Junshi Biosciences and Coherus Announce Positive Results from Phase 3 Esophageal Cancer Study of Toripalimab Published in Cancer Cell

- Toripalimab plus chemotherapy demonstrates improvement in co-primary endpoints of PFS and OS in patients with advanced ESCC -

- PFS and OS benefits were observed across all PD-L1 expression subgroups, including in patients with low PD-L1 expression -

SHANGHAI, China and REDWOOD CITY, Calif., March 04, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. today announced the online publication in Cancer Cell of Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): a multi-center randomized phase 3 trial. The manuscript publication was accompanied by a Cancer Cell editorial preview entitled Jupiter-06 establishes immune checkpoint inhibitors as essential first-line drugs for the treatment of advanced esophageal squamous cell carcinoma.

JUPITER-06 achieved the co-primary endpoints of progression free survival (“PFS”) and overall survival (“OS”) with statistically significant and clinically meaningful improvements for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone. The study results were first presented in a mini-oral session during the European Society for Medical Oncology (“ESMO”) Congress 2021.

“The clinically meaningful results of JUPITER-06, as published in this internationally recognized, peer-reviewed journal, demonstrate toripalimab's ability to deliver significant benefits to patients receiving first-line treatment of advanced or metastatic esophageal squamous cell carcinoma,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences.

“Toripalimab interacts with PD-1 through a differentiated domain on the PD-1 surface, the FG loop, and has strong receptor internalization upon binding, resulting in a consistent reduction of PD-1 from the T-cell surface. We have hypothesized that this unique feature could enable a more robust response to antigen stimulation, and in our clinical trials, including JUPITER-06, we are closely monitoring PD-L1 expression as well as clinical efficacy in both PD-L1 high and PD-L1 low patient populations,” commented Dr. Sheng Yao, Senior Vice President of Junshi Biosciences.

“The robust results from the JUPITER-06 study add to the emerging body of clinical evidence of toripalimab’s clinical activity across multiple tumor types. Importantly, ESCC patients with low PD-L1 expression represent a high unmet need, and we are encouraged by these results in patients with ESCC and the potential of toripalimab plus chemotherapy to offer improved clinical outcomes for these patients,” said Denny Lanfear, CEO of Coherus. “We are working closely with our partners at Junshi Biosciences to make toripalimab and additional complementary immuno-oncology agents available to patients in the U.S. as part of our mission to advance patient care and outcomes in oncology.”

Highlights from the peer-reviewed manuscript are summarized below. A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab in combination with paclitaxel plus cisplatin (”TP”) chemotherapy (the “toripalimab arm”) or placebo in combination with TP chemotherapy (the “placebo arm”), followed by toripalimab or placebo maintenance. The co-primary endpoints were PFS as assessed by a blinded independent central review (“BICR”) and OS.

• A statistically significant improvement in OS was detected in the toripalimab arm:
  Median OS in the toripalimab and placebo arms were 17 vs. 11 months respectively. An interim analysis of OS revealed that, by the cutoff date of March 22, 2021, there were 70 deaths in the toripalimab arm (27.2%) vs. 103 deaths in the placebo arm (40.1%) (hazard ratio (“HR”) = 0.58; 95% confidence interval (“CI”), 0.43-0.78; P=0.0004).
• One-year OS rates were 66.0% vs. 43.7% for the toripalimab arm vs. the placebo arm, respectively.
• A statistically significant improvement in PFS was detected in the toripalimab arm:
  Median PFS in the toripalimab arm and placebo arm were 5.7 vs 5.5 months, respectively, (HR = 0.58; 95% CI, 0.46–0.74; P<0.0001).
• One-year PFS rates were 27.8% vs. 6.1% for the toripalimab arm vs. the placebo arm, respectively.
• Treatment effects generally favored the toripalimab arm across subgroup analyses, including among patients with low/negative PD-L1 tumor expression (PD-L1 CPS<1):
  The OS and PFS benefits were observed across key subgroups, including all PD-L1 expression subgroups. Specifically, the HRs for PFS between the toripalimab and placebo arms were 0.58 (95% CI, 0.44-0.75), 0.66 (95% CI, 0.37-1.19), and 0.56 (95% CI, 0.41-0.78) in the PD-L1 CPS ≥ 1, CPS < 1, and CPS<10 subgroups respectively. The HRs for OS between the toripalimab and placebo arms were 0.61 (95% CI, 0.44-0.87), 0.61 (95% CI, 0.30-1.25), and 0.61 (95% CI, 0.40-0.93) in the CPS ≥ 1, CPS < 1, and CPS<10 subgroups respectively. The Combined Positive Score (“CPS”) equals the total number of PD-L1 staining cells (tumor cells and immune cells) divided by the total number of viable tumor cells, multiplied by 100.
• The addition of toripalimab to TP did not lead to an unacceptable increase in toxicity:
  Incidence of grade >3 treatment emergent adverse events (“TEAEs”) was similar between the two arms. By the cutoff date, 99.2% of patients in each arm experienced at least one TEAE. Of those, 8.2% in each arm were fatal, though only 0.4% (toripalimab) and 1.2% (placebo) were deemed to be related to treatment. No new safety signals were observed.

Junshi Biosciences and Coherus are evaluating the potential to register toripalimab in combination with platinum-based chemotherapy for the first-line treatment of advanced or metastatic ESCC in the United States. In late 2021, the United States Food and Drug Administration (“FDA”) granted Orphan Drug Designation (“ODD”) for toripalimab for the treatment of esophageal cancer. In China, the supplemental New Drug Application for this indication was accepted in July 2021 by the National Medical Products Administration (“NMPA”).

About JUPITER-06

The JUPITER-06 Study (ClinicalTrials.gov identifier: NCT03829969) is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial comparing the efficacy and safety of toripalimab versus placebo in combination with TP as a first-line treatment for patients with advanced or metastatic ESCC. Between January 28, 2019 and November 30, 2020, 514 treatment-naïve advanced or metastatic ESCC patients from 72 centers across China were randomized (1:1) to receive toripalimab or placebo plus TP followed by toripalimab or placebo maintenance. The co-primary endpoints were PFS, defined as the time from randomization to the first documented disease progression or death from any cause assessed by BICR per RECIST v1.1; and OS, defined as the time from randomization to death from any cause. Secondary endpoints included PFS assessed by the investigator, PFS in the per-protocol population, objective response rate (“ORR”), duration of response (“DoR”), disease control rate (“DCR”), PFS and OS rates at 1-year and 2-year, and safety. Both arms received a median of 6 cycles of TP, and a median of 7 cycles of either toripalimab or placebo. By the cutoff date, 91 (35.4%) patients in the toripalimab arm and 69 (26.8%) patients in the placebo arm remained on the study treatment. Professor Ruihua Xu, from Sun Yat-sen University Cancer Center, is the principal investigator for this study.

About Toripalimab
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 promote 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:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. 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 non-small cell lung cancer (“NSCLC”) with no EGFR or ALK sensitizing mutations.

In the United States, the FDA has granted priority review for the toripalimab biologics license application (“BLA”) for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which has no FDA-approved immuno-oncology treatment options. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date for April 2022 for the toripalimab BLA. 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 designation for the treatment of esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (“EUA”) in over 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.

In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. A BLA for toripalimab for the treatment of metastatic or recurrent nasopharyngeal carcinoma is currently under priority review by the FDA, with a target action date of April 30, 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of cancers of the lung, breast, liver, skin, kidney, stomach, esophagus, and bladder.

Coherus markets UDENYCA^® (pegfilgrastim-cbqv), a biosimilar of Neulasta^® in the United States, and expects to launch the FDA-approved Humira^® biosimilar YUSIMRY™ (adalimumab-aqvh) in the United States in 2023. The FDA is currently reviewing the BLA for CIMERLI™, formerly known as CHS-201, a biosimilar of Lucentis^® (ranibizumab), with a target action date of August 2022. Coherus is also developing CHS-305, a biosimilar of Avastin^® (bevacizumab).

Forward-Looking Statements
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™ (adalimumab-aqvh); expectations for the potential of toripalimab plus chemotherapy to offer improved clinical outcomes; and expectations to make toripalimab and additional complementary immuno-oncology agents available to patients in the U.S.

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 and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risk of Coherus’ execution of its change in strategy from a focus on biosimilars to a strategy using cash from its portfolio of FDA-approved therapeutics to fund an immuno-oncology franchise; 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 litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant 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 December 31, 2021, filed with the Securities and Exchange Commission on February 23, 2022, including the section therein captioned “Risk Factors” and in other documents we file with the Securities and Exchange Commission.

UDENYCA^®, YUSIMRY™ and CIMERLI™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. Trademarks and trade names of other companies appearing in this Press Release are, to the knowledge of Coherus, the property of their respective owners.

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