Astra reveals more about its TIGIT hand
It’s becoming clear that AstraZeneca sees biliary tract cancer as a key use for its anti-TIGIT x PD-1 bispecific rilvegostomig. A new clinicaltrials.gov listing reveals that the antibody, which is derived from work with Compugen, has just entered its third phase 3 study, Destiny-BTC01. Like Artemide-Biliary01 the new study concerns biliary tract cancer (BTC) – the former in the adjuvant setting and Destiny-BTC01 as a first-line combo with Enhertu. Rilvegostomig’s other pivotal trial is a datopotamab deruxtecan combo in the more typical TIGIT setting of first-line NSCLC. But Astra’s focus on BTC is intriguing, as there appear to be just three other studies of anti-TIGIT projects in this cancer type: Keyvibe-005, a basket trial of Merck & Co’s vibostolimab, SCCC-20Y22 (Gilead/Arcus’s domvanalimab) and ZSAB-TOP (BeiGene’s ociperlimab plus Tevimbra combo). The last two are academic sponsored, as was the separate zs-BTC study combining ociperlimab with Tevimbra that was withdrawn from clinicaltrials.gov. It’s likely that the design of Destiny-BTC01 was influenced by Enhertu’s recent tumour-agnostic approval in late-line HER2-positive cancers, since one of the highest response rates in the Destiny-Pantumor02 trial, which supported that accelerated approval, was seen in BTC.
Pivotal trials of rilvegostomig
Study | Cancer | Setting | Primary endpoint |
---|---|---|---|
Tropion-Lung10 | Stage IIIB-IV, non-squamous NSCLC | 1st-line, +/- datopotamab deruxtecan | OS & PFS in TROP2+ve patients vs Keytruda (n=675) |
Artemide-Biliary01 | Biliary tract cancer | Adjuvant, chemo combo | Recurrence-free survival vs chemo (n=750) |
Destiny-BTC01 | Biliary tract cancer | 1st-line, HER2+ve, Enhertu combo (also has Enhertu monoRx cohort) | OS vs Imfinzi + chemo (n=620) |
Source: OncologyPipeline.
1910