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RYBREVANT▼ (amivantamab) plus lazertinib show strong favourable overall survival trend versus osimertinib in EGFR-mutated advanced lung cancer

September 8, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – IASLC 2024, Johnson & Johnson, Johnson & Johnson Innovative Medicine, NSCLC

New longer-term data from the MARIPOSA study confirm superior outcomes of amivantamab plus lazertinib regimen compared to osimertinib monotherapy as first-line therapy
Results from an interim analysis featured in late-breaker oral presentation at WCLC

8 September 2024 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with RYBREVANT®▼ (amivantamab) combined with lazertinib provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. The data show a strong and improving overall survival (OS) trend favouring amivantamab plus lazertinib at approximately three years of follow-up. 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) taking place in San Diego, California from 7-10 September (Abstract #1146).

At 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 based on an analysis performed at the request of a health authority* (Median OS not estimable [NE] vs 37.3 months; hazard ratio [HR]=0.77; 95 percent confidence interval [CI], 0.61-0.96; nominal P=0.019). Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint. The primary efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR).
“By combining the multi-targeted mechanism of amivantamab with lazertinib, a central nervous system penetrant third-generation tyrosine kinase inhibitor, we are advancing a chemotherapy-free regimen for the first-line treatment of patients with EGFR-mutant NSCLC. This approach blocks EGFR and METpathways and leverages the immune system, offering patients an opportunity for prolonged benefits,” said Shirish M. Gadgeel, M.D., Chief of Division of Hematology and Oncology, Associate Director at Henry Ford Cancer Institute and presenting author.** “Even more encouraging is the marked improvement in the hazard ratio and the ongoing separation of survival curves, showing an eight percent improvement at three years for amivantamab plus lazertinib compared to osimertinib. This supports the long-term benefit of the combination as a first-line treatment option in this setting.”

Results further showed amivantamab plus lazertinib demonstrated a trend toward improved central nervous system disease control compared to osimertinib at three years (HR=0.82; 95 percent CI, 0.62-1.09; nominal P=0.165). At the three-year landmark, intracranial PFS was double for amivantamab plus lazertinib versus osimertinib (38 percent vs 18 percent, respectively). More patients remained on treatment at three years with the amivantamab combination compared to osimertinib (40 percent vs 29 percent, respectively; HR=0.80; 95 percent CI, 0.68-0.96; nominal P=0.014). Additionally, more patients receiving amivantamab and lazertinib at the three-year follow up had not started a subsequent therapy versus osimertinib (45 percent vs 32 percent, respectively; HR=0.77; 95 percent CI, 0.65-0.93; nominal P=0.005). Progression-free survival after first subsequent therapy was 57 percent for the amivantamab combination compared to 49 percent for osimertinib (HR=0.73; 95 percent CI, 0.59-0.91; nominal P=0.004).

“At Johnson & Johnson, we are dedicated to advancing lung cancer care, with a focus on delivering precision therapies that can improve outcomes from the earliest stages of treatment,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “These longer-term follow-up results from the MARIPOSA study add to the compelling body of evidence supporting the combination of amivantamab and lazertinib as a potential first-line treatment regimen for patients with EGFR-mutated advanced non-small cell lung cancer.”

“Promising results like these presented at WCLC reinforce our mission to improve the lives of patients diagnosed with lung cancer,” said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “We are encouraged by the favourable overall survival trend observed with amivantamab plus lazertinib and are eager to see how these data evolve as we continue to follow patients over time.”

As previously reported in the MARIPOSA study, the safety profile was consistent with previous reports from Phase 1-2 studies. The rate of discontinuation of all study treatments due to treatment-related adverse events for amivantamab plus lazertinib was 10 percent and 3 percent with osimertinib. The rate of interstitial lung disease (including pneumonitis) was approximately three percent in both arms.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at www.janssen.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea. Janssen Cilag, S.A, Janssen Research & Development, LLC, Janssen-Cilag International NV and Janssen Biotech, Inc., are Johnson & Johnson companies. Visit: www.janssen.com.