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Sintilimab versus pembrolizumab in monotherapy or combination with chemotherapy as first-line therapy for advanced non–small cell lung cancer: Results from phase 2, randomized clinical trial (CTONG1901)

Authors :
Si-Yang Maggie Liu
Qing Zhou
Hong-Hong Yan
Gan Bin
Ming-Yi Yang
Jia-Yi Deng
Hai-Yan Tu
Xuchao Zhang
Jian Su
Jinji Yang
Yi-Long Wu
Source :
Journal of Clinical Oncology. 40:9032-9032
Publication Year :
2022
Publisher :
American Society of Clinical Oncology (ASCO), 2022.

Abstract

9032 Background: Immunotherapy has become standard therapy for untreated advanced NSCLC. However, no direct comparison between anti-PD-1 inhibitors has been reported. Methods: CTONG1901 is an open label, randomized, phase II clinical trial to compare sintilimab and pembrolizumab in monotherapy or combination with chemotherapy for advanced NSCLC at first-line setting. The primary endpoint was objective response rate (ORR). Patient without EGFR and ALK alteration were enrolled. Patients with PD-L1 tumor proportion score (TPS) ≥50% were randomly to receive sintilimab (A) or pembrolizumab (B) ; and with TPSst stage. When ≥4 patients achieve partial response (PR) in sintilimab arms, the study will enter into 2nd stage and the sample size will be calculated based on the ORR results of the 1st stage. Results: The ORR was 57.1% in sintilimab and 33.3% in pembrolizumab arms at the 1st stage. The study successfully entered into the 2nd stage. 48 additional patients should be enrolled after calculation. When 15 PR in sintilimab arms achieved, the primary endpoint will be reached. From Mar. 2020 to Jan. 2022, 71 patients were screened and 68 patients were enrolled in two stages. Histologic subtypes and brain metastasis were well balanced between arms. As of Dec. 31st 2021, the median follow-up was 5.6 months. The confirmed ORR was 45.5% (15/33) in sintilimab vs. 28.6% (10/35) in pembrolizumab arms (A vs. B: 30.8% [4/13] vs. 28.6% [4/14]; C vs. D: 55.0% [11/20] vs. 28.6% [6/21]). Unconfirmed ORR was 57.6% vs. 42.9% and disease control rate (DCR) was 87.9% vs. 91.4% in sintilimab and pembrolizumab arms. The primary endpoint was reached. Survival data was immature. Any grade and 3-4 grade treatment-related adverse events (TRAEs) were comparable in sintilimab and pembrolizumab arms (Table). Conclusions: This is the first head-to-head phase II study to directly compare two anti-PD-1 antibodies as first-line treatment in advanced NSCLC. The result suggested comparable tumor response and similar safety profile between sintilimab and pembrolizumab. Clinical trial information: NCT04252365. [Table: see text]

Subjects

Subjects :
Cancer Research
Oncology

Details

ISSN :
15277755, 0732183X, and 04252365
Volume :
40
Database :
OpenAIRE
Journal :
Journal of Clinical Oncology
Accession number :
edsair.doi...........b7bc58988ea599d007526a5307ff1f2d