{"id":830129,"date":"2025-03-26T11:48:14","date_gmt":"2025-03-26T15:48:14","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and-unprecedented-overall-survival-benefit-in-patients-with-egfr-mutated-non-small-cel\/"},"modified":"2025-03-26T11:48:14","modified_gmt":"2025-03-26T15:48:14","slug":"rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and-unprecedented-overall-survival-benefit-in-patients-with-egfr-mutated-non-small-cel","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and-unprecedented-overall-survival-benefit-in-patients-with-egfr-mutated-non-small-cel\/","title":{"rendered":"RYBREVANT\u00ae (amivantamab-vmjw) plus LAZCLUZE\u2122 (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Median overall survival not yet reached with projected improvement of more than one year versus osimertinib<\/i>\n <\/p>\n

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\n RARITAN, N.J.<\/span>
\n <\/span>, March 26, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Johnson & Johnson\u00a0(NYSE:JNJ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT\u00ae<\/sup> (amivantamab-vmjw) plus LAZCLUZE\u2122 (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR<\/i>) exon 19 deletions (ex19del) or L858R substitution mutations. Median OS is projected to exceed one year beyond the median of three years observed with\u00a0osimertinib and has not yet been reached. This is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib. New compelling data were presented during a proffered paper session at the 2025 European Lung Cancer Congress (ELCC)<\/a> (Abstract #4O).1<\/sup><\/p>\n

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\n \"(PRNewsfoto\/Johnson
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“The survival curve tells a clear story. RYBREVANT plus LAZCLUZE helps patients live longer, and the benefit keeps growing over time,” said trial investigator Professor Nicolas Girard<\/span>*, M.D., Ph.D., Head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris-Saclay University, France<\/span>. “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<\/i>-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.”<\/p>\n

Unlike progression-free survival (PFS), which tracks the time a treatment keeps a patient’s cancer from progressing, OS helps patients understand the impact therapy could have on the ability to live longer from the start of treatment. Extending life expectancy is the most meaningful indicator of a treatment’s impact.<\/p>\n

At a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line RYBREVANT\u00ae<\/sup> plus LAZCLUZE\u2122 had a significantly longer OS compared to those receiving osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92; nominal P<0.005). Median OS for RYBREVANT\u00ae<\/sup> plus LAZCLUZE\u2122 has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period (not reached [NR]; 95 percent CI, 42.9-NR). Comparatively, median OS for osimertinib-treated patients was 36.7 months (95 percent CI, 33.4-41.0) and consistent with prior studies with osimertinib. Fifty-six percent of patients treated with RYBREVANT\u00ae<\/sup> and LAZCLUZE\u2122 were alive at three and a half years compared to 44 percent of patients on osimertinib. Projections based on survival data suggest RYBREVANT\u00ae<\/sup> plus LAZCLUZE\u2122 could extend median OS by at least 12 months compared to osimertinib.1<\/sup><\/p>\n

The RYBREVANT\u00ae<\/sup> combination also prolonged multiple secondary endpoints vs osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR).\u00a0Notably, RYBREVANT\u00ae<\/sup> plus LAZCLUZE\u2122 prolonged time to symptomatic progression (TTSP) \u2013 the time from treatment randomization to the onset of lung cancer symptoms \u2013 by more than 14 months compared to osimertinib (43.6 months vs 29.3 months; HR, 0.69; 95 percent CI, 0.57\u20130.83; nominal P<0.001). This is a key patient-centered measure, highlighting how long quality of life can be preserved before lung cancer symptoms emerge.1<\/sup><\/p>\n

“Right now, only twenty percent of patients with EGFR-<\/i>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,”\u00a0said Joshua Bauml<\/span>, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader,\u00a0Johnson & Johnson\u00a0Innovative Medicine. “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.”<\/p>\n

The safety profile of RYBREVANT\u00ae<\/sup>\u00a0plus LAZCLUZE\u2122 was consistent with the primary analysis, with adverse event (AE) rates comparable to other RYBREVANT\u00ae<\/sup>\u00a0regimens. No new safety signals were identified with the additional longer-term follow-up. Most AEs occurred early during RYBREVANT\u00ae<\/sup>\u00a0and LAZCLUZE\u2122 treatment.1<\/sup>\u00a0RYBREVANT\u00ae<\/sup> research findings suggest that implementing prophylactic measures during the first four months of RYBREVANT\u00ae<\/sup>\u00a0and LAZCLUZE\u2122 treatment may significantly reduce the risk of skin reactions, infusion-related reactions and venous thromboembolic events.2,3,4<\/sup><\/p>\n

The MARIPOSA study met its primary endpoint<\/a>\u00a0in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib. \u00a0<\/p>\n

RYBREVANT\u00ae<\/sup>\u00a0plus LAZCLUZE\u2122 is approved in the United States<\/span>, Europe<\/span> and other markets\u00a0around the world for patients with first-line EGFR<\/i>-mutated NSCLC. These OS results will be shared with health authorities globally.<\/p>\n

\n About the MARIPOSA Study<\/b>\n <\/p>\n

MARIPOSA (NCT04487080<\/a>), which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating RYBREVANT\u00ae\u00a0<\/sup>in combination with LAZCLUZE\u2122\u00a0versus osimertinib and versus LAZCLUZE\u2122\u00a0alone in first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR <\/i>ex19del or substitution mutations. The primary endpoint of the study is PFS (using RECIST v1.1 guidelines**) as assessed by BICR. Secondary endpoints include OS, ORR, DOR, PFS2 and intracranial PFS.5<\/sup><\/p>\n

\n About\u00a0RYBREVANT\u00ae\u00a0<\/sup><\/b>\u00a0<\/p>\n

RYBREVANT\u00ae<\/sup>\u00a0(amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR<\/i> and MET with immune cell-directing activity, is approved in the\u00a0U.S.<\/a>,\u00a0Europe<\/span><\/a>\u00a0and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.6<\/sup><\/p>\n

RYBREVANT\u00ae<\/sup>\u00a0is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 20 insertion mutations, as detected by an FDA-approved test.\u00a0\u00a0<\/p>\n

RYBREVANT\u00ae<\/sup> is approved in the U.S.,<\/a>\u00a0Europe<\/span><\/a>\u00a0and other markets around the world in combination with LAZCLUZE\u2122 (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.<\/p>\n

RYBREVANT\u00ae<\/sup> is approved in the U.S.<\/a>, Europe<\/span><\/a>\u00a0and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR<\/i> exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR<\/i> TKI.<\/p>\n

In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)\u00a0recommended<\/a>\u00a0the approval of SC amivantamab\u00a0and LAZCLUZE\u2122 in Europe<\/span> for the first-line treatment of adult patients with advanced NSCLC with EGFR<\/i> exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR<\/i> exon 20 insertion mutations after failure of platinum-based therapy.<\/p>\n

The National Comprehensive Cancer Network\u00ae <\/sup>(NCCN\u00ae<\/sup>) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae<\/sup>) for NSCLC\u00a7<\/sup>\u00a0prefer next-generation sequencing\u2013based strategies over polymerase chain reaction\u2013based approaches for the detection of EGFR<\/i> exon 20 insertion variants. The NCCN Guidelines include:\u00a0<\/p>\n