Weekly Top News – Ovarian Cancer – March 16, 2020

March 16, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Update on Phase 3 GY004 for cediranib and Lynparza (olaparib) in platinum-sensitive relapsed ovarian cancer (Businesswire) – Mar 12, 2020 – “AstraZeneca and Merck…announced high-level results from the Phase 3 GY004 trial, led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI), that examined primarily the efficacy and safety of investigational medicine cediranib in combination with LYNPARZA versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer….The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib in combination with LYNPARZA vs. platinum-based chemotherapy.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces acceptance of sNDA submission of Zejula (niraparib) for first-line maintenance treatment of ovarian cancer in China by the NMPA (GlobeNewswire) – Mar 16, 2020 – “Zai Lab Limited…announced the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy….GSK submitted a sNDA to the U.S. FDA for the use of ZEJULA in ovarian cancer as first-line maintenance treatment based on the PRIMA study…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; ceralasertib (AZD6738) / AstraZeneca
DUETTE: A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5’Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment. (clinicaltrials.gov) – Mar 10, 2020 – P2; N=256; Not yet recruiting; Sponsor: AstraZeneca; N=192 –> 256
Clinical • Enrollment change • BRCA • CA125

 

eribulin/farletuzumab ADC (MORAB-202) / Eisai
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types (clinicaltrials.gov) – Mar 9, 2020 – P1/2; N=196; Not yet recruiting; Sponsor: Eisai Inc.

 

Opdivo (nivolumab) / Ono Pharma, BMS; COM701 / Compugen
Compugen announces updated clinical data from ongoing COM701 phase 1 study (PRNewswire) – Mar 9, 2020 – P1, N=140; NCT03667716; Sponsor: Compugen Ltd; “COM701 was well-tolerated and with no reported dose-limiting toxicities in both treatment arms…A confirmed partial response in a patient from the COM701 monotherapy dose escalation arm with microsatellite stable primary peritoneal cancer, a type of challenging-to-treat ovarian cancer that was selected as a tumor type for the COM701 monotherapy expansion study based on our preclinical biomarker prediction of likely response to treatment with COM701; the patient is one of the three patients enrolled in the eighth cohort and is continuing on study treatment (more than 18 weeks).”

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