On Friday, the US Food and Drug Administration (FDA) granted approval to Janssen’s EGFR inhibitor, Rybrevant (amivantamab), in combination with chemotherapy as a first-line treatment for patients facing advanced non-small cell lung cancer (NSCLC) characterized by EGFR exon 20 insertion mutations. This regulatory decision stems from the Phase III PAPILLON trial, involving 308 participants randomized to receive either Rybrevant with the chemotherapy drugs carboplatin and pemetrexed or the chemotherapy drugs alone.
Results from the trial revealed that patients treated with the Rybrevant-chemo combination experienced a median progression-free survival of 11.4 months, a notable improvement compared to the 6.7 months observed in patients solely receiving chemotherapy. Although data on overall survival were not fully mature at the time of the cutoff, the FDA highlighted the absence of any concerning trends suggesting a detriment in survival with the Rybrevant-chemo regimen in its approval announcement.
In a separate development on the same day, the FDA converted its earlier accelerated approval of Rybrevant into a full approval for the treatment of previously treated NSCLC patients with EGFR exon 20 insertions. This initial accelerated approval was granted in May 2021, accompanied by the simultaneous approval of Guardant Health’s liquid biopsy assay, Guardant360 CDx, as a means to identify patients with EGFR exon 20 insertion mutations eligible for Rybrevant treatment. The recent approvals mark significant advancements in providing efficacious treatment options for a subset of NSCLC patients with specific genetic mutations.