Posted: Thursday, June 20, 2024
Sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, demonstrated activity in treatment-naive patients with advanced non–small cell lung cancer (NSCLC) when combined with the monoclonal antibody KL-A167 in initial phase II trial results, according to Wenfeng Fang, MD, PhD, of Sun Yat-sen University Cancer Center, Guangzhou, China, and colleagues. Sacituzumab tirumotecan has a manageable safety profile as well, said the team in presenting the results during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8502).
Sacituzumab tirumotecan was given along with KL-A167 to cohorts 1A (n = 40) and 1B (n = 63) of the OptiTROP-Lung01 study. Investigators performed tumor assessments every 6 weeks. Patients in cohort 1A received sacituzumab tirumotecan at 5 mg/kg plus KL-A167 at 1,200 mg, both every 3 weeks. Those in cohort 1B received sacituzumab tirumotecan at 5 mg/kg plus KL-A167 at 900 mg, both every 2 weeks.
Eligible patients had no actionable genomic alterations. The median age of both cohorts was 63. The patients in both cohorts were fairly evenly divided among those who had PD-L1 tumor proportion scores of less than 1%, 1% to 49%, and 50% or more.
After a median follow-up of 14.0 months for cohort 1A, the objective response rate was 48.6%, the disease control rate was 94.6%, median progression-free survival was 15.4 months, and 6-month progression-free survival rate was 69.2%. For cohort 1B (median follow-up, 6.9 months), the objective response rate was 77.6%, the disease control rate was 100%, median progression-free survival was not reached, and 6-month progression-free survival rate was 84.6%. No treatment-related deaths were reported in either cohort.
A dosing schedule of every 2 weeks for the antibody-drug conjugate was recommended for further investigation. A phase III study in the first-line setting of metastatic NSCLC of sacituzumab tirumotecan plus pembrolizumab (vs pembrolizumab alone) is ongoing.
Disclosure: Dr. Fang reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.