Weekly Top News – Breast Cancer– January 13, 2020

January 13, 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu now available in U.S. for HER2 positive unresectable or metastatic breast cancer following two or more prior anti-HER2-based regimens (Businesswire) – Jan 6, 2020 – “Daiichi Sankyo Company, Limited…announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S….ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.”


margetuximab (MGAH 22) / MacroGenics
MacroGenics outlines corporate priorities for 2020 (GlobeNewswire, MacroGenics, Inc.) – Jan 9, 2020 – “Pending acceptance and review of the BLA submitted in December 2019 to the Food and Drug Administration (FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenics expects a Standard Review process in which the FDA will likely require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020…Initial safety and efficacy data are expected in the second half of 2020 from Module A of…phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer.”


letrozole / Generic mfg.; Kisqali (ribociclib) / Novartis
CompLEEment-1: Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC (clinicaltrials.gov) – Jan 8, 2020 – P3; N=3775; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial completion date: May 2021 –> Nov 2019


ZW25 / Zymeworks; Ibrance (palbociclib) / Pfizer
Zymeworks announces agreement with Pfizer and initiation of a new phase 2 trial evaluating ZW25 in combination with Ibrance (palbociclib) (Businesswire) – Jan 12, 2020 – “Zymeworks Inc….announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib….The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned….Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.”


Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer; GDC-0077 / Roche
A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) – Jan 9, 2020 – P3; N=400; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting –> Recruiting


entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals highlights 2020 clinical and corporate outlook (Syndax Press Release) – Jan 10, 2020 – “The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis…Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020.”


Verzenio (abemaciclib) / Eli Lilly
GSK’s Dovato, Sandoz’s Rixathon enter LatAm in Chile, Eli Lilly’s Verzenio tags along (GBI Health) – Jan 9, 2020 – “GBI analysis reveals that Chile’s Institute of Public Health (ISP) recently approved GlaxoSmithKline (GSK)’s antiretroviral Dovato (dolutegravir + lamivudine), Eli Lilly’s CDK4/CDK6 kinase inhibitor Verzenio (abemaciclib), and Novartis subsidiary Sandoz’s biosimilar Rixathon (rituximab). Dovato is indicated to treat HIV-1 infection, while Verzenio is approved for HR+/HER2- advanced or metastatic breast cancer, and Rixathon is used against granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), in addition to the indications approved for Roche’s originator MabThera, namely non-Hodgkin’s lymphoma (NHL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).”


Halaven (eribulin mesylate) / Eisai
Launch of anticancer agent Halaven in China (Eisai Press Release) – Jan 10, 2020 – “Eisai Co., Ltd…announced today that it has launched the in-house developed anticancer agent Halaven(R) (generic name: eribulin mesylate) in China…In a Phase III clinical study (EMBRACE) of Halaven versus treatment of physician’s choice (TPC) in 762 patients with advanced or recurrent breast cancer previously treated with an anthracycline and a taxane, Halaven showed an extended overall survival compared to TPC.”

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