Real-world effectiveness and tolerability of sotorasib in patients with KRAS G12C-mutated metastatic non-small cell lung cancer: the IFCT-2102 Lung KG12Ci study

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Wislez, M | Mascaux, C | Cadranel, J | D Thomas, Q | Ricordel, C | Swalduz, A. | Pichon, E | Veillon, R | Gounant, V | Rousseau-Bussac, G | Madroszyk, A. | Daniel, C | Ravoire, M | Metivier, A.-C. | Fournel, P | Missy, P | Morin, F | Guisier, F | Westeel, V

Edité par CCSD ; Elsevier -

International audience. Introduction: Sotorasib has shown efficacy in a phase 3 trial compared to docetaxel among previously treated non-small cell lung cancer (NSCLC) patients with a KRAS G12C mutation. However, its real-world effectiveness and tolerance, especially post-immunotherapy, remain debated.Methods: This French retrospective multicentre study analysed NSCLC patients receiving at least one dose of sotorasib as part of early access program The main objective was to assess real-world progression-free survival (rwPFS), and secondary objectives included assessment of overall survival (rwOS) and sotorasib-related hepatotoxicity.Results: 458 patients from 76 centres were analysed, with a median age 65.8. Among them, 43.4 % were female, 28.3 % had performance status ≥ 2, 95.4 % were active/former smokers, and 38.0 % had brain metastases with 55.2 % in progression at sotorasib initiation. PD-L1 expression was < 1 %, ≥ 1-49 %, ≥ 50 %, and unknown in 35.1 %, 34.1 %, 23.4 %, and 7.4 % of patients, respectively. Most patients had received prior treatments (96.7 %), including immunotherapy (54.9 %). Median (95 % confidence interval [CI]) rwPFS and rwOS were 3.5 (3.1-4.2) and 8.3 (7.5-9.3) months, with a median (95 % CI) follow-up of 15.8 (13.9-17.3) and 16.4 (15.5-17.3) months, respectively. The real-world objective response rate (rwORR) was 33.2 % and disease control rate (rwDCR) was 63.2 %. In patients with brain metastases, cerebral rwORR and rwDCR were 20.1 % and 66.9 %, respectively. Grade 3-4 adverse events related to hepatotoxicity occurred in 5.2 % of patients. Sotorasib was discontinued for toxicity in 16.5 % of patients.Conclusion: This study gave insights into effectiveness and safety of sotorasib in a real-world setting, in advanced or metastatic KRAS G12C-mutated non-squamous NSCLC.

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