Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Bioscience, Coherus Oncology, Hikma, Excellmab, Dr. Reddy’s, Apotex, LEO Pharma - LARVOL DELTA

Case Report: Radical nephroureterectomy after toripalimab plus disitamab vedotin in biomarker-non-enriched upper tract urothelial carcinoma. (PubMed, Front Oncol) - "The observed lesion reduction is hypothesis-generating and should not be interpreted as evidence of clinical efficacy. Standardized response assessment and longer follow-up are required."

Biomarker • IO biomarker • Journal • Oncology • Solid Tumor • Urothelial Cancer • CDX2 • CTNNB1 • HER-2 • PD-L1 • TACSTD2

Pretreatment 18F-FDG PET/CT Radiomics for Predicting Response to First-Line Targeted Therapy Plus Immunotherapy in Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=228 | Completed | Sponsor: First Affiliated Hospital of Fujian Medical University

New trial • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Efficacy and safety analysis of disitamab vedotin combined with immunotherapy as neoadjuvant treatment to promote conversion to bladder preservation in bladder cancer: A retrospective comparative study with the GC combined with immunotherapy regimen. (PubMed, Urol Oncol) - "In this single-center retrospective cohort, DV plus toripalimab was associated with higher observed rates of strict cCR and strict cCR with initial bladder preservation than GC plus toripalimab among patients with T2-4 disease. These findings are hypothesis-generating and require validation in prospective multicenter studies with longer follow-up."

Journal • Retrospective data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Local Ablation Plus Systemic Therapy for Metachronous Liver and/or Lung Oligometastases From Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=138 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer (clinicaltrials.gov) - P3 | N=560 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P3 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Preliminary results of an open-label, single-arm, multi-center study on disitamab vedotin (DV) combined with torIpalimab and radiotherapy as bladder-preserving therapy in HER2 overexpression muscle-invasive bladder cancer (MIBC; DECIDING study-stage I). (ASCOBT 2024) - P2 | "DV combined with toripalimab instead of chemotherapy in TMT was well-tolerated in this early analysis. TRAE was consistent with prior trials and no DLTs in 28 days recived first drug therapy."

Clinical • Bladder Cancer • Dermatology • Diabetes • Dyslipidemia • Genito-urinary Cancer • Hypertriglyceridemia • Oncology • Pruritus • Solid Tumor • Urothelial Cancer • HER-2

Induction tifcemalimab and toripalimab plus chemotherapy followed by radical therapy for limited-stage SCLC (LungMate-023) (ESMO 2026) - No abstract available

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

EXTENTORCH: A randomized, phase III trial of toripalimab versus placebo, in combination with chemotherapy as a first-line therapy for patients with extensive stage small cell lung cancer (ES-SCLC) (ESMO 2023) - P3 | "Methods Patients with histologically or cytologically confirmed ES-SCLC, stratified by gender and baseline ECOG PS (0 vs. 1) were randomized in a 1:1 ratio to receive 240 mg toripalimab or placebo plus etoposide and cisplatin/carboplatin Q3W for 4-6 cycles, followed by single-agent toripalimab or placebo until progressive disease, intolerable toxicity or up to 2-year treatment. Toripalimab plus chemotherapy had a manageable safety profile, with no new safety signals observed. Conclusions The addition of toripalimab to chemotherapy provided significant improvements in PFS and OS for patients with ES-SCLC with an acceptable safety profile."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • P3 data • Tumor mutational burden • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • TMB

PD-1 blockade with toripalimab incorporated into induction chemotherapy and radiotherapy with or without concurrent cisplatin in locoregionally advanced nasopharyngeal carcinoma (DIAMOND): A multicenter, non-inferiority, phase 3, randomized controlled trial. (ASCO 2025) - P3 | " Patients with non-metastatic T4N1 or N2–3 (AJCC 8th edition) NPC were recruited from 13 centers in China from Aug 2021 to Jul 2022 and randomly assigned (1:1) to receive either toripalimab plus gemcitabine-cisplatin induction chemotherapy and concurrent cisplatin-radiotherapy (standard arm) or standard therapy sparing concurrent cisplatin (cisplatin-free arm). Removing concurrent cisplatin from toripalimab plus chemoradiotherapy provides comparable survival, lower toxicity, and better QoL and tolerability for patients with LANPC."

Clinical • Head-to-Head • Late-breaking abstract • Metastases • P3 data • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Perioperative PD-1 antibody toripalimab plus SOX or XELOX chemotherapy versus SOX or XELOX alone for locally advanced gastric or gastro-oesophageal junction cancer: Results from a prospective, randomized, open-label, phase II trial. (ASCO 2023) - P2 | "Perioperative PD-1 antibody toripalimab plus chemotherapy demonstrated a significantly improved pathological regression and might be a promising option for patients with locally advanced resectable gastric or GEJ cancer. Clinical trial information: NCT04250948."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology

Surufatinib Combined with Toripalimab and Nab-paclitaxel/gemcitabine Chemotherapy as First-Line Treatment for Advanced Pancreatobiliary-Type Ampullary Carcinoma: A Prospective Phase II Clinical Trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Ampulla of Vater Carcinoma • Oncology

Real World Effectiveness and Safety of Toripalimab Across Multiple Solid Tumors in Non-Chinese Population (ESMO 2026) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Oncology • Solid Tumor

Updated results from a phase Ib/II study of the highly potent PI3K-mTOR dual inhibitor WX390 combined with Toripalimab in patients with advanced cervical cancer (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Cervical Cancer • Oncology • Solid Tumor

Toripalimab for extensive-stage small cell lung cancer: insights and future directions. (PubMed, Chin Clin Oncol) - No abstract available

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

Severe Immune-Related Adverse Events Associated with Durable Antitumor Responses Following Immune Checkpoint Inhibitor Therapy: Two Case Reports. (PubMed, Cancer Manag Res) - "Case one involved a patient with heavily pretreated Luminal B1 advanced breast cancer who developed Grade 3 immune-related arrhythmia and heart failure following treatment with Toripalimab combined with chemotherapy. Case two involved a patient with ROS1-fusion advanced lung adenocarcinoma who, after developing resistance to Crizotinib, received chemotherapy and Tislelizumab, leading to Grade 3 immune-related hypopituitarism, adrenal insufficiency, and cutaneous toxicity...However, the association between irAEs and efficacy is not straightforward, as the type and severity of irAEs and the use of immunosuppressive intervention all influence the ultimate clinical benefit. In the absence of reliable predictive biomarkers, clinical decisions should not equate irAEs directly with efficacy markers; rather, the benefits and risks of immune activation should be carefully weighed."

Adverse events • Checkpoint inhibition • IO biomarker • Journal • Breast Cancer • Cardiovascular • Congestive Heart Failure • Endocrine Disorders • Heart Failure • Lung Adenocarcinoma • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • ROS1

Neoadjuvant Spatially Fractionated SBRT Enhances Pathological Response to Toripalimab-Based Immunochemotherapy in Resectable NSCLC (IASLC-WCLC 2026) - P2 | "Conclusions : Neoadjuvant SF-SBRT combined with toripalimab-based immunochemotherapy was feasible and safe, and achieved high pathological response rates in resectable stage II-III NSCLC. These findings suggest that spatially fractionated radiotherapy may function as an immune-reprogramming strategy that amplifies neoadjuvant immunotherapy efficacy and warrants further validation in randomized clinical trials."

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

Real-World Insights of Immunotherapy in Lung Cancer From Western India: A Retrospective Analysis (IASLC-WCLC 2026) - "Among patients receiving first-line ICI (n=224), Pembrolizumab was most used (43.6%),followed by nivolumab (27.9%), atezolizumab (17.9%), durvalumab (8.8%), Serplulimab (1.6%) and Toripalimab (0.3%) administered as monotherapy or in combination regimens & the ORR was 53.8 %. Among patients receiving first-line immunotherapy, mOS was 24.0 months (95% CI 17.0-31.1) in PD-L1 untested cases, 15.8 months (95% CI 12.5-19.2) in PD-L1 positive cases and 10.6 months (95% CI 3.1-18.0) in PD-L1 negative cases (p=0.041). mOS for adenocarcinoma was 24.0 months (95%CI 17.1-31.0) vs 15.4 months (95%CI 13.4-17.5) for other histologies p<0.001 Conclusions : In this real-world Western Indian cohort, immunotherapy showed meaningful survival despite limited biomarker testing, highlighting the need for better patient selection and improved access in resource-constrained settings"

IO biomarker • Real-world • Real-world evidence • Retrospective data • Tumor mutational burden • Endocrine Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1 • TMB

Clinical Study of Central Radiofrequency Ablation (SCART) Combined with Toripalimab in Patients with Bulky Solid Tumors Refractory to Standard Therapy (ChiCTR) - P=N/A | N=32 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University Cancer Institute and Hospital

New trial • Oncology • Solid Tumor

Oncogenic Pathway Alterations Underlying Heterogeneous Outcomes After Immunochemotherapy in EGFR-TKI-Resistant NSCLC (IASLC-WCLC 2026) - "We therefore investigated whether distinct genomic alteration patterns derived from integrated somatic SNV and CNA data were associated with differences in genomic complexity and clinical outcomes after toripalimab plus chemotherapy...Conclusions : In EGFR-TKI resistant NSCLC, heterogeneous benefit from immunochemotherapy appears to be linked to distinct molecular alteration patterns. Alterations involving chromatin plasticity, DDR, and cell-cycle-related genes were associated with different patterns of genomic complexity and survival, supporting a biologically interpretable framework for understanding post-TKI outcome heterogeneity."

Heterogeneity • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • TMB

Toripalimab Consolidation After Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase II, Randomized Controlled Study (IASLC-WCLC 2025) - "Conclusions : In patients with LS-SCLC, toripalimab consolidation significantly improved OS and PFS with an acceptable safety profile. $$graphic_8640471E-A993-4852-A76D-84597A65142A$$$$graphic_{A54EFB69-7C85-4A8C-87EF-4B9837339DBE}$$"

Clinical • P2 data • Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Phase II Clinical Trial of Neoadjuvant anti-PD-1 (Toripalimab) Combined with Axitinib in Resectable Mucosal Melanoma. (PubMed, Ann Oncol) - P2 | "Neoadjuvant toripalimab combined with axitinib in resectable mucosal melanoma demonstrated a promising pathologic response rate with significantly increased infiltrating CD3+ and CD3+CD8+ T cells after therapy."

Journal • P2 data • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • CD8

False-Positive hs-cTnI in a Patient on Immunotherapy: a Case of Macromolecular Interference. (PubMed, Clin Lab) - "Unexplained hs-cTnI elevations in immunotherapy-treated cancer patients should raise suspicion for macromolecular interference. PEG precipitation, dilution tests, and platform comparisons are effective verifica-tion tools. Clinician-laboratory collaboration is key to preventing misdiagnosis."

Journal • Acute Coronary Syndrome • Cardiovascular • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Preliminary efficacy and safety results from RC48-C017: A phase II study of neoadjuvant treatment with disitamab vedotin plus toripalimab in patients with muscle invasive bladder cancer (MIBC) with HER2 expression. (ASCO 2024) - P2 | "Neoadjuvant treatment with DV plus toripalimab showed promising efficacy results and was well tolerated in operable MIBC pts with HER2 expression. These results will support further investigation for DV plus toripalimab in this population."

Clinical • IO biomarker • P2 data • Alopecia • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Pain • Solid Tumor • Urothelial Cancer • HER-2

Real-World Multicentric Study of Toripalimab in NSCLC in India (IASLC-WCLC 2026) - "High response rates were consistently observed across PD-L1 subgroups, particularly in high-expressers. These findings provide critical India-specific evidence that toripalimab is an effective therapeutic option for metastatic NSCLC, offering survival benefits comparable to global standards in a setting where immunotherapy access is a priority."

Clinical • IO biomarker • Real-world • Real-world evidence • Endocrine Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • PD-L1

Case Report: Probable toripalimab-associated ocular myasthenia gravis-like presentation after chemoimmunotherapy. (PubMed, Front Neurol) - "We report a 60-year-old woman with triple-negative right breast cancer who developed bilateral ptosis and mild limitation of horizontal eye movements approximately 2 weeks after receiving nab-paclitaxel, carboplatin, and toripalimab...Toripalimab was discontinued, and oral methylprednisolone 20 mg once daily was administered for 6 days from January 17 to January 22, 2026, beginning the day after discharge...The significance of RYR-IgG and Titin-IgG positivity in this patient remains uncertain because the assay platform and laboratory cut-offs were unavailable. Their detection should not be regarded as confirmation of ocular myasthenia gravis."

Journal • Breast Cancer • CNS Disorders • Dyslipidemia • Immunology • Myasthenia Gravis • Myositis • Oncology • Solid Tumor • Triple Negative Breast Cancer • MB • TTN