Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”,
HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”,
Nasdaq: CHRS) announced the results of the prespecified final
progression-free survival (“PFS”) analysis and the interim overall
survival (“OS”) analysis of the JUPITER-02 study (NCT03581786), a
pivotal Phase 3 trial in first-line treatment of recurrent or
metastatic nasopharyngeal carcinoma (“NPC”). The JUPITER-02
results are summarized in a poster presentation at the annual
meeting of the American Association for Cancer Research (“AACR”).
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 Ruihua Xu, the poster's corresponding author from Sun
Yat-sen University Cancer Center (SYSUCC). “The JUPITER-02 results
validate the potential advancement that toripalimab in combination
with chemotherapy would represent as a new standard-of-care
first-line therapy for patients with advanced NPC.”
Rosh Dias, MD, MRCP, Coherus' Chief Medical
Officer, added, “Innovative immuno-oncology approaches including
anti-PD-1 monoclonal antibody treatments represent a promising new
option for advanced nasopharyngeal carcinoma, for which there are
currently no approved immuno-oncology treatments in the United
States. The significant improvement demonstrated in JUPITER-02 with
the combination of toripalimab and chemotherapy across key
clinically meaningful endpoints compared to chemotherapy alone
supports its use as a potential new standard of care treatment
option for advanced NPC.”
“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. Patricia Keegan, Chief Medical
Officer of Junshi Biosciences. “We believe that toripalimab can
revolutionize the treatment of advanced NPC and are working closely
with the FDA and our partner, Coherus, to provide the first
approved therapy for patients with this rare disease in the
U.S.”
The United States Food and Drug Administration
(“FDA”) granted breakthrough therapy designation for toripalimab in
combination with gemcitabine and cisplatin as first-line treatment
for patients with advanced recurrent or metastatic NPC and for
toripalimab monotherapy for second-line or later treatment of
recurrent or metastatic NPC after platinum-containing chemotherapy.
A biologics license application (“BLA”) for these indications is
under priority review by the FDA. Coherus and Junshi Biosciences
are working closely with the FDA to complete the review process and
schedule any required inspections in China.
About JUPITER-02 Study
Results
JUPITER-02, conducted in mainland China, Taiwan
and Singapore, is the largest Phase 3 clinical study to date to
evaluate a checkpoint inhibitor plus chemotherapy for the
first-line treatment of recurrent or metastatic NPC. Two hundred
eighty-nine patients with advanced NPC, who had received no prior
chemotherapy for recurrent or metastatic disease, were randomized
1:1 to receive toripalimab 240 mg or placebo in combination with
gemcitabine 1000 mg/m2 (d1, 8) and cisplatin 80 mg/m2 (d1), Q3W
followed by toripalimab or placebo monotherapy until disease
progression, intolerable toxicity or completion of two years of
treatment. PFS and response were assessed by the BIRC and by the
investigator per RECIST v1.1. There was one prespecified interim
analysis of PFS at 130 (65%) PFS events and a final analysis at 200
PFS events.
At the final PFS analysis (cut-off date June 8,
2021), the median follow-up time was 22.1 months for the
toripalimab arm and 21.4 months for the placebo arm.
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.
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 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.
In the United States, the FDA has granted
priority review for the toripalimab 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 50
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 monoclonal antibody for
tumors was the first in the world to be approved for clinical
trials by the FDA and NMPA and has since entered Phase Ib/II trials
in both China and the US. Its anti-PCSK9 monoclonal antibody was
the first in China to be approved for clinical trials by the
NMPA.
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 Institute of
Microbiology of the Chinese Academy of Science and Lilly. JS016
administered with bamlanivimab has been granted Emergency Use
Authorizations (EUA) in over 15 countries and regions worldwide.
Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug
designed to hinder virus replication, is in global Phase III
clinical trials. The JS016 and VV116 programs are a part of the
company’s continuous innovation for disease control and prevention
of the global pandemic.
Junshi Biosciences has more than 2,800 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 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 the
United States and Canada. A biologics license application 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 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
biologics license application for 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™ 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 China 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 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 Coherus
files 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.
Coherus Contact Information:IR
Contact:McDavid StilwellChief Financial OfficerCoherus BioSciences,
Inc.IR@coherus.com
Media Contact:Brian
GrancagnoloBrian.Grancagnolo@hkstrategies.com+1 (212)
885-0449
Junshi Biosciences Contact Information
IR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-2250
0300
Goby GlobalBob Aibai@gobyglobal.com + 1 646-389-6658
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800
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