LUMYKRAS (sotorasib) - Advanced non-small cell lung cancer

The clinical benefit of LUMYKRAS (sotorasib) remains low in the marketing authorization (MA) indication.

LUMYKRAS (sotorasib) demonstrated a statistically significant superiority in terms of progression-free survival and objective response rate assessed by an independent review committee in a randomised, open-label phase 3 study versus docetaxel.

However, this result is limited by:

• the lack of clinical relevance of the absolute difference in progression-free survival medians, of around 1 month;
• the open-label implementation of the study, having led to possible assessment biases, particularly in terms of treatment decisions;
• the uncertain reproducibility of measurement of progression-free survival in this study;
• the lack of demonstration of an effect on overall survival, in a context of advanced disease with an unfavourable prognosis;
• the lack of clinical relevance of the objective response rate in this context;
• the absence of any formal conclusion that can be drawn based on the quality-of-life results;
• the safety profile of sotorasib, which does not appear to be more favourable than that of
  docetaxel;

the Committee deems that LUMYKRAS (sotorasib) provides no clinical added value (CAV V) compared with docetaxel.