The BioPharm Brief: Survival, Fast Track, and Tezspire

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here are the stories we’re looking at today.

First, Akeso’s ivonescimab has beaten durvalumab on overall survival in a Phase 3 biliary tract cancer trial. The company reported that the bispecific antibody significantly improved overall survival compared with durvalumab in patients with advanced or metastatic biliary tract cancer. The result comes from a head-to-head Phase 3 study and adds to the clinical development of ivonescimab, which is designed to simultaneously target PD-1 and VEGF. Full data are expected to provide more detail on the magnitude of the survival benefit and the treatment’s safety profile.

Next, CytomX’s Varseta-M has received FDA Fast Track designation for relapsed or refractory metastatic colorectal cancer. The investigational antibody-drug conjugate targets EpCAM using CytomX’s PROBODY platform and delivers a topoisomerase-1 inhibitor payload. In Phase 1 data, Varseta-M produced a 32% confirmed response rate at the 10-mg/kg dose, with an 88% disease control rate across the expansion cohort. CytomX plans to begin a potential registrational trial in the first half of 2027.

And Tezspire has met both co-primary endpoints in a Phase 3 trial of eosinophilic esophagitis. In the 368-patient CROSSING study, tezepelumab significantly improved both histologic remission and dysphagia symptoms at week 24, with those improvements sustained through week 52. The anti-TSLP monoclonal antibody is already approved for severe asthma and chronic rhinosinusitis with nasal polyps, making EoE the latest indication in its broader development program. Full results are expected to be presented at an upcoming medical meeting.

That’s The BioPharm Brief for today. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways:

• Ivonescimab delivers a Phase 3 overall-survival win against durvalumab in biliary tract cancer.
• CytomX’s Varseta-M earns FDA Fast Track designation after encouraging Phase 1 colorectal cancer data.
• Tezspire meets both phase 3 endpoints in eosinophilic esophagitis, with benefits sustained through 52 weeks.