Janssen-Cilag, a Johnson & Johnson company, has received European Commission (EC) approval for a Type II extension of indication for Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for adults with advanced non-small cell lung cancer (NSCLC).
Rybrevant is now approved for epidermal growth factor receptor (EGFR) Exon 19 deletions (ex19del) or Exon 21 L858R substitution (L858R) mutated NSCLC in patients who have not responded to previous therapies.
The approval of the Type II extension of indication application, filed in November 2023, follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2024.
The expanded indication for Rybrevant is supported by findings from the Phase 3 MARIPOSA-2 study which assessed the efficacy and safety of amivantamab combined with chemotherapy in 657 patients.
The combination of amivantamab and chemotherapy achieved the primary endpoint, significantly lowering the risk of disease progression or death by 52% compared to chemotherapy alone.
The median progression-free survival (PFS) was 6.3 months for the combination therapy, compared to 4.2 months for chemotherapy alone.
Furthermore, the combination demonstrated an objective response rate (ORR) of 64%, compared to 36% with chemotherapy alone.
The late-stage trial also indicated that the duo exhibits significant intracranial activity and reduced the risk of intracranial progression or death by 45% compared to chemotherapy alone.
The median intracranial progression-free survival was 12.5 months with Rybrevant plus chemotherapy, versus 8.3 months with chemotherapy alone.
Johnson & Johnson Innovative Medicine EMEA therapeutic area lead and senior director Henar Hevia said: “The approval of amivantamab in combination with chemotherapy addresses a major unmet need for those whose disease has progressed following treatment with an EGFR TKI and who, until now, have faced limited treatment options.”
Furthermore, Rybrevant already has EC approval for use with carboplatin and pemetrexed in first-line treatment of advanced NSCLC with EGFR exon 20 insertion mutations, and as monotherapy for the same condition after platinum-based chemotherapy.
Based on MARIPOSA-2 data, Janssen-Cilag has also submitted extension applications with the EMA for use with lazertinib in first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, and for a subcutaneous monotherapy formulation of amivantamab.
In June, EC approved a type 2 variation for Rybrevant with chemotherapy for advanced NSCLC with activating EGFR exon 20 insertion mutations.
Recently, the US Food and Drug Administration (FDA) approved amivantamab plus lazertinib for first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.
