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

Conversion therapy of tislelizumab plus lenvatinib and GEMOX in unresectable locally advanced biliary tract cancer (ZSAB-TransGOLP): a multicentre, prospective, phase 2 study. (PubMed, Lancet Oncol) - P2 | "With promising efficacy and manageable safety, GOLP represents a potentially feasible and high-efficiency conversion regimen for unresectable locally advanced biliary tract cancer."

Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Perioperative Tislelizumab for Resectable Non-small Cell Lung Cancer: Final Analysis of RATIONALE-315 (IASLC-WCLC 2025) - "Neoadjuvant tislelizumab plus chemotherapy and adjuvant tislelizumab demonstrated statistically significant, clinically meaningful OS benefit and sustained significant EFS improvement compared with neoadjuvant chemotherapy in patients with resectable NSCLC, potentially offering a new treatment paradigm that is generally well tolerated and safe for this population. CI, confidence interval; NE, not estimable; NR, not reached."

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

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

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

Peri-operative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small cell lung cancer: final analysis of the randomized RATIONALE-315 trial. (PubMed, Ann Oncol) - P3 | "Neoadjuvant tislelizumab plus chemotherapy and adjuvant tislelizumab demonstrated a statistically significant, clinically meaningful OS benefit and sustained, clinically meaningful EFS improvement compared with neoadjuvant chemotherapy, with a tolerable safety profile in patients with resectable stage II-IIIA NSCLC. These results support the use of this regimen in this patient population."

Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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

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

Tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) + CT as first-line treatment for locally advanced (LA), unresectable esophageal squamous cell carcinoma (ESCC): PD-L1 tumor area positivity (TAP) score ≥1% subgroup analysis of RATIONALE-306. (ASCO-GI 2026) - P3 | "Background: In RATIONALE-306 (NCT03783442), patients (pts) with LA unresectable or metastatic ESCC who received TIS (intravenously, 200 mg, every 3 weeks) + CT (platinum + fluoropyrimidine or paclitaxel) had longer median overall survival (OS) than pts who received PBO + CT at the interim analysis; improvement was maintained after a ≥3-year follow-up. In this post-hoc analysis, the median OS for pts receiving TIS + CT exceeded two years. The regimen was well tolerated. While the findings require validation in future clinical trials, first-line TIS + CT is an encouraging option for pts who have LA unresectable ESCC with PD-L1 TAP score ≥1%."

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

Exploration of treatment after multiline chemotherapy in recurrent head and neck cancer: Case report. (PubMed, Medicine (Baltimore)) - "These 2 cases suggest that reintroducing paclitaxel in its novel polymeric micellar formulation, pm-Pac, within a combination regimen may overcome prior resistance and provide meaningful disease control in heavily pretreated R/M HNSCC patients. This approach represents a potentially viable salvage strategy, warranting further clinical investigation to confirm its efficacy and optimal integration into the treatment sequence for refractory HNSCC."

IO biomarker • Journal • Head and Neck Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Rationale to Practice: Tislelizumab in Esophageal Carcinoma (I-OSICON 2026) - No abstract available

Esophageal Cancer • Oncology

RATIONALE-315: Association of Residual Viable Tumor (RVT) and Nodal Status With Survival Benefit for Patients (Pts) With Resectable Non-Small Cell Lung Cancer (NSCLC) Treated With Perioperative Tislelizumab (TIS) (ELCC 2026) - No abstract available

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

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

A phase Ⅱ, single-arm, exploratory study of GEMOX regimen combined with tislelizumab and donafenib in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma with high risk of recurrence (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Hunan Provincial People's Hospital; Hunan Provincial People's Hospital

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Three-year median follow-up update of BGB-A317-2002-IIT: A phase 2 study of neoadjuvant tislelizumab plus gemcitabine and cisplatin in patients with cT2–T4aN0M0 muscle-invasive bladder cancer. (ASCO-GU 2026) - P4 | "Clinical Trial Registry Number: ChiCTR2000037670. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

The efficacy and safety of tislelizumab combined with weekly nab-paclitaxel, carboplatin, and cetuximab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a real-world study. (PubMed, Front Immunol) - P=N/A | "Baseline and dynamic inflammatory-nutritional markers may serve as predictive and prognostic indicators, supporting clinical decision-making for this patient population. http://www.chictr.org.cn, identifier ChiCTR2500108877."

Journal • Real-world evidence • Retrospective data • Agranulocytosis • Endocrine Disorders • Granulocytopenia • Head and Neck Cancer • Hematological Disorders • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Tongue Carcinoma

Efficacy and safety of BTK inhibitors in Richter's transformation: a systematic review of clinical evidence. (PubMed, Front Oncol) - "Monotherapy with pirtobrutinib and acalabrutinib showed ORRs of 50% and 40%, respectively. Combination regimens such as zanubrutinib plus tislelizumab and ibrutinib plus nivolumab demonstrated ORRs ranging from 41.6% to 65%, with improved outcomes in treatment-naïve patients...While monotherapy may offer a tolerable option for frail patients, combination regimens may improve outcomes in select populations. Larger, randomized controlled trials are needed to better define the role of BTK inhibition in this high-risk disease."

Journal • Review • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma

Disitamab vedotin plus tislelizumab as nephron-sparing therapy for high-risk upper tract urothelial carcinoma: The phase II DISTINCT-I trial (ESMO 2025) - P2 | "HER2 overexpression (3+/2+: 42.1%) may correlate with enhanced response, warranting biomarker validation. This paradigm challenges RNU dominance in selected patients."

IO biomarker • P2 data • Oncology • Solid Tumor • Urothelial Cancer

Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: China Medical University, China

Checkpoint inhibition • New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Selective bladder preservation after neoadjuvant zanidatamab combined with tislelizumab and chemotherapy in patients with HER2-positive muscle-invasive bladder cancer (HARBOR): A multicenter study. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: ChiCTR2500110562. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Bladder Cancer • Genito-urinary Cancer • 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

Ribociclib (RIB) vs. palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC): A head-to-head phase III study—HARMONIA SOLTI-2101/AFT-58. (ASCO 2023) - P3 | "HER2-E cohort will randomized pts 1:1 to RIB+ET (letrozole or fulvestrant) or PAL+ET. As per recent protocol amendment, BL cohort pts will be treated with paclitaxel plus tislelizumab, an anti PD-1 monoclonal antibody, pts may be offered to try RIB + ET first, and will remain eligible for paclitaxel + tislelizumab upon progression...HARMONIA will recruit in Spain (55 sites), Portugal (5), and US (35) within SOLTI & AFT network. Clinical trial information: NCT05207709."

Clinical • Head-to-Head • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

DKN-01 in Combination With Tislelizumab and Chemotherapy as First-Line Therapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: DisTinGuish. (PubMed, J Clin Oncol) - P2 | "DKN-01 can be safely combined with frontline fluoropyrimidine/oxaliplatin and tislelizumab and demonstrates encouraging activity independent of PD-L1 expression levels. A randomized phase II trial is ongoing (ClinicalTrials.gov identifier: NCT04363801)."

Combination therapy • IO biomarker • Journal • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • DKK1 • HER-2 • PD-L1