Janssen Submits Application to the European Medicines Agency forRYBREVANT▼ (amivantamab) in Combination with Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy
November 23, 2023 – Clinical Trials – Janssen, Johnson & Johnson, NSCLC
- The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of Oncology
- Amivantamab plus chemotherapy demonstrated significant improvements in progression-free survival, compared to chemotherapy alone, in patients with EGFR-mutated advanced non-small cell lung cancer following prior osimertinib therapy
23 November 2023 — 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 chemotherapy (carboplatin and pemetrexed) 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).
“Patients with EGFR-mutated advanced non-small-cell lung cancer treated with osimertinib inevitably develop resistance mechanisms and are faced with poor outcomes on platinum-based chemotherapy alone,” said Catherine Taylor, vice president, EMEA Medical Affairs, Therapy Area Strategy, Janssen-Cilag AG. “Amivantamab is active against a wide range of EGFR and MET alterations, which are key mechanisms of resistance to osimertinib. The addition of amivantamab to chemotherapy has demonstrated the potential to address post-osimertinib resistance while supporting longer disease control.”
Amivantamab was granted a conditional marketing authorisation by the European Commission (EC) in December 2021 as the first fully-human, bispecific antibody for the monotherapy treatment of adult patients with advanced NSCLC with EGFR exon 20 insertion mutations after failure of platinum-based chemotherapy.
The latest submission to the EMA is supported by data from the phase 3 MARIPOSA-2 (NCT04988295) study, evaluating the efficacy and safety of amivantamab and chemotherapy in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib. The amivantamab plus chemotherapy arm met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS), versus chemotherapy alone, reducing the risk of disease progression or death by 52% (Hazard Ratio [HR]= 0.48; 95 percent Confidence Interval [CI], 0.36–0.64; P<0.001).1,2 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. The most common adverse events (AEs) in the amivantamab-containing arms were haematologic, EGFR and MET-related. Infusion-related reactions in the amivantamab plus chemotherapy arm were 58% (all grade).
“The encouraging results from the MARIPOSA-2 study are the first to demonstrate a significant benefit in progression-free survival (PFS) in the post-osimertinib setting. This reinforces the potential of amivantamab plus chemotherapy in this patient population, and our ambition to transform outcomes for patients,” said Kiran Patel MD, vice president, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “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 remain.”
Results from MARIPOSA-2 were recently presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) 2023 Congress (Abstract #LBA15) and simultaneously published in the Annals of Oncology.
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.
