The field of cancer immunotherapy broke new ground last week when the U.S. Food and Drug Administration (FDA) announced the approval of the PD-1 inhibitor nivolumab (Opdivo) for treating patients with metastatic, squamous non-small cell lung cancer (NSCLC) that has progressed during or after treatment with platinum-based chemotherapy.
Nivolumab is the first cancer immunotherapeutic to be approved for the treatment of any type of lung cancer; most prior FDA approvals of cancer immunotherapeutics were for treating patients with melanoma or various hematologic malignancies. With squamous NSCLC accounting for approximately 25 to 30 percent of all the 221,200 lung cancer cases estimated to be diagnosed in the United States in 2015, this approval significantly increases the number of cancer patients who may potentially benefit from cancer immunotherapy.
The approval of nivolumab for use in the treatment of certain patients with NSCLC comes little more than two months after it was approved for treating patients with metastatic or unresectable melanoma who are no longer responding to other drugs and more than three months ahead of schedule. It bears out a prediction made by Drew Pardoll, MD, PhD, professor of oncology, medicine, and pathology and co-director of the Cancer Immunology and Hematopoiesis Program at Johns Hopkins University in a post on this blog in January that, “This year will be the year in which anti-PD-1/PD-L1 immunotherapies—the immune checkpoint inhibitors—will be approved for a broad number of cancer types within one year of its first approval for melanoma.”
According to the FDA, the nivolumab approval for NSCLC was based on results from a randomized phase III clinical trial called CheckMate 017, which showed that patients who received nivolumab lived 3.2 months longer than those who received docetaxel. These data have not yet been presented at a scientific conference or published in a peer-reviewed journal, but the FDA noted that results from the phase II CheckMate 063 clinical trial, which I discussed previously on this blog after they were presented last fall at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology, provided additional evidence to support the safety and efficacy of nivolumab as a treatment for squamous NSCLC.
Last fall, the FDA granted a second PD-1 inhibitor, pembrolizumab (Keytruda), breakthrough therapy designation for the treatment of certain patients with NSCLC. Since this designation is intended to expedite regulatory assessment of new agents and it is only granted to those agents that show substantial improvement over available treatments in early clinical trials, it is likely that we will hear more about this class of cancer immunotherapeutics as a treatment for NSCLC in the near future.
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