On March 21, 2025, Junshi Biosciences announced that the National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for the company’s product, toripalimab, in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (“HCC”) patients.
The supplemental NDA approval is based on data from the HEPATORCH study (NCT04723004), which is a multinational multi-center, randomized, open-label, active-controlled phase 3 clinical study. Professor Jia FAN, an academician of the Chinese Academy of Sciences, from Zhongshan Hospital affiliated to Fudan University, served as the principal investigator. HEPATORCH was launched in 57 clinical centers in the Chinese mainland, China’s Taiwan and Singapore, and a total of 326 patients were enrolled. The study aimed to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic HCC compared to the standard treatment with sorafenib.
In September 2024, the results of the HEPATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. The results of the study showed that the primary endpoints, progression-free survival (“PFS,” based on independent radiographic review) and OS, both achieved positive results.
HEPATORCH demonstrated that compared with sorafenib, toripalimab in combination with bevacizumab could significantly extend the PFS and OS of patients, with a median PFS of 5.8 months vs. 4.0 months, reduce the risk of disease progression or death by 31% (hazard ratio [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), with a median OS of 20.0 months vs. 14.5 months, and reduce the risk of death by 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). The objective response rate (“ORR”) of the toripalimab and bevacizumab group was significantly higher than that of the sorafenib group. The ORR of the two groups were 25.3% and 6.1%, respectively. Furthermore, the combination therapy has a good safety profile in patients with advanced HCC. The toxicity spectrum is consistent with the known toxicity spectrum of the standard monotherapy, and no new safety signal was identified.
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.
More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.
In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are eleven approved indications for toripalimab in the Chinese mainland:
unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);
in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
Post time: Mar-27-2025