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

Optimizing PD-1/PD-L1 inhibitors plus chemotherapy for driver mutation-negative non-squamous NSCLC in China: a cost-effectiveness analysis. (PubMed, Front Pharmacol) - "The network meta-analysis demonstrated that toripalimab, sintilimab, and pembrolizumab combined with chemotherapy provided superior efficacy and favorable safety among 13 PD-1/PD-L1 inhibitors with chemotherapy for non-sqNSCLC...Compared with chemotherapy alone, camrelizumab, tislelizumab, sintilimab with chemotherapy were cost-effective, with ICERs of $28,813.78/QALY, $19,278.47/QALY, and $20,315.01/QALY, respectively...Among currently available first-line treatment strategies for driver mutation-negative non-sqNSCLC in China, toripalimab and sintilimab combined with chemotherapy demonstrated favorable clinical and economic profiles. These findings provide evidence to support treatment selection, reimbursement decisions, and healthcare resource allocation in clinical practice."

HEOR • IO biomarker • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell 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

A Phase 1 study of subcutaneous toripalimab in recurrent or metastatic nasopharyngeal carcinoma. (PubMed, Br J Clin Pharmacol) - P1 | "SC toripalimab showed consistent safety and antitumour activity with IV toripalimab for the first-line treatment of RM-NPC. Similar Ctrough and AUC values in cycle 1 of SC toripalimab 360 mg Q3W with IV toripalimab reference support further study."

Journal • P1 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Subcutaneous versus intravenous toripalimab, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic non-squamous (nsq) non-small cell lung cancer (NSCLC): A randomized phase III trial (ELCC 2026) - P3 | "Methods Patients with histologically or cytologically confirmed recurrent or metastatic nsqNSCLC without EGFR-sensitive mutations or ALK fusions were randomized (1:1) to receive either SC toripalimab (360 mg) or IV toripalimab (240 mg) every 3 weeks plus pemetrexed (500 mg/m 2 ) and carboplatin (area under the curve [AUC] = 5) or cisplatin (75 mg/m 2 ) for up to 4 cycles. Legal entity responsible for the study Shanghai Junshi Biosciences. Funding Shanghai Junshi Biosciences."

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

A Clinical Study to Evaluate the Safety and Tolerability of JS001sc in Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Completed | N=24 ➔ 64

Enrollment change • Trial completion • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial) (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

New P2 trial • pMMR • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor

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 • First-in-human • Metastases • P1 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A single-arm phase Ib study of personalized peptide-pulsed dendritic cell-based multiple target cytotoxic T lymphocyte immunotherapy in combination with toripalimab as second-line therapy in advanced non-small-cell lung cancer. (PubMed, Cancer Immunol Immunother) - P1 | "In this cohort of patients with advanced NSCLC, MCTL/toripalimab therapy demonstrated manageable safety and promising antitumor efficacy as a second-line treatment. Further studies are warranted to confirm these results."

Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications (GlobeNewswire) - "JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.... The 12 indications in the JS001sc NDAs cover all currently approved indications of toripalimab injection in the Chinese Mainland. The NDA is mainly based on the JS001sc-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by principal investigator Professor Lin WU from Hunan Cancer Hospital."

China filing • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Hodgkin Lymphoma • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Soft Tissue Sarcoma • Triple Negative Breast Cancer • Urothelial Cancer

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

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