KEY TAKEAWAYS
- The MARIPOSA-2 phase 3 trial aimed to assess the efficacy of ami in combination with chemo compared to chemo alone in Asian patients with EGFR-mutated NSCLC pts.
- The reported primary endpoint was PFS.
- The result concluded that Ami-chemo improves PFS for Asian NSCLC pts with minimal safety concerns.
Amivantamab (ami) and lazertinib (laz) are targeted therapies for EGFR-mutated non-small cell lung cancer (NSCLC). The MARIPOSA-2 study demonstrated that ami combined with carboplatin-pemetrexed (chemo) significantly improved progression-free survival (PFS) compared to chemo alone, with a notable benefit in global patients. Given the high prevalence of EGFR-mutated NSCLC in Asian populations.
In this study, Victor H. Lee and other researchers specifically assessed the effectiveness of ami-chemo vs. chemo in Asian patients to examine the treatment outcomes by race.
In the interventional study, patients were randomly assigned in a 2:2:1 ratio to receive either a combination of ami-laz-chemo, chemo alone, or ami-chemo. Due to modifications in the ami-laz-chemo arm during the study, data for this group will be presented at a later stage with extended follow-up.
In the report, they focused on the primary endpoint, PFS, comparing ami-chemo to chemo based on blinded independent central review using RECIST v1.1 criteria. Secondary endpoints included Objective Response Rate (ORR), intracranial PFS, and safety outcomes.
Of 657 randomized patients, 63 out of 131, and 127 out of 263 Asian patients were allocated to the ami-chemo and chemo arms. At a median follow-up of 9.5 months, ami-chemo demonstrated a substantial 46% reduction in the risk of disease progression or death compared to chemo (HR 0.54; 95% CI, 0.37–0.81; P=0.002). The median PFS for ami-chemo was 6.8 months, contrasting with 4.2 months for chemo, a result consistent with the overall study population
The ORR for ami-chemo was 66% (95% CI, 53–78), significantly higher than the 32% (95% CI, 24–41) observed with chemo (Odds Ratio, 4.04; 95% CI, 2.13–7.67; P<0.001). Median intracranial PFS was 12.45 months for ami-chemo compared to 8.5 months for chemo (HR, 0.58; 95% CI, 0.34–1.00; P=0.049).
Adverse event (AE) rates in Asian patients were comparable to the overall MARIPOSA-2 population. The most frequent treatment-emergent AEs (TEAEs) in the ami-chemo arm were transient neutropenia and thrombocytopenia, predominantly occurring during Cycle 1. These events were nonserious and associated with low rates of febrile neutropenia and bleeding complications.
The result concluded that in Asian patients, ami-chemo exhibited a superior PFS compared to chemo. Although there were higher occurrences of hematologic toxicities in the ami-chemo arm, they were mostly transient and had minimal clinical impact. These findings aligned with the outcomes observed in the overall study population.
This study is sponsored by Janssen Research & Development, LLC.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/27
Clinical trials: https://clinicaltrials.gov/study/NCT03456076
https://clinicaltrials.gov/study/NCT04988295
Shih JY, Wang J, Wang Y, et al. “Amivantamab plus chemotherapy vs chemotherapy among Asian patients with EGFR-mutant advanced NSCLC after progression on osimertinib: A MARIPOSA-2 subgroup analysis” Presented at ESMO ASIA Congress 2023″, (Abstract: LBA11).
