KEY TAKEAWAYS
- The MARIPOSA phase III trial aimed to compare the efficacy and safety of amivantamab plus lazertinib vs osimertinib in EGFR-mutated NSCLC Asian patients.
- The primary endpoint was PFS. Secondary endpoints included ORR, DoR, and safety.
- Amivantamab plus lazertinib outperformed osimertinib in Asian EGFR-mutant NSCLC with comparable safety across populations.
Amivantamab-lazertinib (ami-laz) is a new drug combination targeting two critical gene alterations in NSCLC: EGFR and MET. It has shown promise in early studies. Osimertinib (osi) is a current standard treatment for EGFR-mutated NSCLC. So, for the study, researchers aimed to compare the efficacy and safety of ami-laz versus osi in EGFR-mutated NSCLC Asian patients.
Patients were randomized (2:2:1) ratio to administered ami-laz, osi, or laz. The primary endpoint was progression-free survival (PFS), evaluated by a blinded independent central review based on RECIST v1.1. Secondary endpoints were duration of response (DoR), objective response rate (ORR), and safety.
Of the 1074 randomized patients, 629 were Asian, with 250/429 and 251/429 allocated to the ami-laz and osi arms, respectively. Among Asian patients, the median age was 63 years, 61%/57% were female, and 44%/43% had a history of brain metastases for ami-laz/osi. At a median follow-up of 22.5 months, ami-laz demonstrated a 35% reduction in the risk of disease progression or death compared to osi in Asian patients (HR, 0.65; 95% CI, 0.50–0.83; P<0.001), with a median PFS of 27.5 vs. 18.3 months, comparable to the overall population.ORR was 88% (95% CI, 84–92) for ami-laz vs. 85% (95% CI, 80–90) for osi (OR, 1.29; 95% CI, 0.76–2.17). The median DoR among confirmed responders was 26.1 months for ami-laz vs. 17.5 months for osi.
Adverse event (AE) rates in Asian patients were similar to the overall MARIPOSA population. EGFR- and MET-related AEs were higher for ami-laz except for diarrhea, which was higher for osi. Venous thromboembolisms (VTEs) were increased for ami-laz, primarily grade 1-2 events occurring in the first 4 months, and effectively managed with anticoagulants. Interstitial lung disease (ILD) incidence was low and similar across arms.
The results showed that amivantamab plus lazertinib outperformed osimertinib in Asian EGFR-mutant NSCLC with comparable safety across populations.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/27
Clinical Trial: https://clinicaltrials.gov/study/NCT04487080
Lu S, Cho BC, Lee JS, Lee SH, Danchaivijitr P, Liu B, Alip A, Xiong H, How SH, Chang GC, Yang JCH, Yoshioka H, Xia K, Martinez M, Bauml JM, Sethi S, Hayashi H. Amivantamab plus lazertinib vs osimertinib as first-line treatment among Asian patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC): MARIPOSA subgroup analysis. Presented at the European Society for Medical Oncology (ESMO) Asia Annual Meeting, Presentation Number LBA10, Lecture Time 10:45 AM – 10:55 AM.
