Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT (amivantamab), in combination with Lazertinib, for the First-Line Treatment of Patients with EGFR Mutated Non-Small Cell Lung Cancer
February 8, 2024 – Drug Discovery – EMA, Janssen, Johnson & Johnson, NSCLC
The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with amivantamab plus lazertinib versus osimertinib.
Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.
8 February 2024 — Beerse, Belgium — The Janssen Pharmaceutical Companies of Johnson & Johnson today 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 lazertinib, for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
“Patients with NSCLC with common EGFR mutations face a five-year survival rate of just 19%. This, coupled with the significant physical and emotional burden of the disease, reinforces the high unmet medical need we must urgently address,” said Catherine Taylor, vice president, EMEA Medical Affairs, Therapy Area Strategy, Janssen-Cilag AG. “We are deeply committed to researching and investing in novel targeted therapies to improve the treatment of lung cancer and offer new hope for patients with this condition.”
MARIPOSA (NCT04487080) is a randomised, phase 3 study evaluating amivantamab in combination with lazertinib compared to osimertinib as first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. The MARIPOSA study met its primary endpoint, resulting in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of amivantamab and lazertinib versus osimertinib, as assessed by blinded independent central review (BICR). The safety profile of amivantamab plus lazertinib was consistent with prior reports of the combination, with mostly Grade 1 or 2 adverse events (AEs) being reported.
“Today’s submission is testament to our steadfast dedication to advancing innovative therapies for those who need them most, now and in the future,” said Kiran Patel MD, vice president, Clinical Development, Solid Tumors, Janssen Research & Development. “Pending approval, this novel combination of amivantamab and lazertinib has the potential to transform first-line treatment for patients with EGFR-mutated NSCLC.”
The pivotal data from the MARIPOSA study were featured in a Presidential Symposium session (Abstract #LBA14) at the 2023 European Society of Medical Oncology (ESMO) Congress. In December 2023, Janssen submitted a marketing authorisation application (MAA) to the EMA seeking approval of lazertinib, in combination with amivantamab, for the equivalent first-line combination treatment indication based on the MARIPOSA study, with further European Commission (EC) approvals expected in the future.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension and Retina. Learn more at www.janssen.com/emea.
