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AstraZeneca's phase 3 TIGIT surprise

Although AstraZeneca had already disclosed in February that it would move its anti-TIGIT/PD-1 bispecific antibody rilvegostomig into phase 3 this year, no details had been provided on its development strategy plans. The surprise came this Wednesday when the phase 3 study was posted on Rilvegostomig will be evaluated in combination with chemotherapy as adjuvant therapy in patients with biliary tract cancer (BTC). The Artemide-Biliary01 trial, set to start in December, intends to enrol 750 BTC patients (intrahepatic or extrahepatic) and the primary endpoint will determine the recurrence-free survival versus chemotherapy alone. Targeting a small indication in a setting without approved checkpoint inhibitors leads to speculation that Astra might be looking for a relatively easy approval pathway for this asset. TIGIT evaluation in BTC is extremely limited, and Merck & Co.'s Keyvibe-005 basket trial for the fixed-dosed combination of vibostolimab and Keytruda seems to be the only company-sponsored trial with a specific focus on these patients. 


Other ongoing trials evaluating TIGIT in biliary tract cancer

AssetTrial nameTrial detailsSponsor
Vibostolimab/ Keytruda FDC
(Merck & Co)
  • Randomised phase 2 basket trial vs Keytruda in selected solid tumours
  • Monotherapy & multiple combinations
  • Includes unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
Merck & Co
(Gilead & Arcus)
  • Phase 2 basket trial in combination with zimberelimab in advanced hepatobiliary cancers
  • Includes intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancers
University of Texas Southwestern Medical Center
  • Phase 2 combination with tislelizumab and gemcitabine/cisplatin for 1st-line unresectable BTC
Shanghai Zhongshan Hospital

Source: OncologyPipeline.


Molecular Drug Targets