J&J JNJ recently reported new positive data from the phase III MARIPOSA study, which compared the combination of Rybrevant and Lazcluze against AstraZeneca’s AZN Tagrisso in first-line EGFR-mutated non-small cell lung cancer (“NSCLC”).

Data from the study suggests that the Rybrevant-Lazcluze combo significantly extends overall survival (“OS”) in NSCLC patients with EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution (L858R) mutations.

At a median follow-up of 37.8 months, patients on J&J’s combo therapy showed longer survival, with median OS not yet reached. In contrast, patients treated with the AstraZeneca drug achieved a median OS of 36.7 months. Notably, 56% of patients treated with J&J’s combo therapy were alive at 3.5 years compared with 44% on AstraZeneca’s drug. This data suggests continued benefit of J&J’s therapy over time, based on which study investigators expect that the combo can extend OS by at least a year over Tagrisso.

We remind investors that the MARIPOSA study already achieved its primary endpoint of statistically significant and clinically meaningful improvement in progression-free survival. Based on this data, J&J secured approval for the Rybrevant-Lazcluze combo in the above indication in the United States and European Union (“EU”) last year.

J&J Boasts Rybrevant-Lazcluze Combo as Next Standard of Care

Through this latest data, J&J intends to take the crown from the AstraZeneca drug, which is the current standard of care for EGFR-mutated NSCLC. However, Tagrisso’s convenience as a once-daily pill remains a major advantage. In contrast, J&J’s regimen requires intravenous infusions, adding a layer of complexity that could limit adoption.

A key step for J&J will be securing FDA approval for a subcutaneous version of Rybrevant, which would significantly reduce administration time. However, the company’s initial attempt was rejected in December due to manufacturing concerns. Until this hurdle is cleared, Tagrisso’s ease of use may keep it the preferred option for doctors and patients.

Recent Developments Related to JNJ's Rybrevant

Last month, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval for a subcutaneous version of Rybrevant combined with Lazcluze in the first-line EGFR-mutated NSCLC indication. A final decision is expected later this year.

In September, the FDA approved the combination of Rybrevant and standard-of-care chemotherapy (carboplatin and pemetrexed) for treating adult patients with advanced NSCLC with EGFR ex19del or L858R mutations after failure of prior therapy, including an EGFR-TKI. This combination received approval for a similar use in the EU last year.

Rybrevant also received approval for a third indication in the United States. Last year, the FDA approved the combination of Rybrevant and chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The combination is also approved for a similar indication in the EU.

Apart from NSCLC, J&J is also developing Rybrevant in other NSCLC settings. The company is evaluating the drug across multiple clinical studies as monotherapy or in combination with drugs like Novartis’ NVS Tabrecta (capmatinib) and docetaxel.

The FDA approved Novartis’ Tabrecta in 2020 under the accelerated pathway to treat adults with metastatic NSCLC whose tumors have a mutation leading to MET exon 14 skipping. This Novartis drug was granted full approval by the FDA in 2022.

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