Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line treatment for irresectable or metastatic melanoma in comparison with dacarbazine, marking a significant milestone in the treatment of this aggressive form of skin cancer.
Study Design and Results
The randomized, controlled, multi-center Phase III study aimed to assess the efficacy and safety of Tuoyi as a first-line melanoma treatment. Enrolling 256 subjects, the study administered toripalimab or dacarbazine treatments at a 1:1 ratio and monitored until disease progression or intolerable toxicity. The primary study endpoint was PFS based on independent imaging evaluation, with secondary endpoints including investigator evaluated PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), and safety. The results indicate that first-line treatment with toripalimab can significantly prolong the PFS of patients with unresectable or metastatic melanoma compared to dacarbazine. Safety data for toripalimab were consistent with previous studies, with no new safety signals identified.
Regulatory and Market Progress
This achievement marks the first key regulatory clinical study in China to achieve positive results in the first-line treatment of advanced melanoma with a PD-(L)1 inhibitor. Tuoyi, China’s first domestic PD-1 inhibitor approved as a second-line treatment for melanoma in December 2018, has garnered six indication approvals in China to date. The company is currently awaiting regulatory decisions for multiple market filings for the drug in the US, EU, and UK.
Pending Indications and Future Prospects
Junshi is also anticipating judgement on four additional indications for Tuoyi filed from April to July this year in China. These include perioperative treatment combined with chemotherapy and as consolidation therapy alone after adjuvant therapy of resectable stage III non-small cell lung cancer (NSCLC), combined with paclitaxel (albumin bound) in PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic triple negative breast cancer, in first-line unresectable or metastatic renal cell carcinoma (RCC) combined with axitinib, and finally in combination with etoposide plus platinum in extensive stage small cell lung cancer (ES-SCLC).-Fineline Info & Tech
