Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) announced today
that the National Comprehensive Cancer Network (NCCN) has updated
the clinical practice guidelines for nasopharyngeal carcinoma (NPC)
to include LOQTORZI™ (toripalimab-tpzi) as a preferred, category 1
first-line treatment option for adults with metastatic or recurrent
locally advanced NPC when used in combination with cisplatin and
gemcitabine. The guidelines also recommend LOQTORZI monotherapy as
the only preferred treatment in subsequent lines of therapy if
disease progression on or after a platinum-containing therapy.
“Inclusion in the NCCN guidelines as a preferred category 1
treatment is an important step forward in treating patients with
R/M NPC. We now have a new standard of care for this rare form of
head and neck cancer,” said Tarek Mekhail, M.D., Medical Director
at AdventHealth Cancer Institute in Orlando, Florida. “Preferred
category 1 placement reinforces that LOQTORZI has strong clinical
data, including PFS and OS, representing a significant advancement
in treating a disease where there have been no FDA-approved options
until now.”
“NPC is an aggressive and life-threatening form of cancer for
which historically there have been limited treatment options. As
the first and only FDA-approved treatment for NPC, LOQTORZI has
demonstrated the potential to significantly extend survival while
slowing disease progression,” said Rosh Dias, M.D., Chief Medical
Officer at Coherus. “The inclusion of LOQTORZI in the updated NCCN
guidelines as the only immunotherapy for use in combination with
chemotherapy that is listed as a preferred regimen with a category
1 listing, and as the only preferred regimen for use in subsequent
lines of treatment for this disease, further reinforces the
clinical benefit of LOQTORZI across all lines of therapy in NPC and
should help quickly establish LOQTORZI as the standard of care for
the treatment of this disease.”
The NCCN recommendations are based on results of the JUPITER-02
Phase 3 study and the POLARIS-02 Phase 2 study. In the JUPITER-02
Phase 3 study, LOQTORZI combined with chemotherapy significantly
improved progression-free survival (PFS), reducing the risk of
disease progression or death by 48% compared to chemotherapy alone.
LOQTORZI also demonstrated a statistically significant and
clinically meaningful improvement in overall survival (OS), with
treatment resulting in a 37% reduction in the risk of death versus
chemotherapy alone. In the POLARIS-02 clinical study, LOQTORZI
demonstrated durable anti-tumor activity in patients with recurrent
or metastatic NPC who failed previous chemotherapy, with an
objective response rate (ORR) of 20.5%, a disease control rate
(DCR) of 40.0%, and a median OS of 17.4 months with an acceptable
safety profile.
LOQTORZI is a next-generation programmed death receptor-1 (PD-1)
monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with
high potency at a unique site on the PD-1 receptor, enabling the
immune system to activate and kill the tumor. In October, Coherus
and Junshi announced the U.S. Food and Drug Administration (FDA)
approval of LOQTORZI in combination with cisplatin and gemcitabine
for the first-line treatment of adults with metastatic or recurrent
locally advanced NPC, and as monotherapy for the treatment of
adults with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
About NPCNPC is a type of aggressive cancer
that starts in the nasopharynx, the upper part of the throat behind
the nose and near the base of the skull. NPC is rare in the United
States, with an annual incidence of fewer than one per 100,000. The
five-year survival rate for all patients diagnosed with NPC is
approximately 60%, however, those who are diagnosed with advanced
disease have a five-year survival rate of approximately 49%.
Due to the location of the primary tumor, surgery is rarely an
option, and patients with localized disease are treated primarily
with radiation and chemotherapy. Patients treated with chemotherapy
alone experience poor prognosis: only 20% experience one-year PFS;
up to 50% developed distant metastasis during their disease course;
and low median OS of 29 months.
LOQTORZI™ is the first FDA-approved therapy for NPC and will
represent a new standard of care for treating the disease when used
in combination with cisplatin and gemcitabine in the first line
setting or as monotherapy in the second line or greater
setting.
About LOQTORZI™
(toripalimab-tpzi)LOQTORZI is a next
generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding
to the PD-1 receptor at a unique site with high affinity and
activates anti-tumor immunity demonstrating improvement in the
overall survival of cancer patients in several tumor types.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LOQTORZI (toripalimab-tpzi) is indicated:
- In combination with cisplatin and
gemcitabine, for the first-line treatment of adults with metastatic
or with recurrent, locally advanced nasopharyngeal carcinoma
(NPC).
- As a single agent, for the treatment of
adults with recurrent unresectable or metastatic NPC with disease
progression on or after a platinum-containing chemotherapy.
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse
ReactionsImmune-mediated adverse reactions listed herein
may not include all possible severe and fatal immune-mediated
adverse reactions. Immune-mediated adverse reactions, which can be
severe or fatal, occur in any organ system or tissue, affect more
than one body system simultaneously, and occur at any time after
starting PD-1/PD-L1 blocking antibody. While immune-mediated
adverse reactions usually manifest during treatment, they can also
manifest after discontinuation of PD-1/PD-L1 blocking
antibodies.
- Monitor for early identification and
management. Evaluate liver enzymes, creatinine, and thyroid
function at baseline and periodically during treatment. In cases of
suspected immune-mediated adverse reactions, initiate appropriate
workup to exclude alternative etiologies, including infection.
Institute medical management promptly, including specialty
consultation as appropriate.
- Withhold or permanently discontinue
LOQTORZI based on severity and type of reaction (see Dosage and
Administration in Prescribing Information). In general, If LOQTORZI
requires interruption or discontinuation, administer systemic
corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent)
until improvement to Grade 1 or less. Upon improvement to Grade 1
or less, initiate corticosteroid taper and continue to taper over
at least 1 month. Consider administration of other systemic
immunosuppressants in patients whose immune-mediated adverse
reactions are not controlled with corticosteroid therapy.
Immune-Mediated PneumonitisLOQTORZI can cause immune-mediated
pneumonitis.
- In patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, immune-mediated
pneumonitis occurred in 2.1% (3/146) of patients, including Grade 2
(1.4%) adverse reactions. Pneumonitis resolved in 67% (2/3) of
these patients.
- In patients receiving LOQTORZI
monotherapy, immune-mediated pneumonitis occurred in 2.6% (22/851)
of patients, including fatal (0.2%), Grade 3 (0.7%), and Grade 2
(1.1%) adverse reactions. Systemic corticosteroids were required in
82% (18/22) of patients with pneumonitis. Pneumonitis led to
permanent discontinuation of LOQTORZI in 1.2% (10/851) of patients.
Pneumonitis resolved in 23% (5/22) of these patients.
Immune-Mediated ColitisLOQTORZI can cause immune-mediated
colitis, which may present with diarrhea. Cytomegalovirus (CMV)
infection/reactivation has been reported in patients with
corticosteroid-refractory immune-mediated colitis. In cases of
corticosteroid-refractory colitis, consider repeating infectious
workup to exclude alternative etiologies. In patients receiving
LOQTORZI monotherapy, immune-mediated colitis occurred in 0.4%
(3/851) of patients, including Grade 3 (0.2%) and Grade 2 (0.1%)
adverse reactions. Colitis resolved in all 3 patients.
Hepatotoxicity and Immune-Mediated HepatitisLOQTORZI can cause
immune-mediated hepatitis.
- In patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, immune-mediated
hepatitis occurred in 0.7% (1/146) of patients, which was a Grade 3
(0.7%) adverse reaction. The patient with immune-mediated hepatitis
required systemic corticosteroids.
- In patients receiving LOQTORZI
monotherapy, immune-mediated hepatitis occurred in 3.3% (28/851) of
patients, including Grade 4 (0.8%), Grade 3 (2.1%), and Grade 2
(0.4%) adverse reactions. Hepatitis led to permanent
discontinuation of LOQTORZI in 1.1% of patients and withholding of
LOQTORZI in 0.8% of patients. Hepatitis resolved in 54% (15/28) of
these patients.
Immune-Mediated EndocrinopathiesAdrenal InsufficiencyLOQTORZI
can cause primary or secondary adrenal insufficiency. For Grade 2
or higher adrenal insufficiency, initiate symptomatic treatment,
including hormone replacement as clinically indicated. Withhold or
permanently discontinue LOQTORZI depending on severity. In patients
receiving LOQTORZI monotherapy, adrenal insufficiency occurred in
0.5% (4/851) of patients, including Grade 2 (0.4%) and Grade 1
(0.1%) adverse reactions. Systemic corticosteroids were required in
75% (3/4) of the patients with adrenal insufficiency. Adrenal
insufficiency led to withholding of LOQTORZI in 0.1% (1/851) of
patients. In the one patient in whom LOQTORZI was withheld,
LOQTORZI was reinitiated after symptom improvement.
HypophysitisLOQTORZI can cause immune-mediated hypophysitis.
Hypophysitis can present with acute symptoms associated with mass
effects such as headache, photophobia, or visual field defects.
Hypophysitis can cause hypopituitarism. Initiate hormone
replacement as indicated. Withhold or permanently discontinue
LOQTORZI depending on severity. In patients receiving LOQTORZI
monotherapy, hypophysitis occurred in 0.4% (3/851) of patients
receiving LOQTORZI, including Grade 3 (0.2%) and Grade 2 (0.1%)
adverse reactions. All three patients received systemic
corticosteroids. Hypophysitis led to permanent discontinuation of
LOQTORZI in 0.1% (1/851) of patients and withholding of LOQTORZI in
0.1% (1/851) of patients. The one patient in whom LOQTORZI was
withheld reinitiated LOQTORZI.
Thyroid DisordersLOQTORZI can cause immune-mediated thyroid
disorders. Thyroiditis can present with or without endocrinopathy.
Hypothyroidism can follow hyperthyroidism. Initiate hormone
replacement for hypothyroidism or institute medical management of
hyperthyroidism as clinically indicated. Withhold or permanently
discontinue LOQTORZI depending on severity.
- In patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, thyroiditis occurred in
2.1% (3/146) of patients receiving LOQTORZI, including Grade 2
(1.4%). Three patients required thyroid hormone replacement
therapy. Thyroiditis resolved in one of the 3 patients.
Hyperthyroidism occurred in 1.4% (2/146) of patients receiving
LOQTORZI in combination with cisplatin and gemcitabine.
Hyperthyroidism resolved in these 2 patients. Hypothyroidism
occurred in 30% (44/146) of patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, including Grade 2 (24%)
and Grade 1 (6%). Eighty percent of the 44 patients required
thyroid hormone replacement therapy. LOQTORZI was withheld in 2.1%
(3/146) of the patients. Of the 3 patients in whom LOQTORZI was
withheld, 2 patients reinitiated LOQTORZI.
- In patients receiving LOQTORZI
monotherapy, thyroiditis occurred in 0.6% (5/851) patients
receiving LOQTORZI, including Grade 2 (0.1%). Two of these 5
patients received systemic corticosteroids and 2 required thyroid
hormone replacement therapy. Thyroiditis resolved in 2 of the 5
patients. Hyperthyroidism occurred in 7% (55/851) of patients
receiving LOQTORZI, including Grade 2 (1.9%). Hyperthyroidism
resolved in 85% (47/55) of the patients. Hypothyroidism occurred in
15% (128/851) of patients receiving LOQTORZI, including Grade 2
(8%). Sixty three percent of the 128 patients required thyroid
hormone replacement therapy. LOQTORZI was withheld in 0.5% of
patients. Of the 4 patients in whom LOQTORZI was withheld, 3
patients reinitiated LOQTORZI.
Type 1 Diabetes Mellitus, which can present with Diabetic
KetoacidosisMonitor patients for hyperglycemia or other signs and
symptoms of diabetes. Initiate treatment with insulin as clinically
indicated. Withhold or permanently discontinue LOQTORZI depending
on severity. In patients receiving LOQTORZI monotherapy, diabetes
mellitus occurred in 0.9% (8/851) of patients receiving LOQTORZI,
including Grade 4 (0.1%), Grade 3 (0.7%), and Grade 2 (0.1%).
Diabetes mellitus led to permanent discontinuation in 0.4% of
patients. Six of the 8 (75%) patients with diabetes mellitus
required long-term insulin therapy.
Immune-Mediated Nephritis with Renal DysfunctionLOQTORZI can
cause immune-mediated nephritis.
- In patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, immune-mediated
nephritis occurred in 0.7% (1/146) of patients receiving LOQTORZI.
The one patient with immune-mediated nephritis (Grade 4) required
systemic corticosteroids and nephritis led to discontinuation of
LOQTORZI. Nephritis resolved in this patient.
- In patients receiving LOQTORZI
monotherapy, immune-mediated nephritis occurred in 0.5% (4/851) of
patients, including Grade 3 (0.5%) adverse reactions. Nephritis
resolved in 75% (3/4) of these patients.
Immune-Mediated Dermatologic Adverse ReactionsLOQTORZI can cause
immune-mediated rash or dermatitis. Exfoliative dermatitis,
including Stevens-Johnson Syndrome (SJS), drug rash with
eosinophilia and systemic symptoms (DRESS), and toxic epidermal
necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies.
Topical emollients and/or topical corticosteroids may be adequate
to treat mild to moderate non-exfoliative rashes. Withhold or
permanently discontinue LOQTORZI depending on severity.
- In patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, immune-mediated
dermatologic adverse reactions occurred in 8% (12/146) of patients,
including Grade 3 (3.4%) and Grade 2 (1.4%) adverse reactions.
Systemic corticosteroids were required in 25% (3/12) of the
patients with immune-mediated dermatologic adverse reactions.
Immune-mediated dermatologic adverse reactions led to permanent
discontinuation of LOQTORZI in 2.1% (3) of patients.
Immune-mediated dermatologic adverse reactions resolved in 92%
(11/12) of these patients.
- In patients receiving LOQTORZI
monotherapy, immune-mediated dermatologic adverse reactions
occurred in 4% (34/851) of patients, including Grade 3 (0.4%) and
Grade 2 (1.4%) adverse reactions. Immune-mediated dermatologic
adverse reactions led to withholding of LOQTORZI in 0.4% (3) of the
patients. Systemic corticosteroids were required in 12% (4/34) of
the patients with immune-mediated dermatologic adverse reactions.
Immune-mediated dermatologic adverse reactions resolved in 71%
(24/34) of these patients.
Other Immune-Mediated Adverse ReactionsThe following clinically
significant immune-mediated adverse reactions occurred at an
incidence of <1% (unless otherwise noted) in patients who
received LOQTORZI or were reported with the use of other PD-1/PD-L1
blocking antibodies. Severe or fatal cases have been reported for
some of these adverse reactions.
- Cardiac/Vascular: Myocarditis,
pericarditis, vasculitis, pericardial effusion
- Nervous System: Meningitis,
encephalitis, myelitis and demyelination, myasthenic
syndrome/myasthenia gravis (including exacerbation), Guillain-Barré
syndrome, nerve paresis, autoimmune neuropathy
- Ocular: Uveitis, iritis and other
ocular inflammatory toxicities can occur. Some cases can be
associated with retinal detachment. Various grades of visual
impairment, including blindness, can occur. If uveitis occurs in
combination with other immune-mediated adverse reactions, consider
a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment
with systemic steroids to reduce the risk of permanent vision
loss.
- Gastrointestinal: Pancreatitis, to
include increases in serum amylase and lipase levels, gastritis,
duodenitis
- Musculoskeletal and Connective Tissue:
Myositis/polymyositis, rhabdomyolysis (and associated sequelae,
including renal failure), arthritis, polymyalgia rheumatica,
dermatomyositis
- Endocrine: Hypoparathyroidism
- Hematologic/Immune: Hemolytic anemia,
aplastic anemia, hemophagocytic lymphohistiocytosis, systemic
inflammatory response syndrome, histiocytic necrotizing
lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune
thrombocytopenic purpura, solid organ transplant rejection
Infusion-Related ReactionsLOQTORZI can cause
severe or life-threatening infusion-related reactions including
hypersensitivity and anaphylaxis.
- In patients receiving LOQTORZI in
combination with cisplatin and gemcitabine, infusion-related
reactions have been reported in 4.1% of patients, including Grade 2
(0.7%) reactions.
- In patients receiving LOQTORZI
monotherapy, infusion-related reactions occurred in 2% of 851
patients, including Grade 3 (0.1%) and Grade 2 (0.6%). LOQTORZI was
withheld for one Grade 3 infusion related reaction. Monitor
patients for signs and symptoms of infusion-related reactions
including rigors, chills, wheezing, pruritus, flushing, rash,
hypotension, hypoxemia, and fever. Interrupt or slow the rate of
infusion for mild (Grade 1) or moderate (Grade 2) infusion-related
reactions. For severe (Grade 3) or life-threatening (Grade 4)
infusion-related reactions, stop infusion and permanently
discontinue LOQTORZI.
Complications of Allogeneic Hematopoietic Stem Cell
Transplant (HSCT)Fatal and other serious complications can
occur in patients who receive allogeneic hematopoietic stem cell
transplantation (HSCT) before or after being treated with a
PD-1/PD-L1 blocking antibody. Transplant-related complications
include hyperacute graft-versus-host-disease (GVHD), acute GVHD,
chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced
intensity conditioning, and steroid requiring febrile syndrome
(without an identified infectious cause). These complications may
occur despite intervening therapy between PD-1/PD-L1 blockade and
allogeneic HSCT. Follow patients closely for evidence of
transplant-related complications and intervene promptly. Consider
the benefit versus risks of treatment with a PD-1/PD-L1 blocking
antibody prior to or after an allogeneic HSCT.
Embryo-Fetal ToxicityLOQTORZI can cause fetal
harm when administered to a pregnant woman. Animal studies have
demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to
increased risk of immune-mediated rejection of the developing fetus
resulting in fetal death. Advise women of the potential risk to a
fetus. Advise females of reproductive potential to use effective
contraception during treatment with LOQTORZI and for 4 months after
the last dose.
LactationThere are no data on the presence of
toripalimab-tpzi in human milk; its effects on the breastfed child,
or on milk production. Maternal IgG is known to be present in human
milk. The effects of local gastrointestinal exposure and limited
systemic exposure in the breastfed child to toripalimab-tpzi are
unknown. Because of the potential for serious adverse reactions in
breastfed children, advise lactating women not to breastfeed during
treatment with LOQTORZI and for 4 months after the last dose.
Serious Adverse Reactions
- In JUPITER-02, when LOQTORZI was
administered in combination with cisplatin and gemcitabine for the
first-line treatment of recurrent, locally advanced or metastatic
nasopharyngeal carcinoma, serious adverse reactions occurred in 43%
of patients. Serious adverse drug reactions in ≥2% were
thrombocytopenia (14%), neutrophil count decreased (10%), pneumonia
(10%), anemia (9%), abnormal hepatic function (2.7%), and rash
(2.1%). There were three fatal adverse reactions (2.1%): one due to
epistaxis; one due to intracranial hemorrhage associated with
immune-related thrombocytopenia and coagulopathy; and one due to
pneumonia. Permanent discontinuation of LOQTORZI, due to an adverse
reaction occurred in 12% of patients. Adverse reactions resulting
in permanent discontinuation of LOQTORZI in ≥1% were pneumonia
(2.1%), pulmonary tuberculosis (1.4%), rash (1.4%), and vomiting
(1.4%). The most common Grade 3 to 4 laboratory abnormalities (≥2%)
were decreased neutrophils (58%), decreased lymphocytes (57%),
decreased hemoglobin (50%) decreased platelets (33%), decreased
potassium (10%), decreased sodium (9%), increased alanine
aminotransferase (6%), increased or decreased magnesium (4.2%
each), decreased calcium (3.5%), increased aspartate
aminotransferase (2.7%), increased bilirubin (2.1%).
- In POLARIS-02, when LOQTORZI was
administered as a single agent to patients with previously treated,
unresectable or metastatic nasopharyngeal carcinoma, serious
adverse reactions occurred in 24% of patients. Serious adverse drug
reactions in ≥2% were pneumonia (4.7%), abnormal hepatic function
(2.6%), and hyperbilirubinemia (2.1%). Fatal adverse reactions
occurred in 3.7% of patients who received LOQTORZI, including death
not otherwise specified (1.6%), tumor hemorrhage (0.5%), hepatic
failure and thrombocytopenia (0.5%), hyponatremia (0.5%), and
sudden death (0.5%). Permanent discontinuation of LOQTORZI due to
an adverse reaction occurred in 9% of patients. Adverse reaction
resulting in permanent discontinuation of LOQTORZI in ≥1% included
pneumonia (1.1%), abnormal hepatic function (1.1%), and
hyperbilirubinemia (1.1%). The most common Grade 3 or 4 laboratory
abnormalities (≥2%), were decreased sodium (11%), decreased
lymphocytes (9%), decreased hemoglobin (6%), increased aspartate
aminotransferase (3.8%), decreased phosphate (3.2%), and increased
alkaline phosphatase (2.2%).
Common Adverse Reactions
- In JUPITER-02, the most common adverse
reactions (≥20%) were nausea (71%), vomiting (68%), decreased
appetite (55%), constipation (39%), hypothyroidism (38%), rash
(36%), pyrexia (32%), diarrhea (31%), peripheral neuropathy (30%),
cough (26%), musculoskeletal pain (25%), upper respiratory
infection (23%), insomnia (23%), dizziness (21%), and malaise
(21%).
- In POLARIS-02, in patients with
previously treated, unresectable or metastatic nasopharyngeal
carcinoma, the most common (≥20%) adverse reactions were
hypothyroidism (27%), fatigue (22%), and cough (20%).
Please see Prescribing Information for LOQTORZI and Medication
Guide
About Coherus BioSciencesCoherus is a
commercial-stage biopharmaceutical company focused on the research,
development and commercialization of innovative immunotherapies to
treat cancer. Coherus is developing an innovative immuno-oncology
pipeline that will be synergistic with its proven commercial
capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody
immunotherapy candidates focused on enhancing the innate and
adaptive immune responses to enable a robust immunologic response
and enhance outcomes for patients with cancer. Casdozokitug is a
novel anti-IL-27 antibody currently being evaluated in two on-going
clinical studies: a Phase 1/2 study in advanced solid tumors and a
Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly
selective, competitively positioned, ADCC-enhanced anti-CCR8
antibody currently in a Phase 1/2 study as a monotherapy in
patients with advanced solid tumors.
Coherus’ earlier-stage immuno-oncology pipeline targets
immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted
antibody, being evaluated in a Phase 1/2 clinical trial in
combination with LOQTORZI in patients with advanced solid tumors,
and CHS-1000, a preclinical program targeting the novel pathway
ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of
Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®,
YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and expects to
launch LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1
inhibitor, in the U.S. in January 2024.
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 find synergies between its
I-O pipeline and its commercial operations; expectations for the
launch date of LOQTORZI™ and expectations that treatment with
LOQTORZI™ in combination with chemotherapy will become the new
standard of care for patients with NPC.
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 related to realizing the
anticipated benefits of the acquisition of Surface; risks related
to Coherus’ existing and potential collaboration partners; risks of
Coherus’ competitive position; the risks and uncertainties of the
regulatory approval process, including the speed of regulatory
review, international aspects of Coherus’ business and the timing
of Coherus’ regulatory filings; the risk of FDA review issues; the
risk that Coherus is unable to complete commercial transactions and
other matters that could affect the availability or commercial
potential of Coherus’ products and product 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’ Quarterly Report on Form 10-Q for
the fiscal quarter ended September 30, 2023 filed with
the Securities and Exchange Commission on November
6, 2023, including the section therein captioned “Risk Factors” and
in other documents Coherus files with the Securities and
Exchange Commission.
UDENYCA®, CIMERLI® YUSIMRY™ and LOQTORZI™ 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:Jami
Taylor, Head of Investor RelationsIR@coherus.comMedia:Mike Beyer,
Red House Communicationsmike@redhousecomms.com Jodi Sievers, VP
Corporate Communications media@coherus.com
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