Pivotal ovarian cancer study of CanariaBio immunotherapy misses main goal
24 Jan 2024
Phase 3AcquisitionLicense out/in
Quest PharmaTech announced that a pivotal study of CanariaBio’s oregovomab in front-line ovarian cancer failed to hit its progression-free survival (PFS) goal at an interim futility analysis.
The Phase III FLORA-5 trial is investigating oregovomab with a standard six-cycle chemotherapy regimen in 615 newly diagnosed patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma, focusing on both adjuvant and neoadjuvant cohorts. Along with the primary endpoint of PFS in the two cohorts, secondary goals include overall survival (OS).
Hopes pinned on OS
Quest noted that while the data safety monitoring board recommended that the study be halted, follow-up should continue as “there is a possibility of significant efficacy” in OS. The company added that it is in talks with the trial’s sponsor, CanariaBio, around continued support of the clinical programme for the CA-125-directed monoclonal antibody.
CanariaBio gained oregovomab after OncoQuest, in which Quest holds a 42.5% stake, sold rights to another Korean-based company.
The decision to stop the study is likely to put a dampener on CanariaBio’s global plans for oregovomab, including a string of recent licensing deals to market the drug in Australia, New Zealand, and select Southeast Asian countries with Specialised Therapeutics, and in the Middle East and North Africa region with Hikma Pharmaceuticals.
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