Longevity & AgingFDA Approves Immunotherapy That May Let Some Rectal Cancer Patients Skip Surgery and Chemo
The FDA has granted accelerated approval to the immunotherapy Jemperli (dostarlimab-gxly) as a stand-alone treatment for adults with previously untreated stage II or III locally advanced rectal cancer whose tumors have a DNA mismatch repair defect (dMMR or MSI-H). That describes roughly 3% of these cancers. Standard care of chemotherapy, radiation and surgery can damage bowel, urinary and sexual function and fertility, and sometimes requires a permanent colostomy. Jemperli blocks PD-1, a signal tumors use to hide from the immune system. In the phase 2 AZUR-1 study of 154 patients, almost three-fourths had not needed surgery, radiation or chemotherapy after more than two years of median follow-up. An earlier Memorial Sloan Kettering study of 50 patients found no detectable cancer after treatment, and 93% stayed cancer-free for at least 12 months. The approval is accelerated, so longer follow-up must confirm that the benefit lasts.
