Dr Jankowski on the Telomere-Targeted Agent THIO With Cemiplimab in Advanced NSCLC

“In the second and third lines [of therapy] we have very exciting results. In the third-line [setting], the median OS was 17.8 months.”

Tomasz Jankowski, MD, PhD, chair of the Department of Pneumology, Oncology and Allergology and assistant professor in the Faculty of Medicine at the Medical University of Lublin, discussed THIO sequenced with cemiplimab-rwlc (Libtayo) for the third-line treatment of patients with immune checkpoint inhibitor (ICI)–resistant advanced non–small cell lung cancer (NSCLC).

During the 2025 ASCO Annual Meeting, Jankowski presented data from a phase 2 study (NCT05208944) which examined the telomere-targeted agent THIO in combination with cemiplimab in patients with advanced NSCLC who experienced disease progression following 1 to 4 prior treatments, including an ICI. The primary end points were safety, overall response rate, and disease control rate (DCR). Duration of response, progression-free survival (PFS), and overall survival (OS) were evaluated as secondary end points, Jankowski said. The study enrolled a total of 79 patients, and the best dose of THIO was determined to be 180 mg in the first part of the trial, Jankowski noted.

Among patients who received THIO in the third line of therapy at all dose levels (n = 22), the estimated median OS was 17.8 months, Jankowski said. Most patients (63%) crossed the OS threshold of 5.8 months. The DCR in the third-line setting was 77% and 77% of patients crossed the PFS threshold of 2.5 months. Four partial responses per RECIST 1.1 criteria were reported among these patients.

In terms of safety, THIO plus cemiplimab was generally well tolerated with most treatment-emergent adverse effects (TEAEs) being grade 1 or 2 in severity. In the overall population, the most common any-grade TEAEs occurring in at least 2 patients included increased aspartate aminotransferase levels (26.6%), increased alanine aminotransferase levels (22.8%), nausea (12.7%), neutropenia (5.1%), anemia (3.8%), pyrexia (3.8%), and decreased appetite (3.8%). No dose-limiting toxicities were reported during the safety lead-in portion of the trial. The study completed enrollment at the selected dose of 180 mg of THIO per cycle in February 2024.