Overview

• Interim PALOMA-2 Cohort 5 data presented at the IASLC World Conference on Lung Cancer reported an objective response rate of 82% by investigator assessment and 87% by independent central review, with confirmed rates of 79% and 83%.
• Responses occurred quickly with a median time to response of 8.1 weeks, while median duration of response, progression-free survival, and overall survival were not reached at a median 6.5 months of follow-up.
• Pharmacokinetic analyses showed mean plasma concentrations for once‑monthly subcutaneous dosing consistent with historical intravenous and every‑two‑weeks subcutaneous regimens.
• Adverse events aligned with expected EGFR/MET inhibition, administration‑related reactions occurred in 12% with one Grade ≥3 event, venous thromboembolic events occurred in 13% with none Grade ≥3, bleeding events were rare at 1%, and 8% discontinued due to treatment‑related adverse events with no new safety signals identified.
• The fully enrolled cohort included 77 treatment‑naïve patients with Ex19del or L858R mutations, median age 63 years, 68% female, 62% Asian, and 43% with baseline brain metastases, and investigators noted fewer administration‑related reactions versus historical regimens.