ANDRE-2023-DOSTARLIMAB

NCT02493829 📎

Regimen

Experimental
Dostarlimab 500 mg IV q3w for 4 doses then 1000 mg IV q6w (anti-PD-1 monoclonal antibody, GSK)
Control
single-arm / no comparator

Population

dMMR advanced solid tumors after ≥1 prior therapy (pan-tumor basket); multiple cohorts including endometrial, CRC, and non-CRC/non-endometrial cohorts. BTC/CCA subgroup: within the 'other solid tumors' dMMR cohort (n not specifically segregated for BTC in primary publication); dMMR BTC estimated <1-2% of any dMMR pan-tumor basket. André T, JAMA Netw Open 2023. Dostarlimab received FDA approval for dMMR solid tumors (August 2021) based on this and the GARNET trial.

Key finding

André 2023 reports the expanded efficacy data for dostarlimab in dMMR solid tumors, providing the third distinct anti-PD-1 agent (after pembrolizumab and nivolumab) with pan-tumor dMMR approval. For BTC, dostarlimab offers a regulatory and mechanistically equivalent alternative to pembrolizumab in dMMR-positive cases, though no head-to-head comparison exists. The durable DoR (24-month DoR rate 69%) supports the clinical narrative that dMMR/MSI-H tumors have deep, lasting IO responses. BTC-specific subgroup data not reported separately due to small N.

Source: PMID 37917058

Timeline

    Guideline citations

    • NCCN BTC (p.34)