Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), and
Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX:
1877; SSE: 688180) today announced that the U.S. Food and Drug
Administration (FDA) approved LOQTORZI™ (toripalimab-tpzi) 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. The approval was based on
results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2
study and is irrespective of a patient’s PD-L1 status. 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 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.
The safety profile of LOQTORZI was consistent with the PD-1
inhibitor class. The incidence of Grade ≥3 adverse events (AEs)
(89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) was similar between
the two arms. AEs leading to discontinuation of LOQTORZI versus
placebo (11.6% vs 4.9%), immune-related adverse events (irAEs)
(54.1% vs. 21.7%), and Grade ≥3 irAEs (9.6% vs. 1.4%) were more
frequent in the LOQTORZI arm.
In the POLARIS-02 clinical study LOQTORZI demonstrated durable
antitumor 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.
NPC is an aggressive cancer that starts in the nasopharynx, the
upper part of the throat behind the nose and near the base of
skull. 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. LOQTORZI is the first
FDA-approved agent for NPC patients.
“LOQTORZI’s first approval is a pivotal event for Coherus as an
innovative oncology company. As a next generation PD-1 inhibitor it
is the keystone of our I-O strategy to extend cancer patient
survival as shown with the impressive results in NPC,” said Denny
Lanfear, Chairman and Chief Executive Officer of Coherus. “We are
particularly excited to now turn our attention to developing
LOQTORZI across multiple tumor types in combination with I-O agents
that target the tumor microenvironment, such as our IL27-targeted
antibody, casdozokitug, and our CCR8 inhibitor CHS-114, potentially
greatly expanding the number of cancer patients achieving improved
survival benefit.”
“Today’s FDA approval of LOQTORZI is very encouraging for those
living with NPC who currently have very limited treatment options
and are in need of new therapies to treat this aggressive and
life-threatening form of cancer,” said Jong Chul Park, M.D.,
Assistant Professor, Harvard Medical School and attending physician
at the Center for Head and Neck Cancers at Massachusetts General
Hospital Cancer Center. “LOQTORZI is a new treatment option that
has demonstrated the ability to significantly improve PFS and OS
and should quickly emerge as the new standard of care when used in
combination with chemotherapy.”
The recommended LOQTORZI dose with cisplatin and gemcitabine is
240 mg every three weeks until disease progression, unacceptable
toxicity, or up to 24 months. The recommended LOQTORZI dose as a
single agent for previously treated NPC is 3 mg/kg every two weeks
until disease progression or unacceptable toxicity.
LOQTORZI is expected to be available in the United States in Q1
2024.
“The impressive results from JUPITER-02 and POLARIS-02 have
provided conclusive evidence that establishes toripalimab, in
combination with chemotherapy or as monotherapy, as the standard
therapy for advanced NPC,” said Professor Ruihua Xu of Sun Yat-sen
University Cancer Center, the principal investigator of JUPITER-02
and POLARIS-02. “This great achievement was only made possible
through the solid foundation laid by countless oncology experts
over decades of in-depth research, as well as the selfless
dedication of the patients and research teams involved in our
toripalimab studies. We hope that this promising therapy will close
the treatment gap for international NPC patients struggling to find
effective therapies, bringing them renewed hope for better
survival.”
“We’re excited to reach another significant company milestone of
‘going overseas’,” said Dr. Ning LI, Chief Executive Officer of
Junshi Biosciences. “Following etesevimab, toripalimab has become
Junshi Biosciences’ second product to receive FDA approval for
commercialization—an achievement that will further enhance the
company’s international presence. Currently, the establishment of
toripalimab’s global commercialization network is in progress, and
the network aims to span over 50 countries. In accordance with the
company’s ‘In China, For Global’ strategy, we will continue working
with our collaborators to promote the commercialization of
toripalimab in other regions, in order to provide innovative and
high-quality drugs from China to more patients overseas.”
About JUPITER-02 JUPITER-02 is the largest
randomized, double-blind, placebo-controlled, international,
multi-center Phase 3 clinical study 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/metastatic disease
were randomized 1:1 to receive LOQTORZI (toripalimab-tzpi) 240 mg
or placebo in combination with gemcitabine 1000 mg/m2 (days 1 and
8) and cisplatin 80 mg/m2 (day 1) of every three-week treatment
cycle, followed by toripalimab-tzpi or placebo monotherapy every 3
weeks until disease progression, intolerable toxicity, or
completion of two years of treatment. JUPITER-02 included all
eligible patients regardless of PD-L1 status and histologies.
In this study, LOQTORZI met the primary endpoint, demonstrating
a significant improvement in PFS (assessed by a Blinded Independent
Review Committee (BIRC)) compared to the chemotherapy alone arm
with toripalimab-tzpi, reducing the risk of disease progression or
death by 48% (HR=0.52 [95% CI: 0.36, 0.74; P<0.0003).
Improvement in PFS was observed irrespective of PD-L1 status.
LOQTORZI demonstrated a statistically significant and clinically
meaningful improvement in OS with treatment resulting in a 37%
reduction in the risk of death versus chemotherapy alone. Median OS
has not been reached in the LOQTORZI arm versus 33.7 months for
chemotherapy treatment alone (HR=0.63 [95% CI 0.45-0.89];
P=0.0083).
LOQTORZI also demonstrated an improvement in ORR, duration of
response (DoR), and DCR. In the study, 77% of patients treated with
LOQTORZI experienced a complete or partial response (19% and 58%
respectively) and the median duration of response was 10 months in
the LOQTORZI arm versus 5.7 months in the chemotherapy alone
arm.
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.Our robust patient support services include:
- Reimbursement support
- Patient support
- Access support
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.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
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
Conference Call Information
When: Friday, October 27, 2023, starting at 4:30 p.m. Eastern
Time / 1:30 p.m. Pacific Time
To access the conference call, please pre-register through the
following link to receive dial-in information and a personal PIN to
access the live call:
https://register.vevent.com/register/BI5e94411d336341ba89d7e9eed804e892
Please dial-in 15 minutes early to ensure a timely connection to
the call.
Webcast Link: https://edge.media-server.com/mmc/p/hpvx6oka
A replay of the webcast will be archived on the “Investors”
section of the Coherus website at http://investors.coherus.com.
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 Phase 1/2
clinical trials in lung and liver cancer. 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 Q1 2024.
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 more than 50 drug candidates, with five
therapeutic focus areas covering cancer, autoimmune, metabolic,
neurological, and infectious diseases. Four of the company’s
innovations have already reached the Chinese or international
markets, one of which is China’s first self-developed anti-PD-1
monoclonal antibody, toripalimab. Additionally, more than 30 drugs
are currently in clinical development. During the COVID-19
pandemic, Junshi Biosciences actively shouldered the social
responsibilities of a Chinese pharmaceutical company through its
involvement in developing etesevimab, MINDEWEI®, and other novel
therapies for the prevention and treatment of COVID-19.
With a mission of “providing patients with world-class,
trustworthy, affordable, and innovative drugs”, Junshi Biosciences
is “In China, For Global.” At present, the company has
approximately 3,000 employees in the United States (California and
Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc).
For more information, please visit: http://junshipharma.com.
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’
expectations for the selectivity and competitive positioning of any
of its product candidates; Coherus’ expectations that LOQTORZI™
will represent the new standard of care for NPC; Coherus’ projected
timing for commercial availability of LOQTORZI™; Coherus’
expectations for the development of LOQTORZI™ in combination with
I-O agents that target the tumor microenvironment; and Coherus’
ability to gain approval for any of its product candidates and the
timing of such approval. 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 of
Coherus’ execution of its change in strategy from a focus on
biosimilars to a strategy using cash from its portfolio to fund an
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’ Quarterly Report on Form
10-Q the quarter ended June 30, 2023, filed with the Securities and
Exchange Commission on August 2, 2023, including the section
therein captioned “Risk Factors” and in other documents Coherus
files with the Securities and Exchange Commission.
Coherus Contact InformationInvestors:Jodi
Sievers, VP Corporate CommunicationsIR@coherus.com
Media:Judy Stecker, Hill & KnowltonSenior Vice President,
U.S. Healthcare Media and Public Affairs
Leadjudy.stecker@hkstrategies.com +1 202 559 7245 — direct
Junshi Biosciences Contact InformationIR
Team:info@junshipharma.com + 86 021-6105 8800
PR Team:Zhi Lizhi_li@junshipharma.com + 86 021-6105
8800
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/0309b960-26f3-48b4-97a8-2076d70bbb71
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