New research suggests that some patients with head and neck cancers can benefit by continuing treatment with an immunotherapy drug after their tumors show signs of enlargement according to investigators at Dana-Farber Cancer Institute and other organizations.
The findings, from CheckMate 141, a phase 3 clinical trial, represent the first time that continued use of an immune checkpoint inhibiting drug has been shown to extend survival in patients whose head and neck tumors have grown during initial treatment with the drug.
The trial involved 139 patients with recurrent or metastatic squamous cell cancer of the head and neck that had progressed after treatment with Opdivo (nivolumab), a Food and Drug Administration-approved drug that works by blocking a molecule that deters immune system T cells from attacking tumor cells. Patients who were doing well clinically and were strong enough to handle further treatment – were given the opportunity to continue taking Opdivo. The others received no further Opdivo.
The 57 patients who continued with Opdivo had a median survival period of 12.7 months, compared to 6.1 months for the 82 patients did not. Almost one quarter of the patients in the first group had their tumors shrink – by more than 30 percent in two cases.
Adverse side effects of the treatment were similar in both groups, although patients who received Opdivo after progression of their disease had higher rates of disorders of the skin or tissue below the skin.
The results underscore that for Opdivo, as for some other immunotherapy drugs, “the benefit is often seen with increased survival, not necessarily tumor shrinkage an response rate,” said study lead author Robert Haddad MD, leader of the Head and Neck Oncology Program at Dana-Farber. “Our findings suggest that for patients with head and neck cancer who are doing well enough, continuing Opdivo therapy after disease progression can often lengthen survival. For such patients, it can be a mistake to give up on these drugs too early, and clinical judgment should be exercised to determine whether it would be beneficial to continue therapy.”
Reference: Phase III Clinical Trials and Phase II/III Clinical Trials in Progress. (Control Number 17-LB-7877-AACR)