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Category: Breast Cancer

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

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Weekly Top News – Breast Cancer – September 2, 2019

September 2, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion030 trial (NCT03498716) for TNBC in 2022 (Credit Suisse) – Aug 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 11; REPORT TITLE: “Adjuvant immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma Team, European, et al; DATE: 08/19/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in December 2019 (Credit Suisse) – Aug 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 11; REPORT TITLE: “Adjuvant immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma Team, European, et al; DATE: 08/19/2019

 

Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka; Tecentriq (atezolizumab) / Roche
European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer (Roche Press Release) – Aug 29, 2019 – “Roche…announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); 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….Approval based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in people with PD-L1-positive metastatic triple-negative breast cancer.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Chugai files for additional indication for anti-HER2 antibody drug conjugate Kadcyla for adjuvant therapy of HER2-positive early breast cancer (Chugai Press Release) – Aug 30, 2019 – “Chugai Pharmaceutical Co., Ltd…announced…that it has filed an application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for an additional indication for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla® (generic name: trastuzumab emtansine), as adjuvant therapy in patients with HER2-positive early breast cancer….This application is based on results from an open-label, randomized, global phase III clinical study (the KATHERINE study), evaluating efficacy and safety of Kadcyla adjuvant therapy compared to Herceptin in almost 1,500 people with HER2-positive early breast cancer who had invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy including Herceptin.”

 

Bavencio (avelumab) / EMD Serono, Pfizer
Bavencio clinical trial estimate: Data from P3 A-Brave trial (NCT02926196) for TNBC in mid-2021 – Aug 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 13; REPORT TITLE: “Adjuvant Immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma team, European, et al; DATE: 08/19/2019

 

Tecentriq (atezolizumab) / Roche
Roche launches VENTANA PD-L1 (SP142) assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq (Roche Press Release) – Aug 29, 2019 – “Roche…announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine Tecentriq® is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab)5 plus chemotherapy (nab-paclitaxel).”

 

Talzenna (talazoparib) / Pfizer
Pfizer wastes no time to launch Talzenna in Argentina (GBI Health) – Aug 28, 2019 – “Pharmaceutical major Pfizer this week launched its anti-breast cancer PARP inhibitor Talzenna (talazoparib) to the Argentina market, less than a month after its approval was published by the National Administration of Drugs, Foods and Medical Devices (ANMAT), as GBI reported. The drug was shown in the Phase III EMBRACA clinical trial to stop disease progression in 63% of patients with BRCA-mutated (gBRCAm) breast cancer versus only 27% in the chemotherapy control group, while increasing progression-free survival (PFS) to 8.6 months compared to 5.6 months in the control arm.”

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Weekly Top News – Breast Cancer – August 26, 2019

August 26, 2019

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-756 trial (NCT03725059) for ER+/HER2- breast cancer in 2031 (Credit Suisse) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 18; REPORT TITLE: “Adjuvant Immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma Team, European, et al; DATE: 08/19/2019

 

Verzenio (abemaciclib) / Eli Lilly; Imfinzi (durvalumab) / AstraZeneca, Celgene
More cancer meds added to Dutch basic health insurance package (NL Times) – Aug 20, 2019 – “From September 1st the medicines durvalumab and abemaciclib will be covered by the basic health insurance package, Minister Bruno Bruins of Medical Care announced. Durvalumab is used to treat a specific form of lung cancer, abemaciclib is an approved treatment for certain forms of breast cancer.”

 

Perjeta (pertuzumab) / Roche
Roche’s Perjeta nails new indication approval in China (GBI Health) – Aug 21, 2019 – “Switzerland-based giant Roche announced a new indication approval from China’s National Medical Products Administration (NMPA) in relation to Perjeta (pertuzumab). The drug will be used in combination with sister product Herceptin (trastuzumab) and chemotherapy as an adjuvant therapy for the treatment of patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (>2 cm in diameter or positive for lymph nodes).”

 

Trazimera (trastuzumab biosimilar) / Pfizer
Pfizer launches Herceptin biosimilar in Japan (Pharma Japan) – Aug 23, 2019 – “Pfizer Japan said…that its biosimilar version of the major cancer drug Herceptin (trastuzumab) is now available with the exact same indications and dosing schedules as Chugai Pharmaceutical’s originator product.”

 

Versavo (bevacizumab biosimilar) / Dr. Reddy’s
Dr. Reddy’s Laboratories announces the launch of Versavo (bevacizumab biosimilar) in India(Businesswire) – Aug 19, 2019 – “Dr. Reddy’s Laboratories Ltd…announced…that it has launched Versavo® (bevacizumab), a biosimilar of Roche’s Avastin® in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer).”

 

Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, Teva
Japan gives further nod to Celltrion’s breast cancer biosimilar (Korea Biomedical Review) – Aug 22, 2019 – “Celltrion Healthcare said that Japan’s Ministry of Health, Labour and Welfare has approved a three-week cycle method for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast cancer.”

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Weekly Top News – Breast Cancer – August 12, 2019

August 12, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio (abemaciclib) available in Canada for metastatic breast cancer (Canada Newswire) – Aug 8, 2019 – “Eli Lilly Canada Inc…is pleased to announce the availability of VERZENIO™ (abemaciclib). VERZENIO is indicated for the treatment of estrogen and/or progesterone hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC)….The approval of VERZENIO is based on the efficacy and safety demonstrated in the pivotal MONARCH 3, MONARCH 2 and MONARCH 1 clinical trials.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Roche wins additional indication for breast cancer treatment Kadcyla (Korea Biomedical Review) – Aug 12, 2019 – “Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety…hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy…The ministry approved the expanded indication after Roche confirmed the treatment’s efficacy through a global phase 3 KATHERINE clinical trial…”

 

Herceptin (trastuzumab) / Roche; Nerlynx (neratinib) / Puma
New early breast cancer option recommended by NICE (PharmaTimes) – Aug 7, 2019 – “The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Pierre Fabre’s Nerlynx (neratinib) as an additional treatment for some people with early hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer….The governing body announced that the drug is only recommended provided that Herceptin (trastuzumab) is the only HER2-directed adjuvant treatment people have had.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission in combination with exemestane for HR+ metastatic breast cancer in 2020 (Syndax) – Aug 8, 2019 – Q2 2019 Results  
[Screenshot]

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports second quarter 2019 financial results and provides clinical and business update (PRNewswire) – Aug 7, 2019 – “…’We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the FDA and take us one step closer to improving outcomes for patients with this difficult to treat disease’.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports second quarter 2019 financial results (Businesswire) – Aug 8, 2019 – P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries’.”

 

Nerlynx (neratinib) / Puma
Knight Therapeutics Reports Second Quarter 2019 Results (GlobeNewswire, Knight Therapeutics)- Aug 8, 2019 – Received regulatory approval from Health Canada for NERLYNX® for the treatment of HER2-positive breast cancer. Reached an agreement with the pan-Canadian Pharmaceutical Alliance (“pCPA”) regarding Probuphine® and to date have obtained reimbursement through public insurance plans administered by Alberta, Saskatchewan and the Non-insured Health Benefit Program (“NIHB”). We have advanced our commercial presence and product pipeline with the regulatory approval of NERLYNX® and the submission of Ibsrela™…Knight plans to launch NERLYNX® in late 2019.

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Primary completion of P3 IMpassion030 trial (NCT03498716) for TNBC on January 15, 2022 (Barclays) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67703402; Page no: 1; REPORT TITLE: “Roche Holding Ltd: ROG: (neo)adjuvant TNBC: Beaten to the punch…”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 07/29/2019

 

EDP1503 / Evelo Biosci; Keytruda (pembrolizumab) / Merck (MSD)
Evelo Biosciences announces positive interim phase 1b clinical data and provides second quarter 2019 financial results (GlobeNewswire) – Aug 6, 2019 – “Oncology: Clinical Studies and Anticipated Milestones – EDP1503 – Phase 1/2; Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.”

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Weekly Top News – Breast Cancer – August 5, 2019

August 5, 2019

Kisqali (ribociclib) / Novartis
Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct phase III trials (GlobeNewswire) – Jul 31, 2019 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “Novartis today announced Kisqali®(ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial. 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 in both the first-line and second-line settings….No new safety signals were observed; adverse events were consistent with previously reported Phase III trial results.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Regulatory submission in EU for HER2 positive breast cancer in Q1 FY 2020 (Daiichi Sankyo) – Aug 1, 2019 – Q1 FY 2019 Results: Regulatory submission in Japan for HER2 positive gastric cancer in Q1 FY 2020

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) in combination with chemotherapy met primary endpoint of pathological complete response (pCR) in pivotal phase 3 KEYNOTE-522 trial in patients with triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) – Jul 29, 2019 – P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck; “Merck…announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly’s Verzenio (abemaciclib) significantly extended life in women with HR+, HER2- advanced breast cancer in MONARCH 2 (Eli Lilly Press Release) – Jul 30, 2019 – P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly and Company; “The analysis showed that treatment with Verzenio in combination with fulvestrant met its secondary endpoint of overall survival. The MONARCH 2 study previously demonstrated a statistically significant improvement in progression-free survival, the trial’s primary endpoint which served as the basis for its approval of this regimen in more than 50 countries around the world. No new safety signals were observed in this analysis of MONARCH 2, consistent with the established safety profile of Verzenio…. Lilly plans to submit these data to regulatory authorities and present the detailed data at an upcoming medical meeting later this year.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: OS data from P3 MONARCH-2 trial (NCT02107703) in HER2- breast cancer in 2020 (Eli Lilly) – Jul 31, 2019 – Q2 2019 Results

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
KHK2375: Completion of P2 trial (NCT03291886) for advanced or recurrent hormone receptor-positive breast cancer in November 2021 (Kyowa Hakko Kirin Pharma) – Aug 2, 2019 – Q2 2019 Results

 

 

Tecentriq (atezolizumab) / Roche; Avastin (bevacizumab) / Roche; Opdivo (nivolumab) / Ono Pharma, BMS; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals provides company update and second quarter 2019 financial results(PRNewswire) – Jul 30, 2019 – “Recent developments include: MARIO-3 Initiating in Q3 – This Phase 2 study in collaboration with Roche/Genentech will evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in TNBC and with Tecentriq and Avastin® in RCC; Arcus Biosciences Collaboration Study Initiating in Q3 – This Phase 1 trial, to be conducted by Arcus, will evaluate a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil® in advanced TNBC patients; Completing MARIO-1 by year end – Infinity anticipates completing enrollment in the second half of 2019 in the expanded combination cohorts in MARIO-1, the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in approximately 225 patients with advanced solid tumors.”

 

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from early P1 trial (NCT03599453) in combination with Ampligen, Intron A and celecoxib for TNBC by 2020 (GlobalData) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67689228; Page no: 176; REPORT TITLE: “Hemispherx Biopharma Inc (HEB) – Financial and strategic SWOT analysis Review”; AUTHOR: GlobalData; DATE: 08/01/2019

 

Ogivri (trastuzumab biosimilar) / Biocon, Mylan
Mylan, Biocon launch biosimilar of cancer drug Herceptin in Australia (Bloomberg Quint) – Aug 1, 2019 – “Biocon Ltd. and Mylan NV on Thursday launched Ogivri, used for treatment of certain breast and stomach cancers, in Australia. It is a biosimilar of Hoffmann-La Roche’s Herceptin.”

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Weekly Top News – Breast Cancer – July 29, 2019

July 30, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory approval in combination with nab-paclitaxel in EU and Japan for 1L TNBC in 2019 (Roche) – Jul 26, 2019 – H1 2019 Results: Regulatory approval in combination with nab-paclitaxel in US and EU for 1L non sq NSCLC in 2019  
[Screenshot]

 

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer
A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial) (ID 4733) (ESMO 2019) – Jul 26, 2019 – Abstract #198P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
Ribociclib (RIB) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) and central nervous system (CNS) metastases: Subgroup analysis from the phase 3b CompLEEment-1 trial (ID 4024) (ESMO 2019) – Jul 26, 2019 – Abstract #333P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

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 (ID 1370) (ESMO 2019) – Jul 26, 2019 – Abstract #336P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Tecentriq (atezolizumab) / Roche
ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer. (ID 4334) (ESMO 2019) – Jul 26, 2019 – Abstract #289TiP; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
First Canadian Interim Analysis from the Phase IIIb CompLEEment-1 Ribociclib + Letrozole HR+ HER2- Advanced Breast Cancer Trial (ID 1109) (ESMO 2019) – Jul 26, 2019 – Abstract #337P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) in combination with chemotherapy met primary endpoint of pathological complete response (pCR) in pivotal phase 3 KEYNOTE-522 trial in patients with triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) – Jul 29, 2019 – P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck; “Merck…announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Faslodex (fulvestrant) / AstraZeneca;Imfinzi (durvalumab) / AstraZeneca, Celgene
H1 2019 Results (AstraZeneca Press Release) – Jul 25, 2019 – “Tagrisso sales of $1,414m, representing growth of 86% in the half (92% at CER) that was driven by 2018 regulatory approvals in the 1st-line EGFR7 -mutated (EGFRm) NSCLC8 setting…Imfinzi sales of $633m, representing growth of 244% (248% at CER)…Lynparza sales of $520m, representing growth of 93% (100% at CER), driven by expanded use in the treatment of ovarian and breast cancer in the US and Europe…The performance from more-mature Oncology medicines in the half included Faslodex growth of 4% (8% at CER) to $521m and an 8% decline in Iressa sales (3% at CER) to $252m…Pipeline: anticipated major news flow – H2 2019 – Tagrisso – NSCLC (1st line, EGFRm): regulatory decision (CN)…”

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Weekly Top News – Breast Cancer – 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

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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