Data from Pharmawand - Curated by EPG Health - Date added 11 September 2019

Bristol-Myers Squibb Company announced long-term pooled efficacy and safety results from the Phase III CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small cell lung cancer (NSCLC). At five years, patients treated with Opdivo (nivolumab) continued to experience long-term overall survival (OS) benefit versus docetaxel. OS rates at five years were 13.4% for Opdivo and 2.6% for docetaxel. The OS benefit for Opdivo-treated patients was observed across all subgroups.

The safety profile for patients treated with Opdivo was consistent with previously reported findings in second-line NSCLC and no new safety signals were seen with extended follow-up. Of patients still on study, only 2 of 70 experienced a new treatment-related select AE between years three and four and there were no new treatment-related select AE’s reported between years four and five among the 55 patients still on study. Among patients with an objective response to Opdivo, 32.2% continued to see a response at five years. 0% of patients with an objective response to docetaxel continued to see a response at five years. The median duration of response was 19.9 months for Opdivo-treated patients and 5.6 months for patients treated with docetaxel. This pooled analysis, which represent the longest follow-up of previously treated NSCLC patients treated with Immuno-Oncology therapy in phase III randomized trials, will be shared in an oral presentation today from 12-12:10 PM CEST (OA14.04) at the International Association for the Study of Lung Cancer (IASLC) 20th World Conference on Lung Cancer (WCLC) in Barcelona, Spain.

About the Analysis : The pooled analysis of the two randomized Phase III CheckMate -017 and CheckMate -057 studies were conducted to determine the long-term efficacy and safety of Opdivo (nivolumab) in a large population of patients (n=854) with previously treated non-small cell lung cancer (NSCLC) across both squamous and non-squamous histologies. This pooled five-year analysis represents the longest follow-up reported from randomized Phase III trials of an Immuno-Oncology therapy in this setting and provides insight into the impact of Opdivo response on long-term overall survival (OS) outcomes. Patients in both studies experienced disease progression during or after first-line platinum-based chemotherapy and were randomized 1:1 to receive Opdivo 3 mg/kg once every two weeks or docetaxel 75 mg/m2 once every three weeks until progression or unacceptable toxicity. After completion of the primary analysis, patients in the docetaxel arm no longer receiving benefit could cross over to receive Opdivo. OS was the primary endpoint for both studies.


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