NMPA Approves sNDA for Toripalimab Plus Bevacizumab in Advanced HCC

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China’s National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for first-line toripalimab (Loqtorzi) in combination with bevacizumab (Avastin) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC).1

The NMPA approval of the sNDA was supported by findings from the multicenter, open-label, active-controlled phase 3 HEPATORCH trial (NCT04723004), which was conducted across 57 centers in mainland China, Taiwan, and Singapore. Findings from the study presented in 2024 at the 27th National Clinical Oncology Conference and the Chinese Society of Clinical Oncology Academic Annual Meeting showed positive results regarding the trial’s primary end points of progression-free survival (PFS) and overall survival (OS) with toripalimab plus bevacizumab in patients with previously untreated unresectable or metastatic HCC. The median PFS was 5.8 months with the investigational combination vs 4.0. months with standard-of-care sorafenib (Nexavar; HR, 0.69; 95% CI, 0.525-0.913; P = .0086). The median OS in these respective arms was 20.0 months and 14.5 months (HR, 0.76; 95% CI, 0.579-0.987; P = .0394). Furthermore, the overall response rate (ORR) was 25.3% with toripalimab plus bevacizumab vs 6.1% with sorafenib.

“The combination of immunotherapy and anti-angiogenic therapy has become the foundation of first-line treatment for advanced liver cancer,” Jia Fan, MD, PhD, president, director of the Department of Oncology and Organ Transplantation Center, and a professor of liver surgery at Zhongshan Hospital in Shanghai, China; vice-director of the Liver Cancer Institute at Fudan University; and the principal investigator of HEPATORCH, stated in a news release. “The HEPATORCH study has fully demonstrated the clinical efficacy of toripalimab in [patients with] liver cancer in China…The…regimen combining toripalimab with bevacizumab will benefit many [patients with] advanced liver cancer in China.”

The combination was also associated with a favorable safety profile, and safety findings from HEPATORCH were consistent with the known safety profile of sorafenib monotherapy. Investigators identified no new safety signals.

HEPATORCH enrolled 326 patients between 18 and 75 years of age with a histological or cytological diagnosis of HCC (or a clinical diagnosis of HCC in patients with cirrhosis).2 Patients were not permitted to have received prior systemic therapy for HCC (those who had received prior adjuvant therapy alone who relapsed 6 months or later following their last line of adjuvant therapy were allowed). Patients also needed to have at least 1 measurable lesion per RECIST 1.1 criteria, Child-Pugh class A disease with no history of hepatic encephalopathy, an ECOG performance status of 0 or 1, a predicted life expectancy of at least 12 weeks, and adequate main organ functions.

Patients were randomly assigned to receive continuous administration of toripalimab at 240 mg every 3 weeks plus bevacizumab at 15 mg/kg every 3 weeks; or continuous administration of sorafenib at 400 mg twice daily. Treatment was continued until the occurrence of protocol-specified termination effects.

Key secondary end points included ORR, duration of response, disease control rate, time to progression, and safety.

“Building on the success of our previously approved 10 indications—the ‘Perfect 10,’—toripalimab has reached another breakthrough achievement with the official approval of its 11th indication, and we are extremely elated!” Jianjun Zou, MD, PhD, the general manager and chief executive officer of Junshi Biosciences—the developer of toripalimab—added in the news release.1 “China has suffered the brunt of liver cancer, and Chinese patients have long faced the challenge of limited treatment options. Junshi Biosciences consistently prioritizes the clinical needs of liver cancer treatment around the world, advancing clinical research through combination strategies tailored to patients across the different stages of disease progression. Our goal is to provide more precise and diverse treatment options for [patients with] liver cancer. Moving forward, we remain dedicated to liver cancer innovation and integrating even greater ‘Chinese Wisdom’ into the fight against this disease.”

References

1. Junshi Biosciences announces approval of sNDA for toripalimab in combination with bevacizumab for 1st-line treatment of advanced hepatocellular carcinoma. News release. Shanghai Junshi Biosciences Co., Ltd. March 21, 2025. Accessed March 25, 2025. https://www.junshipharma.com/en/君实生物宣布特瑞普利单抗联合贝伐珠单抗一线治/
2. Evaluate the safety and efficacy of toripalimab combined with bevacizumab versus sorafenib therapy for HCC. ClinicalTrials.gov. Updated August 14, 2023. Accessed March 24, 2025. https://clinicaltrials.gov/study/NCT04723004