Weekly Top News – Breast Cancer – August 12, 2019

August 12, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio (abemaciclib) available in Canada for metastatic breast cancer (Canada Newswire) – Aug 8, 2019 – “Eli Lilly Canada Inc…is pleased to announce the availability of VERZENIO™ (abemaciclib). VERZENIO is indicated for the treatment of estrogen and/or progesterone hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC)….The approval of VERZENIO is based on the efficacy and safety demonstrated in the pivotal MONARCH 3, MONARCH 2 and MONARCH 1 clinical trials.”


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019


Kadcyla (ado-trastuzumab emtansine) / Roche
Roche wins additional indication for breast cancer treatment Kadcyla (Korea Biomedical Review) – Aug 12, 2019 – “Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety…hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy…The ministry approved the expanded indication after Roche confirmed the treatment’s efficacy through a global phase 3 KATHERINE clinical trial…”


Herceptin (trastuzumab) / Roche; Nerlynx (neratinib) / Puma
New early breast cancer option recommended by NICE (PharmaTimes) – Aug 7, 2019 – “The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Pierre Fabre’s Nerlynx (neratinib) as an additional treatment for some people with early hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer….The governing body announced that the drug is only recommended provided that Herceptin (trastuzumab) is the only HER2-directed adjuvant treatment people have had.”


entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission in combination with exemestane for HR+ metastatic breast cancer in 2020 (Syndax) – Aug 8, 2019 – Q2 2019 Results  


entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports second quarter 2019 financial results and provides clinical and business update (PRNewswire) – Aug 7, 2019 – “…’We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the FDA and take us one step closer to improving outcomes for patients with this difficult to treat disease’.”


Nerlynx (neratinib) / Puma
Puma Biotechnology reports second quarter 2019 financial results (Businesswire) – Aug 8, 2019 – P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries’.”


Nerlynx (neratinib) / Puma
Knight Therapeutics Reports Second Quarter 2019 Results (GlobeNewswire, Knight Therapeutics)- Aug 8, 2019 – Received regulatory approval from Health Canada for NERLYNX® for the treatment of HER2-positive breast cancer. Reached an agreement with the pan-Canadian Pharmaceutical Alliance (“pCPA”) regarding Probuphine® and to date have obtained reimbursement through public insurance plans administered by Alberta, Saskatchewan and the Non-insured Health Benefit Program (“NIHB”). We have advanced our commercial presence and product pipeline with the regulatory approval of NERLYNX® and the submission of Ibsrela™…Knight plans to launch NERLYNX® in late 2019.


Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Primary completion of P3 IMpassion030 trial (NCT03498716) for TNBC on January 15, 2022 (Barclays) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67703402; Page no: 1; REPORT TITLE: “Roche Holding Ltd: ROG: (neo)adjuvant TNBC: Beaten to the punch…”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 07/29/2019


EDP1503 / Evelo Biosci; Keytruda (pembrolizumab) / Merck (MSD)
Evelo Biosciences announces positive interim phase 1b clinical data and provides second quarter 2019 financial results (GlobeNewswire) – Aug 6, 2019 – “Oncology: Clinical Studies and Anticipated Milestones – EDP1503 – Phase 1/2; Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.”

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