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

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

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.Legal entity responsible for the study The authors."

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

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.Clinical trial identification NCT04950322.Legal entity responsible for the study The authors."

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

SHR-A1811-Ib/II-205: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=258 ➔ 76 | Trial primary completion date: Jul 2026 ➔ Apr 2025 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

SHR-1701-III-309: A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer (clinicaltrials.gov) - P3 | N=31 | Terminated | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=572 ➔ 31 | Trial completion date: May 2025 ➔ Aug 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2024 ➔ Aug 2024; Sponsor develops strategy adjustment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cervical Cancer • Oncology • Solid Tumor

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: China Medical University, China

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

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

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Application and future prospects of bispecific antibodies in the treatment of non-small cell lung cancer. (PubMed, Cancer Biol Med) - "At present, in addition to the approved bsAb, amivantamab, three novel bsAbs (KN046, AK112, and SHR-1701) are being evaluated in phase 3 clinical trials and many bsAbs are being evaluated in phase 1/2 clinical trials for patients with non-small cell lung cancer (NSCLC). Herein we present the structure, classification, and mechanism of action underlying bsAbs in NSCLC and introduce related clinical trials. Finally, we discuss challenges, potential solutions, and future prospects in the context of cancer treatment with bsAbs."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-1701-III-307: A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer (clinicaltrials.gov) - P3 | N=737 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Mar 2025 ➔ May 2024

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

SHR-A1811-Ib/II-205: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer (clinicaltrials.gov) - P2 | N=258 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=156 ➔ 258

Enrollment change • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Bifunctional anti-PD-L1/TGF-βRII agent SHR-1701 plus chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Survival results of a phase II trial. (ASCO-GI 2025) - P=N/A | "Eligible pts received SHR-1701 (30mg/kg, iv, d1, q3w) in combination with up to six cycles of albumin-bound paclitaxel (125mg/m2, iv, d1, d8, q3w) and cisplatin (75mg/m2, iv, d1, q3w). The results highlighted that SHR-1701 plus chemotherapy as first-line therapy maintained long-term, durable survival benefit in pts with advanced ESCC."

Clinical • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • TGFB1

Neoadjuvant SHR-1701 (a bifunctional anti-PD-L1/TGF-βRII agent) combined with chemoradiotherapy for resectable locally advanced esophageal squamous cell carcinoma (ESCC): A phase II trial. (ASCO-GI 2025) - P=N/A | "Preoperative therapy included SHR-1701 (30 mg/kg every 3 weeks for 2 cycles), albumin paclitaxel (50 mg/m2, once a week for 5 weeks), carboplatin (AUC=2, once a week for 5 weeks) and radiotherapy (41.4Gy in 23 fractions). The addition of SHR-1701 to neoadjuvant chemoradiotherapy in ESCC demonstrated promising efficacy with acceptable toxicity, and might be a promising approach for neoadjuvant treatment."

Clinical • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • PD-L1 • TGFB1