LUMYKRAS (sotorasib) - Advanced non-small cell lung cancer
Opinions on drugs -
Posted on
Aug 01 2023
Reason for request
Reassessment
Réévaluation.
L'essentiel
Avis favorable au maintien du remboursement « en monothérapie dans le traitement des patients adultes atteints d’un cancer bronchique non à petites cellules (CBNPC) avancé, présentant la mutation KRAS G12C, dont la maladie a progressé après au moins une ligne de traitement systémique antérieure ».
Quel progrès ?
Pas de progrès par rapport au docétaxel.
Quelle place dans la stratégie thérapeutique ?
LUMYKRAS (sotorasib) est une option de traitement dans la prise en charge des patients adultes atteints d’un cancer bronchique non à petites cellules (CBNPC) avancé, présentant la mutation KRAS G12C, dont la maladie a progressé après au moins une ligne de traitement systémique antérieure.
Clinical Benefit
Low
The clinical benefit of LUMYKRAS (sotorasib) remains low in the marketing authorization (MA) indication.
Clinical Added Value
no clinical added value
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.
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