retlirafusp alfa (SHR-1701) / Jiangsu Hengrui Pharma, Dong-A - LARVOL DELTA

SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Ruijin Hospital

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Ovarian Cancer • Solid Tumor

A Randomized, Open-label, Double-cohort Study of Fluzoparib Combined With Famitinib Malate or SHR-1701 for Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: Qinglei Gao

New P2 trial • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • BRCA1 • BRCA2

Effect of SHR-1701 on chemotherapy (chemo)-induced myelosuppression: Data from a phase 3 study in HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA). (ASCO-GI 2025) - P3 | "SHR-1701 showed the capacity to suppress chemo-associated myelosuppression. Safety."

P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • TGFB1

Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial. (PubMed, Cancer Cell) - "Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase III study of SHR-1701 versus placebo in combination with chemo as first-line (1L) therapy for HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA) (ESMO 2024) - P3 | "1L SHR-1701 plus CAPOX showed a statistically significant and clinically meaningful benefit in OS compared with placebo plus CAPOX in pts with HER2-negative G/GEJA, both in PD-L1 CPS ≥5 population and in overall population regardless of PD-L1 level, presenting as a new treatment option."

Clinical • Combination therapy • Late-breaking abstract • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2 • TGFB1

Jiangsu Hengrui Pharma has chalked up a first-in-class approval for retlirafusp alfa, a bifunctional drug that targets PD-L1 and TGF-beta, as a treatment for advanced gastric cancer. (pharmaphorum) - "The green light – in Hengrui's home market of China – is for use of the bispecific fusion protein in combination with fluorouracil and platinum chemotherapy as a frontline treatment for locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma with PD-L1 expression (CPS) of 1 or more....The phase 3 RELIGHT trial reported at the 2024 ESMO congress revealed a significant 34% improvement in overall survival compared to placebo when added to standard CAPOX chemotherapy, coming in at 15.8 months and 11.2 months, respectively, in a HER2-negative advanced gastric/GEJ cancer population of 737 Chinese patients."

China approval • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Jingdong Zhang

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Efficacy and safety of first-line treatments in HER2-negative advanced gastric and gastroesophageal junction cancer (GC/GEJC): A systematic review and Bayesian network meta-analysis (ESMO-IO 2025) - "Among these regimens, cadonilimab +chemo and SHR-1701 +chemo achieved similar OS improvement, ranking first (HR 0.66; 95% Crl 0.54, 0.81) and second (HR 0.66; 95% Crl 0.53, 0.81) respectively, followed by zolbetuximab + chemo (HR 0.76; 95% Crl 0.65, 0.89), sintilimab + chemo (HR 0.77; 95% Crl 0.63, 0.94) and other regimens...Similar results were observed in patients with PD-L1 CPS ≥ 5. Regarding grade ≥3 TRAEs, compared with chemo alone, sugemalimab + chemo (OR 1.145; 95% Crl 0.804, 1.627), SHR-1701 + chemo (OR 1.165; 95% Crl 0.863, 1.557), and tislelizumab + chemo (OR 1.174; 95% Crl 0.919, 1.51)showed better safety profile than other regimens.Conclusions Considering the balance between efficacy and safety, SHR - 1701 + chemo might be considered the preferred first-line treatment for patients with HER2-negative advanced GC/GEJC, particularly those with PD-L1 CPS ≥1 or CPS ≥5."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

PD1/TGFβ In Combination With EZH2 And Chemotherapy For First - Line Treatment Of Gastric Cancer (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

New P2 trial • Gastric Cancer • Oncology • Solid Tumor

A phase 1b/2 study of first-line anti-PD-L1/ TGF-βRII fusion protein SHR-1701 combined with nab-paclitaxel and gemcitabine for advanced pancreatic ductal adenocarcinoma. (PubMed, Signal Transduct Target Ther) - P1/2 | "The interactions within tumor microenvironment were involved disease progression. Overall, first-line SHR-1701 plus AG showed promising anti-tumor activity and controllable safety in advanced or metastatic pancreatic ductal adenocarcinoma, and features of patients more likely to benefit from the combination were drawn."

IO biomarker • Journal • P1/2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9 • TGFB1

SHR-1701 Plus CAPOX for advanced gastric or gastroesophageal junction adenocarcinoma with high-risk features: Results from a phase III study (ESMO-IO 2025) - P3 | "For diffuse-type histology, OS was 16.4 months (95% CI, 12.5- not estimable) versus 9.5 months (95% CI, 5.9-12.4; HR, 0.50; 95% CI, 0.26-0.95). In patients with ≥1 high-risk feature, OS was 14.4 months (95% CI, 12.7-16.8) versus 10.1 months (95% CI, 8.8-11.7; HR, 0.62; 95% CI, 0.49-0.78).Conclusions SHR-1701 plus CAPOX demonstrated OS benefit across high-risk subgroups, including patients with liver metastasis, diffuse-type histology, and peritoneal metastasis."

IO biomarker • Metastases • P3 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • TGFB1

SHR-1701 plus CAPOX in patients with advanced gastric or gastroesophageal junction adenocarcinoma and PD-L1 combined positive score ≥1: A post-hoc analysis of a phase III study (ESMO Asia 2025) - P3 | "In patients with HER2-negative GC/GEJA and PD-L1 CPS ≥1, SHR-1701 in combination with CAPOX chemotherapy demonstrated clinically meaningful improvements in efficacy compared with placebo plus CAPOX, with a manageable safety profile. These findings are consistent with the results observed in the overall study population."

Clinical • Metastases • P3 data • Retrospective data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1 • TGFB1

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination with Other Antitumor Therapies in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma (ChiCTR) - P2 | N=366 | Recruiting | Sponsor: Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

Health-related quality of life with first-line SHR-1701 versus placebo plus chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma: Results from a randomized phase III trial (ESMO 2025) - P3 | "Conclusions First-line SHR-1701 plus CAPOX maintained or improved HRQoL compared with placebo plus CAPOX and significantly reduced deterioration risk across key PRO items. Table: 2108P Time to deterioration Items Median (95% CI) HR (95% CI) SHR-1701 + CAPOX Placebo + CAPOX QLQ-C30 GHS/QoL 10.8 (5.7, NE) 5.7 (4.4, 7.1) 0.76 (0.61, 0.95) Nausea/vomiting 6.0 (3.4, NE) 3.0 (2.3, 4.7) 0.79 (0.64, 0.98) Pain 11.7 (10.4, NE) 6.8 (5.5, 9.7) 0.71 (0.56, 0.90) QLQ-STO22 Pain NR (NE, NE) 6.2 (4.6, 7.5) 0.59 (0.46, 0.76) Reflux 8.1 (5.5, NE) 4.8 (2.8, 6.6) 0.76 (0.61, 0.95)"

Clinical • HEOR • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CASTLE-ZS-03: Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma. (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=351 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer. (PubMed, Cancer Lett) - P2 | "Patients received concurrent SHR-1701 and CRT, followed by two cycles of SHR-1701 plus XELOX and subsequent TME surgery. One patient experienced fatal immune-mediated myocarditis prior to surgery. Overall, the addition of SHR-1701 to CRT demonstrated encouraging efficacy and manageable safety in high-risk LARC, supporting further investigation in larger randomized trials."

Journal • Cardiovascular • Colorectal Cancer • Hematological Disorders • Oncology • Rectal Cancer • Solid Tumor • TGFB1

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=351 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Phase II clinical study of SHR-1701 combined with albumin paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer with malignant pleural effusion (ChiCTR) - P=N/A | N=42 | Recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

ICT-HCC: Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Nanjing Tianyinshan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Hepatocellular Cancer • Oncology • Solid Tumor

Retlirafusp alfa-a bifunctional anti-PD-L1/TGF-βRII agent plus nab-paclitaxel and carboplatin in pre-treated recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): A prospective, single-arm, phase II clinical trial. (ASCO 2025) - P2 | "Even as most pts have progressed on ICIs before enrollment, retlirafusp alfa plus nab-paclitaxel and carboplatin demonstrated promising anti-tumor efficacy and manageable toxicities in pre-treated R/M HNSCC. Long-term efficacy needs to be confirmed by further follow-up."

Clinical • Metastases • P2 data • Anemia • Head and Neck Cancer • Hematological Disorders • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TGFB1

SHR-1701-III-301: A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC (clinicaltrials.gov) - P2/3 | N=62 | Terminated | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=439 ➔ 62 | Recruiting ➔ Terminated; Adjustment of the Company's R&D Strategy

Enrollment change • Trial termination • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Clinical and biomarker analyses of SHR-1701 combined with famitinib in patients with previously treated advanced biliary tract cancer or pancreatic ductal adenocarcinoma: A phase II trial (AACR 2025) - P=N/A | "SHR-1701 plus famitinib showed promising efficacy and manageable toxicity in advanced BTC and PDAC, providing proof-of-concept for targeting PD-L1, TGF-β, and angiogenesis pathways simultaneously. The I/M score may help select patients most likely to benefit from this regimen."

Biomarker • Clinical • IO biomarker • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • TGFB1