toripalimab subcutaneous (JS001sc) / Shanghai Junshi Biosci - LARVOL DELTA

Hepatic arterial infusion chemotherapy combined with lenvatinib and toripalimab for large hepatocellular carcinoma (> 10 cm) with major portal vein tumor thrombosis: a multicenter propensity score matching analysis. (PubMed, Front Immunol) - "Compared with HAIC alone, the combination of HAIC, lenvatinib, and toripalimab can effectively prolong the survival prognosis of patients with large HCC complicated by major PVTT and achieve intrahepatic and PVTT remission. It is a promising treatment approach."

Journal • Cardiovascular • Hematological Disorders • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Thrombosis

Shanghai Junshi Biosciences…is pleased to announce that a multi-center, open-label, randomized controlled phase III clinical study to compare toripalimab injection (subcutaneous injection) (code: JS001sc) and toripalimab injection…in combination with chemotherapy for the first-line treatment of recurrent or metastatic non-squamous...NSCLC...has met primary endpoints (HKEXnews) - "The Company plans to submit the new drug application of this product to the regulatory authorities in the near future."

China filing • P3 data • Lung Non-Squamous Non-Small Cell Cancer

[Translated article] Network meta-analysis of perioperative immunotherapies in non-small-cell lung cancer according to tumor programmed death ligand 1 expression. (PubMed, Farm Hosp) - "Our network meta-analysis provides reliable evidence on the efficacy of perioperative immunotherapy in resectable NSCLC according to PD-L1 expression levels, and may favor competition between therapeutic alternatives. A sensitivity analysis supported these results."

IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety of toripalimab in the treatment of patients with non-small cell lung cancer: a systematic review and meta-analysis. (PubMed, Transl Cancer Res) - "Cochrane Library, Embase, PubMed, and Web of Science were searched to find studies on patients with NSCLC receiving toripalimab. For patients undergoing perioperative neoadjuvant immunochemotherapy, it demonstrated significant efficacy and safety. However, additional RCTs are needed to substantiate our findings."

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

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

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. $$graphic_8640471E-A993-4852-A76D-84597A65142A$$"

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

Toripalimab induces exacerbation of psoriasis in an esophageal cancer patient: a case report. (PubMed, Front Oncol) - "A 60-year-old male patient with a history of well-controlled psoriasis without medication and no other significant medical conditions was hospitalized due to recurrence and exacerbation of psoriasis following two cycles of Toripalimab combined with cisplatin and nab-paclitaxel therapy after esophageal malignancy surgery...For cancer patients with pre-existing autoimmune diseases, particularly those with psoriasis, comprehensive multidisciplinary evaluation is essential before initiating Toripalimab therapy. During immunotherapy cycles, specialized follow-up by dermatologists and clinical pharmacists is recommended to monitor the status of pre-existing dermatological conditions and potential adverse reactions."

Journal • Dermatology • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastroenterology • Gastrointestinal Disorder • Immunology • Oncology • Pneumonia • Psoriasis • Squamous Cell Carcinoma

JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC） (clinicaltrials.gov) - P3 | N=395 | Active, not recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Jun 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Network meta-analysis of perioperative immunotherapies in non-small-cell lung cancer according to tumor programmed death ligand 1 expression. (PubMed, Farm Hosp) - "Our network meta-analysis provides reliable evidence on the efficacy of perioperative immunotherapy in resectable NSCLC according to PD-L1 expression levels, and may favor competition between therapeutic alternatives. A sensitivity analysis supported these results."

IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Adjuvant toripalimab in high-risk renal cell carcinoma after tumor resection (TUOAD-RCC): A prospective phase 2 study. (ASCO 2025) - P2 | "Funded by National Natural Science Foundation of China (82172759); Tianjin Education Commission Research Program Project (2024ZD026 & 2024KJ193); Tianjin Municipal Health Science and Technology Project (TJWJ2024ZD002) Clinical Trial Registration Number: NCT06584435 Background: Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma (RCC) improved overall survival (OS) and disease-free survival (DFS), However, the other immune checkpoint inhibitors (ICIs), including atezolizumab and nivolumab±ipilimumab, failed to have effect on disease control...The 14 patients who discontinued toripalimab received a median of 7 cycles (range from 1 to 16) treatment... Our data preliminarily demonstrated the safety and efficacy of adjuvant toripalimab in RCC at high-risk of recurrence or progression."

Clinical • IO biomarker • P2 data • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Liver Failure • Oncology • Renal Cell Carcinoma • Solid Tumor

Neoadjuvant low-dose carboplatin and docetaxel in combination with toripalimab for early or locally advanced triple-negative breast cancer (NeoTOP): A single-arm phase 2 trial. (ASCO 2025) - P2 | "Four patients prematurely discontinued study treatment due to adverse events (three patients) or tumor progression (one patient), including two discontinued toripalimab only and two discontinued both toripalimab and chemotherapy. The combination of low-dose carboplatin, docetaxel, and toripalimab showed promising efficacy and manageable safety, suggesting the feasibility of this regimen in the neoadjuvant setting for TNBC. Further randomized phase III trials are warranted. Clinical trial information: NCT06618014."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Cost-effectiveness analysis of Toripalimab regimen for extensive-stage small-cell lung cancer in China and America. (PubMed, Front Immunol) - "The cost-effectiveness of the Toripalimab scheme was judged by comparing the ICER with the willingness to pay (WTP). Sensitivity and scenario analyses showed the model to be generally stable. Compared with chemotherapy, the Toripalimab regimen for the treatment of ES-SCLC is cost-effective from the perspective of the Chinese health system, but not from the perspective of the US health system."

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

Efficacy and safety of autologous CIK cell therapy plus Toripalimab with or without chemotherapy in advanced NSCLC: A phase II study. (PubMed, Int J Cancer) - "The combination of CIK cells and toripalimab, with or without chemotherapy, demonstrates promising efficacy and safety in patients with advanced PD-L1-positive NSCLC. The addition of chemotherapy may further enhance therapeutic outcomes, making it a potentially superior strategy compared to CIK cells combined with the anti-PD-1 antibody alone."

IO biomarker • Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy of radiolabelled PD-L1-targeted nanobody in predicting and evaluating the combined immunotherapy and chemotherapy for resectable non-small cell lung cancer. (PubMed, Eur J Nucl Med Mol Imaging) - P=N/A | "Baseline 68Ga-THP-APN09 PET/CT alone could predict efficacy and assist in patient screening for immunotherapy combined chemotherapy in resectable NSCLC, and the follow-up 68Ga-THP-APN09 PET/CT and their change rates could aid in therapy evaluation. Additionally, follow-up 68Ga-THP-APN09 PET/CT could be utilized to monitor the immunotherapy-related thyroiditis during the therapy."

IO biomarker • Journal • Endocrine Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Toripalimab plus platinum-doublet chemotherapy as perioperative therapy for initially unresectable NSCLC: An open-label, phase 2 trial. (PubMed, Med) - P2 | "Toripalimab-based induction treatment of initially unresectable NSCLC yielded a high R0 rate and MPR rate, with a good safety profile and encouraging survival outcomes."

IO biomarker • Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Radiolabelled anti-PD-L1 peptide PET/CT in predicting the efficacy of neoadjuvant immunotherapy combined with chemotherapy in resectable non-small cell lung cancer. (PubMed, Ann Nucl Med) - P=N/A | "Baseline 68Ga-NOTA-WL12 PET/CT has a potential to predict the pathological response of neoadjuvant immunotherapy combined with chemotherapy in patients with resectable NSCLC, whose efficacy is comparable to that of therapy evaluations employing baseline and follow-up CT and 18F-FDG PET/CT examinations."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety of first-line immune checkpoint inhibitor combination therapies in patients with advanced esophageal squamous cell carcinoma: a network meta-analysis. (PubMed, Front Oncol) - "Compared with chemotherapy alone, Sintilimab or camrelizumab plus chemotherapy seemed to achieve the best progression-free survival (hazard ratio = 0.56, 95% CI 0.46-0.68)...Nivolumab plus ipilimumab resulted in a relatively lower incidence of adverse events of grade ≥3 than other regimens. The combination of immune checkpoint inhibitors (ICIs) with chemotherapy provided a high probability of more effective treatment in comparison with chemotherapy alone for patients with advanced ESCC. Toripalimab and sintilimab plus chemotherapy were ranked as providing the highest OS and PFS benefit in the first-line setting, respectively."

Checkpoint inhibition • Clinical • Combination therapy • Journal • Metastases • Retrospective data • Review • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Efficacy and safety of Toliparibumab for the treatment of non-small cell lung cancer: a systematic review and meta-analysis. (PubMed, Front Oncol) - "This research intends to investigate the treatment of non-small cell lung cancer (NSCLC) using Toripalimab, focusing on its effectiveness and safety profile. However, the limited number of studies included indicates the need for additional single-arm and RCT studies to further validate these findings. https://www.crd.york.ac.uk/PROSPERO/, identifier (CRD42024519806)."

Journal • Retrospective data • Review • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia

Unexpected response with toripalimab treatment in a patient with extensive-stage small-cell lung cancer: A case report. (PubMed, Asian J Surg) - No abstract available

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

PD-1 inhibitors in advanced esophageal squamous cell carcinoma: a survival analysis of reconstructed patient-level data. (PubMed, Front Pharmacol) - "Based on reconstructed patient-level data, the toripalimab, tislelizumab, and sintilimab group achieved the longest OS, whereas the sintilimab and tislelizumab group had the lowest risk of recurrence than other treatments. In patients with a combined positive score of ≥10, sintilimab had better OS efficacy than pembrolizumab (HR: 0.71, 95% CI: 0.52-0.96). In terms of tumor proportion score of ≥1%, camrelizumab, nivolumab, and toripalimab showed proximate survival benefits in both OS and progression-free survival...Sintilimab was strongly recommended for patients with high programmed cell death-ligand 1 abundance. [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42024501086]."

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

Cost-efficiency and expanded access modeling of toripalimab versus pembrolizumab in locally advanced or metastatic nonsquamous non-small cell lung cancer. (ASCO 2024) - "We assumed that 14 cycles of toripalimab+Pem (with carboplatin in cycles 1-4) are administered over 9...Extrapolated to the US incident nsNSCLC population of 49,647 patients, if only 5% of patients are treated with toripalimab instead of pembrolizumab estimated savings of $43,611,849 provide access to 3,849 additional toripalimab+pemetrexed maintenance cycles or 274 full toripalimab regimens (all agents for 9... If approved for use in advanced nsNSCLC, toripalimab is estimated, at its market-entry WAC, to save $17. 6 thousand per patient over a median PFS 9. 7 months treatment duration compared to the pembrolizumab regimen over a median PFS 9."

Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC） (clinicaltrials.gov) - P3 | N=356 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Combination therapy • Metastases • New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Rosenberg Reviews the Evolving Role of Toripalimab in Nasopharyngeal Carcinoma (OncLive) - "Dr Rosenberg discusses strategies for managing nasopharyngeal cancer and the role of toripalimab in this treatment paradigm."

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A dose-exploring, randomized, open-label, Phase I study for toripalimab subcutaneous injection in patients with advanced nasopharyngeal carcinoma (AACR 2024) - P1 | "Background Toripalimab, a humanized IgG4K monoclonal antibody specific for PD-1, in combination with gemcitabine and cisplatin (GP) has been approved as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) by the US FDA in October 2023. The exposure of toripalimab 360 mg Q3W SC was comparable to that of 240 mg Q3W IV. Toripalimab SC formulation is planned for phase III clinical development.Table 1 PK parameters of each dose cohort."

Clinical • Metastases • P1 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Biomarkers-Based Cost-Effectiveness of Toripalimab Plus Chemotherapy for Patients with Treatment-Naive Advanced Non-Small Cell Lung Cancer. (PubMed, Adv Ther) - "From the perspective of the Chinese healthcare system, this study's findings suggested that first-line TC represents a cost-effective strategy for patients with advanced NSCLC. However, the cost-effectiveness of first-line TC varied across different subgroups when considering predictive biomarkers."

Biomarker • Cost effectiveness • HEOR • IO biomarker • Journal • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • RB1 • SMARCA4