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– In pivotal Phase 3 JUPITER-02 study, toripalimab plus chemotherapy significantly improved PFS compared to chemotherapy alone in high and low PD-L1 expression subgroups –
– Although median overall survival (OS) analysis was not yet mature, a 40% reduction in risk of death was observed in the toripalimab arm compared to placebo –
– Data to be presented June 6, 2021 at ASCO plenary session –
– Over 30 toripalimab abstracts in more than 10 tumor types published at ASCO 2021 –
SHANGHAI, China and REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced positive results from the pivotal study “JUPITER-02”, a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) compared to chemotherapy alone (assessed by a blinded independent review committee, or BIRC, per RECIST v1.1). JUPITER-02 also met secondary endpoints of PFS assessed by the investigator and objective response rate (ORR) assessed by BIRC. There was also a longer duration of response (DoR), a higher disease control rate (DCR) and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials.
The results are summarized in a late-breaking abstract that will be presented during a plenary session at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) on Sunday, June 6, 2021 from 1–4 pm Eastern Daylight Time. The abstract (LBA2) is now available on the ASCO website.
“Nasopharyngeal carcinoma is an aggressive tumor—especially for patients with advanced NPC. For first line treatment, platinum-based chemotherapy remains the current standard of care, yet mPFS is only about 7 months. We are encouraged by the JUPITER-02 results showing the addition of toripalimab to chemotherapy as first-line treatment provided superior PFS and ORR and longer DoR than chemotherapy alone, and with a safety and tolerability profile consistent with the PD-1 antibody class of drugs, said Dr. Ruihua Xu, President and Professor, Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou. “I believe that these results support the use of toripalimab with chemotherapy as the new standard of care for first-line treatment of patients with recurrent/metastatic NPC.”
More than 30 toripalimab abstracts were accepted for ASCO 2021, including two selected for oral presentations (LBA2 and #9512), describing the antitumor activities observed from various cancers of the nasopharynx, skin, lung, esophagus, stomach, liver, biliary duct, head and neck, and pancreas. Importantly, ten of the abstracts demonstrated toripalimab’s potential in perioperative, adjuvant, or neoadjuvant treatment settings.
"Given the outstanding results, JUPITER-02 is the first study to show a major therapeutic advance for first-line treatment of advanced NPC since the chemotherapy combination of gemcitabine and cisplatin was established as standard of care, which is why I believe this study was selected for presentation at the plenary session at ASCO 2021. We will work to expedite commercialization of toripalimab for this patient population in China, the United States, and other countries to make this exciting new treatment option broadly available to all patients with NPC," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “In addition to the JUPITER-02 trial, results of multiple other studies of toripalimab will be presented during the ASCO annual meeting, which support the current development strategy, such as perioperative immunotherapy in patients with multiple solid tumors, including mucosal melanoma, esophageal cancer, gastric cancer, liver cancer and non-small cell lung cancer, as well as the exploration of toripalimab for treatment of ICC, for which no checkpoint inhibitors have been approved for use."
“ASCO 2021 is a pivotal moment for Coherus as it marks the U.S. medical meeting debut of the immuno-oncology franchise we are building to deliver life-changing medicines addressing both rare and highly prevalent cancers,” said Denny Lanfear, CEO of Coherus. “The strong late-breaking data in advanced NPC add to the favorable efficacy and safety profile that is emerging for toripalimab in the broad development program with more than 15 pivotal clinical trials. Alongside Junshi Biosciences, we look forward to presenting clinical data from these studies and to working together to register toripalimab in the United States and Canada as a potential new therapeutic option across a broad range of tumor types, starting with NPC.”
About JUPITER-02 Results
JUPITER-02, conducted in mainland China, Taiwan and Singapore, is the largest Phase 3 clinical study to evaluate a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. Two hundred eighty-nine patients with advanced NPC who had received no prior chemotherapy for recurrent/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. Progression-free survival and response were assessed by the BIRC and by the investigator per RECIST v1.1. There was one pre-specified interim analysis of PFS at 130 (65%) PFS events with a planned final analysis at 200 PFS events.
By May 30, 2020, the date of the interim analysis data cut, the median treatment duration was 39 weeks in the toripalimab arm and 36 weeks in the placebo arm. The ASCO presentation also includes an updated overall survival (OS) analysis with a data cut-off of February 18, 2021.
A summary of the results is as follows:
