Sotorasib (1) – Lumykras®

• Clinical trials
  • To assess the additional benefit of sotorasib, the pharmaceutical manufacturer has submitted results from the ongoing, open-label, uncontrolled, multicentre Phase I and II study CodeBreak 100.
  • For the present benefit assessment, Phase II of the CodeBreak 100 trial is being considered. This phase included patients with NSCLC and a KRAS p.G12C mutation who had experienced disease progression following treatment with a PD-1/PD-L1 antibody and/or platinum-based combination chemotherapy, as well as targeted therapy for oncogenic driver mutations.

a) Adults with advanced non-small cell lung cancer (NSCLC) with a KRAS p.G12C mutation following first-line treatment with a PD-1/PD-L1 antibody as monotherapy

• An additional benefit is not proven.
• Overall assessment
  • The analyses submitted by the pharmaceutical manufacturer consist of a descriptive comparison of individual arms from various studies without adjustment for potentially relevant effect modifiers or prognostic factors.
  • Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of sotorasib over the appropriate comparator therapy is not proven.

b) Adults with advanced non-small cell lung cancer (NSCLC) with a KRAS p.G12C mutation following first-line treatment with cytotoxic chemotherapy

• The additional benefit is not proven.
• Overall assessment
  • The analyses submitted by the pharmaceutical manufacturer consist of a descriptive comparison of individual arms from various studies without adjustment for potentially relevant effect modifiers or prognostic factors.
  • Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of sotorasib over the appropriate comparator therapy is not proven.

c) Adults with advanced non-small cell lung cancer (NSCLC) harbouring a KRAS p.G12C mutation following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential therapy with a PD-1/PD-L1 antibody and platinum-based chemotherapy

• The additional benefit is not proven.
• Overall assessment
  • The analyses submitted by the pharmaceutical manufacturer consist of a descriptive comparison of individual arms from various studies without adjustment for potentially relevant effect modifiers or prognostic factors.
  • Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of sotorasib over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.