib) / Pfizer
Pfizer presents new evidence of Ibrance (palbociclib) effectiveness in HR+, HER2- metastatic breast cancer patients in four real-world studies at ESMO Congress 2019 (Businesswire) – Sep 24, 2019 – “Pfizer Inc….announced the presentation of four IBRANCE® (palbociclib) real-world analyses. The studies support the effectiveness of IBRANCE combination therapy in everyday clinical practice and provide additional insights on its use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The posters will be presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on Sunday, September 29.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche; Tecentriq (atezolizumab) / Roche
Roche to present new data from its broad oncology portfolio at the European Society for Medical Oncology 2019 Congress (Roche Press Release) – Sep 23, 2019 – “Roche…announced that results from a number of studies across its comprehensive oncology portfolio, covering a broad range of cancers including bladder, lung and breast will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress, taking place from 27 September – 1 October in Barcelona, Spain. A total of 100 abstracts and 15 late-breaking abstracts that include a Roche medicine will be presented at this year’s congress….First positive results from a Phase III cancer immunotherapy combination study in people with previously untreated advanced bladder cancer….First results from the BFAST study testing Foundation Medicine’s FoundationOne® Liquid biopsy assay to identify patients who may be eligible for Alecensa® (alectinib)….First results from the positive Phase III IMpower110 study of Tecentriq® (atezolizumab) monotherapy as an initial treatment for advanced lung cancer.”

Read More …

Weekly Top News – Breast Cancer – September 23, 2019

September 23, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Data from P3 IMpassion031 trial (NCT03197935) for neoadjuvant TNBC in 2020 (Roche) – Sep 17, 2019 – Pharma Day: Data from P3 IMvigor010 trial (NCT02450331) as adjuvant therapy in patients with high-risk muscle-invasive bladder cancer in 2020 
[Screenshot]

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in early 2020 (Morgan Stanley) – Sep 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67912369; Page no: 7; REPORT TITLE: “Pharmaceuticals: Specialist prescribing dynamics: Focus on oncology”; AUTHOR: Purcell, Mark, et al; DATE: 09/05/2019

 

Verzenio (abemaciclib) / Eli Lilly
Lilly’s MONARCH plus study reaches primary endpoint (GBI Health) – Sep 20, 2019 – P3, N=463; MONARCH plus (NCT02763566); Sponsor: Eli Lilly and Company; “US major Eli Lilly’s MONARCH plus Phase III clinical study for protease inhibitor abemaciclib has met the company’s expectations. After receiving an abemaciclib treatment in combination with an aromatase inhibitor (anastrozole/letrozole) or fulvestrant, HR+/HER2- pre-menopausal advanced breast cancer Chinese female patients with tumor progression who had been previously treated with endocrine therapy saw their progression free survival (PFS) significantly prolonged, and experienced good tolerance towards the drug. Furthermore, the safety spectrum is consistent with previous clinical studies.”

 

Tecentriq (atezolizumab) / Roche
Chugai obtains approval for additional indication and formulation for Tecentriq in PD-L1-positive triple negative breast cancer (Chugai Press Release) – Sep 20, 2019 – “Chugai Pharmaceutical Co., Ltd…announced…that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, Tecentriq® [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer. It has also obtained approval for an additional formulation of Tecentriq 840 mg. Tecentriq 840 mg was developed to provide an optimal formulation for breast cancer for which approved dosage is 840 mg once every 2 weeks.”

 

Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer; Ibrance (palbociclib) / Pfizer; Bavencio (avelumab) / EMD Serono, Pfizer; Xtandi (enzalutamide) / Pfizer, Astellas
Pfizer presents scientific advancements in cancer care at the ESMO Congress 2019 highlighting expanded portfolio (Businesswire) – Sep 19, 2019 – P3, N=645; BEACON CRC (NCT02928224); Sponsor: Array BioPharma; P3, N=886; JAVELIN Renal 101 (NCT02684006); Sponsor: Pfizer; P1, N=147; NCT02573259; Sponsor: Pfizer; “Pfizer Inc….is presenting data across its industry-leading oncology portfolio, including company-sponsored and collaborative research studies, spanning 11 therapies in 22 types of cancer, at the European Society for Medical Oncology (ESMO) Congress to be held in Barcelona, Spain, September 27 – October 1, 2019. Data from nearly 50 abstracts involving Pfizer cancer medicines will illustrate the diversity of the portfolio and the company’s cutting-edge scientific approach. For the first time, this will include data presentations on compounds from the acquisition of Array Biopharma Inc.”

 

Ibrance (palbociclib) / Pfizer; Kisqali (ribociclib) / Novartis; Verzenio (abemaciclib) / Eli Lilly
FDA warns against pneumonitis with CDK 4/6 inhibitor drugs for breast cancer (Korea Biomedical Review) – Sep 16, 2019 – “The U.S. Food and Drug Administration added a warning that the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor drugs for breast cancer could cause pneumonitis. However, the regulator made it clear that the medicines’ overall benefit was still greater than the risks for advanced breast cancer patients. The FDA said on Friday that Pfizer’s Ibrance (ingredient: palbociclib), Novartis’ Kisqali (ribociclib), and Lilly’s Verzenio (abemaciclib) might cause rare but severe lung inflammation in patients with advanced breast cancer.”

 

Kisqali (ribociclib) / Novartis
Addition of Kisqali to drug plan in Quebec expands access to treatment for metastatic breast cancer (Canada Newswire) – Sep 19, 2019 – “Novartis Pharmaceuticals Canada Inc… is pleased to announce that Quebec will now reimburse KISQALI® (ribociclib) for eligible patients in combination with an aromatase inhibitor (letrozole) under the province’s public drug program for first-line treatment of postmenopausal women living with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.”access to treatment for metastatic breast cancer.”

 

Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCell
BriaCell announces public disclosure: Remarkable responder in combination study of lead candidate with Keytruda (GlobeNewswire) – Sep 19, 2019 – P1/2a, N=40; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “The top responder…in the Combination Study experienced a highly remarkable reduction in breast cancer tumors….She showed one of the best immune responses and displayed a highly remarkable reduction in breast cancer tumors (metastases) in the adrenal gland and the outer lining of the brain…The data presented today also noted that the Bria-IMT™ regimen administered with KEYTRUDA® was safe and well tolerated. The women who showed the best clinical responses to the combination of the Bria-IMT™ regimen with KEYTRUDA® also showed the best immune responses including a cellular immune response…”

 

Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCell
BriaCell to present September 19th at 2nd Annual Next Gen Immuno-Oncology Congress in Philadelphia (GlobeNewswire) – Sep 16, 2019 – P1/2, N=40; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “BriaCell Therapeutics Corp….announces that the Company will be presenting at the 2nd Annual Next Gen Immuno-Oncology Congress, taking place September 19-20, 2019 at Hilton Garden Inn, Philadelphia Center City….present the latest clinical findings of the Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab…”

Read More …

Weekly Top News – Breast Cancer – September 16, 2019

September 16, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P3 MONARCH-2 trial (NCT02107703) in HER2- breast cancer at ESMO (September 27 – October 1, 2019) (Eli Lilly) – Sep 10, 2019 – World Lung: Data from P2 monarcHER trial (NCT02675231) in metastatic breast cancer at ESMO (September 27 – October 1, 2019) 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
Daiichi Sankyo advances [fam-] trastuzumab deruxtecan (DS-8201) in Japan with regulatory submission in HER2 positive metastatic breast cancer (Daiichi Sankyo Press Release) – Sep 9, 2019 – “Daiichi Sankyo Company…today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer…’We are proud to initiate this critical next step in the regulatory process in Japan and look forward to the presentation of the phase 2 DESTINY-Breast01 study of [fam-] trastuzumab deruxtecan to the scientific community,’ said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.”

 

Ibrance (palbociclib) / Pfizer; Kisqali (ribociclib) / Novartis; Verzenio (abemaciclib) / Eli Lilly
FDA warns against pneumonitis with CDK 4/6 inhibitor drugs for breast cancer (Korea Biomedical Review) – Sep 16, 2019 – “The U.S. Food and Drug Administration added a warning that the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor drugs for breast cancer could cause pneumonitis. However, the regulator made it clear that the medicines’ overall benefit was still greater than the risks for advanced breast cancer patients. The FDA said on Friday that Pfizer’s Ibrance (ingredient: palbociclib), Novartis’ Kisqali (ribociclib), and Lilly’s Verzenio (abemaciclib) might cause rare but severe lung inflammation in patients with advanced breast cancer.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology announces U.S. FDA acceptance of Supplemental New Drug Application for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Sep 11, 2019 – “Puma Biotechnology, Inc….announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease)….The FDA confirmed that the review will have an action date of late April, 2020….The sNDA is supported by the results of the Phase III NALA trial…”

 

Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, Teva
Canada OKs Celltrion’s biosimilar (Korea Biomedical Review) – Sep 10, 2019 – “Celltrion said that Health Canada has given the go-ahead for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast and gastric cancer.”

 

Piqray (alpelisib) / Novartis
Novartis’s kinase inhibitor Piqray makes its way into Latin America (GBI Health) – Sep 11, 2019 – “The National Health Surveillance Agency (ANVISA) this week granted Brazil market clearance to Switzerland-based Novartis’s oncology treatment Piqray (alpelisib), as GBI analysis reveals. The oral drug is developed to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. However, the agency is yet to publish indication details.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)
Pivotal new data from Merck’s broad oncology portfolio at ESMO 2019 Congress (Merck (MSD) Press Release) – Sep 9, 2019 – “Merck…announced new data from its broadoncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, from Sept. 27-Oct. 1, 2019. More than 80 abstracts involving Merck cancer medicines and investigational candidates will be featured at the congress, spanning over 18 tumor types. Three of these abstracts – KEYTRUDA data in triple-negative breast cancer (TNBC), LYNPARZA data in prostate cancer and LYNPARZA data in ovarian cancer – were selected for inclusion in the ESMO Presidential Symposium sessions.”

 

Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCell
BriaCell to present September 19th at 2nd Annual Next Gen Immuno-Oncology Congress in Philadelphia (GlobeNewswire) – Sep 16, 2019 – P1/2, N=40; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “BriaCell Therapeutics Corp….announces that the Company will be presenting at the 2nd Annual Next Gen Immuno-Oncology Congress, taking place September 19-20, 2019 at Hilton Garden Inn, Philadelphia Center City….present the latest clinical findings of the Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab…”

 

leronlimab (PRO 140) / CytoDyn
CytoDyn Announces FDA Clearance to Proceed with Phase 2 Study of Leronlimab (PRO 140) and Regorafenib as a Combination Therapy for Metastatic Colorectal Cancer (GlobeNewswire, CytoDyn Inc.) – Sep 9, 2019 – “CytoDyn Inc…announced today that the FDA has allowed a Phase 2 study to proceed for combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC). The study will be conducted by lead principal investigator, John L. Marshall, M.D., Director, The Ruesch Center for the Cure of GI Cancers Frederick P. Smith Endowed Chair, Chief, Hematology and Oncology Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C. “We have completed our safety review of your application and have concluded that you may proceed with your proposed clinical investigation of Protocol number CD08_mCRC, entitled, “A Phase II Study of Leronlimab (PRO 140) in combination with Regorafenib…”

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: Consensus of $4.2B in 2023 and $4.8B peak (Morgan Stanley) – Sep 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67912369; Page no: 7; REPORT TITLE: “Pharmaceuticals: Specialist prescribing dynamics: Focus on oncology”; AUTHOR: Purcell, Mark, et al; DATE: 09/05/2019

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi sales projection: $3.8B peak (J.P. Morgan) – Sep 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 67911951; Page no: 29; REPORT TITLE: “European Pharma & Biotech: back to school: We still prefer the large ones: Overweight Novo, Astra & Roche”; AUTHOR: Vosser, Richard, et al; DATE: 09/04/2019

Read More …

Weekly Top News – Breast Cancer – September 9, 2019

September 9, 2019

Kisqali (ribociclib) / Novartis
Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results (ESMO 2019) – Sep 3, 2019 – Abstract #336P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
Daiichi Sankyo advances [fam-] trastuzumab deruxtecan (DS-8201) in Japan with regulatory submission in HER2 positive metastatic breast cancer (Daiichi Sankyo Press Release) – Sep 9, 2019 – “Daiichi Sankyo Company…today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer…’We are proud to initiate this critical next step in the regulatory process in Japan and look forward to the presentation of the phase 2 DESTINY-Breast01 study of [fam-] trastuzumab deruxtecan to the scientific community,’ said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.”

 

margetuximab (MGAH 22) / MacroGenics
Zai Lab announces financial results and corporate update for the six months ended June 30, 2019 (GlobeNewswire) – Sep 3, 2019 – “Anticipated Upcoming Milestones…Margetuximab….Initiate bridging trial of heavily pretreated HER2-positive metastatic breast cancer patients in China; MacroGenics to present the results from a pre-specified interim overall survival (OS) analysis and submit a Biologics License Application (BLA) to the U.S. FDA in the fourth quarter of 2019; Potential China CTA approval for the planned global gastric cancer and join MacroGenics to initiate the global registrational trial in combination with checkpoint inhibitor molecules, including INCMGA 0012 and MGD013, for patients with gastric or gastroesophageal junction cancer in 2019”

 

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals announces the initiation of two clinical trials evaluating IPI-549 in novel triple combination therapies for the treatment of solid tumors (PRNewswire) – Sep 4, 2019 – “Infinity Pharmaceuticals, Inc….announced the initiation of two clinical trials for IPI-549…Infinity initiated MARIO-3, a Phase 2 multi-arm study in collaboration with Roche/Genentech evaluating IPI-549 in combination with Tecentriq® and Abraxane® (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq….Additionally, Arcus Biosciences initiated a Phase 1/1b study, in collaboration with Infinity, evaluating IPI-549 in a novel combination regimen with AB298, Arcus’s dual adenosine receptor antagonist, and Doxil®, a chemotherapy, in patients with advanced TNBC.”

 

Nerlynx (neratinib) / Puma
FDA grants Orphan Drug Designation to Puma Biotechnology’s Nerlynx for the treatment of breast cancer patients with brain metastases (Puma Biotech Press Release) – Sep 3, 2019 – “Puma Biotechnology…announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)
Pivotal new data from Merck’s broad oncology portfolio at ESMO 2019 Congress (Merck (MSD) Press Release) – Sep 9, 2019 – “Merck…announced new data from its broadoncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, from Sept. 27-Oct. 1, 2019. More than 80 abstracts involving Merck cancer medicines and investigational candidates will be featured at the congress, spanning over 18 tumor types. Three of these abstracts – KEYTRUDA data in triple-negative breast cancer (TNBC), LYNPARZA data in prostate cancer and LYNPARZA data in ovarian cancer – were selected for inclusion in the ESMO Presidential Symposium sessions.”

 

Verzenio (abemaciclib) / Eli Lilly
Argentina is second market to wave through Eli Lilly’s Verzenio (GBI Health) – Sep 5, 2019 – “Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) this week cleared Eli Lilly’s breast cancer treatment Verzenio (abemaciclib) for marketing, as GBI analysis reveals. The orally administered therapy is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.”

 

Ibrance (palbociclib) / Pfizer
Ibrance exclusivity expiry: 2023 (Trefis) – Sep 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67885259; Page no: 1; REPORT TITLE: “Roche Holding Ltd – Can Roche’s blockbuster drug Herceptin’s Sales Grow?”; AUTHOR: Research Department, et al; DATE: 08/29/2019

Read More …
« Older Entries