Johnson & Johnson ( JNJ ) 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 AstraZeneca Plc ( AZN )‘s Tagrisso (osimertinib) showed Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) significantly extended OS in the first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

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Johnson & Johnson ( JNJ ) said in a Wednesday press release that the median OS is projected to exceed one year beyond the median of three years observed with osimertinib and has not yet been reached.

The pharma giant says this is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib.

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 than 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.

56% of patients treated with Rybrevant plus Lazcluze were alive at three and a half years, compared to 44% of patients on osimertinib.

The Rybrevant plus Lazcluze combination also prolonged multiple secondary endpoints vs. osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR). 

Rybrevant plus Lazcluze prolonged the time to symptomatic progression—the time from treatment randomization to the onset of lung cancer symptoms—by more than 14 months compared to osimertinib (43.6 months vs. 29.3 months).

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 worldwide for patients with first-line EGFR-mutated NSCLC.

Price Action: JNJ stock is up 0.58% at $161.96 at the last check Wednesday.

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