FDA approves dostarlimab for advanced rectal cancer

The accelerated approval adds an immunotherapy option for patients with MSI-H/dMMR stage II/III disease.

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The FDA granted accelerated approval to dostarlimab-gxly for previously untreated stage II/III locally advanced rectal cancer that is MSI-H or dMMR.
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In AZUR-1, 154 patients received dostarlimab 500 mg intravenously every 3 weeks for up to 9 cycles.
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Among 116 evaluable AZUR-1 patients, 47% had a sustained clinical complete response for at least 12 months, and the objective response rate was 79%.
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At a median follow-up of 26.3 months, no progression was observed among patients with sustained complete, complete, or near-complete responses.
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Both supporting trials were single-arm and lacked randomized comparators, and longer follow-up is needed to establish response durability.

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