ABBV-637 Combination Therapy Shows Antitumor Effects in EGFR-Mutated Lung Cancer
Phase I study outcomes indicate ABBV-637 and osimertinib combination therapy demonstrated antitumor effects and a manageable safety profile in EGFR-mutated NSCLC.
Early findings from a Phase I study suggest that the combination therapy of ABBV-637 with osimertinib (OSI) has demonstrated significant antitumor effects in patients with EGFR-mutated non-small cell lung cancer (NSCLC). The study also indicated a manageable safety profile for the drug combination.
The Phase I open-label dose escalation and expansion study (Part 3) evaluated ABBV-637 in combination with osimertinib in patients with relapsed or refractory EGFR-mutated NSCLC. The study assessed treatment-emergent adverse events (TEAEs) and objective response rate (ORR) with ABBV-637 administered intravenously at 12 mg/kg or 20 mg/kg every four weeks, alongside daily 80 mg osimertinib.
Results showed objective response rates (ORR) ranging from 10% to 20% across different study arms, with disease control rates (DCR) between 65% and 80%. The most common treatment-related adverse events included increases in liver enzymes (transaminases), nausea, and fatigue. Grade ≥3 TEAEs were reported in 40.5% of patients, primarily elevated alanine and aspartate aminotransferase levels.
The research indicates that the combination of ABBV-637 and osimertinib holds promise as a potential therapeutic option for EGFR-mutated NSCLC. Further investigation is needed to understand potential bypass mechanisms and optimize patient selection for maximal benefit.