KEY TAKEAWAYS
- The MARIPOSA phase 3 trial aimed to investigate the effectiveness and safety of ami+laz treatment among patients experiencing ami dose interruptions.
- The results showed that early dose modifications of ami per protocol did not impact the efficacy of ami+laz.
Amivantamab (ami), an EGFR-MET bispecific antibody, and lazertinib (laz), a CNS-penetrant 3rd-generation EGFR TKI, constitute first-line therapy. In patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC), ami+laz outperformed osimertinib in progression-free survival (PFS) (Cho Ann Oncol 2023).
Protocol guidelines in the MARIPOSA study (NCT04487080) advised ami dose interruption for related grade ≥2 toxicity. For patients receiving first-line ami+laz, the most significant adverse events occurred within the initial 4 months (mo) (Spira JTO 2023).
Maria Rosario Garcia Campelo and the team spearheaded a study to assess the efficacy and safety of ami+laz in patients who experienced ami dose interruptions within the initial 4 months.
All patients allocated to the ami+laz arm in MARIPOSA were included in the analysis (efficacy set: n=429, safety set: n=421). The study protocol mandated ami dose modifications before laz. Dose interruptions included any cessation of ami for any reason.
About 429 patients were randomized, and 421 received at least one dose in the ami+laz arm. Of these, 49% (206/421) experienced ami dose interruptions within the initial 4 months. The median follow-up was 22.0 months.
For patients with ami dose interruptions within the first 4 months, the median PFS was 23.9 months (95% CI, 18.5–NE). Comparable to all patients in the ami+laz arm, median PFS, objective response rate (ORR), and median duration of response (DoR) were observed among those with and without ami dose interruptions in the initial 4 months.
The results showed that the early dose adjustments of ami per protocol did not adversely affect the effectiveness of the ami+laz combination, now established as the new first-line standard of care for patients with EGFR-mutant advanced NSCLC. Updated analyses will be presented during the meeting, including the impact of dose interruptions on treatment tolerability.
The trial was sponsored by Janssen Research & Development, LLC.
Clinical Trial: https://clinicaltrials.gov/study/NCT04487080
Garcia Campelo MR, Cho BC, Girard N, et al. (2024) ” Effect of amivantamab dose interruptions on efficacy and safety of first-line amivantamab plus lazertinib in EGFR-mutant advanced NSCLC: Exploratory analyses from the MARIPOSA study.” Presented at ELCC 2024. Annals of Oncology (2024) 9 (suppl_3): 1-53. 10.1016/esmoop/esmoop102569 (5MO)
