Weekly Top News – Breast Cancer – October 14, 2019

October 14, 2019

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax’s entinostat advances in late-stage breast cancer study (SeekingAlpha) – Oct 7, 2019 – “Syndax Pharmaceuticals…announces the fifth and final successful interim futility analysis of survival data in the Cancer Research Group-sponsored Phase 3 clinical trial, E2112, evaluating the combination of lead drug entinostat and exemestane (Pfizer’s Aromasin) in patients with advanced HR+/HER2- breast cancer. The study will continue until 410 of the 608 participants have died, currently expected to occur in Q2 2020. If all goes well, the company expects to file a U.S. marketing application in late 2020.”


Kisqali (ribociclib) / Novartis
Kisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 


Piqray (alpelisib) / Novartis
Piqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 


Tecentriq (atezolizumab) / Roche
Roche’s atezolizumab is first breast cancer immunotherapy in Argentina (GBI Health) – Oct 12, 2019 – “Switzerland-based Roche has obtained an indication extension approval from Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) for its immuno-oncology product Tecentriq (atezolizumab) in combination with nab-paclitaxel or paclitaxel to treat triple negative breast cancer. The monoclonal antibody (mAb) was originally indicated against urothelial carcinoma (UC) and metastatic non-small cell lung cancer (NSCLC).”


triptorelin / Generic Mfg.; Xtandi (enzalutamide) / Pfizer, Astellas; pertuzumab/trastuzumab (RG6264) / Roche; Keytruda (pembrolizumab) / Merck (MSD)
SMC accepts lymphoma, lung cancer treatments in latest meeting (PharmaTimes) – Oct 8, 2019 – “In the latest Scottish Medicines Consortium (SMC) meeting, the committee has recommended four new medicines and rejected two…Among the positive opinions are Kite pharma’s Yescarta (axicabtagene ciloleucel), MSD’s cancer blockbuster Keytruda (pembrolizumab), Decapeptyl SR (triptorelin acetate)…Keytruda was approved for metastatic non-squamous non-small cell lung cancer (NSCLC), also through the PACE process…The committee also accepted Decapeptyl for the treatment of early stage breast cancer….On top of the four acceptances, the committee rejected Perjeta (pertuzumab) and Xtandi (enzalutamide) for the treatment of early stage breast cancer and prostate cancer, respectively.”


Zejula (niraparib) / GSK, J&J, Takeda
Clovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) – Oct 14, 2019 – “NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF.”


Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: CHF3,683M in 2023 (Deutsche Bank Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68025177; Page no: 2; REPORT TITLE: “Roche Holding ltd- Roche: ESMO feedback: IMpowering the Tecentriq brand”; AUTHOR: Parkes, Richard, et al; DATE: 09/30/2019


AVID100 / Formation Biologics
Forbius: phase 2 clinical data with tumor-selective anti-EGFR ADC AVID100 featured at AACR-NCI-EORTC and World ADC San Diego (Businesswire) – Oct 10, 2019 – “Forbius…will today present the first clinical data from its Phase 2 development program with novel, tumor-selective anti-EGFR ADC AVID100 at the 10th Annual World ADC in San Diego (Oct. 8 – 11). AVID100 clinical data will also be featured in an upcoming poster presentation at the AACR-NCI-EORTC meeting in Boston (Oct. 26 – 30).”


margetuximab (MGAH 22) / MacroGenics
Margetuximab sales projection: $300-400M peak for 3L HER2+ breast cancer setting (Cowen & Co) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67965816; Page no: 2377; REPORT TITLE: “Biotechnology quarterly”; AUTHOR: Cowen Biotechnology Team, et al; DATE: 09/16/2019


Ibrance (palbociclib) / Pfizer
Ibrance sales projection: $8.7B in 2023 (Infinata) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 1; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

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