FDA approves Tecentriq plus chemo for stage 3 dMMR colon cancer
The FDA on Thursday approved the immune drug Tecentriq, given with chemo, for stage 3 colon cancer with a gene repair defect called dMMR. Patients get it after surgery to help keep the cancer from coming back. In a key trial, adding Tecentriq cut the risk of the cancer returning or death by half.
Some colon cancer patients now have a new way to lower the odds that their cancer comes back.
The FDA approved Tecentriq, also called atezolizumab, on Oct. 8. It is given with standard chemotherapy after surgery for stage 3 colon cancer that is mismatch repair deficient, or dMMR. In these tumors, the system that fixes DNA errors is broken, so the cancer cells carry many mutations. The approval covers adults and children 2 and older.
The FDA also approved Tecentriq Hybreza, a version given as a shot under the skin, for patients 12 and older who weigh at least 40 kilograms, CURE reported.
The decision rests on the ATOMIC trial of 712 patients whose tumors had been removed by surgery. Adding Tecentriq to chemo cut the risk of the cancer returning or death by 50%. After three years, 86% of patients on the combination were alive and cancer-free, compared with 76% on chemo alone, RTTNews reported.
The gain came with more side effects. Serious side effects hit 84.1% of patients on the combination and 71.9% on chemo alone, Oncology Nursing News reported, mostly low counts of a type of white blood cell. Two deaths in the Tecentriq group were judged related to treatment. Data on overall survival are not yet mature.
The drug's maker, Roche, said the safety profile matched what was already known for Tecentriq and the chemo mix. This is Tecentriq's 12th approved use in the United States.
Until now, standard care after surgery for stage 3 colon cancer was chemo alone. About 15% of colon cancers are dMMR or a related type, Oncology Nursing News reported. "One in three patients with stage 3 colon cancer will relapse within five years," said Michael Sapienza, who leads the Colorectal Cancer Alliance.
The trial was paid for by the National Cancer Institute and Genentech, a Roche company. Regulators in Australia, Canada, Israel and Switzerland are still reviewing the drug for this use.
What we know: The FDA approved two forms of Tecentriq with chemo for stage 3 dMMR colon cancer after surgery.
What we don't: Whether the combination helps patients live longer overall.
Where outlets agree CURE, Oncology Nursing News and RTTNews all report that adding Tecentriq to chemotherapy cut the risk of the cancer returning or death by 50% in the ATOMIC trial.
Where they differ RTTNews reports Roche said the combination's safety matched what was already known, while Oncology Nursing News reports severe side effects were more common with Tecentriq added, 84.1% versus 71.9%.