Johnson & Johnson posts Phase 3 win for lung cancer therapy
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The Janssen unit of Johnson & Johnson (NYSE:JNJ) announced Thursday that its bispecific antibody Rybrevant in a combination regimen outperformed AstraZeneca's (AZN) tyrosine kinase inhibitor osimertinib as a first-line therapy in certain patients with lung cancer.
Citing topline data, Janssen said that its pivotal Phase 3 MARIPOSA study met the primary endpoint as Rybrevant plus Lazertinib improved progression-free survival (PFS) compared to osimertinib, a tyrosine kinase inhibitor marketed as Tagrisso.
The changes were statistically significant and clinically meaningful, according to the company.
Rybrevant (amivantamab-vmjw) is already indicated in the U.S. under the FDA's accelerated approval as a second-line option for adults with non-small cell lung cancer (NSCLC) with a gene mutation called EGFR exon 20 insertions.
The open-label MARIPOSA trial enrolled more than 1,000 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or substitution mutations.
The safety profile of the combo was found to be consistent with past data. There was a trend favoring Rybrevant plus Lazertinib in terms of overall survival (OS), one of MARIPOSA's secondary endpoints.
The company will advance the study further to evaluate OS data for clinical and statistical significance.
"Positive topline results from the MARIPOSA study reinforce the potential of the RYBREVANT and lazertinib combination in frontline EGFR-mutated non-small cell lung cancer as a future standard of care," remarked Peter Lebowitz, Janssen's head of oncology.

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