Bristol-Myers reports data from CheckMate-057, CheckMate-017 trials
Bristol-Myers Squibb announced updated results from two pivotal Phase 3 studies, CheckMate -057 and CheckMate -017, which showed more than one-third of previously treated metastatic non-small cell lung cancer patients in both trials experienced ongoing responses with Opdivo, compared to no ongoing responses in the docetaxel arm. The median duration of response with Opdivo versus docetaxel in CheckMate -057 was 17.2 months and 5.6 months, respectively, and in CheckMate -017 it was 25.2 months and 8.4 months, respectively. In CheckMate -057, patients with PD-L1 greater than or equal to 1% had a median DOR of 17.2 months and in patients with PD-L1 less than 1%, it was 18.3 months. In both studies, durability of response was observed in both PD-L1 expressors and non-expressors, and in CheckMate -057, one out of the four complete responses occurred in a patient with less than 1% PD-L1 expression. There were no new safety signals identified for Opdivo in the pooled safety analysis from both studies. No new treatment-related deaths occurred between one and two years' minimum follow-up despite the longer treatment exposure, and new events were observed in 11/418 patients with an additional one year of follow up. Patient-reported outcomes from CheckMate -057 were also presented. Findings show Opdivo provided better preservation of health status, health-related quality of life and symptom control versus docetaxel, as assessed by the EuroQoL-5 Dimensions, visual analog scale, and the Lung Cancer Symptom Score.