Xiuning Le, M.D., Ph.D., The University of Texas MD Anderson Cancer Center, Houston, Texas presented updated results from the expansion cohort of the ongoing Phase I/II SOHO-01 study.
The SOHO-01 study is an ongoing, open-label, multicenter Phase I/II study. The expansion cohort specifically enrolled patients with advanced HER2-mutant NSCLC who had not received HER2-targeted therapy.
Patients with advanced NSCLC harboring a HER2-activating mutation who had experienced disease progression after at least one prior systemic therapy for advanced disease were administered oral BAY 2927088 at a dosage of 20 mg twice daily. The study’s objectives were to assess the safety and anti-tumor activity of BAY 2927088, with efficacy evaluated per RECIST v1.1 and safety assessed using MedDRA v27.0.
Dr. Le and her colleague enrolled a total of 44 patients, who had a median age of 62 years– 63.6% were female, 70.5% had never smoked, and 54.5% had received two or more lines of therapy. The researchers followed up on the patients for 10.9 months.
Of the 43 patients evaluable for efficacy, Dr. Le reported a confirmed objective response rate of 72.1% (n=31; 95% CI 56.3, 84.7), including one complete response (2.3%). The median duration of response and progression-free survival were 8.7 months (95% CI 4.5, not estimable) and 7.5 months (95% CI 4.4, 12.2), respectively.
In a subgroup analysis, patients with tumors harboring HER2 Y772_A775dup (YVMA) exon 20 insertion mutations had an objective response rate of 90.0%. Among the eight patients with previously treated and asymptomatic brain metastases, the objective response rate was 62.5%.
Dr. Le reported that the safety profile of BAY 2927088 was manageable and consistent with previous reports, reinforcing its potential as a promising therapy for patients with advanced NSCLC harboring HER2 mutations.
“These data from the SOHO-01 study underscore the potential of BAY 2927088 as a treatment for patients with advanced NSCLC harboring HER2 mutations,” said Dr. Le. “The drug demonstrated substantial and durable responses in a heavily pretreated patient population, with a manageable safety profile. These findings support the continued investigation of BAY 2927088 in this patient group, especially in light of its recent Breakthrough Therapy designation by the FDA.”
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