On June 5, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported the final overall survival (OS) results of the JUPITER-02 study presented today at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Coherus Biosciences, JUN 5, 2023, View Source [SID1234632465]). 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).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.
Coherus-Final OS Toripalimab Figure 2 ASCO (Free ASCO Whitepaper) 2023
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 Community
As 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 (Free ASCO Whitepaper) 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."
A significant improvement in OS was observed for the toripalimab arm over the placebo arm: HR=0.73 (95% CI: 0.57-0.93), two-sided p=0.0108, median OS 23.8 vs 17.0 months
Abstract #8501: "Perioperative toripalimab + platinum-doublet chemotherapy vs. chemotherapy in resectable stage II/III non-small cell lung cancer (NSCLC): Interim event-free survival (EFS) analysis of the phase 3 NEOTORCH study."
Event free survival (EFS) was significantly improved in the toripalimab arm, HR=0.40, 95% CI (0.277-0.565), P<0.0001, and crossed the pre-specified efficacy boundary
The median EFS was not reached in the toripalimab arm and was 15.1 months in the placebo arm
Abstract #LBA1013: "TORCHLIGHT: a randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel (nab-P) for patients with metastatic or recurrent triple-negative breast cancer (TNBC)"
A statistically significant improvement in PFS was demonstrated for the toripalimab arm in the PD-L1 positive subgroup (mPFS 8.4 vs 5.6 months; HR = 0.653, 95% CI 0.470-0.906, P = 0.0102).
PFS in the ITT population showed a similar trend (mPFS 8.4 vs 6.9 months, HR = 0.773, 95%CI 0.602-0.994)
OS showed a trend towards improved OS in the PD-L1 positive (mOS 32.8 vs 19.5 months; HR = 0.615, 95%CI 0.414-0.914)
More than 20 toripalimab abstracts were accepted for ASCO (Free ASCO Whitepaper) 2023, including two selected for oral presentations (LBA1013 and #8501), describing the antitumor activities observed from various cancers of the nasopharynx, hypopharynx, skin, breast, lung, esophagus, stomach, liver, biliary duct, sarcoma, urothelial, head and neck, endometrial, thyroid, laryngeal, and pancreas.
Coherus Continues to Innovate to Address Unmet Patient Need in Cancer Patients with U.S. Launch of UDENYCA Autoinjector
Coherus recently announced the introduction of a prefilled autoinjector presentation of UDENYCA (pegfilgrastim-cbqv) in the United States. UDENYCA is designed to be administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The autoinjector has a streamlined, easy-to-use design for both in-clinic and at-home care settings, and features push-on-skin activation to reliably deliver a complete dose.
About toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-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. The BLA for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA. The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of ESCC, NPC, mucosal melanoma, soft tissue sarcoma, and small-cell lung cancer (SCLC).
More than 30 company-sponsored toripalimab clinical studies covering over fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.
About UDENYCA
UDENYCA is the only pegfilgrastim brand offering two on-demand options—prefilled syringe (PFS) and autoinjector (AI) providing more choice and flexibility customized to meet the needs of patients and practices. UDENYCA (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device is under review by the FDA. If approved, UDENYCA OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system. Since 2019, over 263,000 patients have been treated with UDENYCA