Patient-Reported Outcomes from the Phase 2 CodeBreaK 100 Trial Evaluating Sotorasib in KRAS p.G12C–Mutated NSCLC

The phase 2 CodeBreaK 100 trial demonstrated that sotorasib monotherapy resulted in a response rate of 37.1% with a median duration of response of 10.0 months, a median progression-free survival of 6.8 months, and a tolerable safety profile in patients with pretreated KRAS p.G12C–mutated non–small-cell lung cancer (NSCLC). At the 2021 ASCO meeting, results of the patient-reported outcome (PRO) analysis of the CodeBreaK 100 trial up to cycle 11 were reported.

Eligible patients with KRAS p.G12C–mutated advanced NSCLC received sotorasib orally daily at 960 mg in 21-day treatment cycles until disease progression. Measures of disease-related symptoms and health-related quality of life (QOL) were administered on day 1 pre-dose of each cycle using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30), Quality-of-Life Questionnaire-Lung Cancer 13 (QLQ-LC13), and Functional Assessment of Cancer Therapy-General (FACT-G). Predefined analyses included change from baseline for global health status/QOL, physical functioning, and key lung cancer symptoms of cough, dyspnea, and chest pain.

A total of 126 patients were included in the PRO cohort; compliance rate for questionnaire completion was ≥71% across the study up to cycle 13. At baseline, patients entering the trial had decreased physical functioning with a mean domain score of 71.7 versus 85.1 in the general population, as well as high symptomatic burden for dyspnea, pain, and cough. At all follow-up assessments until cycle 11, there was maintenance of global health status/QOL and physical functioning measures as measured by EORTC QLQ-C30 during sotorasib treatment. Using QLQ-LC13, there were also improvements or stability in EORTC QLQ-C30 symptoms of cough, dyspnea, and chest pain from baseline during sotorasib treatment. Other lung cancer symptoms including dysphagia and hemoptysis also improved from baseline to cycle 11. The majority of patients were “not at all” or “a little bit” bothered by sotorasib-emergent side effects.

These PRO results indicate that global health status/QOL, physical functioning, and the severity of key lung cancer–related symptoms were maintained or improved with sotorasib therapy, with patients indicating minimal issues with self-reported treatment-related side effects.

Source: Spira AI, et al. J Clin Oncol. 2021;39(suppl 15):Abstract 9057.

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