Dr Felip on Updated Efficacy Data From the Phase 3 MARIPOSA Trial

“We now have rules to manage and prevent AEs. [Considering these rules,] I believe combinations should be the new standard of care.”

Enriqueta Felip, MD, PhD, a professor of medicine at Universitat de Vic, as well as the head of the Thoracic and Head and Neck Cancer Unit at Vall d’Hebron Hospital, discussed efficacy data from the phase 3 MARIPOSA trial (NCT04487080), specifically overall survival (OS) data.

MARIPOSA was an international, randomized trial, that evaluated amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) (n = 429) compared with osimertinib (Tagrisso; n = 429) monotherapy in patients with EGFR-mutated non–small cell lung cancer (NSCLC). Data from the trial supported the August 2024 FDA approval of first-line amivantamab plus lazertinib in advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Felip began by outlining the OS improvement shown in the trial for amivantamab plus lazertinib compared with osimertininb monotherapy (HR, 0.70; 95% CI, 0.58-0.85; P < .001). Felip noted that these results are important to discuss with patients, however, she added that adverse effects (AEs) do occur with the combination.

Regarding safety, common AEs that were observed in at least 20% of patients included rash, nail toxicity, musculoskeletal pain, edema, stomatitis, and fatigue. Felip noted that there are approaches to manage the AEs of the MARIPOSA combination, adding that being able to manage these further support combination therapies as a standard of care in the space.

Felip also mentioned efficacy data from the phase 3 FLAURA 2 (NCT04035486) study that supported the FDA approval of osimertinib plus chemotherapy in February 2024. The study evaluated osimertininb plus chemotherapy (n = 279) compared with osimertinib alone (n = 278) in patients with EGFR-mutated NSCLC. Data from the trial showed that the median progression-free survival was 25.5 months (95% CI, 24.7-not evaluable) in the combination arm vs 16.7 months (95% CI, 14.1-21.3) in the monotherapy arm (n = 278; HR, 0.62; 95% CI, 0.49-0.79; 2-sided P <.0001). Felip concluded that OS was also improved in the combination arm, further supporting combination therapies as the standard of care.