The company is seeking approval of Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed), a drug it believes has the potential to offer a new standard of care to patients.
The treatment is for adult patients with advanced non-small cell lung cancer (NSCLC) with a mutated form of the protein epidermal growth factor receptor (EGFR).
The European Medicines Agency (EMA) defines a type 2 variation as any major variation that may have a significant impact on the quality, safety, or efficacy of a medicinal product. An application for an extension of a therapeutic indication is considered a major variation and is therefore classified as a specific form of type 2 variation.
“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, of 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.”
In December last year (2022) amivantamab was granted a conditional marketing authorization by the European Commission. This was the first fully human, bispecific antibody for the monotherapy treatment of adult patients with advanced NSCLC with a specific form of mutated EGFR after failure of platinum-based chemotherapy.
Amivantamab and chemotherapy
The latest submission to the EMA is supported by data from the phase 3 Mariposa-2 study, evaluating the efficacy and safety of amivantamab and chemotherapy in patients with locally advanced or metastatic EGFR 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%. 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.
Reinforcing the potential
“The encouraging results from the Mariposa-2 study are the first to demonstrate a significant benefit in progression-free survival 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 VP, of 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.”
In Europe, it is estimated that 477,534 patients were diagnosed with lung cancer in 2020. NSCLC accounts for 85% of all lung cancer cases. Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.