Loqtorzi (toripalimab-tpzi)

P3, N=514, Completed, Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Feb 2022 --> Sep 2023

P2, N=32, Recruiting, Eye & ENT Hospital of Fudan University | Not yet recruiting --> Recruiting

P2, N=74, Recruiting, Fudan University

P1, N=134, Completed, Peking University | Recruiting --> Completed

P2, N=79, Not yet recruiting, RemeGen Co., Ltd.

P1, N=48, Not yet recruiting, Coherus Biosciences, Inc.

Of them, 85 received pembrolizumab, 10 received sintilimab, 8 received tislelizumab, 4 received camrelizumab, 2 received toripalimab, and 1 received pabocizumab. The adjuvant chemotherapy regimens used among the chemotherapy alone group includes SOX regimen (132 cases), XELOX (102 cases), S-1 monotherapy (44 cases), and other regimens (15 cases)...Subgroup analysis showed that stage IIIC (HR=0.416, 95%CI: 0.184~0.940), aged ≥60 years (HR=0.336, 95%CI: 0.121~0.934) and extranodal invasion (HR=0.378, 95%CI: 0.170~0.839) were associated with benefit from the combined immune adjuvant chemotherapy, while no association was observed for MMR, HER-2 or EBER status. Stage III gastric/esophagogastric junction cancer patients may benefite from postoperative immune checkpoint inhibitor combined with adjuvant chemotherapy in real-world settings.

P2, N=60, Not yet recruiting, Shanghai Chest Hospital

P2, N=27, Enrolling by invitation, Sun Yat-sen University | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Sep 2023 --> Apr 2024

P2, N=25, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Apr 2024

P2, N=64, Not yet recruiting, Lyvgen Biopharma Holdings Limited

Eight drugs have been approved by the FDA for HNC, including both generic and commercial forms: bleomycin sulfate, cetuximab (Erbitux), docetaxel (Taxotere), hydroxyurea (Hydrea), pembrolizumab (Keytruda), loqtorzi (Toripalimab-tpzi), methotrexate sodium (Trexall), and nivolumab (Opdivo). The most common drugs to treat HPV-associated OPC under these clinical trials and implemented as well for HPV-negative HNC include cisplatin, nivolumab, cetuximab, paclitaxel, pembrolizumab, 5-fluorouracil, and docetaxel...In this context, we identified most mutated genes found in HPV-associated OPC that can represent potential targets for drug development. These include TP53, PIK3CA, PTEN, NOTCH1, RB1, FAT1, FBXW7, HRAS, KRAS, and CDKN2A.

P1/2, N=117, Not yet recruiting, Fudan University

P=N/A, N=32, Not yet recruiting, First Affiliated Hospital of Zhejiang University

P2, N=300, Recruiting, Peking Union Medical College Hospital

Patients recruited from Tianjin Medical University Cancer Institute and Hospital from July 2021 to February 2023 were randomly divided into two groups in a 1∶1 ratio: the experimental group (Toripalimab combined with albumin paclitaxel and cisplatin) and the control group (albumin paclitaxel and cisplatin); patients in both groups underwent three cycles of neoadjuvant therapy. For patients with programmed death-ligand 1(PD-L1) protein expression combined positive score≥20, the experimental group showed higher major pathological response rate than control group (5/5 vs. 0/4, P=0.03). The neoadjuvant therapy of immunotherapy combined with chemotherapy can improve the pathological remission of oral squamous cell carcinoma and the long-term survival benefits and the prognosis of patients.

P2, N=20, Recruiting, Fudan University

P=N/A, N=300, Recruiting, Sun Yat-sen University

P1, N=9, Terminated, Shanghai Junshi Bioscience Co., Ltd. | N=114 --> 9 | Trial completion date: Apr 2024 --> Nov 2023 | Recruiting --> Terminated | Trial primary completion date: Feb 2024 --> Nov 2023; The regimen of JS002 75~300mg Q3W has been completed, and the combination therapy is well tolerated and safe. However, considering that the efficacy did not reach the preset, it is recommended to terminate the trial in advance.

Our findings indicate that this combination may be a potential neoadjuvant therapy regimen in this setting.

P2, N=148, Not yet recruiting, Sun Yat-sen University

P=N/A, N=240, Recruiting, Sun Yat-sen University

P=N/A, N=63, Not yet recruiting, Fudan University

P=N/A, N=112, Recruiting, Sun Yat-sen University

nCRT combined with perioperative toripalimab is effective and safe for locally advanced resectable ESCC. Long-term survival outcomes remain to be determined.

P2, N=140, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting

P1/2, N=306, Recruiting, Risen (Suzhou) Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting

Moreover, patients with high bTMB levels during CRT had prolonged OS (p = 0.027). In conclusion, ctDNA and bTMB have the potential to predict treatment efficacy and survival in ESCC treated with CRT and immunotherapy.

P1, N=18, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P=N/A, N=600, Completed, Sun Yat-sen University | Trial completion date: Jul 2022 --> Jul 2023

On further characterization, we determined that toripalimab is molecularly and functionally differentiated from pembrolizumab, an anti-PD-1 mAb approved previously for treating a wide spectrum of tumors. Additionally, binding of toripalimab to PD-1 induced lower levels of SHP1 and SHP2 recruitment, the negative regulators of T cell activation, in Jurkat T cells ectopically expressing PD-1. Taken together, these data demonstrate that toripalimab is a potent anti-PD-1 antibody with high affinity PD-1 binding, strong functional attributes and demonstrated clinical activity that encourage its continued clinical investigation in several types of cancer.

P2, N=198, Not yet recruiting, Fudan University

P1, N=40, Not yet recruiting, China Medical University, China

P2, N=170, Recruiting, Sun Yat-sen University

P2, N=30, Not yet recruiting, China Medical University, China

P2, N=60, Completed, Xinqiao Hospital of Chongqing | Recruiting --> Completed

P2, N=40, Recruiting, Xinqiao Hospital of Chongqing | Not yet recruiting --> Recruiting | Trial completion date: Mar 2024 --> Mar 2026 | Trial primary completion date: Mar 2023 --> Dec 2025

P2, N=20, Not yet recruiting, RenJi Hospital

P1, N=8, Not yet recruiting, China Medical University, China

The changes of serum VEGF and FR-α levels in patients with bladder cancer can predict the therapeutic effect of toripalimab. Before clinical treatment, the detection of the two indicators must be strengthened, and intervention measures must be formulated as early as possible to improve the prognosis of patients.

P1/2, N=148, Completed, Zhejiang Genfleet Therapeutics Co., Ltd. | Recruiting --> Completed | Trial completion date: Jun 2024 --> Dec 2023

P2, N=29, Not yet recruiting, Ruijin Hospital