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Coherus and Junshi Biosciences Announce Toripalimab in Combination with Chemotherapy Met Primary Progression Free Survival (PFS) Endpoint as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
– 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
– Over 30 toripalimab abstracts in more than 10 tumor types published at ASCO 2021 –
The results are summarized in a late-breaking abstract that will be presented during a plenary session at the 2021 annual meeting of the
“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.
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
“ASCO 2021 is a pivotal moment for Coherus as it marks the
About JUPITER-02 Results
JUPITER-02, conducted in mainland
A summary of the results is as follows:
- A significant improvement in PFS (assessed by BIRC) was observed in the toripalimab plus chemotherapy arm compared to the chemotherapy alone arm (HR = 0.52 [95% CI: 0.36-0.74] two-sided p = 0.0003), median PFS of 11.7 vs. 8.0 months;
- The 1-year PFS rates were 49% and 28%, respectively, for the toripalimab arm compared to the placebo arm;
- An improvement in PFS was observed across relevant subgroups including patients with high PD-L1 expression (TC or IC ≥ 1%; mPFS 11.4 vs. 8.2 month, HR = 0.59 [95% CI: 0.388 – 0.893]) or low PD-L1 expression (TC and IC<1%; mPFS 11.0 vs. 6.0 months, HR=0.35 [95% CI: 0.153 – 0.808]);
- The ORR was 77.4% vs. 66.4% (P = 0.034); the median DoR was 10.0 vs. 5.7 months (HR = 0.50 [95% CI: 0.33-0.78]), P = 0.001);
- The first interim analysis of overall survival was not mature at the interim analysis of PFS. In the updated OS analysis conducted
February 18, 2021, although median OS was not yet mature in either arm, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.60 [95% CI: 0.364-0.997], nominal P = 0.046);
- The incidence of grade ≥3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), grade ≥3 treatment related adverse events (TRAE) (80.8% vs 83.2%), AEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal AEs (2.7% vs 2.8%) was similar between both arms. Immune-related (irAEs) (39.7% vs. 18.9%) and Grade ≥3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab group.
A pre-specified second interim OS analysis will be performed at the same time as the final PFS analysis.
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells.
More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
About Junshi Biosciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system.
Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.
For additional information, please visit www.coherus.com.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.
Humira® is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus’ ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended
Coherus Contact Information: IR Contact:
McDavid Stilwell Coherus BioSciences, Inc.firstname.lastname@example.org +1 (650) 395-0152 Media Contact: Sheryl SeapyReal Chemistry email@example.com (949) 903-4750 Junshi Biosciences Contact Information IR Team: Junshi Biosciences firstname.lastname@example.org + 86 021-2250 0300 Solebury Trout Bob Aibai@soleburytrout.com + 1 646-389-6658 PR Team: Junshi Biosciences Zhi Lizhi_li@junshipharma.com + 86 021-6105 8800
Source: Coherus BioSciences, Inc.