2022 World Conference on Lung Cancer (ePosters)-EP08.01-085. Sintilimab versus Pembrolizumab as Monotherapy or in Combination with Chemotherapy for Treatment Naïve Metastatic Non-small Cell Lung Cancer

EP08.01-085. Sintilimab versus Pembrolizumab as Monotherapy or in Combination with Chemotherapy for Treatment Naïve Metastatic Non-small Cell Lung Cancer

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The CTONG1901 study is a phase II clinical trial that compared the efficacy and safety of sintilimab and pembrolizumab in monotherapy or in combination with chemotherapy as first-line treatment for advanced Non-Small-Cell Lung Cancer (NSCLC). The primary endpoint of the study was the objective response rate (ORR), and secondary endpoints included the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety and tolerability.<br /><br />The study enrolled a total of 68 patients and was conducted in two stages. In the first stage, 20 patients were enrolled, and based on the response rate of pembrolizumab in previous studies, an estimated ORR of 40% was set. When 4 patients achieved a partial response (PR) in the sintilimab arms, the study entered into the second stage, which began in September 2020. The ORR in the first stage was 57.1% for sintilimab and 33.3% for pembrolizumab. In total, 34 evaluable subjects were enrolled in each arm for the two stages.<br /><br />The results showed that sintilimab and pembrolizumab had comparable tumor response, survival benefit, and safety profiles, whether used as monotherapy or in combination with chemotherapy. The ORR in the sintilimab arms was 52.9%, while it was 32.4% in the pembrolizumab arms. The DCR was 88.2% for sintilimab and 97.1% for pembrolizumab. The median duration of response was 11.2 months for sintilimab and could not be calculated for pembrolizumab.<br /><br />In terms of safety, both drugs were generally well-tolerated, with similar rates of treatment-related adverse events (TRAEs). However, grade 3-4 TRAEs were more common in the sintilimab arms compared to the pembrolizumab arms.<br /><br />In conclusion, this phase II study demonstrated comparable efficacy and safety between sintilimab and pembrolizumab as first-line treatment for advanced NSCLC. However, further phase III trials are needed to provide stronger evidence for comparison between the two drugs.

Asset Subtitle

Si-Yang Maggie Liu

Meta Tag

Speaker Si-Yang Maggie Liu

Topic Metastatic Non-small Cell Lung Cancer - Immunotherapy

Keywords

CTONG1901 study

phase II clinical trial

efficacy

safety

sintilimab

pembrolizumab

Non-Small-Cell Lung Cancer (NSCLC)

objective response rate (ORR)

tumor response

chemotherapy