Rybrevant(amivantamab)

Rybrevant (amivantamab) is indicated in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. It is also indicated as monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy. Current approvals also include combinations with carboplatin and pemetrexed for NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI, and for first-line treatment of NSCLC with activating EGFR Exon 20 insertion mutations.

In a pharmacokinetic evaluable dataset from the PALOMA-3 trial, comparing subcutaneous (SC) to intravenous (IV) administration, the geometric mean ratio of Cycle 2 Day 1 Ctrough (SC vs IV) was 1.145 (90% CI: 1.040, 1.261). The geometric mean ratio of Cycle 2 AUCD1-D15 (SC vs IV) was 1.032 (90% CI: 0.976, 1.090). The geometric mean ratio of Observed Cycle 4 Day 1 Ctrough (SC vs IV) was 1.427 (90% CI: 1.266, 1.610). The median progression-free survival for osimertinib versus first-generation EGFR TKI was 18.9 months.

Notable safety findings include hypoalbuminaemia (Any Grade) at 48% and (Grade 3-4) at 5%, and decreased appetite (Any Grade) at 24%. The median duration of study treatment ranged from 17.05 to 18.50 months. The median relative dose intensity for amivantamab was 100.00%.