Tevimbra (tislelizumab-jsgr) / BeOne Medicines - LARVOL DELTA

BGB-HNSCC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Completed | Sponsor: BeOne Medicines AG | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Efficacy and safety of first-line immunotherapy and targeted therapy in advanced HCC: a network meta-analysis with subgroup analysis based on HBV and HCV infection. (PubMed, Front Immunol) - "In the overall population, regimens with significant OS advantage over sorafenib included sintilimab plus bevacizumab biosimilar (HR = 0.57, 95% CrI 0.43-0.75), camrelizumab plus rivoceranib (HR = 0.62, 0.48-0.79), and atezolizumab plus bevacizumab (HR = 0.66, 0.51-0.84). For PFS, top-ranked combinations were camrelizumab plus rivoceranib (HR = 0.52, 0.41-0.66), anlotinib plus penpulimab (HR = 0.53, 0.41-0.68), lenvatinib plus pembrolizumab (HR = 0.55, 0.44-0.68), and sintilimab plus bevacizumab biosimilar (HR = 0.56, 0.45-0.69)...Regarding safety, tislelizumab (RR = 0.42, 0.33-0.52) and nivolumab (RR = 0.45, 0.36-0.56) were associated with the lowest incidence of AEs≥3...In non-viral HCC, the STRIDE regimen (single priming dose tremelimumab plus durvalumab) was the only regimen to significantly improve OS (HR = 0.75, 0.59-0.96)...This etiology-stratified evidence..."

Clinical • Journal • Retrospective data • Review • Hepatitis C • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

Tislelizumab-induced lichenoid drug eruption and cutaneous squamous cell carcinoma: a rare dermatologic immune-related adverse event. (PubMed, BMC Geriatr) - No abstract available

Adverse events • Journal • Lichen Planus • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study. (PubMed, Signal Transduct Target Ther) - P2 | "Treatment-related adverse events of grade ≥3 occurred in 60.0% of patients; immune-mediated adverse events of any grade was observed in 42.2%, with the majority being grade 1 or 2. In conclusion, first-line tislelizumab and ociperlimab plus GemCis yielded clinically promising tumor response and survival outcomes in advanced BTC and were generally well tolerated without new safety signals."

Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • TIGIT

Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6) (ESMO 2025) - P3 | "Background Ivonescimab significantly improved PFS over pembrolizumab as first-line therapy for advanced NSCLC in PD-L1 TPS ≥1%...Methods Eligible patients with untreated stage IIIB-IV squamous NSCLC were randomized (1:1) to ivonescimab 20 mg/kg Q3W or tislelizumab 200 mg Q3W, plus paclitaxel (175 mg/m2) and carboplatin (AUC 5) for 4 cycles, followed by ivonescimab or tislelizumab monotherapy as maintenance treatment...Safety analyses revealed treatment-related SAE in 32.3% vs. 30.2%, and grade≥3 hemorrhagic events occurred in 1.9% vs. 0.8%, for ivonescimab and tislelizumab groups, respectively. Conclusions This phase III trial result suggests first-line ivonescimab-chemotherapy may be a new standard of care for advanced/metastatic squamous NSCLC."

Clinical • IO biomarker • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Tislelizumab combined with induction chemotherapy and concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma: a multicenter, randomized, phase II trial (EC-CRT-002) (ESMO 2025) - P2 | "Conclusions Tislelizumab plus induction chemotherapy and CCRT demonstrated superior efficacy and manageable toxicity compared to CCRT alone in ESCC. The benefit of adjuvant immunotherapy after CCRT remains uncertain."

Clinical • Late-breaking abstract • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma

Fruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase Ib/II study (ESMO 2025) - P1/2 | "Methods Adults with MSS mCRC who had progressed on or had intolerance to ≥2 lines of chemotherapy (including fluorouracil, oxaliplatin, and irinotecan) and previous VEGF/EGFR inhibitors as indicated, were enrolled. Conclusions Fruquintinib + tislelizumab showed efficacy and tolerability in pts with previously treated mCRC; efficacy outcomes were more favorable in pts without liver mets at BL, with a notable improvement in median PFS. Safety data were consistent with known profiles of both treatments."

Metastases • P1/2 data • Colorectal Cancer • Oncology • Solid Tumor

Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial. (PubMed, Lancet) - P3 | "In patients with untreated advanced squamous NSCLC, ivonescimab plus chemotherapy showed significantly improved progression-free survival compared with tislelizumab plus chemotherapy, regardless of PD-L1 status, as well as a manageable safety profile. This regimen could be used as a novel first-line treatment in this patient group."

Journal • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Tislelizumab + Chemotherapy in Gastric Cancer: Long-Term RATIONALE-305 Randomized Trial Follow-up. (PubMed, Adv Ther) - P3 | "Results from RATIONALE-305 continued to show durable and improved efficacy outcomes with tislelizumab + chemotherapy versus placebo + chemotherapy at 3 years in advanced GC/GEJC, supporting PD-L1 as a potential prognostic biomarker."

Clinical • IO biomarker • Journal • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Efficacy and safety of disitamab vedotin (DV) combined with tislelizumab as adjuvant therapy after radical surgery for patients with HER2-expression upper tract urothelial carcinoma (UTUC): A single-arm, prospective, phase II study (ESMO Asia 2025) - P=N/A | "The DV/tislelizumab combination demonstrated promising preliminary efficacy and a manageable safety profile as adjuvant therapy in patients with HER2-expression UTUC."

Clinical • P2 data • Surgery • Oncology • Solid Tumor • Urothelial Cancer • HER-2

First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "Participants were randomized 1:1 to receive tislelizumab, 200 mg, intravenously or placebo every 3 weeks, both with gemcitabine and cisplatin for 4 to 6 cycles. Greater benefit was observed in participants with activated immune signatures, especially high B-cell expression. ClinicalTrials.gov Identifier: NCT03924986."

Clinical • IO biomarker • Journal • P3 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Tislelizumab-Associated Bullous Pemphigoid. (PubMed, Am J Ther) - No abstract available

Journal • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology

SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Cholangiocarcinoma • CNS Disorders • Depression • Gallbladder Cancer • Hepatocellular Cancer • Mood Disorders • Oncology • Psychiatry

Tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) + CT in patients (pts) with locally advanced (LA) esophageal squamous cell carcinoma (ESCC): RATIONALE-306 subgroup analysis (ESMO-GI 2025) - P3 | "Background: In RATIONALE-306 (NCT03783442), pts with metastatic/locally advanced ESCC were randomized to IV TIS 200 mg or PBO every 3 weeks + investigator-chosen CT (platinum + fluoropyrimidine/paclitaxel) until disease progression or intolerable toxicity. Table: 389MO aInvestigator assessed. ORR, objective response rate; OS, overall survival; PFS, progression-free survival."

Clinical • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • PD-L1

Tislelizumab plus chemoradiotherapy (CRT) versus CRT or chemotherapy (CT) as the neoadjuvant treatment for patients (pts) with locally advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A multicenter, randomized controlled, open-label, phase IIb study (TERRIFIC). (ASCO-GI 2026) - P2b | " Pts with histologically confirmed locally advanced GC/GEJC, stage III-IVa and no prior anticancer therapy were enrolled and randomized (2:2:1) to receive TIS (200 mg) plus CRT (45Gy, SOX or S1+nab-PTX) (arm A), CRT (arm B), or CT alone (SOX or S1+nab-PTX) (arm C) for 3 cycles as neoadjuvant treatment. The preliminary results showed that TIS plus CRT had higher pCR rate over CRT or CT alone for pts with locally advanced GC/GEJC, further confirm the improved efficacy of IO as neoadjuvant therapy for GC/GEJC."

Clinical • Metastases • P2b data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Tevimbra: Expiry of patents in US/EU/China/Japan related to composition-of-matter in 2033 (BeOne Medicines) - Annual Report 2025: Patent term extension in US/EU until 2038; Expiry of patents in US related to method of treatment in 2039

Patent • Bladder Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hodgkin Lymphoma • Liver Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Lymphoma • Microsatellite Instability • Nasopharyngeal Carcinoma • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Thoracic Cancer • Urothelial Cancer • Uterine Cancer

Tislelizumab Plus Chemotherapy Followed by Surgery or Radiotherapy and Adjuvant Tislelizumab in Unresectable Stage III NSCLC (IASLC-WCLC 2025) - "Patients received 2-4 cycles of induction TIS plus nab-paclitaxel and platinum. A notable proportion of patients were enabled to receive radical surgery and attained good pathological response. Recruitment is ongoing, and efficacy and safety will be continuously monitored."

Clinical • Surgery • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. (ASCO-GI 2026) - P3 | "Background: HERIZON-GEA-01 (NCT05152147) is a global, open-label, phase 3 trial of zanidatamab (dual HER2-targeted bispecific antibody) + CT ± tislelizumab (anti–PD-1) vs trastuzumab (tras) + CT in 1L HER2+ mGEA. Eligible patients (pts) with previously untreated HER2+ mGEA, regardless of PD-L1 status, were randomized (1:1:1) to zanidatamab (1800 mg [12 mo) vs tras + CT. Zanidatamab + tislelizumab + CT also provided a statistically significant and clinically meaningful OS benefit (mOS >26 mo). The trial is ongoing with additional OS analyses planned for zanidatamab + CT."

Clinical • Late-breaking abstract • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Modeling analysis of RATIONALE-305: Impact of peritoneal metastasis (PM) representation on clinical outcomes in patients (pts) treated with tislelizumab plus chemotherapy (TIS+CT) with gastric cancer/gastroesophageal junction cancer (GC/GEJC). (ASCO-GI 2026) - P3 | "Our analysis showed that lowering PM representation marginally improved OS and ORR, underscoring the poor prognosis of peritoneal disease. In RATIONALE-305, TIS+CT provides clinically meaningful response and survival benefits irrespective of PM, with higher responses in PD-L1+ GC/GEJC."

Clinical • Clinical data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

Neoadjuvant chemoradiotherapy with or without PD-1 inhibitors in MMR-proficient non-metastatic rectal cancer: a meta-analysis of randomized controlled trials. (PubMed, Front Immunol) - "Six trials (n=935; nCRT+PD 1 = 461; nCRT=474) were included; agents evaluated included pembrolizumab, sintilimab, tislelizumab and camrelizumab. Among patients with pMMR non-metastatic rectal cancer, adding PD-1 inhibitors to standard nCRT improves pCR-most markedly when combined with short-course radiotherapy-with no statistically significant increase detected in high-grade neoadjuvant toxicity or major surgical morbidity. These randomized data support progression to confirmatory phase III trials to define optimal sequencing, regimen standardization and long-term oncologic and functional outcomes.Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier 420251137668."

Clinical • Journal • Retrospective data • Review • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Tislelizumab-induced Vogt-Koyanagi-Harada-like uveitis: a case report. (PubMed, BMC Ophthalmol) - "This case strongly implicates tislelizumab as a trigger for VKH-like uveitis and highlights two critical learning points: the potential lack of CSF pleocytosis as a differentiating feature from primary VKH, and the risk of recurrence upon drug rechallenge. It underscores the necessity for close collaboration between oncologists and ophthalmologists to navigate the dual imperatives of cancer control and vision preservation."

Journal • Esophageal Cancer • Immunology • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Uveitis

Fruquintinib in combination with tislelizumab versus trifluridine/tipiracil and bevacizumab in third-line and beyond MSS mCRC without active liver metastases-the IKF-080/AIO-QUINTIS trial. (PubMed, ESMO Gastrointest Oncol) - "Patients with metastatic colorectal cancer (mCRC) who have progressed on fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic agents, and anti-epidermal growth factor receptor (EGFR) therapies have limited treatment options and poor prognosis, with a median overall survival (mOS) of ∼6 months on single-agent regorafenib or trifluridine/tipiracil. Tumor assessments occur every 8 weeks; follow-up continues for up to 18 months after enrolment. Optional translational research includes tumor, blood, and stool sampling to explore biomarkers of response and resistance."

IO biomarker • Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF

HER-OIC: Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer (clinicaltrials.gov) - P1/2 | N=29 | Not yet recruiting | Sponsor: Universitaire Ziekenhuizen KU Leuven

New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University

New P4 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Combination Therapy With Immune Checkpoint Inhibitors and Chemotherapy With Gemcitabine and Nab-Paclitaxel in Pancreatic Cancer: A Systematic Review. (PubMed, Cancer Med) - "Combining ICIs with gemcitabine and nab-paclitaxel appears feasible and safe, with signals of improved efficacy compared with chemotherapy alone. However, evidence remains limited, and further large-scale trials are warranted to confirm survival benefits and optimize therapeutic strategies in pancreatic cancer."

Checkpoint inhibition • Journal • Review • Fatigue • Hematological Disorders • Neutropenia • Oncology • Pain • Pancreatic Cancer • Solid Tumor