RYBREVANT®▼ (amivantamab) plus lazertinib shows favourable overall survival trend in EGFR-mutated advanced non-small cell lung cancer (NSCLC) compared to osimertinib

New longer-term data from the MARIPOSA study demonstrate consistent benefit across post-progression outcomes for chemotherapy-free amivantamab plus lazertinib regimen, compared to osimertinib monotherapy as first-line therapy^[1]

Results featured in a late-breaker oral presentation at the 2024 World Conference on Lung Cancer (WCLC)¹

High Wycombe, UK (11 September, 2024) – Johnson & Johnson today announced longer follow-up data from the Phase 3 MARIPOSA study which demonstrated first-line treatment with RYBREVANT^®▼ (amivantamab) combined with LECLAZA^® (lazertinib) showed a trend towards improved overall survival (OS) compared to osimertinib monotherapy in patients with advanced non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R Exon21 substitution (L858R) mutations at three years of follow up.¹ The data also showed an improvement in post-progression outcomes versus osimertinib.¹ These results were presented in a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) (Abstract #1146) taking place in San Diego, California from 7-10 September.¹

At nearly three years (median follow-up of 31.1 months), 61 percent of patients receiving amivantamab plus lazertinib were alive compared to 53 percent of those treated with osimertinib monotherapy (hazard ratio [HR]=0.77; 95 percent confidence interval [CI], 0.61-0.96; nominal P=0.019).¹ Overall survival will continue to be followed for longer term follow-up as a key secondary endpoint.¹ Post-progression outcomes at a median follow-up of 31.1 months also favoured amivantamab plus lazertinib over osimertinib, including progression-free survival (PFS) after first subsequent therapy (non-evaluable [NE]; 36.0-NE vs. 32.4; 29.3-NE [HR=0.73; 95 percent CI, 0.59-0.91; nominal P=0.004]), median time to treatment discontinuation (26.3 vs. 22.6 [HR=0.80; 95 percent CI, 0.68-0.96; nominal P=0.014]) and time to subsequent therapy (30.0 vs. 24.0 [HR=0.77; 95 percent CI, 0.65-0.93; nominal P=0.005]).¹ At the three-year landmark, intracranial PFS was double for amivantamab plus lazertinib versus osimertinib (38 percent vs 18 percent, respectively; HR, 0.82 (95% CI, 0.62–1.09); P=0.165).¹

While safety data was not reported as part of this abstract, the safety profile of amivantamab and lazertinib, as reported at the European Society for Medical Oncology (ESMO) 2023 Congress, remained consistent with the safety profiles of the individual treatments, with mostly Grade 1 or 2 adverse events (AEs).^[2] Toxicity was largely manageable with dose interruptions and reductions, along with supportive care measures commonly used in the treatment of patients with NSCLC.² The most common Grade 3 or higher treatment-related AEs were rash and paronychia.² Amivantamab plus lazertinib had higher rates of EGFR- and MET-related AEs (hypoalbuminemia and peripheral oedema) and venous thromboembolism (VTE) compared to osimertinib, with higher rates of diarrhoea being observed with osimertinib.² The rate of discontinuation of all study treatments due to treatment-related AEs for amivantamab plus lazertinib was 10 percent.² The rate of interstitial lung disease (including pneumonitis) was less than three percent in both arms.²

“These longer-term follow-up data reinforce our commitment to providing precision therapies that target lung cancer at the earliest possible stage,” said Dr John Fleming, Country Medical Director, Johnson & Johnson Innovative Medicine, UK. “Pushing the boundaries of innovation is crucial to giving patients with EGFR-mutated NSCLC the best possible chance of survival, and we look forward to seeing the MARIPOSA study progress further over time.”

[1] Gadgeel SM, et al. Amivantamab Plus LAZCLUZE™ vs Osimertinib in First-line EGFR-mutant Advanced NSCLC: Longer Follow-up of the MARIPOSA Study. IASLC WCLC 2024. September 8, 2024.

[2] Cho BC, et al. Amivantamab Plus LAZCLUZE™ vs Osimertinib as First-line Treatment in Patients With EGFR-mutated, Advanced Non-small Cell Lung Cancer (NSCLC): Primary Results From MARIPOSA, a Phase 3, Global, Randomized, Controlled Trial. 2023 European Society for Medical Oncology. October 23, 2023.