Weekly Top News – Breast Cancer – November 11, 2019

November 11, 2019

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
EL1SSAR: A Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) – Nov 5, 2019 – P3; N=280; Not yet recruiting; Sponsor: Hoffmann-La Roche


margetuximab (MGAH 22) / MacroGenics
Margetuximab: Second interim OS data from P3 SOPHIA trial (NCT02492711) in HER2+ metastatic breast cancer at SABCS (Dec 10- 14, 2019) (Macrogenics) – Nov 9, 2019 – Corporate Presentation 


llllllllll entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Launch in US for breast cancer in 2021 (Syndax) – Nov 11, 2019 – Q3 2019 Results
Launch US

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports third quarter 2019 financial results and provides clinical and business update (PRNewswire) – Nov 7, 2019 – P3, N=600; E2112 (NCT02115282); P1/2, N=132; AUGMENT-101 (NCT04065399); Sponsor: Syndax Pharmaceuticals; “Pipeline updates: (i) Entinostat: E2112 trial passed final interim OS analysis; trial continues, with final OS analysis expected in 2Q20; (ii) SNDX-5613: The Company expects to report initial clinical data from the…phase 1/2 open-label AUGMENT-101 trial…in 2020.”


Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC at year end 2020 (Jones Trading) – Nov 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 68239157; Page no: 1; REPORT TITLE: “Infinity Pharmaceuticals, Inc.-3Q19 — Reiterating BUY & $3.50 PT. Mature phase 1b data potentially in mid/3Q20 likely to provide mechanistic insight; Phase 2 MARIO-3 data at YE20-10/31/2019 “; AUTHOR: Roy, Soumit, et al; DATE: 10/31/2019


Keytruda (pembrolizumab) / Merck (MSD)
Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) – Nov 5, 2019 – P1/2; N=220; Not yet recruiting; Sponsor: Dragonfly Therapeutics


Verzenio (abemaciclib) / Eli Lilly
COFEPRIS clears Eli Lilly’s onco drug Verzenio for Mexico market (GBI Health) – Nov 4, 2019 – “Eli Lilly last week announced the receipt of a marketing approval from Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) for its anti-cancer treatment Verzenio (abemaciclib). The oral drug is indicated as part of a first- or second-line combination therapy against hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.”


Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to Present Immune Pharmacodynamic Data (IPD) Showing Immune Activation in Phase 2 Melanoma and Triple Negative Breast Cancer Study (GlobeNewswire, Biothera Pharmaceuticals, Inc.) – Nov 8, 2019 – P2, N=164; NCT02981303; Sponsor: Biothera; “In three previous mTNBC studies, CPI monotherapies resulted in a disease control rate of 7-10% (CR +PR+ SD >24 weeks), median overall survival (mOS) of 7-9 months and a 12-month OS of 37-40%. Primary data from the 44-patient Phase 2 study evaluating Imprime PGG and KEYTRUDA show a disease control rate of 25% (N= 11; 1 CR, 6 PR and 4 SD>24 weeks), mOS of 16.4 months and 12-month OS rate of 57.6%….Similar results were observed in the melanoma arm of the study, which tested the combination of Imprime PGG and KEYTRUDA in heavily CPI pre-treated melanoma patients (20 patients; 13/20 had ³2 prior CPI regimens and 17/20 had progressed on pembrolizumab). The disease control rate was 50% (1 CR and 9 SD as best response), 12-month OS rate was 45%.”


Lynparza (olaparib) / Merck (MSD), AstraZeneca; Kisqali (ribociclib) / Novartis; veliparib (ABT-888) / AbbVie; Verzenio (abemaciclib) / Eli Lilly; Keytruda (pembrolizumab) / Merck (MSD); Zejula (niraparib) / GSK, J&J, Takeda
2019 Post European Society for Medical Oncology (ESMO) Report: Highlights from ESMO 2019 Congress – ResearchAndMarkets.com (Businesswire) – Nov 4, 2019 – “Conference highlights included new data from PARP inhibitors in ovarian cancer, such as Zejula, Lynparza and veliparib, as well as a follow-up update for KRAS-targeted drug AMG 510 for colorectal cancer, and CDK4/6-inhibitors, Kisqali and Verzenio, for breast cancer. Key pipeline updates for more established drugs were highly featured including Keytruda for non-small lung cancer and Kisqali for breast cancer.”


Nerlynx (neratinib) / Puma
CANbridge receives Hong Kong Department of Health market approval for Nerlynx (Businesswire) – Nov 5, 2019 – “CANbridge Pharmaceuticals Inc….announced that it received market approval from the Department of Health in Hong Kong for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early‑stage hormone receptor positive HER2-overexpressed/amplified breast cancer, and who completed adjuvant trastuzumab-based therapy less than one year ago.”

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