Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”,
HKEX: 1877; SSE: 688180) and Coherus BioSciences,
Inc. (“Coherus”, Nasdaq: CHRS), today announced the
presentation of positive results and biomarker analyses from the
pivotal study “CHOICE-01” (clinicaltrials.gov identifier#
NCT03856411), a randomized, double-blind, placebo-controlled Phase
3 clinical trial evaluating toripalimab plus chemotherapy as
first-line treatment of advanced squamous or non-squamous non-small
cell lung cancer (“NSCLC”). The final progression-free survival
(“PFS”) analysis confirms the finding of the previous interim PFS
analysis, demonstrating a statistically significant and clinically
meaningful improvement in PFS per RECIST v1.1 compared to
chemotherapy alone. The study also demonstrated an improvement in
overall survival (“OS”) in a prespecified interim OS
analysis. These results will be summarized later today during
the ASCO Plenary Series, in an oral presentation by Professor Jie
Wang, MD, PhD, from the National Cancer Center/National Clinical
Research Center for Cancer/Cancer Hospital, Chinese Academy of
Medical Sciences & Peking Union Medical College. The abstract
is now available on the ASCO website.
“We are excited about the consistently strong clinical evidence
that toripalimab has displayed across multiple tumor types,” said
Dr. Patricia Keegan, Chief Medical Officer at Junshi Biosciences.
“The addition of toripalimab to chemotherapy in patients with
advanced NSCLC provided superior PFS and OS compared to
chemotherapy alone with a manageable safety profile. These results
support the use of toripalimab with chemotherapy as first-line
therapy for advanced NSCLC patients without EGFR/ALK
mutations.”
“In the CHOICE-01 study in patients with non-small cell lung
cancer, toripalimab has once again demonstrated the potential to
delay disease progression and help patients live longer,” said
Theresa LaVallee, PhD, Chief Development Officer at Coherus. “The
study investigators also reported interesting biomarker data with
toripalimab plus chemotherapy having activity independent of PD-L1
expression as well as a statistically significant overall survival
advantage in NSCLC patients who have alterations in the focal
adhesion-PI3K-AKT signaling pathway, a finding which may inform the
design of future toripalimab clinical trials.”
About CHOICE-01A total of 465 treatment-naïve
advanced NSCLC patients without EGFR/ALK mutations were randomized
(2:1): 309 to toripalimab plus chemotherapy (the “toripalimab arm”)
and 156 to placebo plus chemotherapy (the “placebo arm”). The
primary endpoint was PFS assessed by the investigator. Secondary
endpoints included PFS assessed by a blinded independent review
committee (“BIRC”), OS and safety. Patients from the placebo arm
were actively crossed over to toripalimab treatment upon disease
progression.
As of October 31, 2021:
- At the final analysis, a significant improvement in PFS was
detected in the toripalimab arm over the placebo arm (hazard ratio
(“HR”)=0.49; 95% confidence interval (“CI”): 0.39-0.61,
P<0.0001) with median PFS of 8.4 vs. 5.6 months. The 1-year PFS
rates for the toripalimab and placebo arms were 36.7% and 17.2%,
respectively.
- PFS as assessed by BIRC was also significantly longer in the
toripalimab arm.
- A prespecified interim analysis demonstrated a statistically
significant improvement in overall survival for the toripalimab arm
over the placebo arm (median OS not reached vs. 17.1 months, HR =
0.69 (95% CI: 0.52-0.92)).
- The PFS benefits were observed in patients treated with
toripalimab plus chemotherapy across key subgroups, including
histologic subtype and tumor PD-L1 expression.
- Genomic analysis revealed a PFS benefit associated with
high tumor mutation burden and with genetic alterations in the
focal adhesion-PI3K-AKT and IL-7 pathways in patients treated
with toripalimab plus chemotherapy.
- The addition of toripalimab to standard first-line chemotherapy
in patients with advanced NSCLC showed a manageable safety profile
with no new safety signals observed. The incidence of Grade ≥3
adverse events (AEs) was 78.6% in the toripalimab arm vs. 82.1% in
the placebo arm. AEs leading to discontinuation of toripalimab or
placebo were 14.3% vs. 3.2%, respectively.
Junshi Biosciences and Coherus are evaluating potential
registration avenues for toripalimab in combination with
chemotherapy for the first-line treatment of advanced non-small
cell lung cancer in the United States. In China, the supplemental
New Drug Application for this indication was accepted in December
2021 by the National Medical Products Administration (“NMPA”).
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 NSCLC
without EGFR or ALK 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 the 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); and expectations for
the potential of toripalimab plus chemotherapy to offer improved
PFS and OS compared to chemotherapy.
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 0300
Solebury TroutBob Aibai@gobyglobal.com + 1 646-389-6658
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800
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