Weekly Top News – Breast Cancer – November 25, 2019

November 25, 2019

margetuximab (MGAH 22) / MacroGenics
Margetuximab US regulatory estimate: Approval for HER2+ metastatic breast cancer in H1 2020 (Cowen & Co) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68286929; Page no: 2; REPORT TITLE: “Margetuximab BLA in 4Q19; Flotetuzumab data in AML at ASH 2019”; AUTHOR: Peaker, Boris, et al; DATE: 11/06/2019


margetuximab (MGAH 22) / MacroGenics
Margetuximab launch estimate: 2020 for breast cancer and 2022 for gastric cancer (BTIG) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68154141; Page no: 2; REPORT TITLE: “MacroGenics, Inc. – More mature data from SOPHIA looking cleaner with 158F OS HR=0.79”; AUTHOR: Shrader, Thomas, et al; DATE: 10/23/2019


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 – “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…”


Piqray (alpelisib) / Novartis
Alpelisib: “The Committee was reminded of the status of this application and its remaining outstanding issues [treatment of HR-positive/HER2-negative, advanced breast cancer in combination with fulvestrant]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of outstanding issues with a specific timetable.”


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca; Kadcyla (ado-trastuzumab emtansine) / Roche; U3-1402 / Daiichi Sankyo
Positive pivotal data for Daiichi Sankyo’s DS-8201 ([fam]-trastuzumab deruxtecan) in patients with HER2 positive metastatic breast cancer to be presented at SABCS (Businesswire) – Nov 19, 2019 – “Positive data from the pivotal phase 2 DESTINY-Breast01 trial of DS-8201 ([fam-] trastuzumab deruxtecan), an investigational HER2 targeting antibody drug conjugate (ADC), will be unveiled….Trial-in-progress updates from the pivotal phase 3 development program of DS-8201 in patients with HER2 positive metastatic breast cancer, including a head-to-head study with ado-trastuzumab emtansine, and in patients with HER2 low metastatic breast cancer, also will be presented. An overview of the phase 1/2 trial for U3-1402, an investigational HER3 targeting ADC, in HER3 expressing advanced/unresectable or metastatic breast cancer also will be featured at SABCS.”


Tecentriq (atezolizumab) / Roche; Kisqali (ribociclib) / Novartis; Lenvima (lenvatinib) / Eisai, Merck (MSD)
Breast and kidney cancer drugs approved on NHS Scotland (Medical Xpress) – Nov 22, 2019 – “Lenvatinib has been accepted for use in combination with another targeted drug called everolimus (Afinitor), which stops cancer growing by starving it of blood…Access to the targeted treatment ribociclib has also been approved for some women with breast cancer in Scotland whose cancer has spread near to where their tumor first appeared, or to another part of the body….Based on the clinical trial evidence presented by atezolizumab’s manufacturer, the SMC decided the treatment did not offer enough value to patients for the drug combination to be cost effective.”


sacituzumab govitecan (IMMU-132) / Immunomedics
IMMU-132 clinical trial estimate: Data from P3 ASCENT trial (NCT02574455) for TNBC in mid-2020 (Zacks) – Nov 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68305709; Page no: 3; REPORT TITLE: “Immunomedics, Inc.(IMMU) Zacks company report”; AUTHOR: Research Department; DATE: 11/08/2019


tremelimumab (CP-675206) / AstraZeneca, Pfizer; Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
GUIDE2REPAIR: Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment (clinicaltrials.gov) – Nov 20, 2019 – P2; N=270; Not yet recruiting; Sponsor: Centre Georges Francois Leclerc


Ibrance (palbociclib) / Pfizer
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (clinicaltrials.gov) – Nov 25, 2019 – P; N=1; Active, not recruiting; Sponsor: Pfizer


Kadcyla (ado-trastuzumab emtansine) / Roche
Kadcyla: “The Committee discussed the issues identified in this application, mainly relating to the wording of the indication in relation to the studied population and the request for 1 year of market protection [extension of indication to include the adjuvant treatment of adult patients with HER2-positive early breast cancer]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The Committee adopted a 2nd request for supplementary information with a specific timetable.”

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