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

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

Long-Term Outcomes Following Neoadjuvant SBRT Combined With Immunochemotherapy in Stage II-III NSCLC (IASLC-WCLC 2026) - P2, P3 | "Treatment consisted of SBRT delivered to the primary tumor (24 Gy in three fractions) followed by two cycles of intravenous tislelizumab (200 mg) plus platinum-based chemotherapy...Conclusions : These survival data support a robust long-term benefit of incorporating SBRT into induction immunochemotherapy for patients with resectable stage IIa to IIIb NSCLC. This approach is being further evaluated in the ongoing phase III SACTION2401 trial (NCT06598527), which compares induction immunochemotherapy with or without SBRT."

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

Effect of Thymosin a-1 on Treatment Completion and Pneumonitis in Chemoradiation Plus Immunotherapy for LA-NSCLC: A Randomized Phase II Trial (IASLC-WCLC 2026) - "Methods : This prospective, randomized, phase II study (GASTO-1098) enrolled patients with unresectable LA-NSCLC who received induction chemo-immunotherapy followed by CCRT and tislelizumab consolidation...Conclusions : Adding Tα1 to CCRT followed by consolidation immunotherapy significantly improved the 12-month consolidation immunotherapy completion rate in LA-NSCLC patients, reduced grade ≥2 pneumonitis, and showed favorable PFS and immune reconstitution trends. Longer follow-up is warranted."

Clinical • P2 data • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Solid Tumor

Phase 2 Study of Investigational Agents Plus Tislelizumab ± Chemotherapy in Untreated Locally Advanced/Metastatic NSCLC (IASLC-WCLC 2026) - P2 | "Investigational agents were BGB-A445 (OX40 agonist), LBL-007 (anti-LAG-3), and BGB-15025 (HPK1 inhibitor). Conclusions : Novel investigational agents in combination with tislelizumab ± chemotherapy were generally tolerable but did not improve efficacy in untreated, locally advanced/metastatic NSCLC. No new safety signals were identified."

IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • PD-1 • PD-L1

The Role of Immunotherapy in the Treatment of Metastatic Gastric Cancer (IASGO 2026) - "HERIZON-GEA-01 showed thatzanidatamab plus chemotherapy improved progression-free survival versus trastuzumab pluschemotherapy, while adding tislelizumab also produced an encouraging overall-survival benefit...Nivolumab plus ipilimumab failed to improve survival in CheckMate 649, andATTRACTION-6 increased response rate without improving overall survival and caused greater toxicity.However, in MSI-H/dMMR advanced G/GEJC, the phase II NO LIMIT trial showed robust and durableactivity with first-line nivolumab plus low-dose ipilimumab, supporting biomarker-defined dualcheckpoint blockade...The EP4 antagonist ONO-4578 plus nivolumab and chemotherapy showed encouragingphase II activity. ASP2138, a CLDN18.2/CD3 bispecific T-cell engager, is being evaluated withpembrolizumab and chemotherapy, while zolbetuximab plus nivolumab and chemotherapy showedpromising activity in ILUSTRO and is being tested in phase III LUCERNA. Future progress will depend on biomarker-driven combinations..."

IO biomarker • Metastases • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • MSI • PD-L1 • TIGIT

Tislelizumab as a New Treatment Option for Metastatic/Recurrent Esophageal Cancer (IASGO 2026) - "2022; 40:3065–3076. PMID: 35442766"

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

Integrating Systemic and Local Therapy: Recent Clinical Trial Updates (Results of Clinical trials) (IASGO 2026) - "The REGATTA trial, an open-label, randomized phase III studyconducted in Korea, Japan, and Singapore, evaluated whether gastrectomy followed by chemotherapy(S-1 plus cisplatin) was superior to chemotherapy alone in patients with AGC and a single noncurablefactor involving the liver, peritoneum, or para-aortic lymph nodes...The Neo-REGATTA trial conducted in China evaluated docetaxel, oxaliplatin, andS-1 (the DOS regimen) followed by radical resection versus chemotherapy alone in patients withadvanced gastric adenocarcinoma and a single noncurable factor...In the prospective phase II AIO-FLOT3 trial, patients with limitedmetastatic disease received four cycles of neoadjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, anddocetaxel) followed by surgical resection...More recently, the addition of molecularly targeted agents (e.g., trastuzumab andzolbetuximab) or immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab, and tislelizumab) toconventional two- or..."

Clinical • Gastric Adenocarcinoma • Gastric Cancer • Solid Tumor

A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov) - P3 | N=416 | Not yet recruiting | Sponsor: Shanghai Jeyou Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Node-sparing modified short-course radiotherapy combined with CAPOX and tislelizumab versus conventional short-course preoperative chemoradiotherapy for proficient mismatch repair or microsatellite stable locally advanced rectal cancer (mRCAT-III): A multicenter, randomized, open-label, phase 3 trial. (ASCO 2026) - P3 | "Following randomization, patients will receive short-course radiotherapy (conventional or node-sparing) followed by four cycles of CAPOX ± tislelizumab: tislelizumab 200 mg IV on day 1, oxaliplatin 130 mg/m² IV on day 1, and capecitabine 1000 mg/m² orally on days 1-14, and Total mesorectal excision (TME) will be performed at weeks 14-15. Compared with conventional short-course preoperative chemoradiotherapy, node-sparing modified radiotherapy combined with CAPOX and PD-1 blockade significantly improved pCR rates in patients with pMMR/MSS LARC, with a manageable safety profile. This regimen represents a promising and highly effective neoadjuvant strategy for MSS rectal cancer. Clinical trial information: NCT06507371."

Clinical • Late-breaking abstract • Metastases • Mismatch repair • P3 data • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

PET/CT-Guided Neoadjuvant Tislelizumab Plus Chemotherapy/Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma: RATIONALE-213 Final Analysis. (PubMed, Clin Cancer Res) - "Tislelizumab with chemotherapy/chemoradiotherapy as neoadjuvant treatment for resectable ESCC yielded promising pCR rates and favorable survival outcomes with a tolerable safety profile in both PET-/CT-guided responders and PET nonresponders."

Journal • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Update results from phase II study of tislelizumab plus HAIC followed by resection for hepatocellular carcinoma with portal vein tumor thrombus (PVTT) (ESMO 2026) - No abstract available

P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

SFRT With Tislelizumab and Chemotherapy as Neoadjuvant Therapy in Patients With Unresectable Stage III NSCLC (IASLC-WCLC 2026) - P2/3 | "Conclusions : Preoperative SFRT followed by immunochemotherapy is well tolerated, feasible, and leads to a clinically significant Surgical conversion rate. These findings warrant validation in future randomized controlled trials."

Clinical • Dermatitis • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

HERIZON-GEA-01: Exploratory analysis of response characteristics and PFS2 in advanced or metastatic gastroesophageal adenocarcinoma (mGEA) (ESMO-GI 2026) - P3 | "Background HERIZON-GEA-01 (NCT05152147) is a global phase 3 trial evaluating zanidatamab (zani) + chemotherapy (CT) ± tislelizumab (tis) vs trastuzumab (tras) + CT in treatment (tx)-naive patients (pts) with HER2+ mGEA. Prolonged PFS2 in experimental arms suggests that pts still benefit from subsequent tx. Safety in responders was similar to the overall safety population."

Metastases • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Selinexor plus tislelizumab in patients with relapsed/refractory NK/T-cell lymphoma after failure of PD-1 blockade: the phase 1b TOUCH trial. (PubMed, Oncologist) - P1/2 | "Selinexor plus tislelizumab demonstrated manageable toxicity and substantial activity in patients with relapsed/refractory NKTCL previously treated with CPI, supporting further evaluation of nuclear export inhibition as a strategy to re-engage antitumor immunity after failure of PD-1 blockade."

Journal • P1 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • XPO1

High 5: Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer with a High Tumor Burden (ESMO 2026) - No abstract available

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

A Single-Center, Prospective, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Infusion Chemotherapy (HAIC), Donafinib and Tislelizumab as First-Line Therapy in Patients With Unresectable Hepatocellular Carcinoma (ESMO 2026) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Phase II study of sitravatinib in combination with tislelizumab in patients with advanced biliary tract cancer who have failed to at least 1 prior systemic treatment. (ASCO 2024) - P2 | "Sitravatinib/tiselizumab combination as 2L therapy in patients with advanced BTC demonstrated meaningful efficacy and an acceptable safety profile. Especially, patient selection using HRD biomarker might be a promising strategy in this setting."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Cardiovascular • Dermatology • Gastrointestinal Cancer • Hypertension • Oncology • Solid Tumor • HRD

Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC). (ASCO 2025) - P3 | "TQB2450-III-12 is a multicenter, randomized, double-blind, parallel-controlled phase III study of benmelstobart (PD-L1 inhibitor) in combination with chemotherapy followed by sequential combination with anlotinib (multi-targeted angiogenesis inhibitor) versus tislelizumab plus chemotherapy as first-line therapy for locally advanced or metastatic sq-NSCLC...Paclitaxel (175 mg/m2, day 1) and carboplatin (area under the concentration [AUC] of 5, day 1) were given every 3 weeks... Benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib significantly improved PFS, with a manageable safety profile. It might be a new first-line treatment for sq-NSCLC."

Clinical • Combination therapy • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Combining first-line tislelizumab (Tevimbra) with platinum-etoposide chemotherapy demonstrated encouraging efficacy with an acceptable safety profile in patients with extensive-stage small cell lung cancer (ES-SCLC), according to a multicenter, real-world retrospective analysis presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) (Cancer Network) - "At a median follow-up of 6.3 months, the 124 patients treated with first-line tislelizumab plus platinum-etoposide chemotherapy achieved a median progression-free survival (PFS) of 7.2 months and a median overall survival (OS) of 19.3 months. The investigators concluded that the regimen provided encouraging efficacy in a real-world ES-SCLC population, most of whom had stage IV disease. Among the cohort, 91.9% had stage IV disease at presentation, 27.4% had brain metastases, and 18.5% had liver metastases."

Retrospective data • Small Cell Lung Cancer

A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-nave Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=556 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). (ASCO 2024) - P2 | "Background: Integrating immunotherapy with trastuzumab and chemotherapy has shown a significant improvement in overall response rate (ORR) and progression-free survival (PFS) in HER2-overexpression gastric or gastroesophageal junction cancer (GC/GEJC). The combination of RC48, Tislelizumab, and S-1 showed notable efficacy with manageable safety in the first-line treatment of advanced HER2-overexpressing GC/GEJC patients. These findings support further exploration in this context."

Clinical • IO biomarker • Metastases • P2 data • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • HER-2 • PD-L1

Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (ESCC, RATIONALE 302): Impact on health-related quality of life (HRQoL). (ASCO 2022) - P3 | " Adults with advanced or metastatic ESCC whose disease progressed following prior systemic therapy were randomized 1:1 to either TIS 200 mg IV every 3 weeks or ICC (paclitaxel, docetaxel, or irinotecan). The analysis showed that ESCC pts treated with TIS in the second line had a longer maintenance of HRQoL compared to pts treated with ICC. These results, along with improved survival and favorable safety profile, suggest TIS represents a potential new second-line treatment option for pts with advanced or metastatic ESCC."

Clinical • HEOR • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fatigue • Gastrointestinal Disorder • Oncology • Pain • Squamous Cell Carcinoma

Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Trial (NEOSTART) (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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

First-Line Chemotherapy With or Without Tislelizumab for Extensive-Stage Small Cell Lung Cancer: RATIONALE-312 Phase 3 Study (IASLC-WCLC 2023) - P3 | "Here, we present the final analysis of the randomized, double-blind, placebo-controlled, phase 3 RATIONALE-312 study (NCT04005716), which compared efficacy and safety of tislelizumab plus chemotherapy with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. Eligible patients in China with previously untreated ES-SCLC were randomized 1:1 to receive 4 cycles of tislelizumab 200 mg or placebo with etoposide plus carboplatin or cisplatin intravenously every 3 weeks, followed by tislelizumab 200 mg or placebo as maintenance until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. Tislelizumab in combination with chemotherapy as first-line treatment for patients with untreated ES-SCLC demonstrated significant clinical benefit and a manageable safety profile compared with placebo plus chemotherapy."

Clinical • P3 data • Hematological Disorders • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor