Patient-Relevant Outcomes From the Phase III MARIPOSA-2 Trial: Amivantamab-Chemotherapy Versus Chemotherapy in...

The MARIPOSA-2 study demonstrated improved progression-free survival with amivantamab and chemotherapy compared with chemotherapy alone in patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC) with disease progression on or after treatment with osimertinib. This publication describes the results of patient-reported outcomes (PROs) measures and time to symptomatic progression (TTSP) for 2 treatment arms.

PRO instruments included the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire Core 30 (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System Physical Function Short Form 8c, and the NSCLC Symptom Assessment Questionnaire. Changes from baseline were analyzed using mixed-effects models for repeated measures. Treatment comparisons were based on least-squares means. The hazard ratio for TTSP was estimated using a stratified Cox regression model with P value derived from a stratified log-rank test.

Patients received amivantamab-chemotherapy (n = 131) or chemotherapy alone (n = 263). PRO scores were stable over time with little or no group differences in least-squares mean change from baseline. At 6 months postbaseline, 55.1% of patients in the amivantamab-chemotherapy arm reported improved or stable EORTC QLQ-C30 global health status/QoL scores compared with 29.1% in the chemotherapy arm. TTSP was prolonged for the amivantamab-chemotherapy treatment group versus chemotherapy alone (hazard ratio [HR] [95% CI], 0.73 [0.55-0.96]; nominal P  = .0259).

PRO results indicate that the clinical benefits of adding amivantamab to chemotherapy were achieved without compromising health-related QoL. Amivantamab-chemotherapy prolonged TTSP versus chemotherapy alone.