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Antibody-Based Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
Toripalimab (TuoyiTM) is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences in China. It received its first conditional approval by the Chinese FDA for the second-line treatment of unresectable or metastatic melanoma that has failed previous systemic therapy in 2018, and was commercially launched in 2019. The conditional approval was based on an objective response rate (ORR) in a single-arm clinical trial. The full approval of toripalimab for this indication will depend on whether the ongoing, randomized controlled clinical trial confirms the long-term clinical benefit in patients with advanced melanoma.
Advances in the structural characterization of complexes of therapeutic antibodies with PD-1 or PD-L1
Published in mAbs, 2023
Mengzhen Jiang, Man Liu, Guodi Liu, Jiawen Ma, Lixin Zhang, Shenlin Wang
Developed by Shanghai Junshi Biosciences Co., Ltd, toripalimab was approved by the NMPA in 2018. Toripalimab is currently indicated as a treatment for melanoma, nasopharyngeal cancer, urothelial cancer, and NSCLC.91–128–130 The PD-1–toripalimab-Fab structure showed that an unusually long HCDR3 (18 amino acids) at the VH domain of toripalimab41 (Figure 5), which is longer than the HCDR3 of any other anti-PD-1 mAb that has been characterized. This long HCDR3 and the LCDR1 and LCDR3 of toripalimab form multiple H-bonds with the residues on the FG loop of PD-1, as key binding factors (Figure 5). In addition, van der Waals interactions between the HCDR1, HCDR2 and LCDR1 of toripalimab and the FG of PD-1 are critical in complex stability.57 Like camrelizumab, the interaction sites of the PD-1–toripalimab-Fab partially overlap with that of the PD-1–PD-L1 complex, thus the antibody sterically hinders PD-1-PD-L1 binding.41 In contrast to camrelizumab, toripalimab’s binding to PD-1 is not related to glycosylation. It is worth noting that this glycosylation-independent toripalimab-PD-1 binding makes toripalimab less likely to be affected by dysregulated glycosylation modifications of PD-1.
The pharmacotherapeutic management of nail unit and acral melanomas
Published in Expert Opinion on Pharmacotherapy, 2022
Julianne M. Falotico, Shari R. Lipner
Pembrolizumab, a PD-1 inhibitor, showed durable response durations and efficacy that were similar in AM groups versus other melanoma subtypes [82]. PFS and OS are significantly improved with anti-PD-1 regimens compared to anti-CTLA-4 regimens [16,66]. Studies on nivolumab yielded mixed results, with one study showing similar OS rates between AM and CM [84], and another showing better ORR, OS, and PFS in CM compared to AM [85]. Results are also mixed in studies on pembrolizumab and nivolumab monotherapy, with approximately half showing limited efficacy in AM patients compared to CM patients [86,87,90], and half showing similar or better ORR, PFS, DCR, and/or OS in AM versus CM patients [88,89,91]. NUM is understudied compared to other forms of AM, with anti-PD-1 response rates lower in NUM than AM of palms/soles [86], highlighting the need for further research on immunotherapies and novel combinations in specific NUM populations. Although both pembrolizumab and ipilimumab are well tolerated, current evidence suggests that anti-PD-1 therapy is more efficacious in AM patients. Currently, we therefore recommend anti-PD-1 therapy over CTLA-4 in AM and NUM patients. Toripalimab is another PD-1 inhibitor, but appears to be more efficacious in CM than AM [81], and was associated with higher treatment-related deaths compared to other PD-1 inhibitors [92].
A cost-effectiveness analysis of first-line toripalimab plus chemotherapy in advanced nonsquamous non-small cell lung cancer in China
Published in Expert Review of Clinical Pharmacology, 2023
Zhiwei Zheng, Gaofeng Zhu, Xueqiong Cao, Hongfu Cai, Huide Zhu
For a total cost of $35,405.18, the toripalimab plus chemotherapy group gained a total lifetime by 2.94 years and 1.82 QALYs, whereas the chemotherapy group gained total lifetime by 1.71 years and 1.05 QALYs for a total cost of $19,191.15. The incremental cost was $16,214.03, and the incremental QALY was 0.77. As a result, the toripalimab with chemotherapy group had a cost-effective benefit, as the ICER was $21,057.18/QALY, which was less than the $37,663.26/QALY WTP threshold in China. The results of the basic-case analysis are shown in Table 2.