KEY TAKEAWAYS
- The phase I trial aimed to present updated efficacy and safety results of the oral PD-L1 inhibitor INCB099318 in an ongoing Phase 1 study for advanced solid tumor patients.
- The primary endpoints were safety, tolerability, and MTD.
- The results showed good tolerability and promising efficacy, warranting further exploration for select advanced solid tumors.
Early findings from a Phase 1 trial suggest INCB099318, an oral PD-L1 inhibitor, holds promise for treating advanced solid tumors with encouraging efficacy and manageable safety.
David J. Pinato and his research group spearheaded the study that aimed to present the updated findings on the preliminary efficacy and safety of the oral PD-L1 inhibitor INCB099318 from an ongoing Phase 1 multicenter study in advanced solid tumor patients.
Eligible individuals aged ≥18 with ECOG PS ≤1, experiencing disease progression post-treatment or deemed ineligible for/without access to standard treatment, participated. In Part 1, doses escalated from 100 mg BID using a Bayesian optimal interval design, with selected doses slated for expansion in Part 2. Primary endpoints included evaluating INCB099318 safety and tolerability and determining the pharmacologically active/maximum tolerated dose (MTD). Secondary and exploratory endpoints included pharmacokinetics(PK), objective response rate (ORR) per RECIST v1.1, and biomarkers of pharmacologic activity.
About 101 patients received INCB099318 at 100 to 800 mg QD or BID (Part 1, n=64; Part 2, n=37). The median age was 58 years (range, 29-89), with 59.4% women, 86.1% White, 68.3% having ≥2 prior lines of treatment, and 9.9% having prior immunotherapy. Common tumor types included cervical (17.8%), ovarian (10.9%), and colorectal (5.9%). No dose-limiting toxicities(DLTs) were observed, and MTD was not reached. In Part 2, three dose levels were expanded (400 mg BID, n=18; 800 mg BID, n=14; 800 mg QD, n=5). Overall, 81.2% of patients discontinued treatment, with 68.3% due to disease progression. Treatment-emergent adverse events (TEAEs) occurred in 93.1% of patients. Various responses were observed, and updated results will be presented.
The study demonstrated favorable tolerability across all tested doses, and the preliminary safety and response outcomes provide a foundation for the potential advancement of INCB099318 in the treatment of specific advanced solid tumors. The study was sponsored by Incyte Corporation.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT04272034
Pinato DJ.’’A Phase 1 Study Exploring the Safety and Tolerability of the Small Molecule PD-L1 Inhibitor INCB099318 in Select Advanced Solid Tumors.’’Presented at: ESMO-IO 2023. (Presentation Number 134P).
