Nivolumab (26) – Opdivo®

• Clinical trials
  • CheckMate 816 is a multicentre, open-label, randomised controlled trial comparing nivolumab in combination with platinum-based chemotherapy with platinum-based chemotherapy alone.

Adults with resectable non-small cell lung cancer (NSCLC) with tumour cell PD-L1 expression ≥ 1 % and a high risk of recurrence; neoadjuvant therapy

• Consequently, the G-BA has determined that nivolumab in combination with platinum-based chemotherapy offers a non-quantifiable additional benefit for the neoadjuvant treatment of resectable NSCLC with tumour cell PD-L1 expression ≥ 1 % in adults at high risk of recurrence.
• The certainty of the evidence is classified as ‘hint’.
• mortality
  • For the endpoint of overall survival, there is a statistically significant difference in favour of nivolumab in combination with platinum-based chemotherapy, which is assessed as a clear advantage.
  • At the time of the current data cut-off, the median survival time had not yet been reached in either study arm.
• Morbidity – Failure of the curative approach (event-free survival, EFS)
  • To illustrate the failure of the curative treatment approach, the event-free survival (EFS) endpoint from the CheckMate 816 study is used as an approximation.
  • There is a statistically significant difference in favour of nivolumab in combination with platinum-based chemotherapy, both in terms of the event rate and the time-dependent analysis, which is considered a clear advantage.
• Morbidity – Health Status (EQ-5D VAS)
  • No statistically significant difference was observed between the treatment groups for the health status endpoint.
• quality of life
  • Data on health-related quality of life were not collected in the CheckMate 816 trial.
• Side effects – severe adverse events (CTCAE grade ≥ 3)
  • For severe AEs (CTCAE grade ≥ 3), there was a statistically significant advantage with nivolumab in combination with platinum-based chemotherapy.
• Side effects – disorders of the blood and lymphatic system (CTCAE grade ≥ 3)
  • In detail, statistically significant advantages were observed in favour of nivolumab in combination with platinum-based chemotherapy for disorders of the blood and lymphatic system (CTCAE grade ≥ 3).
• Overall assessment
  • For overall survival, there is a statistically significant difference in favour of nivolumab in combination with platinum-based chemotherapy, which is considered a clear advantage.
  • In the morbidity endpoint category, a statistically significant difference in favour of nivolumab in combination with platinum-based chemotherapy was observed for the endpoint ‘failure of curative treatment’ (event-free survival, EFS), which is considered a clear advantage.
  • For the health status endpoint (assessed using the EQ-5D-VAS), there is no statistically significant difference between the treatment arms.
  • Data on health-related quality of life were not collected in the CheckMate 816 trial.
  • With regard to side effects, nivolumab in combination with platinum-based chemotherapy showed an advantage in terms of severe AEs (CTCAE grade ≥ 3). More specifically, advantages were observed for specific AEs.
  • Overall, there are clear advantages in the endpoints ‘overall survival’ and ‘failure of curative treatment’, as well as an advantage regarding side effects.
  • These advantages are not offset by any disadvantages.
  • However, given the relevant limitations in the available data, the extent of the additional benefit cannot be quantified with certainty.

Courtesy translation only, please refer to the German original.