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Weekly Top News – Breast Cancer – October 28, 2019

October 28, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in Japan for ovarian cancer, muscle-invasive urothelial cancer (adjuvant) and hepatocellular cancer in 2020 (Chugai) – Oct 25, 2019 – Q3 2019 Results: Regulatory submissions in Japan for early breast cancer and NSCLC (neoadjuvant) in 2021 
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Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi: P2 data from P1/2 BEGONIA trial (NCT03742102) for 1L metastatic TNBC in H2 2020 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P1/2 STUDY 1108 (NCT01693562) in advanced solid tumors in H2 2019 
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Piqray (alpelisib) / Novartis
Piqray: CHMP opinion in EU for breast cancer in H1 2020 (Novartis) – Oct 22, 2019 – Q3 2019 Results 
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[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data from P3 DESTINY-Breast02 trial (NCT03523585) for pre-treated HER2 breast cancer in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive, unresectable and/or metastatic breast cancer in 2021 
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[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data from P3 DESTINY-Breast04 trial (NCT03734029) for HER2-low, unresectable and/or metastatic breast cancer in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P2 DESTINY-Gastric01 trial (NCT03329690) for HER2-overexpressing advanced gastric cancer in H1 2020 
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Kisqali (ribociclib) / Novartis
Kisqali: Regulatory submission for HR+, HER2(-) breast cancer (adjuvant) in 2023 or later (Novartis) – Oct 22, 2019 – Q3 2019 Results 
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[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Acceptance of regulatory submission for pre-treated HER2 breast cancer (based on DESTINY-Breast02 trial) in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Acceptance of regulatory submission for HER2-positive/negative unresectable and/or metastatic breast cancer (based on DESTINY-Breast03, DESTINY-Breast04 trial) in 2021 or later 
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margetuximab (MGAH 22) / MacroGenics
MacroGenics Announces Second Interim Overall Survival Data from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer (GlobeNewswire, MacroGenics, Inc.) – Oct 22, 2019 – P3, N=624; SOPHIA (NCT02492711); Sponsor: MacroGenics; “Among the approximately 85% of patients carrying a CD16A 158F allele, the median OS was prolonged by 4.3 months in the margetuximab arm compared to the trastuzumab arm (23.7 months versus 19.4 months; HR=0.793; 95% CI: 0.607-1.035; p=0.087). Among the approximately 15% of patients who were homozygous for the CD16A 158V allele, the trastuzumab arm performed better than the margetuximab arm. The final pre-specified OS analysis is planned after 385 events have accrued, which is projected to occur in 2020. The first sequential primary endpoint of progression-free survival (PFS) in the ITT population was achieved, with statistical significance as previously reported.”

 

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

 

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

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