KEY TAKEAWAYS
- The phase II trial aimed to compare the efficacy and safety of sintilimab and pembrolizumab, alone or combined with chemotherapy, in untreated advanced NSCLC.
- The primary endpoint was ORR. The secondary endpoints were DCR, DOR, PFS OS, and safety.
- The study showed promising efficacy and tolerability in a phase II study of untreated NSCLC, regardless of PD-L1 expression levels.
PD-1 inhibitors have transformed the treatment of advanced non-small cell lung cancer (NSCLC). Researchers aimed to compare the efficacy and safety of sintilimab and pembrolizumab, alone or combined with chemotherapy, in untreated advanced NSCLC.
Patients with high PD-L1 ≥50% underwent a 1:1 randomization for sintilimab or pembrolizumab monotherapy, while those with PD-L1 <50% were 1:1 randomized for combination therapy with sintilimab or pembrolizumab plus chemo.
The primary endpoint was the objective response rate (ORR), and secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
Sample size calculation followed an optimal two-stage design with 20 patients in the first stage and a total of 68 patients across two stages. This update presented the final analysis of the study.
With a median follow-up of 8.6 months (95% CI, 8.1-9.0 months), 71 patients (sintilimab arms, n=35; pembrolizumab arms, n=36) were enrolled. The primary endpoint was met, with 18 patients treated with sintilimab achieving a partial response (PR).ORR was 46.2% (sintilimab monotherapy), 54.5% (combination therapy), 42.9% (pembrolizumab monotherapy) and 45.4% (combination therapy).
The median PFS was 6.9 vs 8.1 months, and the median OS was 14.9 vs 21.3 months for all sintilimab-treated and pembrolizumab-treated patients. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred more frequently in patients treated with combination therapy compared with monotherapy.
The study showed promising efficacy and tolerability in a phase II study of untreated NSCLC, regardless of PD-L1 expression levels.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/2263
Clinical Trial: https://clinicaltrials.gov/study/NCT04252365
Liu SYM, Deng JY, Yan HH, Yang MY, Xu CR, Zheng MY, Gan B, Zhang XC, Tu HY, Yang JJ, Chen HJ, Wang BC, Li Y, Zhou Q, Wu YL. PD-L1 Expression Guidance on Sintilimab versus Pembrolizumab in Untreated Advanced NSCLC (CTONG1901).
