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

A Phase I/II Study of TJ004309 for Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=376 | Active, not recruiting | Sponsor: TJ Biopharma Co., Ltd. | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Apr 2025

IO biomarker • Trial completion date • Trial primary completion date • Solid Tumor

SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital

Biomarker • New P2 trial • Oncology

Safety and efficacy of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced esophageal squamous cell carcinoma in China (GASTO 1071): a non-randomised, two-cohort, phase 2 trial. (PubMed, EClinicalMedicine) - P2 | "Patients received neoadjuvant therapy comprised of albumin-bound paclitaxel, nedaplatin and toripalimab every 3 weeks, for 2 cycles, followed by CCRT (total dose 60Gy in cohort A, 50Gy in cohort B, combined with oral capecitabine). Further investigation is warranted. None."

Journal • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Pneumonia • Squamous Cell Carcinoma

9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06079112 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=320 | Not yet recruiting | Sponsor: LaNova Medicines Limited | Initiation date: Dec 2024 ➔ Jun 2025

Trial initiation date • Oncology • Solid Tumor

A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2024 ➔ Apr 2025

Enrollment open • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Toripalimab With Chemotherapy for Sinus Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Glenn J. Hanna

New P2 trial • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor • Squamous Cell Carcinoma • PD-L1

Junshi Biosciences Announces the sNDA Approval of Toripalimab for the 1st-line Treatment of Melanoma (GlobeNewswire) - "Shanghai Junshi Biosciences Co., Ltd...announced that the supplemental new drug application ('NDA') for toripalimab (trade name: TUOYI) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration ('NMPA')....The supplemental NDA approval is based on data from the MELATORCH study (NCT03430297)."

Melanoma

Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Neoadjuvant toripalimab combined with chemotherapy in locally advanced HNSCC (Frontiers) - P2 | N=90 | NCT04164238 | "The untreated LA-HNSCC patients received two cycles of neoadjuvant TP+toripalimab regimen (paclitaxel 175mg/m2 d1, cisplatin 75mg/m2 d1, Toripalimab 240mg d1, every 3 weeks)....All the patients completed the entire treatment courses with an ORR of 78.3% (18/23). Any grades of treatment related adverse events (TRAEs) were reported in 12 patients (52.2%), and 3 patients occurred 3-4 grades TRAEs. No delay for curative treatment was observed. 12 patients underwent radical surgery and 6 patients turned out with pathological complete response (pCR), with a pCR rate of 50%. With a median follow-up of 15 months, 12 surgery patients kept event-free survival, however, 3 out of 11 who received CRT suffered from local recurrence or metastases."

P2 data • Squamous Cell Carcinoma of Head and Neck

Drug type of adjuvant PD-1 inhibitors in hepatocellular carcinoma patients at high risk of recurrence after resection: a prospective, multicentric cohort study (APASL 2025) - P | "The corresponding median RFS for those receiving tislelizumab, sintilimab, camrelizumab, toripalimab, and penpulimab were 26.0 (95% CI 19.5–32.5, n=162), 30.4 (95%CI 22.4–38.4, n=101), 26.9 (95%CI 14.3–39.6, n=80), 32.5 (95%CI 21.6–43.5, n=22), and 31.0 (95%CI 12.8–49.2, n=13) months, respectively. Adjuvant PD-1 inhibitors improve the RFS and OS of patients with HCC at high risk of recurrence. There was no significant difference in the effectiveness of different types of PD-1 inhibitors."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Multicenter phase II study of anlotinib and toripalimab in patients with advanced soft tissue sarcoma (STS) and bone sarcoma (BS). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04172805 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Preliminary outcomes from a phase 1b/2 study of the highly potent PI3K-mTOR dual inhibitor WX390 combined with toripalimab in patients with advanced cervical cancer (AACR 2025) - "Abstract is embargoed at this time."

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

Therapeutic advantages of thymosin α1 combined with toripalimab for elderly patients with advanced melanoma: Preliminary results from a phase II study. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Melanoma • Oncology • Solid Tumor

Updated results of adjuvant toripalimab for locally advanced head and neck squamous cell carcinoma patients who achieved pathological complete response after neoadjuvant immunochemotherapy and surgery: A single-arm, phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: ChiCTR2300067960 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Toripalimab plus docetaxel, oxaliplatin, and capecitabine for untreated metastatic gastric and esophagogastric junction adenocarcinoma: A TORNADO study. (ASCO 2025) - P4 | "Clinical Trial Registration Number: ChiCTR2000030877 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Long-term outcomes of toripalimab plus chemotherapy and radiotherapy for treatment-naive advanced esophageal squamous cell carcinoma: Results from a phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: ChiCTR2100046715 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Adjuvant toripalimab in high-risk renal cell carcinoma after tumor resection (TUOAD-RCC): A prospective phase 2 study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06584435 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Safety and efficacy of neoadjuvant disitamab vedotin in combination with pertuzumab with or without toripalimab for HER2-positive breast cancer: An open-label phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06178159 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of disitamab vedotin in combination with RC148 versus albumin-bound paclitaxel ± toripalimab for patients with HR-negative HER2-low-expressing unresectable locally advanced or metastatic breast cancer: An open-label, randomized, controlled phase II study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06642545 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A randomized phase 2 study of casdozokitug, an IL-27 targeting antibody, in combination with toripalimab plus bevacizumab in patients with unresectable and/or locally advanced or metastatic hepatocellular carcinoma. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06679985 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer. (ASCO 2025) - P2/3 | "Clinical Trial Registration Number: NCT05980481 The abstract will be released to the public on June 2, 2025 at 8:00 AM EDT"

Clinical • Late-breaking abstract • Metastases • Gastric Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant toripalimab plus CapeOX in patients with locally advanced EBV-positive gastric or esophagogastric junction adenocarcinoma (GC/EGJC): Results from the phase II NICE trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04744649 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

An interim analysis of phase III study on neoadjuvant chemotherapy versus perioperative toripalimab plus neoadjuvant chemotherapy for locally advanced esophageal squamous cell carcinoma: Henan Cancer Hospital Thoracic Oncology Group 1909 (HCHTOG1909). (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04280822 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P3 data • P3 data: top line • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • Thoracic Cancer

Toripalimab with chemoradiotherapy followed by toripalimab maintenance therapy for newly diagnosed, high-risk, locally advanced cervical cancer (TorCH-CC): A single-arm phase II study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06416696 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor