Weekly Top News – Breast Cancer – April 29, 2019

April 29, 2019

Faslodex (fulvestrant) / AstraZeneca; SHR6390 / Jiangsu Hengrui Medicine

A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov) – Apr 25, 2019 – P3; N=288; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive, unresectable and/or metastatic breast cancer in 2020 or later (AstraZeneca) – Apr 26, 2019 – Q1 2019 Results: Data from P3 DESTINY-Breast04 trial (NCT03734029) for HER2-low, unresectable and/or metastatic breast cancer in 2020 or later
P3 data
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Regulatory submission in US for HER2 positive metastatic breast cancer in H1 FY 2019 (Daiichi Sankyo) – Apr 26, 2019 – FY 2018 Results: Regulatory submissions in Japan for HER2 positive metastatic breast cancer in H2 FY 2019, EU in H1 FY 2020
BLA • European regulatory • Japanese regulatory
[Screenshot]

 

Talzenna (talazoparib) / Pfizer

Pfizer receives positive CHMP opinion for Talzenna (talazoparib) for patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (Pfizer Press Release) – Apr 26, 2019 – “Pfizer Inc….announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU). The indication the CHMP adopted is for TALZENNA as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC)….The Marketing Authorization Application was submitted based on results from the EMBRACA trial, the largest Phase 3 trial performed to date of a PARP inhibitor in patients with gBRCA-mutated LA or MBC.”
European regulatory

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Approval and launch in US/EU/Japan/Asia for HER2 positive breast cancer in FY 2020 (Daiichi Sankyo) – Apr 26, 2019 – FY 2018 Results
BLA • European regulatory • Japanese regulatory • Launch Europe • Launch Japan • Launch non-US • Launch US • Non-US regulatory
[Screenshot]

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche

SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx). (ASCO 2019) – Apr 26, 2019 – Abstract #1000; Pres time: Jun 4, 2019; 09:45 AM – 09:57 AM; Location: Hall D1; No abstract available.
Clinical • P3 data

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Acceptance of regulatory submission in US for HER2 positive metastatic breast cancer previously treated with T-DM1 (based on DESTINY-Breast01 trial) in H2 2019 (AstraZeneca) – Apr 26, 2019 – Q1 2019 Results
BLA
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Data from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer in H2 2019 (AstraZeneca) – Apr 26, 2019 – Q1 2019 Results: Data from P3 DESTINY-Breast02 trial (NCT03523585) for pre-treated HER2 breast cancer in 2020 or later
P2 data • P3 data
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at SABCS (December 10-14, 2019) (Daiichi Sankyo) – Apr 27, 2019 – FY 2018 Results
P2 data
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo; Keytruda (pembrolizumab) / Merck (MSD)

DS-8201 + Keytruda: Initiation of P1b trial for breast cancer in Q3 FY 2019 (Daiichi Sankyo) – Apr 26, 2019 – FY 2018 Results
New P1 trial
[Screenshot]

 

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