[2023. 11. 29.][NASDAQ:CHRS]Coherus and Junshi Biosciences Announce Publication of Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Trial Evaluating LOQTORZI™ (toripalimab-tpzi) as Treatment for Nasopharyngeal Carcinoma, in the Journal of the American Medical Association

[2023. 11. 29.][NASDAQ:CHRS]Coherus and Junshi Biosciences Announce Publication of Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Trial Evaluating LOQTORZI™ (toripalimab-tpzi) as Treatment for Nasopharyngeal Carcinoma, in the Journal of the American Medical Association

Coherus BioSciences and Junshi Biosciences Announce Breakthrough in Cancer Treatment

REDWOOD CITY, Calif. and SHANGHAI, China, Nov. 28, 2023 (GLOBE NEWSWIRE) -- In a groundbreaking development, Coherus BioSciences, Inc. (Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) have revealed the final results of the JUPITER-02 trial (NCT03581786) in a recent publication in the Journal of the American Medical Association (JAMA). The study evaluated the combination of LOQTORZI™ (toripalimab-tpzi), an immune checkpoint inhibitor, with gemcitabine and cisplatin chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).

The JUPITER-02 trial demonstrated a remarkable 37% reduction in the risk of death for NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone. This groundbreaking discovery is a significant milestone in the treatment of this aggressive form of head and neck cancer.

Dr. Robert Ferris, Director of UPMC Hillman Cancer Center, emphasized the urgent need for new treatment options for patients with rare cancers like NPC. He stated, "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."

LOQTORZI is the first and only FDA-approved treatment for recurrent or metastatic NPC, irrespective of PDL-1 status, and is set to become available in the United States in January 2024. The addition of LOQTORZI to gemcitabine-cisplatin chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, with a median OS that was not reached in the LOQTORZI arm versus 33.7 months in the placebo arm.

Moreover, LOQTORZI exhibited a consistent positive effect on OS across various subgroups, including PD-L1 expression and EBV copy number high and low subgroups. The combination therapy also demonstrated superior progression-free survival (PFS), with a median PFS of 21.4 months compared to 8.2 months with chemotherapy alone.

These results have positioned LOQTORZI as a promising treatment option for NPC patients, filling a critical unmet need. The safety profile of LOQTORZI was consistent with other toripalimab clinical trials and the PD-1 inhibitor class.

Professor Ruihua Xu, principal investigator from Sun Yat-sen University Cancer Centre, noted, "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."

Dr. Jianjun Zou, Global Research and Development President of Junshi Biosciences, highlighted the global impact of this innovative treatment, which has received approval in both China and the U.S. He stated, "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."

This groundbreaking research opens up new possibilities for NPC patients and underscores the importance of ongoing advancements in cancer treatment.

About NPC: Nasopharyngeal carcinoma (NPC) is a rare and aggressive cancer that originates in the upper part of the throat behind the nose, near the base of the skull. It has a low incidence rate in the United States, with limited treatment options. The five-year survival rate for advanced NPC is approximately 49%, highlighting the urgent need for effective therapies.

About LOQTORZI™ (toripalimab-tpzi): LOQTORZI is a next-generation anti-PD-1 monoclonal antibody that has demonstrated significant improvement in overall survival in several tumor types. It is the first and only FDA-approved treatment for recurrent or metastatic NPC, marking a new standard of care for this rare and aggressive cancer.