BeiGene Advances its First ADC Into Phase III in Ovarian Cancer

Chinese developer BeiGene has launched GOG-3144/ENGOT-ov108, the first Phase III program for BG-C9074, a B7-H4 antibody-drug conjugate (ADC) discovered by DualityBio and in-licensed by BeiGene in December 2024 for more than USD 1.3 billion in aggregate consideration. The 600-patient, double-blind trial evaluates BG-C9074 plus bevacizumab versus bevacizumab alone as maintenance after first-line platinum chemotherapy plus bevacizumab in ovarian, fallopian tube or primary peritoneal cancer, with progression-free survival (PFS) as the primary endpoint.

BG-C9074 carries a TopI inhibitor payload at a drug-to-antibody ratio (DAR) of 6. Phase I data showed a 45.5% confirmed objective response rate (ORR) and 100% disease control rate (DCR) across 6.5 mg/kg, 7 mg/kg, and 8 mg/kg cohorts in ovarian cancer, giving BeiGene a credible entry into the B7-H4 ADC race against programmes such as Pfizer/Genmab's eltrekibart and AstraZeneca/Daiichi Sankyo's puxitatug samrotecan.

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