On Oct. 19, the U.S. Food and Drug Administration (FDA) approved dostarlimab (brand name: Jemperli) to treat a specific type of rectal cancer called microsatellite instability-high (MSI-H)/mismatch repair deficient cancer. This cancer is caused by the accumulation of certain genetic mutations that prevent rectal cells from repairing DNA damage and accounts for 5-10% of rectal cancers. In a study of 154 people with this type of rectal cancer who were treated with dostarlimab, 68% had a complete clinical response at one year, which meant doctors could not see evidence of tumors on imaging or other methods for tracking the tumors. In the study, which the drug's manufacturer, GSK, submitted to the FDA, people received nine infusions of the drug: once every three weeks for six months.
Dostarlimab is a checkpoint inhibitor, which means it releases the brakes that hold back the immune system from recognizing and attacking tumors. The drug allows immune cells to destroy cancer, making it a powerful weapon for seeking out cancer cells no matter where they spread or hide.
Standard treatment for rectal cancer involves chemotherapy, radiation, and surgery to remove the rectum that requires patients to wear colostomy bags for the rest of their lives. The dostarlimab approval means more patients whose tumors have specific mutations could avoid those aggressive therapies altogether. “We have patients who would have lost the ability to bear children who have had children because this therapy replaced chemotherapy, radiation, and life-altering surgery in one swoop," Diaz says. "That’s a big deal.”
“The doctor told me it was Stage III colorectal cancer, and that the treatment plan would include chemo, radiation, and surgery. And that I would never carry another baby again, and would most likely have a colostomy bag for the rest of my life,” says Spill. “It didn’t seem real until I heard the words that I was not going to carry another baby. I immediately stopped thinking about me, and started thinking about my husband and what it meant for my son. We had just started our lives together; we were supposed to have all these kids.”
“It was a double whammy that threw me down,” she says. But the surgeon introduced her to Cercek, who was waiting to hear from the FDA about starting an immunotherapy trial for patients like Roth. “They told me I would be the first patient in the study, and there wasn’t scientific evidence that it would work.” Still, Roth wanted to try. She agreed to become Memorial Sloan Kettering’s first patient on the study, and then spent two months waiting for the FDA to greenlight the trial so she could begin receiving the drug. “I was calling Sloan Kettering incessantly to see if the FDA approved [the study],” she says. “The second the FDA gave its stamp of approval, Dr. Cercek’s team called me to New York to start the first round of treatment less than a week later.”
By her second infusion, Spill felt the tumor was shrinking because she no longer had major constipation. By the fourth infusion, scans showed the tumor had shrunk by 50%. The study originally called for patients to get chemotherapy, radiation, and surgery if needed after six months on dostarlimab. But a nurse pulled Spill’s mother aside after that appointment to tell her that the first three patients in the study did not need any additional treatments because their tumors had disappeared. Following Roth’s results, the study was revised to make chemotherapy, radiation, and surgery an option only if needed: if the tumors hadn’t gone away. It wasn’t a guarantee that Spill would have the same results as those first patients, but “it gave me hope, and all I could think about was maybe I could have another baby,” she says.
“I see beauty in absolutely everything in life now,” Spill says.
What comes next for dostarlimab
Cercek says the results point toward a potentially new model for managing some rectal cancers, which may include relying on immunotherapy like dostarlimab and monitoring patients more carefully before automatically turning to chemotherapy, radiation, or surgery. Some of the patients in the trial who were treated on dostarlimab underwent surgery after finishing their infusions if their doctors still felt there might be tumors remaining. Among them, despite the doctors’ suspicions, 80% did not turn out to have evidence of tumors in their specimens, says Cercek.
“We still have a lot of learning about what complete clinical response means,” she says, and with immunotherapy, that might mean a more patient-centric, individualized approach that involves more time for the immune system to respond to the immunotherapy and become trained to attack the cancer. “If it looks like the tumor is responding, we need to give it more time with better techniques to determine whether or not the tumor is truly gone.”
Cercek and her team are studying the best ways to monitor how tumors respond to dostarlimab by looking at snippets of genetic information that tumors shed in the blood, or more advanced imaging to accurately capture changing tumor sizes. “We need to improve on those techniques but also to teach the oncology community that there is a very, very high chance that the tumor might disappear, even if it might not look like it at six months. We need to continue watching and waiting and giving it time.”
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