- Medical Updates

Long-term pooled efficacy and safety results from the phase 3 CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small cell lung cancer ( NSCLC ) were announced.
At five years, patients treated with Nivolumab ( Opdivo ) continued to experience long-term overall survival ( OS ) benefit versus Docetaxel.
OS rates at five years were 13.4% for Nivolumab and 2.6% for Docetaxel. The OS benefit for Nivolumab-treated patients was observed across all subgroups.

The safety profile for patients treated with Nivolumab 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 adverse effect between years three and four and there were no new treatment-related select adverse effect’s reported between years four and five among the 55 patients still on study.

Among patients with an objective response to Nivolumab, 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 Nivolumab-treated patients and 5.6 months for patients treated with Docetaxel.

The pooled analysis of the two randomized CheckMate -017 and CheckMate -057 studies were conducted to determine the long-term efficacy and safety of Nivolumab in a large population of patients ( n=854 ) with previously treated non-small cell lung cancer across both squamous and non-squamous histologies.
Patients in both studies experienced disease progression during or after first-line platinum-based chemotherapy and were randomized 1:1 to receive Nivolumab 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 Nivolumab.
Overall survival was the primary endpoint for both studies. ( Xagena )

Source: BMS, 2019