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

European Commission Approves TEVIMBRA as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025 (Businesswire) - "The EC approval is based on results from the Phase 3 RATIONALE-315 trial....Data from this trial will be presented as a Late-Breaking Abstract (#MA04.08)1 at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain, September 6-9, 2025."

EMA approval • P3 data • Non Small Cell Lung Cancer

First-line (1L) tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) + CT in extensive-stage small cell lung cancer (ES-SCLC): long-term follow-up (LTFU) of RATIONALE-312 (ESMO 2025) - No abstract available

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Surgery for Resectable Lung Cancer With Radiographic Disease Control After Chemoimmunotherapy: A Retrospective Cohort Study (IASLC-WCLC 2025) - "Conclusions : For patients with resectable stage IIB-IIIB NSCLC who achieved radiographic disease control after tislelizumab combined with chemotherapy, surgical intervention may provide additional survival benefits. The long-term follow-up data and large sample prospective studies are required for further validation."

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

Four-year follow-up from the phase 2 study TD-NICE: neoadjuvant treatment of tislelizumab combined with chemotherapy in resectable esophageal squamous cell carcinoma. (PubMed, BMC Cancer) - P0 | "Our study identified that chemoimmunotherapy plus surgery could improve overall survival in resectable ESCC, and patients had significant benefits from surgery and R0 tumor resection."

Journal • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Longitudinal ctDNA Profiling in HER2-Altered NSCLC Treated With HER2 Adc: Preliminary Results From the RESOLUTION Trial (IASLC-WCLC 2025) - "A total of 28 eligible patients will receive disitamab vedotin (2.0 mg/kg), tislelizumab (200 mg), and bevacizumab (7.5 mg/kg), all administered intravenously every 3 weeks, until disease progression or unacceptable toxicity. The first-stage interim analysis revealed acceptable efficacy to support proceeding to the further stage. Longitudinal ctDNA analysis enabled dynamic monitoring of tumor burden and early detection of disease progression, underscoring its potential as a non-invasive tool for real-time treatment response assessment."

Circulating tumor DNA • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • HER-2 • TP53

Tislelizumab (TIS) with or without capecitabine (CAP) continuation in gastric or gastro-oesophageal junction cancer (GC/GEJC): RATIONALE-305 post hoc analysis (ESMO 2025) - No abstract available

Retrospective data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Tevimbra: “Extension of indication to include first-line treatment of adult patients with extensive-stage Small Cell Lung Cancer…based on final results from study BGB-A317-312…as a consequence, sections 4.1, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance.” (European Medicines Agency) - CHMP Final Minutes of the meeting on 24 - 27 Mar 2025: “The committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable”

CHMP • Lung Cancer • Oncology • Small Cell Lung Cancer

Tislelizumab-based First-line Therapy in Advanced NSCLC: A Real-World Study (ESMO 2025) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Individualized treatment of nasopharyngeal carcinoma with lung metastasis in an elderly patient: A case report. (PubMed, Oncol Lett) - "The patient underwent intensity-modulated radiotherapy for the nasopharyngeal tumor (70 Gy/35 fractions) with concurrent oral capecitabine, followed by stereotactic body radiotherapy (60 Gy/12 fractions) and immunotherapy (tislelizumab) for progressive lung lesions. Maintenance therapy with capecitabine was continued and the patient achieved stable disease with minimal adverse effects. This case highlights the efficacy of individualized multimodal therapy, including precision radiotherapy, chemotherapy and immunotherapy, in an elderly patient with NPC with metastasis, offering a potential framework for similar cases."

Journal • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Tislelizumab Plus Sitravatinib or Anlotinib as Maintenance Therapy in Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) (IASLC-WCLC 2025) - "Conclusions : TIS plus Sitra or Anlo yielded promising efficacy with manageable toxicities as maintenance therapy in ES-SCLC patients after induction TIS + chemo. This enhanced maintenance strategy warrants further exploration in larger-scale trials."

Clinical • Cardiovascular • Fatigue • Hypertension • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Single-Cell Analysis Revealed the Characteristics of Tumors With Different Responses to Neoadjuvant Chemo Immunotherapy in Stage II-IIIB NSCLC (IASLC-WCLC 2025) - P2 | "Neoadjuvant tislelizumab plus platinum-based doublet chemotherapy for up to 4 cycles was administered...Finally, tumor cell trajectory analysis showed that the pCR and non-pCR groups exhibit different evolutionary trajectories. Conclusions : Our study provides novel insights into the different cellular and molecular components that correspond to NSCLC NCIT responsiveness, which will benefit future personalized chemo-immunotherapy."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

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

BTK Inhibitors in Relapsed/Refractory Richter Transformation: A Systematic Review (SOHO 2025) - "In the phase 1/2 BRUIN study (N = 74), pirtobrutinib monotherapy, a non-covalent BTKi, achieved an ORR of 48.6% (95% CI, 36.9-60.6%), with a median PFS of 3.6 (95% CI, 2.4-4.6) months and a median OS of 11.8 (95% CI, 6.9-19.5) months...Acalabrutinib (Eyre et al...(2022; N = 9) assessed the combination of ibrutinib-selinexor, which demonstrated an ORR of 11% and stable disease in 55% of patients... BTKi-based therapies, as monotherapy and in combination with other agents, demonstrate variable but notable activity in R/R RT. Response rates ranged from 11% to 65% across studies, with the highest ORR observed for the combination of nivolumab-ibrutinib and for tislelizumab-zanubrutinib. These findings highlight the potential of BTKi-based regimens as treatment options for R/R RT."

Review • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Richter's Syndrome

Triple Therapy with Interventional Treatment, Donafenib, and Anti-PD-1 Antibodies in Unresectable Hepatocellular Carcinoma: A Retrospective Real-World Study in China. (PubMed, J Hepatocell Carcinoma) - "This retrospective study included 89 patients with uHCC who received donafenib, anti-PD-1 monoclonal antibodies (tislelizumab or sintilimab), and interventional therapies (TACE and/or HAIC) between March 2022 and December 2023. Grade ≥3 treatment-related adverse events occurred in 30.3% of patients; no treatment-related deaths were reported. The combination of interventional therapies, donafenib, and anti-PD-1 monoclonal antibodies demonstrated promising efficacy and manageable safety in uHCC, warranting further validation in prospective trials."

Journal • Real-world evidence • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

Chemoradiotherapy (CRT) followed by sequential tislelizumab (TIS) + CAPOX and TIS for organ preservation in low rectal cancer (RELIEVE-01): primary results (ESMO 2025) - No abstract available

Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

New Immunotherapeutic Horizons in Richter's Transformation: Synergistic Approaches with Targeted Agents (SOHO 2025) - "BTK inhibitors, such as ibrutinib and zanubrutinib, have been shown to modulate immune function, reducing regulatory T-cell activity and altering cytokine profiles...Pembrolizumab and nivolumab achieved response rates of approximately 13% to 20%, with a median OS of less than 6 months...The landscape shifted with the RT1 trial, which evaluated the combination of tislelizumab, a PD-1 inhibitor, with zanubrutinib in 48 patients with RT...The MOLTO trial adopted a triplet strategy, combining atezolizumab, a PD-L1 inhibitor, with venetoclax and obinutuzumab...Support for combination strategies comes from a recent case series by Smith et al, in which six RT patients were treated with lisocabtagene maraleucel (liso-cel)...9,10 Given these encouraging results, epcoritamab is being tested in combination with venetoclax, R-CHOP, and other immune modulators...Other bispecific constructs under investigation include glofitamab and mosunetuzumab, each with distinct pharmacokinetic..."

IO biomarker • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • HAVCR2 • LAG3 • NOTCH1 • PD-L2 • TP53

Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: First Affiliated Hospital of Guangxi Medical University | Trial completion date: Nov 2026 ➔ Oct 2027 | Trial primary completion date: Nov 2026 ➔ Oct 2024

Trial completion date • Trial primary completion date • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

TASK-01-RW: TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma: Study on Efficacy and Immune Microenvironment (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

Disitamab Vedotin plus Tislelizumab as Nephron-Sparing Therapy for High-Risk Upper Tract Urothelial Carcinoma: The Phase II DISTINCT-I Trial (ESMO 2025) - No abstract available

P2 data • Oncology • Solid Tumor • Urothelial Cancer

Antibody-drug conjugates for non-muscle invasive bladder cancer: current status and future development. (PubMed, Curr Opin Urol) - "The findings underscore the potential of ADCs to revolutionize NMIBC management by providing novel bladder-sparing strategies in patients traditionally limited by BCG failure. Future research should concentrate on optimizing patient selection, treatment sequencing, and combination strategies to improve long-term outcomes, enhancing survival and quality of life."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

A single-arm, multicenter, prospective Phase II study of tislelizumab in combination with nimotuzumab and GP induction followed by IMRT and tislelizumab plus nimotuzumab for high-risk locally advanced nasopharyngeal carcinoma (ESMO 2025) - No abstract available

Clinical • Combination therapy • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Efficacy and Safety of Tislelizumab Combined With Tofacitinib and Docetaxel for NSCLC After Failure of First-Line Immunotherapy (IASLC-WCLC 2025) - "Exploratory objectives will focus on identifying potential biomarkers through blood, urine, and tumor tissue analyses. Adverse events will be monitored throughout the trial and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0."

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

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

SBRT Combined With Tislelizumab and Granulocyte-Macrophage Colony-Stimulating Factor in Advanced NSCLC Progressing on Immunotherapy (IASLC-WCLC 2025) - P2 | "For the safety outcomes, mild treatment-related adverse events (AEs) occurred in 60% of patients, and one patient experienced grade ≥3 immune-related rash. Conclusions : The study suggests that the integration of SBRT with Tislelizumab and GM-CSF may augment immunotherapy efficacy, presenting a promising therapeutic approach for advanced NSCLC patients following immunotherapy resistance."

Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CSF2