According to the phase 3 ACROSS study, aumolertinib plus chemotherapy showed a statistically significant improvement to progression-free survival (PFS) among patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR sensitizing mutations with tumor suppression gene mutations, compared to aumolertinib monotherapy.

These data were first presented by Jie Wang, MD, National Cancer Center, Beijing, China, at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain.

This open-label trial phase 3 trial enrolled 126 patients with advanced NSCLC harboring EGFR sensitizing mutations with tumor suppression gene mutations who had not received prior treatment with an EGFR tyrosine kinase inhibitor (TKI). Patients were randomized on a 1-to-1 basis to receive either aumolertinib plus chemotherapy (carboplatin plus pemetrexed; combination arm, n= 62) or aumolertinib alone (monotherapy arm, n = 64). The primary end point was PFS with secondary end points including objective response rate (ORR), disease control rate (DCR) and duration of response, overall survival (OS), and safety.

Of the 120 patients randomized, 118 received at least 1 dose of the treatment agents (combination arm, n = 54; monotherapy arm, n = 64). With a median follow-up duration of 25.3 months, the median PFS was 19.78 months in the combination arm vs 16.53 months in the monotherapy arm (hazard ratio [HR], 0.55; P = .0205). The OS data was immature at this time. The most common treatment-emergent adverse events, occurring in ≥ 20% of patients, included white blood cell count decrease, neutrophil count decrease, platelet count decrease, anemia, AST increase, ALT increase, CK increase, serum creatinine increase, nausea, constipation, and rash. There was no change in the safety profile of aumolertinib with the addition of chemotherapy.

Dr Wang et al concluded “aumolertinib combined with platinum-pemetrexed showed a statistically significant [increase] in PFS compared to aumolertinib monotherapy.”

Source:

Wang J, Wang Z-J, Zhong J, et al. Aumolertinib plus chemotherapy for NSCLC with EGFR and concomitant tumor suppressor genes (ACROSS 2): Phase III study. Presented at the IASLC 2025 WCLC. September 6-9, 2025; Barcelona, Spain. Abstract PL02.09