Bristol-Myers Squibb has presented a batch of clinical trial data showing that a combination of its immunotherapies Yervoy and Opdivo reduced tumours in patients with lung cancer with an acceptable tolerability profile.
Updated results from the Opdivo (nivolumab)/Yervoy (ipilimumab) arms in CheckMate-012, a multi-arm Phase Ib trial evaluating the former in patients with chemotherapy-naïve advanced non-small cell lung cancer (NSCLC), showed objective response rates ranging from 13% to 39%.
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 ranged from 4.9 months to 10.6 months, the firm said.
On the safety side, the new dosing schedules resulted in less toxicity than previously-reported ones, and were characterised by low frequency of treatment-related adverse events leading to discontinuation (3% to 10%) and no treatment-related deaths.
Clinical data from combinations of Opdivo+Yervoy have already been reported in previously untreated metastatic melanoma, showing increased efficacy (but also a rise in side effects), and US regulators are currently considering whether the firm should be able to market the dual therapy in this indication.
Preliminary data from this trial “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,” noted Naiyer Rizvi, director of Thoracic Oncology and Immunotherapeutics for the Division of Haematology and Oncology at Columbia University Medical Centre.
Last week BMS filed a supplemental Biologics License Application seeking permission to market Opdivo for previously treated patients with non-squamous non-small cell lung cancer, adding to its approved indications in squamous NSCLC and advanced melanoma.