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– Toripalimab plus chemotherapy resulted in a 37% reduction in the risk of death, HR=0.63, versus chemotherapy alone, in nasopharyngeal carcinoma patients –
– No treatments are approved for NPC in the US;if approved, toripalimab will address a critical unmet need –
REDWOOD CITY, Calif., June 05, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) announced the final overall survival (OS) results of the JUPITER-02 study presented today at the American Society for Clinical Oncology (ASCO) Annual Meeting. JUPITER-02 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).
The final analysis of the JUPITER-02 clinical trial (NCT03581786) demonstrated a statistically significant and clinically meaningful improvement in OS for NPC patients who were treated with toripalimab in combination with gemcitabine and cisplatin chemotherapy, versus chemotherapy treatment alone. Median OS has not been reached in the toripalimab arm versus 33.7 months for chemotherapy treatment alone, HR=0.63 (95% CI 0.45-0.89); P=0.0083.
“There are limited options for patients living with this very aggressive form of head and neck cancer. These results are remarkable, with meaningful improvement over chemotherapy alone, and this is practice-changing," said Jennifer Choe, M.D., Ph.D., Assistant Professor of Medicine and the Head and Neck Medical Oncology Disease Team Lead in the Division of Hematology and Oncology at Vanderbilt University Medical Center. "I was impressed with the primary endpoint outcome, extending progression-free survival from 8.2 months with chemotherapy alone to 21.4 months with the addition of toripalimab, and now with the strong overall survival data, this will be a new standard of care for patients, if approved.”
Rosh Dias, M.D., Coherus’ Chief Medical Officer, echoed Dr. Choe's remarks, “This landmark trial demonstrates a significant survival advantage for patients with recurrent or metastatic nasopharyngeal carcinoma who were treated with toripalimab. No other PD-1 inhibitor currently approved in the U.S. has had a successful Phase 3 trial in recurrent or metastatic NPC that met its primary endpoints. Toripalimab, therefore, addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and we look forward to bringing this important medicine to patients upon approval.”
The Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the U.S. FDA. In May 2023, FDA completed the required pre-licensing inspection of partner Shanghai Junshi Biosciences Ltd.’s toripalimab manufacturing site in China, and Coherus continues to collaborate with FDA to complete the clinical site inspections. Coherus projects potential approval in the third quarter of 2023 and plans to launch toripalimab in the United States directly, if approved.
Toripalimab JUPITER-02 Overall Survival Results
JUPITER-02 is a Phase 3, randomized study which examined the use of toripalimab versus placebo in combination with gemcitabine and cisplatin as a first-line treatment in recurrent/metastatic NPC.
At the final OS analysis, the median overall survival follow-up time was 36.0 months. A significant improvement in OS was observed in the toripalimab arm, and median OS was not yet reached, compared to 33.7 months in the placebo arm. The 2-year and 3-year OS rates for toripalimab + chemotherapy versus placebo + chemotherapy were 78.0% vs. 65.1%, and 64.5% vs. 49.2% respectively.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1c6824a5-8c2a-43f8-bd14-ee90d8f1ce5d
A consistent effect on OS, favoring the toripalimab arm, was observed in nearly all subgroups, including PD-L1 high and PD-L1 low expression subgroups.No new safety signals were identified in the toripalimab arm since the interim report. The incidence of Grade ≥3 adverse events (AEs) (89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) were similar between the two arms. AEs leading to discontinuation of toripalimab versus placebo (11.6% vs 4.9%), immune-related (irAEs) (54.1% vs. 21.7%) and Grade ≥3 irAEs (9.6% vs. 1.4%) were more frequent in the toripalimab arm.
These data were presented in a poster discussion session today by Prof. Rui-hua XU, Sun Yat-sen University Cancer Center, JUPITER-02 principal investigator:
Abstract #6009/Poster #1: “Final Overall Survival Analysis of JUPITER-02: a Phase 3 study of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)”
Commitment to the NPC CommunityAs there are limited resources for patients living with NPC and their caregivers, Coherus has launched a new educational resource, NPCFacts.com, for patients living with NPC which includes detailed information about the types of NPC, the causes, diagnosis, and current treatment options.
In addition to education about nasopharyngeal carcinoma, the website includes links to patient advocacy organizations providing additional resources for patients and their caregivers. Head and Neck Cancer Alliance, Support for People with Oral Head and Neck Cancer (SPOHNC), and Thyroid Head and Neck Cancer Foundation (THANC) are some of the organizations included on the website.
The website also includes a companion website for healthcare professionals treating patients with NPC with educational resources and peer-to-peer education.
Additional toripalimab clinical data presented at ASCO include:
CHOICE-01, NEOTORCH, and Torchlight Studies Demonstrate Clinical Benefit of Toripalimab in NSCLC and TNBC Abstract # 9003: “Final overall survival and biomarker analyses of CHOICE-01: A double-blind randomized phase 3 study of toripalimab versus placebo in combination chemotherapy for advanced NSCLC without EGFR/ALK mutations.”
