KEY TAKEAWAYS
- The PAPILLON subgroup phase 3 study aimed to compare ami-chemo vs chemo efficacy in Asian patients.
- The primary endpoint of the study was to access PFS.
- The result concluded that ami-chemo showed superior PFS with a well-tolerated safety profile.
In the phase 3 PAPILLON study, Amivantamab (ami), an EGFR-MET bispecific antibody, demonstrated significant progression-free survival (PFS) improvement in treatment-naive patients with Ex20ins advanced non-small cell lung cancer (NSCLC) as compared to traditional chemotherapy (chemo). Given the higher incidence of EGFR mutations in Asians, Byoung Chul Cho and his research group conducted a focused evaluation of ami-chemo versus chemo in this population based on race.
In the interventional study, patients were randomly assigned in a 1:1 ratio to receive a combination of amivantamab and chemo or chemo alone. The study’s primary objective was to assess PFS through an anonymous independent central review. Additional objectives included evaluating the objective response rate (ORR), PFS following the first subsequent therapy (PFS2), overall survival (OS), and monitoring safety. Patients in the chemo arm who experienced disease progression were permitted to switch to ami monotherapy.
The study was conducted on randomized 308 patients (pts). Among those, 186 were Asian (ami-chemo, 97; chemo, 89); the median age was 57/62 years, 56%/58% female, and 21%/25% had a history of brain metastases for ami-chemo/chemo, respectively. At a median follow-up of 16.6 months, the median PFS for Asian pts was 11.5 months (95% CI, 9.8–13.7) for ami-chemo vs 5.6 months (95% CI, 4.9–7.0) for chemo (HR, 0.34; 95% CI, 0.23–0.49; P<0.001); this was comparable to the overall population. The 18-month PFS rate was 31% for ami-chemo vs 3% for chemo. ORR was 70% (95% CI, 60–79) for ami-chemo vs 51% (95% CI, 40–62) for chemo (odds ratio, 2.16; 95% CI, 1.19–3.93; P=0.012).
Median PFS2 was not estimable for ami-chemo vs 18.8 months for chemo (HR, 0.46; 95% CI, 0.26–0.83; P=0.008). Median interim OS was not estimable vs 24.4 months for ami-chemo vs chemo (HR, 0.65; 95% CI, 0.34–1.24; P=0.189) despite crossover among chemo-randomized pts who had progressed. AE rates in Asian pts were similar to the overall PAPILLON population. The most common ami-chemo treatment-emergent adverse events (TEAEs) (>50%) were paronychia, neutropenia, rash, anemia, and leukopenia; no new safety signals. Discontinuation of ami due to treatment-related AEs was 8%.
The study demonstrated that in Asian patients, the combination of ami and chemo showed better PFS compared to just chemo, and the safety profile was acceptable. These findings align with the results observed in the entire study population. This study is sponsored by Janssen Research & Development, LLC.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/45
Clinical trial: https://clinicaltrials.gov/study/NCT04538664
Zhou C, Tang K, Liu B, et al. “Amivantamab plus chemotherapy vs chemotherapy as a first-line treatment among Asian patients with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer (NSCLC): PAPILLON subgroup analysis”. Presented at ESMO ASIA 2023. (Abstract: 513MO)
