Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today
announced that LOQTORZI™ (toripalimab-tpzi) is now available
through select specialty distributors in the United States.
LOQTORZI is indicated in combination with cisplatin and gemcitabine
for the first-line treatment of adults with metastatic or recurrent
locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy
for the treatment of adults with recurrent, unresectable, or
metastatic NPC with disease progression on or after
platinum-containing chemotherapy. 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.
“For people with rare cancers such as NPC, the prognosis is poor
and treatment options have been limited,” said John Hopper, Founder
of the Patient Activation Group, Co-Chair of the NORD Rare Cancer
Coalition and board director of rare cancer foundation-SARC
(Sarcoma Alliance for Research through Collaboration). “The
availability of LOQTORZI as a new treatment option for advanced NPC
represents a meaningful step forward for NPC patients and gives
further hope to rare cancer advocates that there will be more
options for rare cancer patients in the future.”
NPC affects approximately 2000 patients in the U.S. annually.
Until now the standard of care was chemotherapy. In December, the
NCCN committee classified LOQTORZI as a preferred category 1
treatment option in combination with gemcitabine and cisplatin. The
decision was 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.
“We are proud to bring LOQTORZI to a patient population that has
had no FDA-approved options available, and our mission is to
establish LOQTORZI plus chemotherapy as the new standard of care
for relapsed/metastatic NPC. LOQTORZI has demonstrated impressive
clinical benefits, including PFS and OS, offering R/M NPC patients
new hope for extended survival,” said Paul Reider, Chief
Commercial Officer of Coherus. “As the first and only FDA-approved
treatment for this type of cancer, we’ll work tirelessly to support
physician education and patient access, while activating the NPC
patient community through our partnership with patient advocacy
groups and our own NPCfacts.com community.”
“The launch of LOQTORZI is a foundational milestone, signaling
Coherus’ emergence as a commercial-stage immuno-oncology company,”
said Denny Lanfear, Chairman and Chief Executive Officer of
Coherus. “We believe LOQTORZI will play a key role in
next-generation novel immuno-oncology treatment combinations aimed
at extending patient survival across multiple tumor types through
our own internal pipeline as well as our external
collaborations.”
LOQTORZI is commercially available for purchase through select
specialty distributors including Cencora (formerly ABC), Cardinal
and McKesson. Each carton contains one 240 mg/6 mL (40 mg/mL)
single-dose vial. Contact Coherus BioSciences Customer Services at
1-844-562-6004 for more information. LOQTORZI Solutions™ for HCPs
is now online and offers healthcare professionals comprehensive
practice and patient support that includes extensive patient
assistance and office resources to ensure successful access and
reimbursement. Billing will occur under the medical benefit using
an Unclassified HCPCS code J3490 or J3590 with a unique NDC number
of 70114-0340-01. Coherus expects a product-specific, permanent
J-code to be assigned to LOQTORZI in mid-2024.
About LOQTORZI Solutions™ Coherus is
committed to supporting patients with programs for zero
out-of-pocket costs or patient assistance for eligible patients so
that they may benefit from a proven PD-1 immunotherapy, with less
financial burden. Through LOQTORZI Solutions, our robust patient
support services include reimbursement support, patient support,
and access support. More specific product information can be found
on LOQTORZI.com.
Commitment to the NPC communityGiven the
limited resources available to patients and caregivers contending
with NPC, Coherus has launched a new educational community
resource, NPCFacts.com, which includes detailed information
about the types of NPC as well as its causes, diagnosis, and
treatment options. Currently there are over 2000 patients and
caregivers enrolled in this program and product education is
underway.
In addition to education about nasopharyngeal carcinoma, the
website includes links to patient advocacy organizations providing
additional resources, including the Head and Neck Cancer
Alliance, Support for People with Oral Head and Neck
Cancer, and Thyroid Head and Neck Cancer Foundation. The
website includes a companion website for healthcare professionals
treating patients with NPC, including educational resources and
opportunities for peer-to-peer education.
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 antitumor immunity demonstrating improvement in the
overall survival of cancer patients in several tumor types.
INDICATIONS AND IMPORTANT SAFETY
INFORMATION
INDICATIONSLOQTORZI (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
Reactions
Immune-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 LOQTORZI
(toripalimab-tpzi), a novel next generation PD-1 inhibitor.
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 achieve synergies between
its I-O pipeline and its commercial capabilities; Coherus’
projections about the the time that it will take for a specific,
permanent J-code to be assigned to LOQTORZI; Coherus’ expectations
that LOQTORZI will be a part of different I-O combinations across
multiple tumor types; and Coherus’ projection that it will continue
to advance additional novel treatments either internally or through
external collaborations. 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, 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 integration process following Coherus’ acquisition of Surface
Oncology, Inc.; the risks and uncertainties of the regulatory
approval process, including the speed of regulatory review,
international aspects of Coherus’ business; 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’ 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’ Quarterly Report on Form 10-Q for the 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
that Coherus files with the Securities and Exchange
Commission.
Coherus Contact InformationInvestors:Jami
Taylor, Head of Investor Relations
for CoherusIR@coherus.com
Media:Mike Beyer, Red House
Communicationsmike@redhousecomms.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/4e990167-4494-4e92-846d-443b1e1cba43
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