The FINANCIAL — Bristol-Myers Squibb Company on September 7 announced updated results from the Opdivo (nivolumab)+Yervoy (ipilimumab) arms in CheckMate -012, a multi-arm Phase 1b trial evaluating Opdivo in patients with chemotherapy-naïve advanced non-small cell lung cancer (NSCLC).
In this study, Opdivo was administered as monotherapy or as part of a combination with other agents, including Yervoy, at different doses and schedules. Results from other cohorts in CheckMate -012 have been previously-unreported. These updated results include findings from the administration of four new dosing schedules of Opdivo+Yervoy (n=148), which resulted in confirmed objective response rates (ORR) ranging from 13% to 39% depending on the administered regimen. Median duration of response was not reached in any of these arms with a median follow-up of 6.2 months to 16.6 months, and median progression-free survival (PFS) ranged from 4.9 months to 10.6 months, according to Bristol-Myers Squibb Company.
The types of treatment-related serious adverse events (SAEs) reported in these cohorts for CheckMate -012 were consistent with other previously-reported Opdivo+Yervoy cohorts of this trial. The new dosing schedules in this study resulted in less toxicity than previously-reported dosing schedules, and were characterized by low frequency of treatment-related adverse events (AEs) leading to discontinuation (3% to 10%) and no treatment-related deaths. These data will be presented today at the 16th World Conference on Lung Cancer (WCLC) (Abstract #786).
“Clinical results from Opdivo+Yervoy have already been reported in previously untreated metastatic melanoma, showing the potential of dual immune checkpoint blockade targeting both PD-1 and CTLA-4,” said Naiyer Rizvi, M.D., director of Thoracic Oncology and Immunotherapeutics for the Division of Hematology and Oncology at Columbia University Medical Center. “The preliminary results from this trial in advanced non-small cell lung cancer similarly push the envelope of benefit with an immunotherapy combination strategy in the first-line treatment of advanced non-small cell lung cancer which warrants further studies.”
Non-small cell lung cancer accounts for approximately 85% of all lung cancer cases. Five year survival rates vary globally depending on the stage and type of lung cancer.
“The results we are reporting today for Opdivo+Yervoy in non-small cell lung cancer are very promising as they further expand our scientific rationale and clinical data for combining Immuno-Oncology agents,” said Michael Giordano, senior vice president, head of Development, Oncology. “Overall survival data for Opdivo in the second-line treatment of squamous non-small cell lung cancer marked great progress in Immuno-Oncology; yet an unmet need remains for first-line treatments that offer durable, long-term survival and greater tolerability. We are hopeful that as we continue to advance Phase 3 clinical research of Opdivo-based combinations in the first-line setting that we will be able to offer lung cancer patients an option that fills this unmet need.”
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