AstraZeneca's phase 3 TIGIT surprise

2 November 2023

ApexOnco Editorial Team

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 clinicaltrials.gov. 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

Asset	Trial name	Trial details	Sponsor
Vibostolimab/ Keytruda FDC (Merck & Co)	Keyvibe-005	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)	Industry-led Merck & Co
Domvanalimab (Gilead & Arcus)	SCCC-20Y22	Phase 2 basket trial in combination with zimberelimab in advanced hepatobiliary cancers Includes intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancers	Investigator-led University of Texas Southwestern Medical Center
Ociperlimab (BeiGene)	ZSAB-TOP	Phase 2 combination with tislelizumab and gemcitabine/cisplatin for 1st-line unresectable BTC	Investigator-led Shanghai Zhongshan Hospital