9P First-line (1L) osimertinib (osi) ± platinum-pemetrexed in EGFRm advanced NSCLC: FLAURA2 patient-reported outcomes (PROs)

In FLAURA2 (NCT04035486), 1L osi + platinum-pemetrexed (pem) chemotherapy (CTx) (n=279) significantly improved PFS vs osi alone (n=278) in EGFRm advanced NSCLC (HR 0.62; 95% CI 0.49, 0.79; p<0.0001 per investigator). Safety of osi + CTx was consistent with individual Tx profiles and was associated with higher incidence of G≥3 AEs vs osi. Most G≥3 AEs occurred during platinum-based CTx induction phase (pem + platinum CTx, 4 cycles Q3W) but reduced during maintenance. We report FLAURA2 PROs. Symptoms, function and HRQoL were measured using EORTC QLQ-C30/LC13 questionnaires (Table). Score (range 0–100) changes from baseline (BL) to progression/19 mos were analysed by a mixed-effects model. A clinically meaningful within-pt change was defined as ≥10 point change from BL. Tolerability was assessed with PRO-CTCAE items. EORTC questionnaire completion/PRO-CTCAE visit compliance was ≥80/≥75% to Wk 82. Non-clinically meaningful improvements in global health status/quality of life (GHS/QoL) and physical function were seen in both arms: average least-squares mean (LSM) change in GHS/QoL from BL (95% CI) over all visits was 3.32 (1.67, 4.98) with osi + CTx and 7.38 (5.70, 9.07) with osi. Non-clinically meaningful worsening of fatigue/appetite loss (LSM change from BL 95% CI) was seen with osi + CTx in induction (10 wks: 2.98 0.65, 5.32/9.30 6.13, 12.46), but improved during maintenance (28 wks: -0.33 -2.66, 2.00/5.52 2.60, 8.44). A trend to improvement in dyspnoea, chest pain and cough was seen in both arms; clinically meaningful improvement for cough from Wks 5 (osi + CTx) and 6 (osi). PRO-CTCAE results showed osi + CTx and osi were similarly well tolerated except nausea/vomiting (more common with osi + CTx). A trend to improved HRQoL and several symptoms was seen after induction CTx. Negative changes in HRQoL from adding CTx to osi were not clinically meaningful and were mostly transient (trended back to BL post-induction CTx).Table: 9PMedian total study drug exposure, mos (range) at data cut-off 3 Apr 2023Osi + CTx: Platinum CTx, 2.8 (0.7, 4.1); Pem, 8.3 (0.7, 33.8); Osi, 22.3 (0.1, 33.8)Osi alone: 19.3 (0.1, 33.8)PRO toolPrespecified primary scalesScheduleEORTC QLQ-C30GHS/QoL, physical function, fatigue, appetite lossBL, Q3W to Wk 10 decreased symptom score = improved symptom burden Open table in a new tab