Johnson & Johnson Releases New Data from Phase III MARIPOSA Trial of Rybrevant-Lazcluze Combination in Non-Small Cell Lung Cancer
Compared to osimertinib, Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) significantly extended overall survival.
Johnson & Johnson has shared new, positive data from the Phase III MARIPOSA clinical trial of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. Compared head-to-head with osimertinib, the Rybrevant-Lazcluze combination demonstrated a significantly extended rate of overall survival (OS).1
The OS improvement over osimertinib for Rybrevant plus Lazcluze was achieved at a median follow up of 37.8 months. The median OS has not yet been reached, but it is projected to exceed one year beyond the median of three years observed with osimertinib according to J&J. Of patients treated with Rybrevant plus Lazcluze, 56% were alive at 3.5 years compared to 44% on osimertinib.
In a press release, trial investigator, Professor Nicolas Girard, MD, PhD, head of medical oncology, Institut Curie, and professor of thoracic oncology and respiratory medicine at the Paris-Saclay University, France, said: "The survival curve tells a clear story. Rybrevant plus Lazcluze helps patients live longer, and the benefit keeps growing over time. We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients. These results reinforce that we are entering a new era for EGFR-mutated non-small cell lung cancer; with this evidence in hand, we need to ensure every patient gets the most effective treatment in the first line for the best possible chance at longer survival."
The combination also shined across multiple secondary endpoints, including intracranial progression free survival (PFS), intracranial duration of response, and intracranial overall response rate. Additionally, Ryrbrevant plus Lazcluze prolonged time to symptomatic progression by over 14 months compared to osimertinib.
"Right now, only twenty percent of patients with EGFR-positive NSCLC survive beyond five years. These MARIPOSA results suggest that Rybrevant plus Lazcluze can change this dire statistic that has been stagnant for far too long," Joshua Bauml, MD, vice president, lung cancer disease area stronghold leader, Johnson & Johnson Innovative Medicine, said in the press release. "This regimen isn't just extending survival, it's offering hope. By using Rybrevant plus Lazcluze first, we're delaying the need for chemotherapy and giving patients and their families more time."
Outcomes from the MARIPOSA study have seen much success dating back to October 2023 when J&J announced it had met its primary endpoint of PFS. Data from the time showed median PFS, at a follow up of 22 months, was 23.7 months for Rybrevant plus Lazcluze compared to 16.6 months for osimertinib. Over 1,000 patients were enrolled in MARIPOSA.2
In an earlier press release, Peter Lebowitz, MD, PhD, global therapeutic area head, oncology, Janssen Research & Development, LLC, said: “Rybrevant is a first-in-class bispecific antibody that targets major oncogenic driver pathways and, when combined with lazertinib, may lead to a more complete and synergistic response against the tumor. The prolonged duration of progression-free survival and favorable trend in overall survival observed in the MARIPOSA study show the potential of Rybrevant in combination with lazertinib to transform first-line treatment in EGFR-mutated NSCLC.”
References
1. RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer. News release. Johnson & Johnson. March 26, 2025. Accessed March 26, 2025. https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and-unprecedented-overall-survival-benefit-in-patients-with-egfr-mutated-non-small-cell-lung-cancer-302412036.html
2. Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer. News release. Johnson & Johnson. October 23, 2023. Accessed March 26, 2025. https://www.jnj.com/media-center/press-releases/landmark-phase-3-mariposa-study-shows-rybrevant-amivantamab-vmjw-plus-lazertinib-resulted-in-30-percent-reduction-in-risk-of-disease-progression-or-death-compared-to-osimertinib-in-patients-with-egfr-mutated-non-small-cell-lung-cancer
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