Duke Health announced on Apr. 15 that a clinical trial has shown immunotherapy can delay or potentially replace chemotherapy as the first treatment for patients with advanced colorectal cancer. The study, conducted at Duke University Hospital, found that using immunotherapy medications delayed the need for chemotherapy by about eight months and produced fewer severe side effects.
This development is significant as colorectal cancer rates rise among younger people, many of whom face aggressive disease and challenging life circumstances. Chemotherapy is often not curative in metastatic cases and can severely impact quality of life.
The early phase trial involved patients with stage IV microsatellite stable colorectal cancer that had not spread to the liver, bone, or brain. Participants received a combination of two immunotherapy drugs—Botensilimab and Balstilimab—and were monitored every six weeks. Two patients experienced partial immune responses, meaning their tumors shrank by at least 30 percent. Nicholas DeVito, M.D., assistant professor at Duke University School of Medicine and principal investigator for the study, said these outcomes are meaningful: “Delaying or avoiding chemotherapy are very meaningful outcomes, especially for young patients.”
DeVito explained why moving immunotherapy to the forefront was crucial: “Chemotherapy is rarely, if ever, curative in the metastatic setting,” he said. “Which is why we felt it was crucial to move immunotherapy first rather than testing it later.” He also highlighted one patient’s experience: Spencer Laird, age 30, who saw his lung tumors shrink or disappear after receiving dual immunotherapy at Duke Cancer Center instead of more rounds of chemotherapy.
The research team plans to expand into a phase two trial aiming toward U.S. Food and Drug Administration approval for this approach. “We’ve broken a barrier with this trial and demonstrated that immunotherapy can be a first-line therapy for this disease,” DeVito said. “These early results justify us moving forward aggressively to expand this approach…and ultimately make this a real option for more people.”
Located in Durham, North Carolina, Duke University Hospital was founded in 1925 and admitted over 41,000 patients during its most recent reported year according to their annual report.
