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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