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Category: Breast Cancer

Weekly Top News – IBD – July 22, 2019

July 22, 2019

Halaven (eribulin mesylate) / Eisai
Anticancer agent Halaven approved for treatment of locally advanced or metastatic breast cancer in China (Eisai Press Release) – Jul 17, 2019 – “Eisai Co., Ltd….announced today that Eisai received New Drug Approval for Eisai’s in-house developed anticancer agent Halaven® (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA). This approval is based on the results of Study 304…Halaven demonstrated a statistically significant extension in the study’s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).”

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Primary completion of P3 KEYNOTE-522 trial (NCT03036488) for TNBC in September 2025 and interim data from the trial in Q4 2019 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 437; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Piqray (alpelisib) / Novartis
Piqray: Regulatory submissions in US for HER2+ breast cancer, TNBC, 2L/3L HNSCC and ovarian cancer in 2023 or later (Novartis) – Jul 18, 2019 – Q2 2019 Results: CHMP opinion in EU for breast cancer in H2 2019   
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Verzenio (abemaciclib) / Eli Lilly
Verzenio clinical trial estimate: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in 2021 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 333; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Kisqali (ribociclib) / Novartis
NICE U-turn for Kisqali in breast cancer (PharmaTimes) – Jul 17, 2019 – “The National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative…The recommendation is based on the second line subpopulation of the MONALEESA-3 trial…There will be immediate access to the combination treatment in England through the Cancer Drugs Fund (CDF) and in Wales through the Welsh New Treatment Fund, whilst Novartis await the NICE Technology Appraisal.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology’s licensing partner Knight Therapeutics receives regulatory approval from Health Canada to commercialize Nerlynx (neratinib) for extended adjuvant treatment of hormone receptor positive, HER2-positive early stage breast cancer (Businesswire) – Jul 16, 2019 – “Puma Biotechnology…announced that its licensing partner Knight Therapeutics Inc. (Knight) has received marketing authorization from Health Canada to commercialize NERLYNX® (neratinib) in Canada for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy…Health Canada approval was based on the Phase III ExteNET trial…Treatment with neratinib in the approved Health Canada indication resulted in a 51% reduction in the risk of invasive disease recurrence or death at 2 years versus placebo after patients completed one year of therapy following a trastuzumab-based regimen.”

 

Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, Allergan; Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, Allergan
Amgen and Allergan’s Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) now available in the United States (Amgen Press Release) – Jul 18, 2019 – “Amgen…announced that MVASI (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTI (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in the United States (U.S.). MVASI…is approved for the treatment of five types of cancer: mCRC, NSCLC, recurrent glioblastoma, metastatic renal cell carcinoma and metastatic cervical cancer. KANJINTI is FDA approved for all approved indications of Herceptin: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.”

 

Piqray (alpelisib) / Novartis
Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased (Novartis Press Release) – Jul 18, 2019 – “Piqray (alpelisib, formerly BYL719) was approved and launched in the US as the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.”

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Weekly Top News – Breast Cancer – July 15, 2019

July 15, 2019

Tecentriq (atezolizumab) / Roche
Brazil issues new indication nod for Roche’s Tecentriq in triple-negative breast cancer (GBI Health) – Jul 11, 2019 – “Brazil’s National Health Surveillance Agency (ANVISA) recently issued a new indication approval for Swiss major Roche’s programmed death-ligand 1 (PD-L1) immunotherapy Tecentriq (atezolizumab). The approved indication is for use in triple-negative breast cancer (TNBC), and adds to earlier approvals for urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC) issued in October 2017, as reported by GBI.”

 

Ibrance (palbociclib) / Pfizer
New treatment approved for patients with breast cancer in Scotland (The Scotsman) – Jul 8, 2019 – “A new drug for patients with advanced breast cancer has been approved for use by the NHS in Scotland. The Scottish Medicines Consortium (SMC) said palbociclib (Ibrance) can increase the time before the condition progresses and delay the need for chemotherapy.”

 

Ibrance (palbociclib) / Pfizer
Ibrance pricing: Wholesale acquisition cost of $11,856.54/package (Cantor Fitzgerald) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67546938; Page no: 83; REPORT TITLE: “Don’t hibernate this summer; Take the good with the bad into 2H19”; AUTHOR: Research Department; DATE: 06/27/2019

 

Halaven (eribulin mesylate) / Eisai
Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer (clinicaltrials.gov) – Jul 8, 2019 – P2; N=118; Completed; Sponsor: Asan Medical Center; Active, not recruiting –> Completed; Trial completion date: Dec 2019 –> Jun 2019

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: $3-12B (analyst projection: $5B) peak (Trefis) – Jul 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67553223; Page no: 5; REPORT TITLE: “Roche Holding Ltd- Trefis report: Roche Holdings – $37.70 Trefis price estimate”; AUTHOR: Research Department, et al; DATE: 06/30/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda sales projection: $10B+ peak (Trefis) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67553248; Page no: 9; REPORT TITLE: “Merck & Co., Inc. Trefis report: Merck – $88.45 Trefis price estimate”; AUTHOR: Research Department; DATE: 07/01/2019

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: >$2B by 2021 (Trefis) – Jul 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67545638; Page no: 2; REPORT TITLE: “Roche Holding Ltd- Can Roche’s #1 therapeutic area with $28 billion in revenue grow further?”; AUTHOR: Research Department, et al; DATE: 06/27/2019

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi WW sales projection: $3.7B+ (consensus: $3.8B) in 2024 (Guggenheim) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67545132; Page no: 1; REPORT TITLE: “AZN.LN – Imfinzi sailing into new waters with positive CASPIAN results”; AUTHOR: Fernandez, Seamus, et al; DATE: 06/27/2019

 

Piqray (alpelisib) / Novartis
NCCN updates clinical practice guideline for breast cancer (Journal of Clinical Pathways) – Jul 9, 2019 – “The National Comprehensive Cancer Network (NCCN) updated their Clinical Practice Guideline for the treatment of breast cancer. In the workup for recurrent stage IV (M1) disease, an option was added to assess for PIK3CA mutation with tumor or liquid biopsy if the tumor is HR-positive and HER2-negative and if considering therapy with alpelisib…In the section for systemic therapy for ER-negative and/or PR-positive recurrent or stage IV (M1) disease, fulvestrant plus alpelisib was added as a category 1 option for PIK3CA-mutated tumors.”

 

Kisqali (ribociclib) / Novartis
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.(clinicaltrials.gov) – Jul 8, 2019 – P1/2; N=26; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Recruiting –> Active, not recruiting; N=86 –> 26

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Weekly Top News – Breast Cancer – July 8, 2019

July 8, 2019

Nerlynx (neratinib) / Puma
Puma Biotechnology submits a Supplemental New Drug Application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Jul 1, 2019 – “Puma Biotechnology, Inc….has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) 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 treatments (third-line disease)….The sNDA is supported by the results of the Phase III NALA trial…”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly aims to reshape Korea’s breast cancer treatment market (Korea Biomedical Review) – Jul 5, 2019 – “Lilly Korea is seeking to reshape Korea’s breast cancer treatment market on the occasion of its winning the sales approval for its Verzenio, a cyclin-dependent kinase (CDK) 4/6 inhibitor, from the Ministry of Food and Drug Safety, the company said Friday. The ministry approved the drug in combination with an aromatase inhibitor or as a combination therapy with fulvestrant in treating HR+/HER2-progressive or metastatic breast cancer with advanced disease after endocrine therapy in May.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Topline data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC in 2020 (Oppenheimer) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67540721; Page no: 2; REPORT TITLE: “Infinity Pharmaceuticals-Initiating coverage- 1st-in-class PI3K-γ inhibitor offers proxy for MDSCs in I-O; Initiating with outperform and $3 PT”; AUTHOR: Degeeter, Kevin, et al; DATE: 06/26/2019

 

Taclantis (paclitaxel injection concentrate for nanodispersion) / Sun Pharma
SPARC gains on acceptance of NDA by USFDA (Dalal Street Investment Journal) – Jul 1, 2019 – “Sun Pharma Advanced Research Company (SPARC) informed the bourses that USFDA has accepted the company’s New Drug Application (NDA) for Taclanti (Paclitaxel Injection Concentrate for Suspension)….Paclitaxel is one of the most widely used cytotoxic agents and is approved for the treatment of Breast cancer, Ovarian cancer, Non-Small Cell Lung cancer and Pancreatic cancer.”

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi US sales projection: $1,217M (guidance: $1,057M) in FY2019; Imfinzi WW sales projection: $1,624M (guidance: $1,350M) in FY2019 (Barclays) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531192; Page no: 1; REPORT TITLE: “AZN/NOVN/ROG: US oncology tracker: May edition (watch out for the tortoise…)”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 06/24/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda sales projection: $19.5B (previously $18.4B) in 2023 (Morgan Stanley) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67521900; Page no: 1; REPORT TITLE: “Merck & Co. Inc – Merck: Bumping PT on higher LT growth prospects”; AUTHOR: Risinger, David, et al; DATE: 06/21/2019

 

ALT02 (trastzumab biosimilar) / Alteogen, Qilu Pharma
China OKs Alteogen’s Herceptin biosimilar for clinical trials (Korea Biomedical Review) – Jul 4, 2019 – “Alteogen said that Qilu Pharmaceutical, its Chinese partner, has received investigational new drug (IND) approval for ALT-02, a Herceptin biosimilar, from the China Food and Drug Administration.”

 

Avastin (bevacizumab) / Roche; Kisqali (ribociclib) / Novartis
RIBBIT: Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line (clinicaltrials.gov) – Jul 5, 2019 – P3; N=158; Recruiting; Sponsor: iOMEDICO AG; Trial completion date: Jun 2025 –> Jun 2026; Trial primary completion date: Jun 2024 –> Jun 2025

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Weekly Top News – Breast Cancer – July 1, 2019

July 2, 2019

Nerlynx (neratinib) / Puma
Puma Biotechnology submits a Supplemental New Drug Application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Jul 1, 2019 – “Puma Biotechnology, Inc….has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) 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 treatments (third-line disease)….The sNDA is supported by the results of the Phase III NALA trial…”

 

capivasertib (AZD5363) / Otsuka, AstraZeneca
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (clinicaltrialsregister.eu) – Jun 26, 2019 – P3; N=800; Ongoing; Sponsor: AstraZeneca AB

 

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer (GlobeNewswire) – Jun 28, 2019 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®; 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.The CHMP recommendation is based on data from the Phase III IMpassion130 study…”

 

Talzenna (talazoparib) / Pfizer
Talzenna: “The Committee confirmed that all issues previously identified in this application had been addressed [treatment of adult patients with germline breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer].” (EMEA) – Jun 26, 2019 – CHMP Final Minutes for the meeting on 23-26 April 2019: “The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201 regulatory estimate: Submission for approval in HER2+ breast cancer in June-September 2019 (J.P. Morgan) – Jun 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67534138; Page no: 1; REPORT TITLE: “Daiichi Sankyo (4568): Raise price target and reiterate overweight rating “; AUTHOR: Kumagai, Naomi, et al; DATE: 06/20/2019

 

epirubicin / generics
MYELOSUPPRESSION AND MONITORING OF ABSOLUTE NEUTROPHIL COUNTS IN EPIRUBICIN/CYCLOPHOSPHAMIDE-TREATED BREAST CANCER PATIENTS: RESULTS FROM A PHASE-2A COLLABORATIVE TRIAL OF THE AGO-B AND CESAR STUDY GROUPS (MASCC-ISOO 2019) – Jun 24, 2019 – Pres time: Jun 23, 2019; 02:16 PM – 02:19 PM; Location: Station 2; “ANC monitoring may be most informative if measured on day 11 or day 12 to assess the first occurrence (incidence) and on days 13 to 15 for the presence of grade 4 neutropenia (prevalence). A reliable and early detection system for grade 4 neutropenia offers an opportunity for the instigation of preventative measures to mitigate the infection risk for patients.”

 

Zirabev (bevacizumab biosimilar) / Pfizer
Pfizer receives U.S. FDA approval for its oncology biosimilar, Zirabev (bevacizumab-bvzr) (Businesswire)- Jun 28, 2019 – “Pfizer Inc…announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer…The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of ZIRABEV to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparative study…”

 

Talzenna (talazoparib) / Pfizer; ZEN-3694 / Zenith Capital Corp
Zenith Epigenetics announces dosing of first patient in triple negative breast cancer trial with Pfizer(GlobeNewswire) – Jun 27, 2019 – “Zenith Epigenetics Ltd….announced today that it has dosed the first patient in a Phase 1b/2 clinical trial undertaken in collaboration with Pfizer Inc….The trial will evaluate the combination, safety and efficacy of the Company’s ZEN-3694, a novel and differentiated bromodomain and extra-terminal domain inhibitor (‘BETi’), and Pfizer’s talazoparib, a poly ADP ribose polymerase inhibitor (‘PARPi’), in patients with locally advanced or metastatic triple negative breast cancer without germline BRCA1/2 mutations.”

 

Minerva Biotechnologies announces FDA acceptance of IND application for huMNC2-CAR44 T cells to treat metastatic breast cancer (Businesswire) – Jun 24, 2019 – “Minerva Biotechnologies…announced today that the U.S. FDA…has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR44, an autologous CAR T cell therapy for solid tumors. huMNC2-CAR44 targets MUC1* (muk one star), a cleaved form of MUC1 present on over 75% of solid tumor cancer cells. Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7AB binds to and dimerizes its truncated extracellular domain. Minerva intends to commence clinical trials in breast cancer before the end of 2019.”

 

Arvinas receives authorization to proceed for ARV-471, a PROTAC protein degrader to treat patients with locally advanced or metastatic ER+ / HER2- breast cancer (GlobeNewswire) – Jun 25, 2019 – “Arvinas, Inc….announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for ARV-471, an oral estrogen receptor (ER) PROTAC® protein degrader, designed to selectively target ER for the treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer. Arvinas expects to initiate a Phase 1 clinical trial for ARV-471 in the third quarter of 2019.”

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Weekly Top News – Breast Cancer – June 24, 2019

June 24, 2019

docetaxel / generics; carboplatin / generics
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer (clinicaltrials.gov) – Jun 18, 2019 – P3; N=580; Recruiting; Sponsor: Shanghai Institute Of Biological Products

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201 China launch estimate: By 2021 (Deutsche Bank Research) – Jun 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458052; Page no: 1; REPORT TITLE: “China watch P322: Takeaways from ASCO – Pyrotinib, enjoy while you can”; AUTHOR: Hu, Jack, et al; DATE: 06/06/2019

 

Talzenna (talazoparib) / Pfizer
European Commission approves Talzenna (talazoparib) for patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (Businesswire) – Jun 21, 2019 – “Pfizer Inc…today announced that the European Commission approved TALZENNA®(talazoparib)…as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy…The European Commission’s approval of TALZENNA…is based on results from the EMBRACA trial…”

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from KEYNOTE-242 trial for adjuvant TNBC in 2026 or later (Merck (MSD)) – Jun 21, 2019 – Investor Day: Data from P3 KEYNOTE-630 trial (NCT03833167) for high-risk locally advanced cutaneous squamous cell carcinoma in 2026 or later

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from P3 KEYNOTE-412 trial (NCT03040999) for locally advanced HNSCC in 2023 (Merck (MSD)) – Jun 21, 2019 – Investor Day: Data from P3 KEYNOTE-756 trial (NCT03725059) for ER+/HER2- breast cancer in 2026 or later

 

HLX02 (trastuzumab biosimilar) / Fosun Pharma
European Medicines Agency accepted first “China-developed” biosimilar – Henlius HLX02 Marketing Authorization Application for review (PRNewswire) – Jun 21, 2019 – “Henlius…announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02….HLX02 is indicated for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer, HER2+ metastatic breast cancer, and untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.”

 

Halaven (eribulin mesylate) / Eisai
Eisai’s breast cancer treatment Halaven enters Peru (GBI Health) – Jun 20, 2019 – “Uruguay-based Biotoscana this week obtained clearance from Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) to market Japan-based Eisai’s microtubule inhibitor Halaven (eribulin mesylate), GBI analysis reveals. While the agency does not disclose approved indications, the drug is developed as a treatment for metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens.”

 

Rozlytrek (entrectinib) / Roche
Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek (Roche Press Release) – Jun 18, 2019 – “Roche…announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours…Rozlytrek is also undergoing regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer….The data package for this first approval of Rozlytrek includes the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, as well as data from the Phase I/II STARTRK-NG study in paediatric patients.”

 

Verzenio (abemaciclib) / Eli Lilly
proMONARCH: A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) – Jun 17, 2019 – P4; N=650; Not yet recruiting; Sponsor: Eli Lilly and Company

 

ORIN1001 / Fosun Pharma
Breast cancer drug gets FDA’s fast-track treatment (China Daily) – Jun 17, 2019 – “Shanghai Fosun Pharmaceutical Group Co Ltd announced on Sunday its experimental drug ORIN1001 has received fast-track designation from the US Food and Drug Administration for the treatment of patients with relapsed, refractory and metastatic breast cancer, including triple-negative breast cancer, or TNBC.”

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Weekly Top News – Breast Cancer – June 17, 2019

June 17, 2019

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in late 2020 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201: BLA submission for HER2 positive metastatic breast cancer previously treated with T-DM1 (based on DESTINY-Breast01 trial) in H1 FY2019 (Daiichi Sankyo) – Jun 13, 2019 – ASCO 2019: NDA submission in Japan for HER2 positive gastric cancer (based on DESTINY-Gastric01 trial) in H1 FY2020 
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Herceptin (trastuzumab) / Roche; pyrotinib (HTI-1001) / Jiangsu Hengrui Medicine
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (clinicaltrials.gov) – Jun 11, 2019 – P3; N=1192; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

 

Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, Allergan
FDA approves Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab) (PRNewswire) – Jun 13, 2019 – “Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma…Approval based on totality of evidence demonstrating Kanjinti is biosimilar to Herceptin.”

 

Ibrance (palbociclib) / Pfizer
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate (clinicaltrials.gov) – Jun 14, 2019 – P3; N=131; Completed; Sponsor: Pfizer; Active, not recruiting –> Completed

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PENELOPE-B trial (NCT01864746) for breast cancer in December 2020 and final completion of trial in November 2023 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Kisqali (ribociclib) / Novartis; Afinitor (everolimus) / Novartis
Triplet therapy confers benefit among certain patients with advanced breast cancer (Healio) – Jun 13, 2019 – P1/2, N=107; TRINITI-1 (NCT02732119); Sponsor: Novartis Pharmaceuticals; ‘”Preclinical evidence suggests that the addition of everolimus (an mTOR inhibitor) to ribociclib (a CDK4/6 inhibitor) and exemestane (an aromatase inhibitor) may restore sensitivity to both CDK4/6 inhibitor and endocrine-based therapy,’ Aditya Bardia, MD, MPH…told HemOnc Today….Ninety-five patients (median age, 58 years; 81% white) who were refractory to endocrine-based therapy and progressed after receiving CDK4/6 inhibitors were evaluable as of Oct. 24, 2018…The triplet therapy [everolimus, ribociclib and exemestane] demonstrated a clinical benefit rate of 41.1% (95% CI, 31.1-51.5) at 24 weeks, which was four times the minimum threshold for the study. The disease control rate was 61.1% (95% CI, 50.7-70.9), and the overall response rate was 8.4% (95% CI, 3.7-15.9), including one complete response and seven partial responses. Median PFS was 5.7 months (95% CI, 3.6-9.1), with a 1-year…

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in September 2020 and final completion of trial in September 2025(Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

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Weekly Top News – Breast Cancer – June 10, 2019

June 10, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: “Tecentriq + nab-paclitaxel was well tolerated, with no cumulative toxicities and no new or late-onset safety signals”; Metastatic triple negative breast cancer (Roche) – Jun 4, 2019 – ASCO 2019: “Although not formally testable due to the pre-specified statistical analysis plan, updated median OS improvement from 18 to 25 months was observed in the PD-L1+ population (HR 0.71)”  
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Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion 131 trial (NCT03125902) for 1L TNBC in H1 2020 (Cowen & Co) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67405938; Page no: 1; REPORT TITLE: “Roche Holding Ltd.- Estimates raised on higher new product sales forecasts”; AUTHOR: Scala, Stephen, et al; DATE: 05/29/2019

 

Focus V (anlotinib) / Advenchen, Sino Biopharmaceutical; Keytruda (pembrolizumab) / Merck (MSD)
Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 Antibody (clinicaltrials.gov) – Jun 5, 2019 – P2/3; N=100; Recruiting; Sponsor: Henan Cancer Hospital

 

Nerlynx (neratinib) / Puma
Puma Biotechnology presents results from phase III NALA trial of neratinib in patients with HER2-positive metastatic breast cancer at the ASCO 2019 Annual Meeting (Businesswire) – Jun 4, 2019 – P3, N=621; NALA (NCT01808573); Sponsor: Puma Biotechnology; “For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (hazard ratio=0.76, p=0.0059) compared to treatment with lapatinib plus capecitabine…For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that trended positively in favor of the neratinib plus capecitabine arm of the study (hazard ratio = 0.88, p=0.21)…Puma plans to submit its New Drug Application to the U.S. Food and Drug Administration based on the Phase III NALA trial results in the second quarter/third quarter of 2019.”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: “Margetuximab plus chemotherapy improved PFS (CBA: HR=0.76, P=0.033; Inv: HR=0.70, P=0.001), ORR, and CBR, compared with trastuzumab plus chemotherapy”; Breast cancer(Macrogenics) – Jun 5, 2019 – ASCO 2019: “Enhanced PFS benefit with margetuximab in exploratory subpopulation of low-affinity CD16A-158F carriers (HR=0.68, P=0.005)”  
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Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion 131 trial (NCT03125902) for 1L TNBC in September 2020 (Barclays) – Jun 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382590; Page no: 13; REPORT TITLE: “European Pharmaceuticals: IO: Bringing its power to bear in the realm of curative intent”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 05/24/2019

 

Kadcyla (ado-trastuzumab emtansine) / Roche; tucatinib (ARRY-380) / Seattle Genetics
A Study of Tucatinib vs. Placebo in Combination With Trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer (clinicaltrials.gov) – Jun 5, 2019 – P3; N=460; Not yet recruiting; Sponsor: Seattle Genetics, Inc.

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Regulatory approval in US for 3/4 L HER2 positive metastatic breast cancer in 2020(Macrogenics) – Jun 5, 2019 – ASCO 2019: Regulatory submission in EU in 3/4 L HER2 positive metastatic breast cancer in 2020  
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Tecentriq (atezolizumab) / Roche
Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Roche Press Release) – Jun 3, 2019 – P3, N=900; IMpassion130 (NCT02425891); Sponsor: Hoffmann-La Roche; “Data include results from the second overall survival (OS) interim analysis from the phase III IMpassion130 study evaluating Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®[paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the initial (first-line) treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)….At the second interim analysis, statistical significance was not met for overall survival (OS) in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078).”

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Weekly Top News – Breast Cancer – June 3, 2019

June 3, 2019

letrozole / generics
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov) – May 29, 2019 – P3; N=426; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

 

Keytruda (pembrolizumab) / Merck (MSD)
Imprime PGG + Keytruda: “Imprime PGG in combination with pembrolizumab shows promising clinical benefit in previously-treated, metastatic TNBC patients”; Triple negative breast cancer (Biothera) – Jun 2, 2019 – ASCO 2019: “Clinical response is evident as early as 6 weeks on treatment”  

 

 

Ibrance (palbociclib) / Pfizer
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer (clinicaltrials.gov) – May 31, 2019 – P3; N=200; Not yet recruiting; Sponsor: Kyoto Breast Cancer Research Network

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in Q4 2019 (Barclays) – Jun 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382590; Page no: 33; REPORT TITLE: “European Pharmaceuticals: IO: Bringing its power to bear in the realm of curative intent”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 05/24/2019

 

Hervelous (trastuzumab biosimilar) / Alvogen, Prestige BioPharma Pte Ltd, Hanwha Chem
European Medicines Agency accepts Marketing Authorisation Application for Prestige BioPharma’s trastuzumab biosimilar HD201 for review (PharmiWeb) – May 28, 2019 – “Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue®). HD201…is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma….positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.”

 

Kisqali (ribociclib) / Novartis
Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial (GlobeNewswire) – Jun 1, 2019 – P3, N=672; MONALEESA-7 (NCT02278120); Sponsor: Novartis Pharmaceuticals; “The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy…as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer…The significant extension in survival met the early efficacy stopping criteria at a pre-specified interim analysis following 192 deaths (median OS, not reached vs. 40.9 [95% CI: 37.8-NE] months; HR=0.712 [0.535-0.948]; p=0.00973). Overall survival rates in the intent-to-treat population (n=672) at 42 months were 70.2% for Kisqali combination therapy compared to 46.0% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment. No new safety signals were observed.”

 

Halaven (eribulin mesylate) / Eisai
New study investigating Halaven (eribulin) in metastatic breast cancer (Pharmafield) – May 31, 2019 – “Eisai Europe Ltd and MedSIR have announced a new study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer (MBC)…The REVERT study will investigate the clinical activity of Halaven® (eribulin) in MBC and will investigate the efficacy of a combined endocrine-chemotherapy therapeutic approach in the condition….The first data readout from the REVERT study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer is estimated to be in late 2021.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology presents interim results of phase II CONTROL trial of neratinib in extended adjuvant treatment of HER2-positive early stage breast cancer at the ASCO 2019 Annual Meeting (Businesswire) – Jun 2, 2019 – P2, N=137; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “The results of the trial showed that the incidence of grade 3 diarrhea for the 137 patients who received the loperamide prophylaxis was 30.7% and that for the 137 patients in this cohort, 20.4% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 3 days. For the 64 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 28.1% and that for the 64 patients in this cohort, 10.9% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 2.5 days.”

 

Kisqali (ribociclib) / Novartis
BioItaLEE: Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole(clinicaltrials.gov) – May 28, 2019 – P3; N=287; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting –> Active, not recruiting; Trial completion date: Oct 2021 –> Nov 2022; Trial primary completion date: Oct 2021 –> Dec 2020

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Weekly Top News – Breast Cancer – May 27, 2019

May 27, 2019

etrasimod (APD334) / Arena
Etrasimod: “Etrasimod 2 mg induced significantly higher rates of endoscopic improvement, histologic improvement and remission, and mucosal healing”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
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etrasimod (APD334) / Arena
Etrasimod: “Patients who received etrasimod 2 mg exhibited significant decreases in both fecal calprotectin and C-reactive protein versus placebo”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019

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brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrials.gov) – May 23, 2019 – P3; N=1000; Not yet recruiting; Sponsor: Allergan

 

Entyvio (vedolizumab) / Takeda
Entyvio (vedolizumab) approved in Japan for the treatment of patients with moderately to severely active Crohn’s disease (Takeda Press Release) – May 22, 2019 – “Takeda…announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Entyvio…for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan.”

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

mirikizumab (LY3074828) / Eli Lilly
Lilly’s mirikizumab met primary endpoint and key secondary endpoints in phase 2 study, including reductions of gastrointestinal lesions (PRNewswire) – May 21, 2019 – P2, N=180; SERENITY (NCT02891226); Sponsor: Eli Lilly; “Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing….We look forward to initiating Phase 3 trials to further evaluate mirikizumab’s benefit-risk profile for the treatment of Crohn’s disease.”

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P3; N=372; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

 

mirikizumab (LY3074828) / Eli Lilly
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P2; N=240; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
EU regulators slap safety restriction on Pfizer’s Xeljanz (pharmaphorum) – May 20, 2019 – “European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.”

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Weekly Top News – Breast Cancer – May 20, 2019

May 20, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo; capivasertib (AZD5363) / Otsuka, AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca; Imfinzi (durvalumab) / AstraZeneca, Celgene; Faslodex (fulvestrant) / AstraZeneca
AstraZeneca continues to redefine cancer treatment at the 2019 ASCO Annual Meeting (AstraZeneca Press Release) – May 16, 2019 – “AstraZeneca will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 31 May to 4 June 2019….In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers.”

 

Verzenio (abemaciclib) / Eli Lilly
Serious side effects of cancer drug Verzenio suspected in Japan (The Mainichi Daily News) – May 17, 2019 – “Japan’s health ministry Friday warned medical personnel of a potential side effect of breast cancer drug Verzenio on the lungs after 14 patients in the country taking the drug developed a serious lung disease and three of them died…Of the 14 cases, the drug’s adverse effects were suspected in at least four of them including one that died, according to the ministry.”

 

Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
Nab-Paclitaxel improves disease-free survival in early breast cancer: GBG 69–GeparSepto (J Clin Oncol) – May 13, 2019 – P3, N=1,200; GeparSepto (NCT01583426); “At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m2 compared with NAB-paclitaxel 150 mg/m2.”

 

Kisqali (ribociclib) / Novartis; capmatinib (INC280) / Incyte, Novartis
Novartis data at ASCO and EHA demonstrate novel approaches to reimagining medicine in cancer and serious blood disorders (PRNewswire) – May 16, 2019 – P3, N=672; MONALEESA-7 (NCT02278120); P2, N=364; GEOMETRY mono-1 (NCT02414139); Sponsor: Novartis Pharmaceuticals; “Overall survival results from MONALEESA-7 with Kisqali (ribociclib) plus endocrine therapy in premenopausal women with HR+/HER2- advanced breast cancer, to be presented at ASCO. Primary results of GEOMETRY study for capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC) at ASCO”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to present clinical data from phase 2 triple negative breast cancer study at ASCO 2019 Annual Meeting (Biothera Press Release) – May 16, 2019 – P2, N=64; NCT02981303; Sponsor: Biothera Pharmaceuticals; “Biothera Pharmaceuticals…announced today that it will present primary clinical data from its phase 2 study in chemo-refractory metastatic triple negative breast cancer at the American Society of Clinical Oncology (ASCO) 2019 annual meeting, May 31-June 4 in Chicago. The study is evaluating Imprime PGG in combination with KEYTRUDA (pembrolizumab)…in triple negative breast cancer patients whose disease has progressed following treatment with one or more lines of chemotherapy for metastatic disease.”

 

ME-344 / MEI; Avastin (bevacizumab) / Roche
MEI Pharma to present new clinical results on ME-401 and ME-344 programs at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (MEI Pharma Press Release) – May 15, 2019 – “Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and complete results from the investigator-initiated study of ME-344 in combination with Avastin® in patients with HER2-negative breast cancer…The company also announced that an abstract on the PI3Kδ inhibitor ME-401 was selected for an oral presentation at the 15th International Conference on Malignant Lymphoma (15-ICML)….The abstract relates to updated data from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma, both as a monotherapy and in combination with rituximab.”

 

Verzenio (abemaciclib) / Eli Lilly
New cancer drugs approved for NHS use in Scotland (Belfast Telegraph) – May 13, 2019 – “The Scottish Medicines Consortium (SMC) has accepted Abemaciclib (Vernezios), a drug that can prolong the time breast cancer takes to progress and delay the need for chemotherapy, allowing patients more quality time with their family…The decision on Abemaciclib (Vernezios) was welcomed by Health Secretary Jeane Freeman.”

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche
MacroGenics Announces Positive Results from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer (GlobeNewswire, MacroGenics, Inc.) – May 15, 2019 – P3, N=530; SOPHIA (NCT02492711); Sponsor: MacroGenics; “The study met its first sequential primary endpoint of progression-free survival (PFS). The median PFS of patients treated with margetuximab and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy (hazard ratio [HR]=0.76; 95% CI: 0.59-0.98; P=0.033). Among the approximately 85% of patients carrying the CD16A 158F allele, a pre-specified exploratory subpopulation in the study, PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months; HR=0.68; 95% CI: 0.52-0.90; P=0.005). The objective response rate (ORR), a secondary outcome measure in the SOPHIA study, was 22% in the margetuximab arm (95% CI: 17.3-27.7%) compared to 16% in the trastuzumab arm (95% CI: 11.8-21.0%). The data cut-off date for the primary PFS analysis of the study was October 10, 2018.”

 

Nerlynx (neratinib) / Puma; Tykerb (lapatinib) / Novartis
Puma’s Nerlynx edges out Novartis’ Tykerb in late-stage breast cancer study (SeekingAlpha) – May 16, 2019 – P3, N=621; NALA (NCT01808573); Sponsor: Puma Biotechnology, Inc; “Results from a Phase 3 clinical trial, NALA, evaluating Puma Biotechnology’s (PBYI +3.2%) Nerlynx (neratinib) + Roche chemo agent Xeloda (capecitabine) (N + C) compared to Novartis’ (NVS +1.6%) Tykerb (lapatinib) + Xeloda (L + C) showed a treatment advantage…The overall response rate (ORR) in patients with measurable disease at study entry in the N + C arm was 33% but the difference (27% in the L + C arm) was not statistically significant….On the safety front, the incidences of treatment-related adverse events were comparable, although the rate of serious (Grade 3) diarrhea was 24% in the N + C group versus 13% in the L + C group.”

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