Weekly Top News – Ovarian Cancer – March 30, 2020

March 30, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza + cediranib: Acceptance of regulatory submission in US for recurrent platinum-resistant ovarian cancer (based on CONCERTO trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
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Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Acceptance of regulatory submission in US for BRCA mutated ovarian cancer (based on SOLO-3 trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
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ofranergene obadenovec (VB-111) / VBL Therapeutics
VBL therapeutics announces positive outcome of the interim analysis in the OVAL phase 3 ovarian cancer pivotal study (GlobeNewswire) – Mar 26, 2020 – P3, N=400; OVAL (NCT03398655); Sponsor:VBL Therapeutics; “VBL Therapeutics…announced an encouraging outcome of the planned interim analysis in the OVAL study, a double-blind controlled potential-registration study in patients with platinum-resistant ovarian cancer…The DSMC confirmed that the study met the interim pre-specified efficacy criterion, of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm, and recommended the study continuance. The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.”

 

Bavencio (avelumab) / EMD Serono, Pfizer; magrolimab (Hu5F9-G4) / Forty Seven Inc, Ono Pharma
Magrolimab + Bavencio: “The combination of magrolimab + avelumab has a tolerable safety profile and no maximum tolerated dose was reached”; Solid tumor (Forty Seven) – Mar 26, 2020 – ASCO-SITC 2020: “Ovarian cancer pt had SD by RECIST but had -46% reduction in tumor size and was a PR by irRECIST and GCIG CA-125 criteria and remains on treatment for 9+ months” 
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Paclical (micellar paclitaxel) / Oasmia, HLB Bio Group
Elevar Therapeutics acquires global rights to European approved Apealea from Oasmia Pharmaceutical (PRNewswire) – Mar 25, 2020 – “Elevar Therapeutics, Inc…announced…an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea®, except in Nordics, Russia, and certain countries in Eastern Europe….The companies are also in discussions with the FDA to determine the best route for a New Drug Application (NDA) in the US.”

 

Opdivo (nivolumab) / Ono Pharma, BMS; Yervoy (ipilimumab) / Ono Pharma, BMS
CheckMate 032: A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) – Mar 24, 2020 – P1/2; N=1131; Active, not recruiting; Sponsor: Bristol-Myers Squibb; N=1620 –> 1131

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