European Commission approves new first-line treatment for NSCLC

Cancer survivor and friend outside

Patients who have non-small cell lung cancer (NSCLC) may have a newly approved treatment option if they live under the jurisdiction of the European Commission (EC). Topline data from the phase 3 MARIPOSA study demonstrated superior overall survival benefit of amivantamab (Rybrevant) plus lazertinib (Lazcluze)compared to osimertinib, the current standard of care.

Janssen-Cilag International NV, a Johnson & Johnson company, announced the EC approval on Jan. 21, 2025. The first-line treatment supports adults with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

The study met its primary endpoint of progression-free survival (PFS) as well as its final pre-specified endpoint of overall survival (OS), demonstrating clinically meaningful and statistically significant improvement in OS compared to the current standard of care, osimertinib monotherapy. Median OS is expected to exceed one year.

Prior results from the MARIPOSA study showed the safety profile of amivantamab in combination with lazertinib to be consistent with phase 1-2 study findings, with mostly Grade 1 or 2 adverse events. The most common treatment emergent adverse events of any grade were paronychia (68%), infusion-related reactions (63%) and rash (62%). Toxicity was largely manageable with dose interruptions and reductions, along with supportive care measures commonly used to treat NSCLC.

“[The] approval marks an important moment in lung cancer care, bringing a new option to patients through a chemotherapy-free regimen and potentially offering more time with their loved ones,” said Henar Hevia, PhD, senior director, EMEA Therapeutic Area Lead, Oncology.

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