SHANGHAI, China, Oct. 29, 2023 — Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) today announced that the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.
In the JUPITER-02 Phase 3 study, LOQTORZI combined with chemotherapy significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 48% compared to chemotherapy alone. LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
The safety profile of LOQTORZI was consistent with the PD-1 inhibitor class. The incidence of Grade ≥3 adverse events (AEs) (89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) was similar between the two arms. AEs leading to discontinuation of LOQTORZI versus placebo (11.6% vs 4.9%), immune-related adverse events (irAEs) (54.1% vs. 21.7%), and Grade ≥3 irAEs (9.6% vs. 1.4%) were more frequent in the LOQTORZI arm.
In the POLARIS-02 clinical study LOQTORZI demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.
NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. LOQTORZI is the first FDA-approved agent for NPC patients.
“The impressive results from JUPITER-02 and POLARIS-02 have provided conclusive evidence that establishes toripalimab, in combination with chemotherapy or as monotherapy, as the standard therapy for advanced NPC,” said Professor Ruihua Xu of Sun Yat-sen University Cancer Center, the principal investigator of JUPITER-02 and POLARIS-02. “This great achievement was only made possible through the solid foundation laid by countless oncology experts over decades of in-depth research, as well as the selfless dedication of the patients and research teams involved in our toripalimab studies. We hope that this promising therapy will close the treatment gap for international NPC patients struggling to find effective therapies, bringing them renewed hope for better survival.”
“We’re excited to reach another significant company milestone of ‘going overseas’,” said Dr. Ning LI, Chief Executive Officer of Junshi Biosciences. “Following etesevimab, toripalimab has become Junshi Biosciences’ second product to receive FDA approval for commercialization—an achievement that will further enhance the company’s international presence. Currently, the establishment of toripalimab’s global commercialization network is in progress, and the network aims to span over 50 countries. In accordance with the company’s ‘In China, For Global’ strategy, we will continue working with our collaborators to promote the commercialization of toripalimab in other regions, in order to provide innovative and high-quality drugs from China to more patients overseas.”
“Toripalimab’s first overseas marketing approval was realized due to Junshi Biosciences’ innovative drug development strategies, which focused on the clinical needs of Chinese and Asian patients, and used to bridge the global treatment gap for new, life-prolonging products to all patients with NPC outside of China” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “This approval marks a great beginning for Junshi Biosciences as toripalimab enters the global market. Beyond toripalimab, we have many more promising indications for toripalimab as well as additional drugs being studied in international clinical trials. We strive to meet patients’ clinical needs across the globe by developing and providing new and more effective variety of treatment options. This goal provides strong motivation for our company as we become an international innovation-centric enterprise.”
“LOQTORZI’s first approval is a pivotal event for Coherus as an innovative oncology company. As a next generation PD-1 inhibitor it is the keystone of our I-O strategy to extend cancer patient survival as shown with the impressive results in NPC,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. “We are particularly excited to now turn our attention to developing LOQTORZI across multiple tumor types in combination with I-O agents that target the tumor microenvironment, such as our IL27-targeted antibody, casdozokitug, and our CCR8 inhibitor CHS-114, potentially greatly expanding the number of cancer patients achieving improved survival benefit.”
NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of the skull. NPC is rare in the United States, with an annual incidence of fewer than one per 100,000. The five-year survival rate for all patients diagnosed with NPC is approximately 60%, however, those who are diagnosed with advanced disease have a five-year survival rate of approximately 49%.
Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Patients treated with chemotherapy alone experience poor prognosis: only 20% experience one-year PFS; up to 50% developed distant metastasis during their disease course; and low median OS of 29 months.
LOQTORZITM is the first FDA-approved therapy for NPC and will represent a new standard of care for treating the disease when used in combination with cisplatin and gemcitabine in the first line setting or as monotherapy in the second line or greater setting.