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

The molecular landscape of patients with malignant histiocytosis (ASH 2025) - "Responders received a range of agents matched to their mutations: trametinib ( BRAFV600E, MAP2K1F53I, KRASQ16H/PTEND24G/EPHB1R327C, MAP2K1F53I/BCL2/CDKN1B/KIT, and CALR), dabrafenib + trametinib( BRAFG596R/KRASQ61H) , imatinib ( MAP2K1C121S/METG28881T/DUSP2G137D/HIST1H3BC97Y/GRIN2AS1216C and PTPN11/STK11/GNA11/JAK2) , chidamide + sintilimab( IDH2G515A/RHOAG50T/TET23344delC), sirolimus( PTEN/FGFR3/SETD2) and sorafenib ( BRAFD594G/KRASK117N/TP53). Despite this complexity, durable clinical responses to targeted agents are achievable, even in heavily mutated cases. These findings support the use of comprehensive genomic profiling in MH to identify therapeutic targets and guide precision treatment strategies."

Clinical • IO biomarker • Sarcoma • Solid Tumor • ADGRG6 • BCL2 • BCL6 • BRAF • CALR • CDK1 • CDKN1A • CDKN1B • CDKN2A • CDKN2B • CREBBP • CYTOR • DNMT3A • EGFR • FGFR3 • GNA11 • JAK2 • KRAS • MAP2K1 • NF1 • NRAS • NRF1 • PTEN • PTPN11 • SETD2 • STK11 • TET2 • TP53

A chemotherapy-free regimen of sintilimab, rituximab, and lenalidomide ± polatuzumab vedotin in elderly patients with newly diagnosed diffuse large B-cell lymphoma (ASH 2025) - "No treatment-related deaths were observed.The chemotherapy-free regimen of sR2± polatuzumab vedotin demonstrates promising efficacy and afavorable safety profile in older patients with DLBCL. These findings warrant further prospectivevalidation."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Orelabrutinib, sintilimab, and temozolomide (OST) in relapsed/refractory primary central nervous system lymphoma (ASH 2025) - P2 | "Clinically meaningful survival benefit was observed (median PFS 9.0 months; 2-year OS 53.1%).Disease status was a key determinant of efficacy, with relapsed patients significantly outperformingthose with refractory disease. The chemo-free regimen was generally well tolerated, supporting itsfurther evaluation in prospective studies."

IO biomarker • Atrial Fibrillation • B Cell Lymphoma • CNS Lymphoma • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Primary Central Nervous System Lymphoma • Respiratory Diseases • BCL2 • PD-1

Real-world safety profile of PD-1 inhibitors in Epstein–Barr Virus–Associated lymphoproliferative disorders: A retrospective analysis from west China hospital (ASH 2025) - "Notably, patients in our cohort received PD-1inhibitor, sindilizumab, at a dose of 100 mg every month, while standard regimens in solid tumor trialstypically employed 200 mg every three weeks.ResultsHLH reactivation occurred in 9.5% (7/74) of EBV-HLH patients and 4.3% (1/23) of CAEBV patients, with amedian onset of 5–7 days following PD-1 inhibitor initiation; no HLH episodes were reported in solidtumor cohorts (p < 0.01 vs both EBV-HLH and CAEBV groups).Fever was reported in 47.3% of EBV-HLH and 39.1% of CAEBV patients, typically within 24 hours of PD-1inhibitor administration-significantly higher than the <15% reported in solid tumor trials (p < 0.01).Anemia was observed in 89.2% and 82.6% of EBV-HLH and CAEBV patients, respectively, with Grade ≥3anemia in 59.5% and 34.8%, compared to 10–15% overall and 2–4% Grade ≥3 anemia in solid tumorcohorts (p < 0.001).Thrombocytopenia occurred in 78.4% and 56.5%, with Grade ≥3 events in 36.5% and21.7%, respectively,..."

IO biomarker • Real-world • Real-world evidence • Retrospective data • Dermatology • Endocrine Disorders • Epstein-Barr Virus Infections • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Neutropenia • Rare Diseases • Solid Tumor • Thrombocytopenia • IL6 • MB

125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors. (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Li Min

Checkpoint inhibition • New P2 trial • Oncology • Solid Tumor

First-in-human phase I study of the anti-TIGIT and PVRIG bispecific antibody as monotherapy or with sintilimab for advanced solid tumors (ESMO Asia 2025) - P1 | "SIM0348 plus sintilimab was well tolerated and demonstrated antitumor activity in participants with advanced NSCLC."

First-in-human • Metastases • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TIGIT

Long-Term Disease Control with Combined Immunotherapy and Oral Chemotherapy in Primary Intraosseous Adenoid Cystic Carcinoma of the Mandible with Initial Pulmonary Metastasis (ESMO Asia 2025) - "Two cycles of docetaxel + sintilimab followed, but severe nausea/vomiting led to discontinuation of intravenous chemotherapy. Oral fluoropyrimidines (S-1, capecitabine) are favorable for maintenance due to low toxicity. ACC, an immunologically "cold" tumor, typically responds poorly to immunotherapy, but combined sintilimab and oral capecitabine here enabled prolonged control, suggesting potential for advanced PIACC."

Adenoid Cystic Carcinoma • Oncology

Phase II trial of PD-1 inhibitor sintilimab in recurrent/progressive meningioma (ESMO Asia 2025) - P=N/A | "Sintilimab failed to improve PFS-6 in both grade 1 and grade 2/3 recurrent/progressive meningiomas. When evaluating PD-1 inhibitor treatment for recurrent/progressive meningioma patients, who generally have a longer expected survival and high TMB, the use of the Immunotherapy Responses Assessment in Neuro-Oncology (iRANO) criteria may be more appropriate to avoid overlooking potential clinical benefits."

IO biomarker • P2 data • Tumor mutational burden • Brain Cancer • Meningioma • Oncology • Solid Tumor • PD-L1 • TMB

Survival benefits of immune checkpoint inhibitor plus chemotherapy as first-line treatment for squamous non-small cell lung cancer in the Chinese national medical insurance list: A Bayesian network meta-analysis (ESMO Asia 2025) - "Considering the PFS and OS benefits of camrelizumab plus chemotherapy as first-line treatment for sqNSCLC, it may be regarded as a preferred therapeutic option."

Checkpoint inhibition • Reimbursement • Retrospective data • US reimbursement • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Crossover-adjusted overall survival (OS) benefit with sintilimab in EGFR-TKI-resistant NSCLC: Post-hoc analysis of ORIENT-31 (ESMO Asia 2025) - P3 | "Background: In Orient-31 (NCT03802240), baseline characteristics for sintilimab+IBI305+chemo (Arm A) and chemo-alone (Arm C) groups in EGFR-TKI-resistant NSCLC were reported. This crossover-adjusted analysis demonstrates a significant overall survival benefit for sintilimab-based therapy in EGFR-TKI-resistant NSCLC. Propensity score matching confirmed robust OS improvement (23.3 vs 15.0 months; HR 0.62, 95% CI 0.41-0.96; p=0.030), indicating conventional ITT analysis underestimated treatment efficacy due to crossover contamination."

Clinical • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Comparative efficacy of immune checkpoint inhibitors in advanced non-small cell lung cancer (ESMO Asia 2025) - "Predominant ICIs were sintilimab (31%) and tislelizumab (30%). We propose and validate the novel NIHRI prognostic tool. The integrated nomogram provides a non-invasive, cost-effective method for quantitative prognosis prediction in NSCLC immunotherapy, facilitating personalized clinical decision-making."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A pivotal phase II, randomized, controlled, open-label, trial (MIZAR-003) to assess the efficacy and safety of GC101 TIL, an autologous tumor-infiltrating lymphocyte (TIL) cell therapy, for patients with advanced anti-PD-1 refractory melanoma in later-line therapy (ESMO Asia 2025) - P2 | "Background: Tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma has been limited by intensive lymphodepletion (high-dose cyclophosphamide/fludarabine) and high-dose IL-2, which cause significant toxicity. We explored GC101 TIL therapy using a low-intensity preconditioning regimen, cyclophosphamide 20 mg/kg/day from day -5 to day -3 and a single 600 mg oral hydroxychloroquine dose on day -5, along with IL-2-free TIL infusion, which showed encouraging outcomes in a prior phase I trial. This phase II study evaluates the optimized GC101 TIL therapy in melanoma patients refractory to PD-1 antibodies.Trial design: MIZAR-003 (NCT06703398) is a pivotal phase II, multicenter, randomized, open-label, parallel group, treatment study that will randomize 98 pts (1:1) to either Arm A: GC101 TIL therapy (study intervention includes tumor tissue resection>150mm3, preconditioning, 100mg sintilimab injection, TIL infusion, and thereafter, 4-dose 100mg..."

Clinical • Metastases • P2 data • Tumor-infiltrating lymphocyte • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor

Interim results and ctDNA biomarker analysis from the phase III SCIENCE trial: Neoadjuvant chemotherapy or chemoradiotherapy with/without sintilimab for resectable locally advanced esophageal squamous cell carcinoma (ESMO Asia 2025) - P3 | "Plasma samples were collected at baseline (BL), before the second cycle of neoadjuvant therapy (C1) and preoperatively (BS). CtDNA analysis was performed using Genecast MinerVa Prime assay, a personalized, tumor-informed MRD method."

Biomarker • Circulating tumor DNA • Clinical • IO biomarker • Metastases • P3 data • P3 data: top line • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

YOUNG-NEOS: Phase II study of neoadjuvant nab-paclitaxel, oxaliplatin s-1, and sintilimab for resectable early-onset GC/GEJC patients (ESMO Asia 2025) - P2 | "For perioperative backbone chemotherapy in resectable gastric cancer, Japanese and Chinese guidelines recommend a doublet regimen of fluoropyrimidines plus oxaliplatin, while Western guidelines favor a triplet regimen that adds docetaxel...The study is powered at 80% to detect an increase in pCR rate from 6% to 20% with significance level of 0.05. The first patient will be recruited on September 2025, with full accrual expected by September 2027."

Clinical • P2 data • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2

IBI343 combined with Sintilimab and SOX as first-Line therapy for CLDN18.2-positive locally advanced unresectable or metastatic HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) (ESMO Asia 2025) - P1/2 | "This study is recruiting at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine. To date, 7 pts have been enrolled, and dose escalation is ongoing."

Clinical • IO biomarker • Metastases • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

Phase II trial of adjuvant sintilimab in lymph node-positive esophageal squamous cell carcinoma (ESCC) after radical surgery without neoadjuvant treatment (ESMO Asia 2025) - P2 | "Adjuvant sintilimab appears to be a feasible treatment for LN+ ESCC patients after radical surgery without neoadjuvant therapy. The safety profile is manageable. Given that efficacy data are still immature due to limited follow-up and ongoing patient enrollment, further accrual and extended follow-up are necessary to draw definitive conclusions about its clinical benefit."

Clinical • P2 data • Surgery • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

FOLFOX-HAIC combined with sintilimab and donafenib for advanced hepatocellular carcinoma: A single-arm, phase II study (ESMO Asia 2025) - "The combination of mFOLFOX6-HAIC with sintilimab and donafenib exhibited an encouraging short-term efficacy for advanced HCC by improving the ORR and DCR, with acceptable toxicity. We will report more data in the future."

Metastases • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

Comparative pathologic complete response of neoadjuvant chemotherapy with PD-1/PD-L1 inhibitors in locally advanced gastric or gastroesophageal junction adenocarcinoma: A systematic review and Bayesian network meta-analysis (ESMO Asia 2025) - "Moderate effects were seen with Camrelizumab + NCT (OR 4.65, CrI: 1.72–13.2; SUCRA 56.94) and Durvalumab + NCT (OR 3.09, CrI: 0.688–13.9; SUCRA 40.12). Atezolizumab + NCT (OR 2.20, CrI: 0.739–8.27; SUCRA 28.04) and Toripalimab + NCT (OR 3.23, CrI: 0.563–20.3; SUCRA 43.21) showed lower efficacy. The addition of PD-1/PD-L1 inhibitors to NCT may enhance pCR in locally advanced gastric or GEJ cancer. The addition of PD-1/PD-L1 inhibitors to NCT may enhance pCR in locally advanced gastric or GEJ cancer. Tislelizumab, Pembrolizumab, and Sintilimab demonstrated the most promising results, although wide credible intervals reflect substantial uncertainty for several regimens. Further comparative trials and long-term outcome data are needed to optimize NICT strategies."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Reduced-intensity CRT plus PD-1 inhibitor for elderly ESCC: A retrospective cohort (ESMO Asia 2025) - P | "We tested a triple-optimised regimen—non-platinum monotherapy, 50.4 Gy radiotherapy and concurrent PD-1 inhibitor—to preserve efficacy and improve safety. This retrospective study enrolled consecutive patients aged ≥70 years with histologically confirmed ESCC (stage II–IV, ECOG PS 0–2) who were registered at the Cancer Center, Chongqing University Three Gorges Hospital, between January 2022 and July 2023, and were followed until August 2025.Treatment comprised 50.4 Gy/28 fractions delivered over 5.5 weeks, concurrent single-agent chemotherapy (S-1 or weekly nab-paclitaxel) and a PD-1 inhibitor (tislelizumab n=18, camrelizumab n=10, sintilimab n=6) for six cycles, followed by PD-1 inhibitor maintenance until progression or intolerance. Moderate-dose radiotherapy combined with single-agent chemotherapy and PD-1 inhibitor is active and well tolerated in elderly ESCC, including PD-L1-negative subgroups. These real-world data support prospective validation."

IO biomarker • Retrospective data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • PD-L1

High pathological response and excellent surgical safety with neoadjuvant radiotherapy plus SOX and sintilimab in locally advanced gastroesophageal junction adenocarcinoma: A prospective single-center study (ESMO Asia 2025) - P=N/A | "Prospective evidence for radiotherapy plus SOX (S-1 and oxaliplatin) with PD-1 blockade in GEJA is limited... Neoadjuvant radiotherapy plus SOX and sintilimab achieved high pCR/MPR rates, 100% R0 resection, and excellent safety in locally advanced GEJA. This triple-modality approach warrants further evaluation in randomized trials and has the potential to redefine the neoadjuvant standard for this population."

Clinical • Metastases • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): Results from phase II part of FRUSICA-2 (ESMO Asia 2025) - P2/3 | "Background: FRUSICA-2 is a randomized, open-label, active-controlled phase 2/3 study (NCT05522231) designed to evaluate the efficacy and safety of Fruquintinib (F) + Sintilimab versus Axitinib or Everolimus monotherapy for 2L treatment of RCC. Results from this F monotherapy of the FRUSICA-2 indicated a comparable anti-tumor efficacy compared with other 2L VEGFR-TKI monotherapies, along with a manageable safety profile in 2L RCC pts after first-line VEGFR-TKI therapy."

Clinical • Metastases • Monotherapy • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Sintilimab plus platinum-based chemotherapy with vs without autologous CIK cell therapy in metastatic NSCLC: A multicenter randomized study (ESMO Asia 2025) - P2 | "Eligible patients (pts) were randomized (1:1) to receive four cycles of sintilimab plus chemotherapy with or without CIK cells for up to 8 cycles, maintained with sintilimab ± pemetrexed (for non-squamous) until progression or intolerable toxicity. This study demonstrated that the addition of CIK cells to chemo-immunotherapy significantly improved efficacy, along with manageable toxicity in advanced NSCLC, which provided a promising treatment regimen."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Glycan profiling of therapeutic monoclonal antibodies: Rapid, non-denaturing single-step digestion via pH-tuned enzymatic cleavage. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "Validation with trastuzumab (IgG1) and sintilimab (IgG4) showed nearly identical N-glycan profiles to conventional methods, retaining chromatographic properties and yielding comparable FA2 peak areas and glycoform abundances. MS revealed consistent glycoform profiles between methods (27 vs. 25 glycoforms in optimized vs. conventional), with strong abundance correlation. These results demonstrate that the method is not only applicable to multi-sample scenarios but also fully MS compatible, offering a robust tool for biopharmaceutical development, batch consistency assessments, and biomarker discovery in glycobiology research."

Journal

Safety and efficacy of hepatic artery infusion chemotherapy (HAIC) or lenvatinib combined with sintilimab as neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma: A prospective, randomized, two-cohort, exploratory phase II clinical study. (ASCO-GI 2026) - P=N/A | "Clinical Trial Registration Number: NCT05621499 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Sintilimab combined with lenvatinib versus hepatic artery infusion chemotherapy (HAIC) for neoadjuvant treatment of resectable hepatocellular carcinoma with high risk of recurrence: A prospective, two-arm, randomized, phase II clinical study. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT05519410 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor