Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Mankind Pharma, Fortvita Biologics - LARVOL DELTA

Sintilimab plus Bevacizumab biosimilar IBI305 and chemotherapy as a first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma (SBAGA): a single-arm, phase Ib/II study. (PubMed, Nat Commun) - P1/2 | "Nonetheless, sintilimab plus IBI305 and chemotherapy demonstrated promising antitumor activity and favorable PFS with manageable toxicity in HER2-negative advanced GA/GEJA. Trial number: NCT05640609."

IO biomarker • Journal • P1/2 data • Fatigue • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CLDN18 • HER-2 • PD-L1

Real-World Comparative Effectiveness of Four Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer (IASLC-WCLC 2026) - "Conclusions : In this real-world cohort of advanced lung cancer, camrelizumab, pembrolizumab, sintilimab, and tislelizumab demonstrated distinct effectiveness under several specific circumstances. Both PD-L1 expression pattern and histologic subtype may influence the relative clinical benefit and prognosis associated with different ICIs."

Checkpoint inhibition • Clinical • HEOR • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1

Predictive Model for First-Line Chemo-Immunotherapy in Driver-Negative Lung Adenocarcinoma With Brain Metastases (IASLC-WCLC 2026) - "Immune checkpoint inhibitors (ICIs) included tislelizumab (n=20), pembrolizumab (n=18), camrelizumab (n=17), sintilimab (n=15), toripalimab (n=5), and durvalumab (n=1), all administered in combination with chemotherapy. Conclusions : A prediction model incorporating Ki-67, PD-L1, NLR, and neurologic symptoms demonstrated strong discriminative ability for estimating systemic response to first-line chemo-immunotherapy in LUAD-BM. DoR was associated with PFS, whereas TTR was not, indicating that the maintenance of tumor response rather than early response onset may be more relevant to long-term outcomes."

Clinical • Predictive model • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Association of Early Versus Late Time of Day Immune Checkpoint Inhibitors Administration With Survival Outcomes in Gastric and Esophageal Cancers: A Meta-Analytical Evaluation (ACG 2026) - "Eligible studies included patients with advanced gastric or esophageal cancer treated with ICIs, including nivolumab, pembrolizumab, sintilimab, camrelizumab, tislelizumab, toripalimab, and durvalumab, administered either as monotherapy or in combination with chemotherapy. A total of 702 patients were included, comprising 520 patients with gastric cancer and 182 patients with esophageal cancer. In gastric cancer, early ICI administration was associated with significantly improved OS (pooled HR, 0.61; 95% CI, 0.49â0.77) and PFS (pooled HR, 0.62; 95% CI, 0.43â0.89). In esophageal cancer, early administration was associated with improved PFS (pooled HR, 0.40; 95% CI, 0.22â0.72)."

Checkpoint inhibition • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Local Ablation Plus Systemic Therapy for Metachronous Liver and/or Lung Oligometastases From Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=138 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Comparison of the efficacy of transarterial chemoembolization combined with different molecular targeted agents and/or immune checkpoint inhibitors for unresectable hepatocellular carcinoma: a systematic review and network meta-analysis. (PubMed, J Gastrointest Oncol) - "For OS, TACE + anlotinib + sintilimab (TACE + Anl + Sin), TACE + donafenib + toripalimab (TACE + Don + Tor), TACE + lenvatinib + tislelizumab (TACE + Len + Tis), TACE + sorafenib + camrelizumab (TACE + Sor + Cam), and TACE + apatinib + camrelizumab (TACE + Apa + Cam) were all significantly superior to TACE alone...For PFS, compared with TACE alone, TACE + Anl + Sin, TACE + Don + Tor, TACE + lenvatinib + pembrolizumab (TACE + Len + Pem), TACE + Len + Tis, and TACE + Apa + Cam significantly prolonged PFS...For DCR, TACE + Len + Tis showed the best performance, while TACE + atezolizumab + bevacizumab (TACE + Ate + Bev), TACE + Anl + Sin, and TACE + Apa + Cam also demonstrated relatively high DCR. Compared with TACE alone, TACE combined with MTAs and ICIs can significantly improve outcomes in patients with uHCC. TACE + Anl + Sin, TACE + Len + Tis, and TACE + Apa + Cam may be promising treatment options, although more prospective studies are needed for further validation."

Checkpoint inhibition • Journal • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

Optimizing PD-1/PD-L1 inhibitors plus chemotherapy for driver mutation-negative non-squamous NSCLC in China: a cost-effectiveness analysis. (PubMed, Front Pharmacol) - "The network meta-analysis demonstrated that toripalimab, sintilimab, and pembrolizumab combined with chemotherapy provided superior efficacy and favorable safety among 13 PD-1/PD-L1 inhibitors with chemotherapy for non-sqNSCLC...Compared with chemotherapy alone, camrelizumab, tislelizumab, sintilimab with chemotherapy were cost-effective, with ICERs of $28,813.78/QALY, $19,278.47/QALY, and $20,315.01/QALY, respectively...Among currently available first-line treatment strategies for driver mutation-negative non-sqNSCLC in China, toripalimab and sintilimab combined with chemotherapy demonstrated favorable clinical and economic profiles. These findings provide evidence to support treatment selection, reimbursement decisions, and healthcare resource allocation in clinical practice."

HEOR • IO biomarker • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sintilimab‑related cystitis/ureteritis in high‑grade endometrial stromal sarcoma: A case report and structured literature review. (PubMed, Hum Vaccin Immunother) - "We present a 44‑year‑old female patient with high‑grade endometrial stromal sarcoma who developed severe urinary frequency, urgency, and dysuria after three cycles of sintilimab combined with nab‑paclitaxel and carboplatin...A subsequent urine culture grew Enterococcus faecalis, and the addition of piperacillin-tazobactam resulted in further symptom resolution...Subsequently, due to disease progression, treatment was switched to tislelizumab, and the urinary symptoms did not recur. The patient's urinary symptoms were sintilimab‑related cystitis/ureteritis with possible concomitant or partially suppressed bacterial infection. This case, together with a structured literature review of other immunotherapy‑related cystitis/ureteritis cases and subsequent ICI use, provides a practical reference for the diagnosis and management of ICI‑related urological irAEs and for subsequent anti‑tumor treatment."

Journal • Review • Infectious Disease • Oncology • Sarcoma • Solid Tumor • Uterine Cancer

Clinical activity of chidamide-containing regimens after prior PD-1-based therapy in two patients with microsatellite-stable metastatic colorectal cancer: a case series and narrative review. (PubMed, Front Oncol) - "Case 1: A 60-year-old woman with BRAF V600E-mutant, right-sided, MSS mCRC received third-line surufatinib plus camrelizumab, with a best response of stable disease (SD) and a progression-free survival (PFS) of 5 months...Case 2: A 43-year-old man with recurrent RAS/BRAF wild-type MSS mCRC received fifth-line surufatinib plus sintilimab (PR, PFS 8.5 months) and, after progression, seventh-line chidamide plus sintilimab plus bevacizumab (SD, PFS 5.5 months)...As descriptive observations, these findings are hypothesis-generating only and are insufficient to demonstrate reversal of immunotherapy resistance or survival benefit. Prospective biomarker-driven studies are warranted to evaluate epigenetic-immunotherapy combinations in this subgroup."

IO biomarker • Journal • Colorectal Cancer • Gene Therapies • Oncology • Solid Tumor • BRAF

Nilvanstomig (ZG005), an anti-PD-1/TIGIT bispecific antibody, plus bevacizumab vs. sintilimab plus bevacizumab biosimilar as first-line therapy for advanced hepatocellular carcinoma: A randomized, multi-center, phase II trial. (ASCO 2026) - P2 | "This study evaluated ZG005 plus bevacizumab vs. sintilimab plus IBI305 (a bevacizumab biosimilar) as first-line therapy for aHCC. The combination of ZG005 and bevacizumab as first-line treatment in patients with aHCC demonstrated an early encouraging efficacy with an acceptable safety profile. Higher response rates and prolonged PFS were observed with the ZG005-based regimens. Longer follow up of the current study and future phase 3 trials are warranted to validate the efficacy and safety of ZG005 in combination with bevacizumab in aHCC."

Bispecific • Clinical • Metastases • P2 data • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor • TIGIT

ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P3 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy of Fruquintinib Plus Sintilimab in Special Populations with Advanced Renal Cell Carcinoma: A Subgroup Analysis of FRUSICA-2 Study (ESMO 2026) - No abstract available

Clinical • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomarker-Directed Sintilimab Monotherapy/combo in Untreated Advanced NSCLC: A Phase II Umbrella Trial (CTONG1702) (IASLC-WCLC 2026) - "This report presents data from seven cohorts: Sintilimab monotherapy: Cohort 14 (PD-L1 TPS ≥ 50%), Cohort 15 (PD-L1 TPS < 50% with TMB-High), Cohort 16 (PD-L1 TPS < 50% with KRAS/TP53 co-mutations); Sintilimab plus platinum-based chemotherapy: Cohort 17 (PD-L1 TPS < 1% non-squamous cell carcinoma, sintilimab + pemetrexed + cisplatin/carboplatin) and Cohort 18 ( PD-L1 TPS < 1% squamous cell carcinoma, sintilimab + gemcitabine + carboplatin); Sintilimab + fruquintinib: Cohort 22 (PD-L1 TPS < 50%) and Cohort 23 (PD-L1 TPS ≥ 50%). The most common adverse events was proteinuria. Conclusions : TMB-High seems to be a good predictor for long PFS and OS of sintilimab monotherapy; Sintilimab combined with fruquintinib showed prolonged PFS and OS, especially in PD-L1 ≥ 50%, suggesting a novel chemo-free regimen worth exploring."

Biomarker • IO biomarker • Metastases • Monotherapy • P2 data • Tumor mutational burden • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • Squamous Cell Carcinoma • KRAS • TMB • TP53

Sintilimab Plus Axitinib for Advanced Fumarate Hydratase-Deficient Renal Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "This combination therapy warrants further validation in a randomized clinical trial. ClinicalTrials.gov Identifier: NCT04387500."

Clinical • Journal • P2 data • Dyslipidemia • Genito-urinary Cancer • Hematological Disorders • Hypertriglyceridemia • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • FH

Sintilimab Combined With Albumin-Bound Paclitaxel and SOX Regimen as Conversion Therapy for Unresectable Advanced Gastric Cancer Achieving Complete Remission: A Case Report and Literature Review. (PubMed, Clin Case Rep) - "For carefully selected patients with unresectable advanced gastric cancer, immunochemotherapy combining PD-1 inhibitor with albumin-bound paclitaxel and S-1/oxaliplatin may achieve deep remission and enable successful R0 resection. Our findings suggest that this multimodal conversion approach could be considered in selected cases with favorable performance status and MDT-supported indications, as pathological complete remission appears to be attainable in this context."

Journal • Gastric Cancer • Oncology • Solid Tumor

Sintilimab Plus P-Gemox (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly-Diagnosed Advanced, Extranodal Natural Killer/T Cell Lymphoma, Nasal Type: A Multicenter, Phase 2 Cohort of the Open-Label Spirit Study (ASH 2022) - P2 | "Combination of sintilimab plus P-GEMOX Regimen yielded promising clinical activity with a manageable safety profile, supporting immunochemotherapy as a new first-line treatment option for pts with advanced ENKTL. Treatment and follow-up are currently ongoing and further studies have been initiated to explore biomarkers to better predict response and long-term survival."

Clinical • IO biomarker • P2 data • Anemia • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Sintilimab Plus Chemotherapy vs Osimertinib as First-Line Therapy in EGFR-Mutant NSCLC With High PD-L1 Expression: A Phase II Trial (IASLC-WCLC 2026) - "No significant differences were observed in ORR,DCR, or AE incidence between the two groups. Further investigation is warranted."

Clinical • IO biomarker • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • PD-L1

Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer. (ASCO 2025) - P3 | " Eligible pts received ICI pembrolizumab or sintilimab combined with chemotherapy, as 1st line treatment for stage IIIC-IV NSCLC without driver mutation. In this randomized trial, all three efficacy endpoints of immunochemotherapy were significantly improved through Early vs Late ToD dosing in pts with previously untreated stage IIIC-IV NSCLC. The near doubling in PFS and OS in our trial support the need for further randomized trials to determine the relevance of ToD for ICI efficacy and their underlying circadian mechanisms in pts with various cancer types."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Advanced Hepatitis B Virus Related Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting | Initiation date: May 2026 ➔ Aug 2026

Enrollment open • Trial initiation date • Hepatitis B • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

A multicenter, randomized, controlled, open-label, phase II trial of autologous tumor-infiltrating lymphocytes (GC101 TIL) in patients with advanced melanoma. (ASCO 2026) - P2 | "Clinical Trial Registration Number: NCT06703398 Background: Tumor-infiltrating lymphocyte (TIL) therapy is effective in advanced melanoma but hampered by toxicity from high-dose IL-2 and lymphodepletion (cyclophosphamide/fludarabine)...GC101 therapy consists of tumor resection, low-intensity preconditioning (cyclophosphamide 20 mg/kg/d, pre-infusion d -5 to- 3; hydroxychloroquine 600 mg, pre-infusion d -5), followed by infusion of IL-2-free TIL and sintilimab (100 mg at infusion, then 100 mg Q6W × 4)... GC101 TIL significantly improved PFS and ORR versus investigator-choice chemotherapy in anti-PD-1-resistant melanoma, with manageable safety, supporting its potential as a new later-line therapy."

Clinical • Late-breaking abstract • Metastases • P2 data • Tumor-infiltrating lymphocyte • Eye Cancer • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. (PubMed, Hepatology) - P2 | "Sintilimab plus bevacizumab combined with radiotherapy provides favorable treatment response and survival outcomes along with an acceptable safety profile in the first-line setting for HCC patients with PVTT. (ClinicalTrials.gov Identifier: NCT05010434)."

Journal • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

Organ-preservation value of sequential PD-1 inhibitors followed by selective sintilimab/IBI310/lenvatinib in non-metastatic MSI-H/dMMR gastric and colon cancer. (ESMO 2026) - No abstract available

dMMR • Metastases • MSI-H • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Beyond PCR: Prognostic Biomarkers in Non-pCR Patients After Neoadjuvant Chemoimmunotherapy for Potentially Resectable Stage IIIA/IIIB NSCLC (IASLC-WCLC 2026) - P2 | "Methods : This prospective, single-arm phase 2 trial (Neo-Pre-IC, NCT04326153) enrolled patients with initially unresectable stage IIIA/IIIB NSCLC who received neoadjuvant sintilimab plus chemotherapy...B-cell infiltration and MHC-I-mediated immune crosstalk represent key immune correlates of favorable outcomes in this subgroup. This establishes a biomarker-driven framework for personalized postoperative management, enabling safe de-escalation of maintenance immunotherapy in low-risk non-pCR patients and guiding treatment intensification in high-risk patients."

Biomarker • Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CD8

Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Guangdong Provincial People's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

New P2 trial • Gastric Cancer • Oncology • Solid Tumor • PD-L1