Effect of SHR-1701 on chemotherapy (chemo)-induced myelosuppression: Data from a phase 3 study in HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA).

• DOI: 10.1200/jco.2025.43.4_suppl.335
• Publication Date: 2025-01-27T14:31:24Z
• Authors: Zhi Peng; Jufeng Wang; Yanqiao Zhang; Hongli Li; Qun Zhao; Xiaodong Zhu; Shaozhong Wei; Ying Cheng; Kangsheng Gu; Jun Bai; Yigui Chen; Zhongtao Zhang; Jun Zhang; Junsheng Wang; Zuoxing Niu; Yueyin Pan; Zhigao Wang; Wenliang Wang; Hongxia Han; Lin Shen
• Keywords: Gastric adenocarcinoma

335 Background: Blocking TGF-β signaling has the potential to facilitate recovery from chemo-induced myelosuppression. SHR-1701 is a bifunctional agent targeting PD-L1 and TGF-β. Methods: In multicenter, randomized, double-blind phase 3 study (NCT04950322), plus CAPOX demonstrated statistically significant clinically meaningful benefit in OS compared with placebo patients (pts) previously untreated, unresectable locally advanced or metastatic HER2-negative G/GEJA (ESMO 2024, LBA60). Here, we reported effect of on chemo-associated Results: total, 364 366 pts arm received assigned treatment. As May 20, KM estimated median follow-up 13.6 mo, all medications showed similar exposure duration between two arms (Table). Occurrence treatment-related adverse events was generally comparable (any grade, 97.8% vs 98.4% arm; grade ≥3, 62.6% 59.0%). reduced incidence any decreased platelet count, neutrophil white blood cell count by 8.7%, 10.1%, 11.2%, for 9.1%, 4.3%, 1.6%, respectively Compared arm, less used growth factors (30.2% 42.9%) (32.7% 39.6%). Conclusions: capacity suppress Clinical trial information: NCT04950322 . Safety. CAPOX(N=364) Placebo CAPOX(N=366) Treatment difference (SHR-1701 placebo) (day), (IQR) SHR-1701/placebo 137.0 (65.5-251.5) 127.5 (62.0-190.0) NA Capecitabine 122.0 (83.0-138.0) (73.5-135.0) Oxaliplatin 107.0 (66.0-123.0) 108.5 (64.0-121.0) Treatment-related hematological toxicities, n (%) % Any Grade ≥ Platelet 217 (59.6%) 69 (19.0%) 250 (68.3%) 103 (28.1%) -8.7% -9.1% Neutrophil 163 (44.8%) 44 (12.1%) 201 (54.9%) 60 (16.4%) -10.1% -4.3% White 147 (40.4%) 13 (3.6%) 189 (51.6%) 19 (5.2%) -11.2% -1.6%