Janssen submits application to EMA for amivantamab-based lung cancer regimen in new indication

Today, the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT^®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI).

This submission is supported by data from the Phase 3 MARIPOSA-2 study, which featured in a Late-Breaking Presidential Symposium session at the ESMO 2023 Congress and was simultaneously published in Annals of Oncology.

Data highlights are as follows:

• In the Phase 3 MARIPOSA-2 study, amivantamab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 52 percent in patients with EGFR-mutated NSCLC who progressed on or after osimertinib (hazard ratio [HR]=0.48; 95 percent confidence interval [CI], 0.36–0.64; P<0.001).
• The safety profile for amivantamab plus chemotherapy was consistent with that of the individual components and no new safety signals were found for the addition of amivantamab to chemotherapy.

What does this mean for patients and the medical community?  

• In Europe, it is estimated that 477,534 patients were diagnosed with lung cancer in 2020. NSCLC accounts for 85 percent of all lung cancer cases.

• Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division. EGFR ex19del or L858R mutations are the most common EGFR mutations.
• The five-year survival rate for people with advanced, EGFR-mutated NSCLC treated with EGFR TKIs is less than 20 percent.
• Osimertinib is the current first-line standard of care in common EGFR-mutated patients. The MARIPOSA-2 data are the first to demonstrate a significant benefit in PFS in the post-osimertinib (an EGFR TKI) setting, reinforcing the potential of amivantamab plus chemotherapy in patients with EGFR-mutated NSCLC.
• Pending approval, this amivantamab-based combination has the potential to offer a new standard of care for this patient population, where high unmet medical needs persist.