Nivolumab

The FDA expanded the approval of nivolumab plus ipilimumab for treatment of lung cancer, according to the agents’ manufacturer.

Thomas A. Abrams, MD, senior physician at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, spoke with Healio about treatment options for patients with hepatocellular carcinoma. He discusses first-line treatment, guidance on aspirin use and important, recent FDA approvals.

The programmed death-1 receptor and its programmed death ligand-1 are key components of an immune checkpoint that has now been successfully targeted in several malignancies. Antibodies directed against PD-1 (pembrolizumab and nivolumab) as well as PD-L1 (atezolizumab and durvalumab) are now approved in a number of malignancies, including non-small cell lung cancer. Of these, only pembrolizumab treatment is contingent upon verification of PD-L1 expression.

The FDA approved nivolumab plus ipilimumab for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

Nivolumab administered 4 weeks before surgery induced pathologic complete responses and radiographic tumor regressions in about half of a cohort of patients with Merkel cell carcinoma, according to results of the phase 1/phase 2 CheckMate 358 study published in Journal of Clinical Oncology.

COM701, a novel first-in-class immune checkpoint inhibitor, demonstrated antitumor activity alone and in combination with nivolumab among patients with advanced solid tumors, according to results of a phase 1 study presented at the virtual American Association for Cancer Research Annual Meeting.

The FDA granted priority review to nivolumab plus ipilimumab combined with a limited chemotherapy course as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer.

Two treatment regimens showed efficacy as second-line therapy for older adults with non-small cell lung cancer, according to results of separate studies published in Cancer.

The FDA granted fast track designation to IPI-549 in combination with nivolumab for the treatment of advanced urothelial cancer.

About three-quarters of patients with advanced melanoma who achieved complete responses to single-agent anti-PD-1 therapy remained in remission at 3 years, according to results of a single-center retrospective study published in Journal of Clinical Oncology.