The FDA on October 19 granted accelerated approval to Jemperli, known generically as dostarlimab, as the first and only immunotherapy for adults with stage II or III locally advanced rectal cancer that is microsatellite instability-high or mismatch repair deficient, the Oncology Nursing Society reports. The decision could let many patients skip chemotherapy, radiation, and surgery entirely.
The approval was based on AZUR-1, a single-arm trial of 154 patients who received dostarlimab intravenously every three weeks for nine cycles. According to independent central review, 47 percent of evaluable patients achieved a sustained clinical complete response lasting 12 months. Investigator assessments put the figure even higher at 68 percent, and 76 percent of patients had no detectable evidence of cancer one year or more after treatment. Critically, no disease recurrences have been reported among responders after a median follow-up of more than two years.
The therapy works by harnessing the immune system against tumors with specific genetic fingerprints, and its organ-sparing potential is the most exciting part for patients, oncologist Andrea Cercek told OncLive. Instead of the standard gauntlet of chemoradiation followed by surgery — which can leave patients with permanent bowel, bladder, and sexual side effects — responding patients enter careful surveillance with regular scans and endoscopies.
Jemperli was discovered by AnaptysBio and licensed to GSK's Tesaro unit, and news of the approval sent AnaptysBio shares up 5.8 percent to $49.31 in Monday trading, according to Dow Jones Newswires. The application carried Fast Track, Breakthrough Therapy, and Priority Review designations plus a National Priority Voucher, bringing approval months ahead of its February 2027 target date. GSK plans to present full AZUR-1 data as a late-breaking abstract at the ESMO Congress in Madrid on October 25.