247P Efficacy of adebrelimab with chidamide, gemcitabine, and S-1 in locally advanced or metastatic pancreatic cancer: A phase II study

Methods: Pts with PD-L1+ mNSCLC and progression after 1 prior anti-PD-L1 tx were enrolled to acasunlimab (Arm A: 100 mg Q3W x2 cycles then 500 mg Q6W) or acasunlimab with pembrolizumab (pembro) to maximize PD-1 blockade (Arm B: 100 mg + pembro 200 mg Q3W; Arm C: 100 mg + pembro 400 mg Q6W).Tumor PD-L1 status (TPS 1%) was centrally assessed (PD-L1 IHC 22C3 PharmDx).Primary endpoint: ORR; other endpoints: PFS, OS, safety. Results: As of Dec 2, 2024, 125 pts (87 centrally PD-L1+; 65 Ph3-eligible) were dosed: 22 (16; 11) in Arm A, 42 (26; 22) in Arm B, 61 (45; 32) in Arm C. In Arm C, 49.2% of ITT pts and 53.1% of Ph3-eligible pts remained on trial at data cutoff.Baseline pt and tumor characteristics across arms were similar.Most common TRAEs in ITT (all grades; n, %) were asthenia (21, 16.8%); AST increased (18, 14.4%); ALT increased (16, 12.8%); diarrhea (16, 12.8%); fatigue (16, 12.8%); and decreased appetite (13; 10.4%).Transaminase elevations were mostly grade 1-2 and generally manageable.Time-to-event and response outcomes are presented in the table.Table.Time-toevent and response outcomes in CPI-treated mNSCLC.Conclusions: Acasunlimab plus pembro showed promising OS and durable benefit in PD-L1+ mNSCLC post-CPI (Arm C 12 mo OS rate of 64%).Safety was manageable, with generally reversible hepatic events.The Q6W regimen offered better tolerability, durability of response, and survival, supporting its evaluation in the ongoing Ph3 trial (NCT06635824).

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Journal
Immuno-Oncology Technology
Published
2025-12-01
DOI
https://doi.org/10.1016/j.iotech.2025.101446
Primary Topic
Pancreatic and Hepatic Oncology Research
Type
article
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article

247P Efficacy of adebrelimab with chidamide, gemcitabine, and S-1 in locally advanced or metastatic pancreatic cancer: A phase II study

X. Pu, J. Li, J. Du, Y. Wu et al.
Immuno-Oncology Technology
Pancreatic and Hepatic Oncology Research
article

247P Efficacy of adebrelimab with chidamide, gemcitabine, and S-1 in locally advanced or metastatic pancreatic cancer: A phase II study

X. Pu, J. Li, J. Du, Y. Wu, D. Cao, X. Li, B. Wang, C. Chen, X. Liu
article en

Abstract

Methods: Pts with PD-L1+ mNSCLC and progression after 1 prior anti-PD-L1 tx were enrolled to acasunlimab (Arm A: 100 mg Q3W x2 cycles then 500 mg Q6W) or acasunlimab with pembrolizumab (pembro) to maximize PD-1 blockade (Arm B: 100 mg + pembro 200 mg Q3W; Arm C: 100 mg + pembro 400 mg Q6W).Tumor PD-L1 status (TPS 1%) was centrally assessed (PD-L1 IHC 22C3 PharmDx).Primary endpoint: ORR; other endpoints: PFS, OS, safety. Results: As of Dec 2, 2024, 125 pts (87 centrally PD-L1+; 65 Ph3-eligible) were dosed: 22 (16; 11) in Arm A, 42 (26; 22) in Arm B, 61 (45; 32) in Arm C. In Arm C, 49.2% of ITT pts and 53.1% of Ph3-eligible pts remained on trial at data cutoff.Baseline pt and tumor characteristics across arms were similar.Most common TRAEs in ITT (all grades; n, %) were asthenia (21, 16.8%); AST increased (18, 14.4%); ALT increased (16, 12.8%); diarrhea (16, 12.8%); fatigue (16, 12.8%); and decreased appetite (13; 10.4%).Transaminase elevations were mostly grade 1-2 and generally manageable.Time-to-event and response outcomes are presented in the table.Table.Time-toevent and response outcomes in CPI-treated mNSCLC.Conclusions: Acasunlimab plus pembro showed promising OS and durable benefit in PD-L1+ mNSCLC post-CPI (Arm C 12 mo OS rate of 64%).Safety was manageable, with generally reversible hepatic events.The Q6W regimen offered better tolerability, durability of response, and survival, supporting its evaluation in the ongoing Ph3 trial (NCT06635824).

Immuno-Oncology TechnologyVol. 28
Jiangsu University (CN), Nantong University (CN), Sichuan University (CN), Nanjing General Hospital of Nanjing Military Command (CN), West China Hospital of Sichuan University (CN), Nanjing Drum Tower Hospital (CN), Affiliated Hospital of Jiangsu University (CN), Yancheng First People's Hospital (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Changzhou No.2 People's Hospital (CN)
Good health and well-being
Openalex Percentile: Top 30%
Pancreatic and Hepatic Oncology Research
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