J&J : RYBREVANT + LAZCLUZE Outperforms Osimertinib In Phase 3 Trial For EGFR-Mutated Lung Cancer

Johnson & Johnson

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(RTTNews) - Johnson & Johnson (JNJ) announced results for the gold standard endpoint in cancer treatment of overall survival or OS from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer or NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

Median OS is projected to exceed one year beyond the median of three years observed with osimertinib 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, the company said.

According to the company, at a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line RYBREVANT plus LAZCLUZE had a significantly longer OS compared to those receiving osimertinib. Median OS for RYBREVANT plus LAZCLUZE has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period. Comparatively, median OS for osimertinib-treated patients was 36.7 months and consistent with prior studies with osimertinib. Fifty-six percent of patients treated with RYBREVANT and LAZCLUZE were alive at three and a half years compared to 44 percent of patients on osimertinib. Projections based on survival data suggest RYBREVANT plus LAZCLUZE could extend median OS by at least 12 months compared to osimertinib.

The company also announced that RYBREVANT combination prolonged multiple secondary endpoints vs osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR). Notably, RYBREVANT plus LAZCLUZE prolonged time to symptomatic progression (TTSP) - the time from treatment randomization to the onset of lung cancer symptoms - by more than 14 months compared to osimertinib . This is a key patient-centered measure, highlighting how long quality of life can be preserved before lung cancer symptoms emerge.

The company stated that the safety profile of RYBREVANT plus LAZCLUZE was consistent with the primary analysis, with adverse event (AE) rates comparable to other RYBREVANT regimens. No new safety signals were identified with the additional longer-term follow-up. Most AEs occurred early during RYBREVANT and LAZCLUZE treatment. RYBREVANT research findings suggest that implementing prophylactic measures during the first four months of RYBREVANT and LAZCLUZE treatment may significantly reduce the risk of skin reactions, infusion-related reactions and venous thromboembolic events.

The MARIPOSA study met its primary endpoint in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib. RYBREVANT plus LAZCLUZE is approved in the United States, Europe and other markets around the world for patients with first-line EGFR-mutated NSCLC. These OS results will be shared with health authorities globally.