Bristol-Myers Squibb Company has announced that Opdivo (nivolumab) is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with classical Hodgkin lymphoma (cHL) who relapsed of progressed after receiving autologous hematopoietic stem cell transplantation (auto-HSCT) and were treated with brentuximab vedotin following transplantation.
Opdivo is an inhibitor of the programmed cell death (PD) 1 protein, a protein that plays an important role in down-regulating the immune system. By blocking PD-1, Opdivo releases this inhibition on immune cells, allowing them to effectively attack tumor cells. The drug has already been approved for patients with inoperable or metastatic melanoma, metastatic non-small cell lung cancer, and advanced renal carcinoma.
“Today’s approval of Opdivo delivers a transformational and exciting new option for these patients and the hematologists who treat them. By expanding this Immuno-Oncology therapy into a hematologic malignancy, we continue to deliver upon our unwavering commitment to provide treatments that work directly with the body’s immune system for patients who are in need of new options,” Chris Boerner, head of U.S. Commercial for Bristol-Myers Squibb said in a press release. “This is our second Immuno-Oncology agent in blood cancer in less than a year for patients impacted by diseases with a deep unmet need.”
The approval is the first for a PD-1 inhibitor to treat cHL patients. It was based on the overall response rate observed in two Opdivo clinical trials, the Phase 2 CheckMate -205, single-arm, open-label study whose results are to be presented in the upcoming American Society of Clinical Oncology Annual Meeting in June 2016; and the Phase 1 CheckMate -039, an open-label, dose escalating study.
Combined analysis of both studies revealed that among 95 patients with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin, 65% showed objective response – among which 7% had a complete response to Opdivo with a median response duration of 8.7 months. Such results granted Opdivo an accelerated approval, but continued approval for this subset of patients is dependent on confirmatory trials to verify and describe Opdivo clinical benefits.
“It is important to have new treatment options for patients with difficult-to-treat diseases who have exhausted the current available options. Because of the unique pathology and biology of classical Hodgkin lymphoma, it makes sense from a scientific standpoint to investigate a PD-1 inhibitor,” said Dr. Anas Younes, medical oncologist and chief of Lymphoma Service, Memorial Sloan Kettering Cancer Center. “The recent clinical data with Opdivo in patients with classical Hodgkin lymphoma who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is encouraging and has the potential to impact our approach to treating these individuals in the future.”