Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai
Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE:
688180) 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:
- 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
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 BiosciencesFounded
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 BioSciencesCoherus 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 StatementsExcept 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.
Coherus Contact InformationInvestors:McDavid
StilwellChief Financial OfficerCoherus BioSciences,
Inc.IR@coherus.com
Media:Kelli PerkinsRed Housekelli@redhousecomms.com
Junshi Biosciences Contact InformationIR
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-2250
0300Solebury TroutBob Aibai@gobyglobal.com+ 1 646-389-6658
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800
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