7P Patient-relevant endpoints from PAPILLON: Amivantamab plus chemotherapy vs chemotherapy as first-line treatment of EGFR exon 20 insertion-mutated (Ex20ins) advanced NSCLC
Résumé
Amivantamab (ami) is an EGFR-MET bispecific antibody with immune cell-directing activity. In PAPILLON (NCT04538664), ami plus carboplatin-pemetrexed (ami-chemo) significantly prolonged progression-free survival (PFS) vs chemo (median, 11.4 vs 6.7 months [mo]; HR, 0.40; [95% CI, 0.30–0.53]; P<0.001; Zhou NEJM 2023). We evaluated time to symptomatic progression (TTSP) and patient-reported outcomes (PROs) from PAPILLON. These analyses included 153 patients (pts) randomized to ami-chemo and 155 to chemo (intent-to-treat population [ITT]) who died or discontinued treatment. TTSP was defined as time from randomization to onset of new/worsening lung cancer symptoms requiring change in anticancer therapy, another clinical intervention, or death, whichever occurred first. PROs were measured using the EORTC-QLQ-C30 and PROMIS-PF 8c instruments; P values were nominal. At a median follow-up of 14.9 mo, median TTSP was significantly longer for ami-chemo vs chemo (NE vs 20.1 mo; HR, 0.67 [95% CI, 0.46–0.98]; P=0.04). Median treatment duration was 9.7 mo for ami-chemo and 6.7 mo for chemo. At 6 mo (189 days), the percentage of ITT pts with improved/stable physical functioning relative to baseline was 54% for ami-chemo vs 41% for chemo (P<0.02). There were higher percentages of pts with improved or stable emotional functioning (63% vs 47%; P=0.01), cognitive functioning (47% vs 38%), role functioning (50% vs 41%), and global health status (51% vs 42%) for ami-chemo vs chemo, respectively (P>0.05 for all). At 6 mo, 43% vs 25% of pts reported no dyspnea (P<0.01), 36% vs 31% reported no pain (P>0.05), and 18% vs 8% reported no fatigue for ami-chemo vs chemo (P<0.02), respectively. Updated results will include data from PROMIS-PF 8c. Ami-chemo significantly prolonged time to symptomatic progression vs chemo. More pts in the ITT population reported improved or stable functioning and absence of lung cancer-related symptoms for ami-chemo vs chemo. The deeper tumor responses and improved disease control observed with ami-chemo corresponded with improved patient-relevant endpoints in first-line EGFR Ex20ins advanced NSCLC.