Patient-reported outcomes (PROs) from the phase III IMspire150 trial of atezolizumab (A) + cobimetinib (C) + vemurafenib (V) in patients (pts) with BRAFV600+melanoma.

Abstract

10073 Background: In IMspire150, A+C+V significantly improved investigator-assessed progression-free survival vs placebo (Pbo)+C+V in previously untreated pts with unresectable stage IIIc/IV BRAFV600+melanoma. PRO data from this trial are now reported. Methods: 514pts were randomized 1:1 to 28-day cycles of A+C+V or Pbo+C+V. Pts received C+V in cycle 1; A or Pbo was added on days 1 and 15 from cycle 2 onward. Pts completed the EORTC QLQ-C30 questionnaire on day 1 of cycle 1 (baseline), days 1 and 15 of cycle 2 and cycle 3, day 1 from cycle 4 onward, within 28-d of treatment discontinuation, and ≤6 months post-treatment. Prespecified secondary PRO endpoints were time to confirmed deterioration (TTCD; defined as time from randomization to first ≥10-point decrease from baseline held for 2 consecutive assessments, or 1 assessment followed by death on treatment) in quality of life (QoL) and physical functioning (PF). Prespecified exploratory endpoints were TTCD in role functioning (RF); mean change from baseline and percentage of pts with a clinically meaningful change (≥10 points from baseline) in QoL, PF, and RF. Results: Questionnaire completion rates were > 80% for most of the treatment period. At baseline, mean QoL, PF, and RF scores were moderate to high (Table). At week 6 (cycle 2), following initiation of A, QoL, PF, and RF scores declined, but returned to near-baseline levels at week 10 (cycle 3) and were largely maintained until week 36 (cycle 10), when < 50% of pts contributed data. In this time, ≥56% pts in both arms did not experience a clinically meaningful deterioration in QoL, PF, and RF. TTCD on QoL (hazard ratio [HR] 1.23; 95% CI 0.90-1.67), PF (HR 1.27; 95% CI 0.93-1.74), and RF (HR 1.15; 95% CI 0.86-1.55) favored Pbo, but only one-third of pts overall experienced a confirmed deterioration. Conclusions: PRO data showed that A+C+V did not worsen QoL, PF, and RF in pts with advanced BRAFV600+melanoma, thus supporting its use as a treatment option. Clinical trial information: NCT02908672. [Table: see text]