RYBREVANT in combination with chemotherapy is recommended for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer

Johnson and Johnson announce that the CHMP of the EMA has recommended the approval of a Type II extension of indication for RYBREVANT in combination with chemotherapy, for the treatment of adult patients with advanced non-small cell lung cancer with epidermal growth factor receptor Exon 19 deletions or Exon 21 L858R substitution mutations, after failure of prior therapy including an EGFR tyrosine kinase inhibitor.

“Resistance mechanisms after disease progression on osimertinib are diverse and polyclonal, with up to half being EGFR and MET-based alterations. There are no targeted therapies approved for the post-osimertinib setting, and outcomes with the current standard of care, platinum-based chemotherapy, are poor,” said Antonio Passaro, M.D., Ph.D., Medical Oncologist, Division of Thoracic Oncology at the European Institute of Oncology in Milan, Italy^*. “The combination of amivantamab and chemotherapy offers renewed hope and a new standard of care for these patients, with improvements observed in response rates, progression-free survival, and intracranial efficacy, even in patients with previously untreated brain metastases.”

“EGFR gene mutations are the most common actionable oncogenic mutations in NSCLC, with ex19del or L858R mutations representing up to 90 percent of all EGFR mutations,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, our dedication to transforming the treatment of lung cancer with innovative therapies is unwavering, and we are proud to take another step forward for patients in need of new, targeted treatment options.”

The MARIPOSA-2  data also demonstrated that the amivantamab combination regimens may provide intracranial activity, critical for a disease where nearly 30 percent of patients develop brain metastases. Specifically, amivantamab plus chemotherapy reduced the risk of intracranial progression or death by 45 percent compared to chemotherapy alone, with a median intracranial progression-free survival of 12.5 versus 8.3 months.

The safety profile is consistent with that of its individual components. Adverse events of Grade 3 or higher, mainly due to haematologic toxicities, were reported by 72 percent of patients treated with amivantamab plus chemotherapy, and 48 percent with chemotherapy alone. The most common Grade 3 or higher AEs included neutropenia, thrombocytopenia, anaemia, and leukopenia. Grade 3 or 4 bleeding events were seen in one percent of patients treated with amivantamab plus chemotherapy, and in no patients with chemotherapy.

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Related Topics and Keywords

chemotherapy, CHMP, EGFR-mutated non-small cell lung cancer, RYBREVANT®▼ (amivantamab)