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SHANGHAI, China, and REDWOOD CITY, Calif., April 08, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) announced the results of the prespecified final progression-free survival (“PFS”) analysis and the interim overall survival (“OS”) analysis of the JUPITER-02 study (NCT03581786), a pivotal Phase 3 trial in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”). The JUPITER-02 results are summarized in a poster presentation at the annual meeting of the American Association for Cancer Research (“AACR”).
In the final PFS analysis, results from JUPITER-02 demonstrated that toripalimab in combination with chemotherapy provided a statistically significant improvement in PFS assessed by the blinded independent review committee (“BIRC”) compared to chemotherapy plus placebo, with an improvement in median PFS of 13.2 months (21.4 versus 8.2 months). Furthermore, the addition of toripalimab to chemotherapy provided significant improvements in the secondary endpoints of PFS assessed by the investigator, objective response rate (“ORR”) and duration of response (“DoR”), while maintaining a safety profile consistent with that in previously reported toripalimab clinical trials. Although the median OS (“mOS”) was not yet mature in either arm, the interim OS analysis showed a trend favoring the toripalimab arm and will be formally tested in a prespecified final analysis.
“First-line treatment options for advanced NPC remain limited for this difficult-to-treat tumor, resulting in poor outcomes for patients due to therapeutic resistance to chemotherapy, which is the current standard of care,” said Professor Ruihua Xu, the poster's corresponding author from Sun Yat-sen University Cancer Center (SYSUCC). “The JUPITER-02 results validate the potential advancement that toripalimab in combination with chemotherapy would represent as a new standard-of-care first-line therapy for patients with advanced NPC.”
Rosh Dias, MD, MRCP, Coherus' Chief Medical Officer, added, “Innovative immuno-oncology approaches including anti-PD-1 monoclonal antibody treatments represent a promising new option for advanced nasopharyngeal carcinoma, for which there are currently no approved immuno-oncology treatments in the United States. The significant improvement demonstrated in JUPITER-02 with the combination of toripalimab and chemotherapy across key clinically meaningful endpoints compared to chemotherapy alone supports its use as a potential new standard of care treatment option for advanced NPC.”
“We are excited that the updated results from JUPITER-02 confirm that the addition of toripalimab to chemotherapy significantly extends the median PFS of patients with advanced NPC by more than a year,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “We believe that toripalimab can revolutionize the treatment of advanced NPC and are working closely with the FDA and our partner, Coherus, to provide the first approved therapy for patients with this rare disease in the U.S.”
The United States Food and Drug Administration (“FDA”) granted breakthrough therapy designation for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. A biologics license application (“BLA”) for these indications is under priority review by the FDA. Coherus and Junshi Biosciences are working closely with the FDA to complete the review process and schedule any required inspections in China.
About JUPITER-02 Study Results
JUPITER-02, conducted in mainland China, Taiwan and Singapore, is the largest Phase 3 clinical study to date to evaluate a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic NPC. Two hundred eighty-nine patients with advanced NPC, who had received no prior chemotherapy for recurrent or metastatic disease, were randomized 1:1 to receive toripalimab 240 mg or placebo in combination with gemcitabine 1000 mg/m2 (d1, 8) and cisplatin 80 mg/m2 (d1), Q3W followed by toripalimab or placebo monotherapy until disease progression, intolerable toxicity or completion of two years of treatment. PFS and response were assessed by the BIRC and by the investigator per RECIST v1.1. There was one prespecified interim analysis of PFS at 130 (65%) PFS events and a final analysis at 200 PFS events.
At the final PFS analysis (cut-off date June 8, 2021), the median follow-up time was 22.1 months for the toripalimab arm and 21.4 months for the placebo arm.
A summary of the results is as follows:
