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Chemo-free rectal cancer treatment is now FDA-approved. The FDA granted accelerated approval to dostarlimab (Jemperli) for adults with stage II/III dMMR/MSI-H locally advanced rectal cancer — making it the first immunotherapy cleared for this indication. Phase 2 AZUR-1 trial data showed nearly 3 in 4 patients avoided surgery, radiation, and chemotherapy after more than two years of follow-up, with zero recurrences among those who achieved a complete response.
Chemo-free rectal cancer treatment gets the green light
The FDA granted accelerated approval to dostarlimab (Jemperli, GSK) on October 19, 2026, for adults with stage II or III locally advanced rectal cancer that is mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) — making it the first immunotherapy approved specifically for this patient population. The decision was based on data from the phase 2 AZUR-1 trial, which enrolled 154 previously untreated patients who received dostarlimab 500 mg IV every 3 weeks for up to nine cycles.
The results were striking: 71% of patients achieved a clinical complete response (cCR) and entered nonoperative management, with zero recurrences reported among those who responded at a median follow-up of over two years. This is a meaningful quality-of-life advancement — standard treatment (chemoradiation followed by surgery) can cause lasting bowel, bladder, sexual, and fertility dysfunction, and sometimes requires a permanent colostomy.
By the Numbers
Why it matters: For a cancer where standard care often means life-altering surgery and radiation, dostarlimab offers a biomarker-guided path to potential cure — without the associated morbidity. Clinicians should test eligible patients for dMMR/MSI-H status, as this approval opens a fundamentally different treatment approach for those who qualify.
