Junshi Biosciences' toripalimab has received approvals in India and Hong Kong for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). These approvals cover toripalimab in combination with cisplatin and gemcitabine for first-line treatment, and as a single agent for patients with disease progression after platinum-based chemotherapy.
Approvals Based on Key Clinical Trials
The approvals are based on data from the Phase 3 JUPITER-02 trial and the Phase 2 POLARIS-02 trial. The JUPITER-02 trial (NCT03581786) demonstrated that toripalimab, combined with gemcitabine and cisplatin, significantly improved progression-free survival (PFS) compared to chemotherapy alone. Specifically, the median PFS was 21.4 months in the toripalimab arm versus 8.2 months in the placebo arm (HR, 0.52; 95% CI, 0.37-0.73).
Overall survival (OS) data from JUPITER-02, with a median follow-up of 36.0 months, showed a trend towards improved survival, with the median OS not yet reached in the toripalimab arm compared to 33.7 months in the placebo arm (HR, 0.63; 95% CI, 0.45-0.89; P = .008).
The POLARIS-02 trial (NCT02915432) evaluated toripalimab as a single agent in patients with recurrent or metastatic NPC refractory to standard chemotherapy. The overall response rate (ORR) was 20.5% (95% CI, 15.0%-27.0%), and the disease control rate (DCR) was 40.0% (95% CI, 33.0%-47.3%). The median duration of response (DOR) was 12.8 months (95% CI, 9.4-NE).
European Commission Approves Toripalimab for NPC and ESCC
In September 2024, the European Commission (EC) approved toripalimab (Loqtorzi) for two indications: in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC), and in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
The EC's decision was supported by data from the JUPITER-02 trial for NPC and the JUPITER-06 trial (NCT03829969) for ESCC. The JUPITER-06 trial demonstrated that toripalimab plus chemotherapy resulted in superior PFS and OS in patients with advanced or metastatic ESCC. The median OS was prolonged by 6 months to 17 months, and the risk of disease progression or death was significantly reduced by 42%.
Clinical Significance
Nasopharyngeal carcinoma, a malignant tumor of the nasopharynx, affects over 120,000 individuals globally each year. Esophageal cancer is also a significant global health concern, with over 511,000 new cases and 445,000 deaths in 2022. These approvals mark a significant advancement in the treatment landscape for these cancers, particularly in regions where these diseases are prevalent.
According to Ruihua Xu, MD, PhD, Principal Investigator and President of Sun Yat-sen University Cancer Center, the approvals reflect the pioneering leadership of Chinese researchers in the diagnosis, treatment, and clinical research of NPC and ESCC. He expressed hope that this "Chinese Solution" will transform the outlook for patients who have long lacked effective treatment options.
Junshi Biosciences' Global Strategy
Jianjun Zou, MD, PhD, General Manager and CEO of Junshi Biosciences, stated that these approvals signify the expansion of the company's global commercial strategy into Europe, following successes in China and the US. The company aims to continue collaborating with partners to provide high-quality, innovative therapies to more patients worldwide. Toripalimab has now been approved for marketing in over 30 countries and regions across three continents.
Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2, thereby promoting the immune system’s ability to attack and kill tumor cells. Junshi Biosciences has conducted over 40 company-sponsored clinical studies covering more than fifteen indications globally.
