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Subcutaneous Amivantamab Plus Lazertinib Maintains Efficacy With Improved Safety and Convenience VS Intravenous Administration in NSCLC (PALOMA-3)

*May 2024*

Key Points:

  • In patients with refractory EGFR-mutated advanced non–small cell lung cancer (NSCLC), subcutaneous amivantamab plus lazertinib was noninferior to intravenous (IV) amivantamab, as assessed by pharmacokinetics and objective response rate (ORR).
  • Administration time was reduced from 2 to 5 hours with IV amivantamab to less than 5 minutes with subcutaneous amivantamab.
  • Subcutaneous administration had lower rates of infusion-related reactions (IRRs) and venous thromboembolism.

 

In patients with EGFR-mutated refractory advanced NSCLC, subcutaneous amivantamab plus lazertinib is noninferior to IV amivantamab, as assessed by pharmacokinetics and ORR, according to results from the randomized phase 3 PALOMA-3 trial presented at the 2024 ASCO Annual Meeting (LBA8505).

Subcutaneous amivantamab also provided significant safety advantages over IV amivantamab, including lower rates of IRRs (13% vs 66%) and venous thromboembolic events (9% vs 14%). The administration time was less than 5 minutes with subcutaneous amivantamab versus 2 to 5 hours with IV administration.

These findings “helped us establish that the subcutaneous formulation of amivantamab is noninferior to intravenous amivantamab when combined with lazertinib both in terms of pharmacokinetic parameters but also in terms of clinical outcomes,” noted Presenter Natasha B. Leighl, MD, FRCPC, FASCO, of the Princess Margaret Cancer Centre, in Toronto.

“[These findings] helped us establish that the subcutaneous formulation of amivantamab is noninferior to intravenous amivantamab when combined with lazertinib both in terms of pharmacokinetic parameters but also in terms of clinical outcomes.”—Dr. Natasha B. Leighl

Researchers also noted improvements in secondary efficacy endpoints, including numerically longer duration of response and progression-free survival (PFS) and a significant improvement in overall survival (OS; HR 0.62; nominal P = .02).

Given its noninferior efficacy, improved safety profile, and greater convenience, Dr. Leighl concluded that subcutaneous amivantamab “is really an advance both for patients and providers.”

Discussant Jessica Lin, MD, of Massachusetts General Hospital and Harvard Medical School, called the results “highly impactful and clinically meaningful” and noted they indicate that subcutaneous amivantamab should help alleviate the time and clinical toxicity associated with this treatment for metastatic lung cancer. Read more.