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GSK Advances B7-H4 ADC Mocertatug Rezetecan to Five Phase 3 Trials After Strong Phase 1b Data in Gynecological Cancers

GSK's Phase 1b BEHOLD-1 trial of mocertatug rezetecan (Mo-Rez), a B7-H4-targeted ADC, showed confirmed objective response rates (ORR) of 62% in 34 platinum-resistant ovarian cancer (PROC) patients at 5.8 mg/kg and 67% in 12 endometrial cancer (EC) patients at 4.8 mg/kg 1 2 . Responses remain durable with median follow-up of 6 months for PROC and 4 months for EC; low interstitial lung disease rate of ~3-4% (all grade 1-2) 1 2 . Strong data prompts GSK to initiate five pivotal Phase 3 trials in 2026: BEHOLD-Ovarian01 (PROC), Ovarian02 (platinum-sensitive), Ovarian03 (front-line HR-proficient ovarian), Endometrial01 (2L EC), and Endometrial02 (1L MMR-proficient EC) 1 2 . Data presented at Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico; GSK views Mo-Rez as a potential blockbuster asset 1 3 . Mo-Rez licensed from Hansoh Pharma; GSK has existing sales in these cancers from Jemperli and Zejula totaling ~$1.8B last year 1 . Sources: 1. https://w...

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FDA's Vinay Prasad to Depart as Head of Vaccines and Biologics Division Amid Controversy

Novo Nordisk Faces Double Departures: GLP-1 Expert Retires as Obesity Leader Joins Boehringer Ingelheim

FDA Rejects Replimune's RP1 Melanoma Treatment for Second Time, Citing Unresolved Trial Issues