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Coherus and Junshi Biosciences Present Results of Phase 3 Study of Toripalimab in First Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma at 2022 AACR Annual Meeting
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
“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.
About JUPITER-02 Study Results
JUPITER-02, conducted in mainland
At the final PFS analysis (cut-off date
A summary of the results is as follows:
- The addition of toripalimab to gemcitabine-cisplatin (“GP”) chemotherapy as first-line treatment for advanced NPC patients provided superior PFS, OS, ORR and DoR than GP chemotherapy alone:
- Significant improvement in PFS: mPFS 21.4 vs. 8.2 months, HR=0.52 (95% CI: 0.37, 0.73), P <0.0001.
- Significant improvement in ORR: 78.8% vs. 67.1% (P = 0.0221).
- Significant improvement in DoR: mDoR 18.0 vs. 6.0 months, HR=0.49, P = 0.0003.
- Although mOS was not mature in either arm, a 41% reduction in risk of death was observed in the toripalimab arm over the placebo arm, HR=0.59 (95% CI: 0.37, 0.94), nominal P =0.0238.
- The safety profile was consistent with that previously reported in other toripalimab clinical trials with no new safety signals identified with toripalimab added to GP.
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 promotes 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 by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal 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.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are four approved indications for toripalimab in China:
- unresectable or metastatic melanoma after failure of standard systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
- locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
- in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
The first three indications have been included in the National Reimbursement Drug List (NRDL) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.
In addition, two supplemental New Drug Applications (NDAs) for toripalimab are currently under review by the National Medical Products Administration (NMPA) in China:
- in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic ESCC.
- in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
About Junshi Biosciences
In the face of the COVID-19 pandemic, Junshi Biosciences responded swiftly and strongly, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the
Junshi Biosciences has more than 2,800 employees in
Coherus is a commercial stage biopharmaceutical company building a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta® in
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, statements regarding Coherus’ ability to build its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ expectations for the launch date of YUSIMRY™ and other products; Coherus’ plans to file additional BLAs for toripalimab; beliefs about toripalimab’s ability to enhance treatment of patients; and potential for toripalimab plus chemotherapy to represent a new standard of care in the future.
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; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus’ business, the need to schedule inspections in
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Coherus Contact Information:
Chief Financial Officer
+1 (212) 885-0449
Junshi Biosciences Contact Information
+ 86 021-2250 0300
+ 1 646-389-6658
+ 86 021-6105 8800
Source: Coherus BioSciences, Inc.