OBR OncologyFDA Approves Amivantamab Combo for Advanced NSCLC

A Paradigm Shift in NSCLC Treatment: Unveiling the Impact of Amivantamab Combo on EGFR Mutation Challenges

The US Food and Drug Administration’s (FDA’s) recent approval of the amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed marks a significant advancement in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations. This approval, grounded in the results of the phase 3 PAPILLON clinical trial, showcases the efficacy of this new regimen in improving progression-free survival for patients with EGFR exon 20 insertion mutations, setting a new standard of care in this domain.

Key Points:

• The FDA has approved amivantamab-vmjw (Rybrevant) combined with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
• Full approval was granted following accelerated approval in 2021, based on significant improvement in progression-free survival (PFS) demonstrated in the phase 3 PAPILLON trial.
• The PAPILLON study was a randomized, multicenter trial involving 308 patients, comparing the amivantamab combination with carboplatin and pemetrexed alone.
• Primary efficacy was measured by PFS, with a secondary endpoint of overall survival (OS). The median PFS for the amivantamab group was 11.4 months versus 6.7 months for the control group.
• Although OS data are not yet mature, there is no current trend indicating a detriment.
• The combination treatment was acknowledged at the ESMO Annual Congress as a new standard of care for this patient population.
• However, 42% of patients in the treatment group experienced dose interruptions, and 15% discontinued due to adverse reactions, indicating a need for careful side effect management.
• Common adverse reactions included rash, nail toxicity, stomatitis, and infusion-related reactions, among others, with specific dosage recommendations based on body weight provided in the prescribing information.

“This is not a completely easy drug, and [we] have to aggressively manage these side effects.”
– Dr. Benjamin Besse, highlighting the importance of managing adverse reactions in the new treatment regimen.

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