Weekly Top News – Breast Cancer – November 18, 2019

November 18, 2019

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


Tecentriq (atezolizumab) / Roche; Kisqali (ribociclib) / Novartis; Lenvima (lenvatinib) / Eisai, Merck (MSD)
NHS Scotland adopts five new medicines (Holyrood Magazine) – Nov 11, 2019 – “Medicines to treat kidney and breast cancer are among five new treatments which have been accepted for use within NHS Scotland, by the Scottish Medicines Consortium (SMC). Ribociclib (Kisqali) for breast cancer treatment, lenvatinib (Kisplyx) for kidney cancer…were all accepted for use in the NHS after SMC committee members heard a range of evidence on the medications…However, the SMC also rejected an immunotherapy drug, known as atezolizumab. The medicine is used to treat patients with bladder of urinary cancer, or non-small cell lung cancer (NSCLC).”


GDC-9545 / Roche; Herceptin (trastuzumab) / Roche; ipatasertib (GDC-0068) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Perjeta (pertuzumab) / Roche
Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium (Businesswire) – Nov 18, 2019 – P3, N=500; FeDeriCa (NCT03493854); Sponsor: Hoffmann-La Roche; P3, N=4,804; APHINITY (NCT01358877); Sponsor: Hoffmann-La Roche; “Genentech…announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019…New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta® (pertuzumab) and Herceptin® (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC)….Genentech will also present data from the primary analysis of the Phase III FeDeriCa study…”


Keytruda (pembrolizumab) / Merck (MSD)
OncoSec presents immunological data associated with positive tumor response from Tavo KEYNOTE studies evaluating patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting (PRNewswire) – Nov 12, 2019 – P2, N=100; PISCES (NCT03132675); Sponsor: OncoSec Medical Incorporated; P2, N=25; KEYNOTE-890 (NCT03567720); Sponsor: OncoSec Medical Incorporated; “The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported….underscoring a predictable and consistently well-tolerated safety profile.”


Kadcyla (ado-trastuzumab emtansine) / Roche
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (GlobeNewswire) – Nov 15, 2019 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. Based on this recommendation, a final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future….The recommendation from the CHMP is based on results from the phase III KATHERINE study…”


Lynparza (olaparib) / Merck (MSD), AstraZeneca
AZ’s Lynparza is first PARP inhibitor to enter Cuba market (GBI Health) – Nov 15, 2019 – “According to GBI analysis, UK-based AstraZeneca last week obtained marketing approval from Cuba’s Center for State Control of Drugs and Medical Devices (CECMED) for its oncology therapy Lynparza (olaparib). The oral drug is used a treatment against breast cancer susceptibility gene (BRCA)-mutated ovarian and breast cancers. However, the agency does not publish indication details.”

Lenvima (lenvatinib) / Eisai, Merck (MSD); Halaven (eribulin mesylate) / Eisai
Biotoscana heralds upcoming arrival of Eisai’s Lenvima, Halaven to Argentina (GBI Health) – Nov 11, 2019 – “Biotoscana, a subsidiary of Canada’s Knight Therapeutics, last week announced plans to launch Eisai’s oncology drugs Halaven (eribulin mesylate) and Lenvima (lenvatinib) to the Argentina market in December 2019 or January 2020. The treatments were in-licensed by Biotoscana for Latin America ex-Mexico in 2017, as GBI reported…Halaven’s registration filing is as a breast cancer treatment, while Lenvima’s indications are against hepatic, kidney, and thyroid cancers.”


Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCell
BriaCell to present clinical findings at the 2019 San Antonio Breast Cancer Symposium December 12th and 13th (GlobeNewswire) – Nov 12, 2019 – P1/2, N=60; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “BriaCell Therapeutics Corp….is pleased to announce its lead product candidate, Bria-IMT™, will be featured in two poster sessions during the 2019 San Antonio Breast Cancer Symposium® (SABCS) taking place December 10-14 in San Antonio, Texas.”


Verzenio (abemaciclib) / Eli Lilly
Lilly’s breast cancer therapy abemaciclib market filing accepted for review in China (GBI Health) – Nov 15, 2019 – “According to the Center for Drug Evaluation’s (CDE) website, US major Eli Lilly’s market filing for import of CDK4/6 inhibitor abemaciclib has been accepted for review. Abemaciclib is a cell-cycle inhibitor designed to block the growth of cancer cells by specifically inhibiting CDK4/6. Lilly initiated a multi-center Phase III clinical trial including China that enrolled 450 post-menopausal patients globally suffering from locally recurrent or metastatic breast cancer, with 360 of those to be in China, as GBI reported in 2016. The MONARCH plus Phase III clinical study was concluded ahead of schedule…”

Syros reports third quarter 2019 financial results and highlights key accomplishments and upcoming milestones (Syros Press Release) – Nov 12, 2019 – “Syros plans to complete enrollment in the newly diagnosed unfit AML cohorts of the ongoing Phase 2 trial in the fourth quarter of this year…Syros plans to report potential proof-of-concept data from the ongoing cohort evaluating SY-1425 in combination with azacitidine in RARA-positive patients with relapsed or refractory AML in 2020; Syros plans to complete investigational new drug application-enabling studies by year-end and initiate a Phase 1 trial of SY-5609 in the first quarter of 2020 in patients with select solid tumors, including breast, lung and ovarian cancers…”

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