Dr Le on SOHO-01 Data With BAY 2927088 in HER2-Mutated NSCLC

Xiuning Le, MD, PhD, associate professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, discusses updated findings from the phase 1/2 SOHO-01 trial (NCT05099172).

SOHO-01 examined the oral, reversible TKI BAY 2927088, which has been shown to potently inhibit activating HER2 mutations in preclinical models. Data from SOHO-01 presented during the 2024 IASLC World Conference on Lung Cancer showed that patients with advanced non–small cell lung cancer harboring HER2 activating mutations or HER2 exon 20 insertions who were targeted therapy naive (n = 43) achieved an investigator-assessed objective response rate (ORR) of 72.1% (95% CI, 56.3%-84.7%), including a 2.3% complete response rate. The disease control rate (DCR) was 83.7% (95% CI, 69.3%-93.2%), the median duration of response (DOR) was 8.7 months (95% CI, 4.5-not evaluable [NE]), and the median progression-free survival (PFS) was 7.5 months (95% CI, 4.4-12.2), Le adds.

Moreover, patients with HER2 YVMA insertions (n = 30) experienced an ORR of 90.0% (95% CI, 73.5%-97.9%) and a DCR of 96.7%, Le highlights. Among these patients, the median DOR was 9.7 months (95% CI, 5.5-NE) and the median PFS was 9.9 months (95% CI, 6.9-NE), Le says. In the safety population (n = 44), patients experienced any-grade treatment-related adverse effects (TRAEs; 95.5%) and grade 3 or higher TRAEs (43.2%). The most common any-grade TRAEs included diarrhea (86.4%), rash (43.2%), paronychia (25.0%), and nausea (25.0%). Three patients experienced TRAEs leading to treatment discontinuation, 31.8% had dose reductions due to TRAEs, and 11.4% experienced serious TRAEs.