– Final overall survival analysis of the JUPITER-02 trial shows first-line treatment with LOQTORZI plus chemotherapy significantly prolongs survival in patients with recurrent or metastatic NPC irrespective of PDL-1 status–
– Treatment resulted in a 37% reduction in the risk of death versus chemotherapy alone –
-– LOQTORZI is the first and only FDA-approved treatment for recurrent or metastatic NPC in all lines of therapy and will be available to NPC patients in the U.S. in January 2024 –
REDWOOD CITY, Calif. And SHANGHAI, China, Nov. 28, 2023 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. ((Coherus, NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180) announced today the publication of the final overall survival (OS) results from the pivotal JUPITER-02 study (NCT03581786), a randomized, double-blind, placebo-controlled, international, multi-center Phase 3 clinical trial evaluating the immune checkpoint inhibitor LOQTORZI™ (toripalimab-tpzi), in combination with the chemotherapy agents gemcitabine and cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) in the Journal of the American Medical Association (JAMA). As previously reported at the 2023 American Society of Clinical Oncologists (ASCO) Annual Meeting, the final analysis revealed a 37% reduction in the risk of death in NPC patients treated with toripalimab plus chemotherapy versus chemotherapy alone.
In October, Coherus and Junshi announced the U.S. Food and Drug Administration (FDA) approval of LOQTORZI 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. Coherus plans to launch LOQTORZI in the United States in January 2024.
“There are limited options for patients living with this aggressive head and neck cancer. New treatment options are desperately needed for underserved cancer patients particularly ones with rare cancers,” said Robert Ferris, M.D., Ph.D., director of UPMC Hillman Cancer Center in Pittsburgh, PA. “As these data demonstrate, toripalimab clearly has the potential to significantly extend both progression-free and overall survival for patients living with NPC, and I believe this approach will offer a new standard of care for patients.”
“The final OS data published in JAMA demonstrates the potential of LOQTORZI to significantly extend survival while slowing the progression of NPC, an aggressive form of cancer which up until now has had no approved therapies and therefore represents an important unmet need for patients in the US living with NPC,” said Rosh Dias, M.D., Chief Medical Officer at Coherus. “As a next-generation PD-1 monoclonal antibody showing both a statistically significant and clinically meaningful OS advantage, and as the first and only FDA approved treatment for NPC, LOQTORZI should quickly become the new standard of care when used in combination with chemotherapy to treat patients living with NPC.”
Titled Toripalimab plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma, the paper highlights the addition of LOQTORZI to gemcitabine-cisplatin (GP) chemotherapy as first-line treatment for patients with recurrent or metastatic NPC provided superior OS compared to GP alone [HR=0.63 (95% CI: 0.45-0.89), two-sided p=0.008]. The median OS was not reached in the LOQTORZI arm and was 33.7 months in the placebo arm. The 2-year and 3-year OS rates were 78.0% vs. 65.1%, and 64.5% vs. 49.2% respectively. A consistent effect on OS, favoring the LOQTORZI arm, was observed in the majority of the subgroups, including PD-L1 expression and EBV copy number high and low subgroups. The addition of LOQTORZI to chemotherapy also provided superior progression-free survival (PFS) compared to chemotherapy alone, with a median PFS of 21.4 vs. 8.2 months [HR=0.52 (95% CI: 0.37, 0.73)]. The safety profile was consistent with that previously reported in other toripalimab clinical trials and consistent with the PD-1 inhibitor class. The full results can be found in the online edition of JAMA.
“From the oral presentation at the ASCO Annual meeting’s Plenary Session, to the cover article of Nature Medicine, and now publication in JAMA, the survival benefits of JUPITER-02 have become increasingly evident, gradually establishing the status of toripalimab plus chemotherapy as the first-line standard treatment for advanced NPC. We are extremely proud to contribute to the international advancement of the clinical diagnosis and treatment of NPC,” said Professor Ruihua Xu, JUPITER-02’s principal investigator from Sun Yat-sen University Cancer Centre. “The latest 3-year follow-up data showed that the combination of toripalimab with GP chemotherapy significantly reduced the risk of death by 37% and the risk of disease progression by 48%, and the 3-year OS rate reached 64.5%, an encouraging result for the first-line treatment of advanced NPC. Moreover, the addition of toripalimab did not increase the incidence of grade≥3 adverse events, nor did it increase the incidence of fatal adverse events and displayed a manageable safety profile.”
“Toripalimab in combination with chemotherapy is the world’s first and only first-line treatment for recurrent/metastatic NPC to achieve both statistically and clinically significant OS benefits in a Phase 3 study,” said Dr. Jianjun Zou, Global Research and Development President of Junshi Biosciences. “At present, this innovative treatment has been approved in China and the U.S. And through extensive cooperation, we strive for toripalimab to reach other parts of the world to provide more patients with better treatment options.”
About NPC
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.
LOQTORZI 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.
About LOQTORZI™ (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PDâ -â 1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
