AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on emerging immune control mechanisms applicable to
inflammation and immuno-oncology indications, today announced that
the U.S. Food and Drug Administration (FDA) approved GSK’s
Biologics License Application (BLA) for JEMPERLI (dostarlimab-gxly)
for the treatment of adult patients with mismatch repair deficient
(dMMR) recurrent or advanced endometrial cancer, as determined by
an FDA-approved test, that has progressed on or following prior
treatment with a platinum-containing regimen.
JEMPERLI was generated by AnaptysBio using its proprietary
somatic hypermutation (SHM) antibody platform and subsequently
developed by TESARO, Inc., now a part of GSK, under a collaboration
agreement. Eight AnaptysBio-generated therapeutic antibodies have
advanced into clinical development to date, and JEMPERLI is the
first AnaptysBio-generated antibody to obtain FDA approval.
“The approval of JEMPERLI is a transformative milestone for
AnaptysBio. This event provides important validation for our
proprietary SHM antibody discovery platform and provides
significant potential future milestone and royalty revenue to
support AnaptysBio’s growth,” said Hamza Suria, president and chief
executive officer of AnaptysBio. “While AnaptysBio has partnered
certain pipeline assets, our primary value-creation strategy
remains focused on advancing wholly-owned, first-in-class
therapeutic antibodies from discovery through development, and we
look forward to multiple upcoming clinical data readouts from our
product pipeline through 2021 and 2022.”
Treatment of patients with recurrent or advanced dMMR
endometrial cancer, who have progressed on, or are being dosed
following, prior treatment with a platinum-based chemotherapy, is
the first indication approved by the FDA for JEMPERLI. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. AnaptysBio
has earned a $20.0 million milestone payment as a result of this
FDA approval. In 2020, AnaptysBio received milestone payments of
$10.0 million and $5.0 million for the FDA’s and EMA’s acceptances
of the BLA and Marketing Authorisation Application (MAA) filings
for JEMPERLI, respectively.
The FDA recently accepted a subsequent BLA filing for JEMPERLI
for the treatment of adult patients with dMMR recurrent or advanced
solid tumors who have progressed on or following prior treatment.
AnaptysBio recently received a $10.0 million payment from
GSK as a result of this milestone. Payments totaling an additional
$45 million will be due to AnaptysBio upon the achievement of
future regulatory milestones for JEMPERLI in the United States and
Europe. Furthermore, $165 million in sales milestones are due to
AnaptysBio upon achievement of certain annual JEMPERLI sales
revenues. Royalties due to AnaptysBio for dostarlimab range from 8%
to 25% of global net sales, where AnaptysBio will receive 8% of
annual global net sales below $1 billion, and 12-25% of net sales
above $1 billion. JEMPERLI is also being developed by
GSK for the treatment of other tumor types and treatment settings,
including currently ongoing phase III trials in recurrent or
primary advanced endometrial cancer in combination with
chemotherapy standard of care (RUBY) and the phase III FIRST study
of platinum-based therapy with dostarlimab and niraparib versus
standard of care platinum-based therapy as first-line treatment of
stage III or IV non-mucinous epithelial ovarian cancer.
In addition, JEMPERLI is being evaluated as monotherapy and in
combination therapy across multiple tumor types and other cancers,
including platinum-resistant ovarian cancer, non-small cell lung
cancer, multiple myeloma and melanoma.
GSK continues to develop additional antibodies partnered with
AnaptysBio, including cobolimab, an AnaptysBio-generated anti-TIM-3
antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist
antibody. Under the terms of the collaboration, AnaptysBio is due
to receive development and regulatory milestone payments for each
of the first two indications for each of these antibodies.
AnaptysBio can potentially receive a total of $1.1 billion in
aggregate milestone payments under this collaboration. In addition,
AnaptysBio will receive royalties ranging from 4% to 8% on global
net sales of cobolimab and GSK4074386 and 1% of GSK’s global net
sales of ZejulaTM.
Important Safety Information for JEMPERLI
Indication
- JEMPERLI is indicated for the treatment of adult patients with
mismatch repair deficient (dMMR) recurrent or advanced endometrial
cancer (EC), as determined by an FDA-approved test, that has
progressed on or following prior treatment with a
platinum-containing regimen.
- This indication is approved under accelerated approval based on
tumour response rate and durability of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial(s).
Important Safety Information
Immune-Mediated Adverse Reactions
- Immune-mediated adverse reactions, which can be severe or
fatal, can occur in any organ system or tissue and can occur at any
time during or after treatment with a PD-1/PD-L1–blocking antibody,
including JEMPERLI.
- Monitor closely for signs and symptoms of immune-mediated
adverse reactions. Evaluate liver enzymes, creatinine, and thyroid
function tests at baseline and periodically during treatment. For
suspected immune-mediated adverse reactions, initiate appropriate
workup to exclude alternative etiologies, including infection.
Institute medical management promptly, including specialty
consultation as appropriate.
- Based on the severity of the adverse reaction, withhold or
permanently discontinue JEMPERLI. In general, if JEMPERLI requires
interruption or discontinuation, administer systemic
corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until
improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate
corticosteroid taper and continue to taper over at least 1 month.
Consider administration of other systemic immunosuppressants in
patients whose immune-mediated adverse reaction is not controlled
with corticosteroids.
Immune-Mediated Pneumonitis
- JEMPERLI can cause immune-mediated pneumonitis, which can be
fatal. The incidence of pneumonitis in patients receiving
PD-1/PD-L1 inhibitors, including JEMPERLI, may be increased in
patients who have received prior thoracic radiation.
- Immune-mediated pneumonitis occurred in 1.1% (5/444) of
patients, including Grade 2 (0.9%) and Grade 3 (0.2%) pneumonitis.
Pneumonitis led to discontinuation of JEMPERLI in 0.7% of patients.
Systemic corticosteroids were required in all patients with
pneumonitis. Pneumonitis resolved in 80% of the 5 patients. Three
patients reinitiated JEMPERLI after symptom improvement; of these,
33% had recurrence of pneumonitis.
Immune-Mediated Colitis
- JEMPERLI can cause immune-mediated colitis. Cytomegalovirus
infection/reactivation have occurred in patients with
corticosteroid-refractory immune-mediated colitis treated with
PD-1/PD-L1–blocking antibodies. In cases of
corticosteroid-refractory colitis, consider repeating infectious
workup to exclude alternative etiologies.
- Immune-mediated colitis occurred in 1.4% (6/444) of patients,
including Grade 3 (0.7%) and Grade 2 (0.7%). Colitis did not lead
to discontinuation of JEMPERLI in any patients. Systemic
corticosteroids were required in 17% (1/6) of patients with
colitis. Colitis resolved in 50% of the 6 patients. Of the 2
patients in whom JEMPERLI was withheld for colitis, both
reinitiated JEMPERLI.
Immune-Mediated Hepatitis
- JEMPERLI can cause immune-mediated hepatitis, which can be
fatal. Immune-mediated Grade 3 hepatitis occurred in 0.2% (1/444)
of patients. Systemic corticosteroids were required, and the event
resolved.
Immune-Mediated Endocrinopathies
- Adrenal Insufficiency
- JEMPERLI can cause primary or secondary adrenal insufficiency.
For Grade 2 or higher adrenal insufficiency, initiate symptomatic
treatment per institutional guidelines, including hormone
replacement as clinically indicated. Withhold JEMPERLI if not
clinically stable. Adrenal insufficiency occurred in 0.9% (4/444)
of patients, including Grade 3 (0.5%) and Grade 2 (0.5%). Adrenal
insufficiency resulted in discontinuation in 1 (0.2%) patient and
resolved in 25% of the 4 patients.
- Hypophysitis
- JEMPERLI can cause immune-mediated hypophysitis. Hypophysitis
can present with acute symptoms associated with mass effect such as
headache, photophobia, or visual field cuts. Hypophysitis can cause
hypopituitarism. Initiate hormone replacement as clinically
indicated. Withhold JEMPERLI if not clinically stable.
- Thyroid Disorders
- JEMPERLI can cause immune-mediated thyroid disorders.
Thyroiditis can present with or without endocrinopathy.
Hypothyroidism can follow hyperthyroidism. Initiate hormone
replacement or medical management of hyperthyroidism as clinically
indicated. Withhold JEMPERLI if not clinically stable.
- Thyroiditis occurred in 0.5% (2/444) of patients; both were
Grade 2. Neither event of thyroiditis resolved; there were no
discontinuations of JEMPERLI due to thyroiditis.
- Hypothyroidism occurred in 5.6% (25/444) of patients, all of
which were Grade 2. Hypothyroidism did not lead to discontinuation
of JEMPERLI and resolved in 40% of the 25 patients. Systemic
corticosteroids were not required for any of the 25 patients with
hypothyroidism.
- Hyperthyroidism occurred in 1.8% (8/444) of patients, including
Grade 2 (1.6%) and Grade 3 (0.2%). Hyperthyroidism did not lead to
discontinuation of JEMPERLI and resolved in 63% of the 8 patients.
Systemic corticosteroids were not required for any of the 8
patients with hyperthyroidism.
- Type 1 Diabetes Mellitus, Which Can Present with Diabetic
Ketoacidosis
- JEMPERLI can cause type 1 diabetes mellitus, which can present
with diabetic ketoacidosis. Monitor patients for hyperglycemia or
other signs and symptoms of diabetes. Initiate treatment with
insulin as clinically indicated. Withhold or permanently
discontinue JEMPERLI depending on severity.
Immune-Mediated Nephritis with Renal
Dysfunction
- JEMPERLI can cause immune-mediated nephritis, which can be
fatal. Nephritis occurred in 0.5% (2/444) of patients; both were
Grade 2. Nephritis did not lead to discontinuation of JEMPERLI and
resolved in both patients. Systemic corticosteroids were required
in 1 of the 2 patients experiencing nephritis.
Immune-Mediated Dermatologic Adverse
Reactions
- JEMPERLI can cause immune-mediated rash or dermatitis. Bullous
and exfoliative dermatitis, including Stevens-Johnson syndrome
(SJS), toxic epidermal necrolysis (TEN), and drug rash with
eosinophilia and systemic symptoms (DRESS), have occurred with
PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical
corticosteroids may be adequate to treat mild to moderate
non-bullous/exfoliative rashes. Withhold or permanently discontinue
JEMPERLI depending on severity.
Other Immune-Mediated Adverse Reactions
- The following clinically significant immune-mediated adverse
reactions occurred in <1% of the 444 patients treated with
JEMPERLI 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.
- Nervous System: Meningitis, encephalitis, myelitis and
demyelination, myasthenic syndrome/myasthenia gravis,
Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy
- Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
- Ocular: Uveitis, iritis, other ocular inflammatory toxicities.
Some cases can be associated with retinal detachment. Various
grades of visual impairment to include blindness can occur.
- Gastrointestinal: Pancreatitis, including 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
- Endocrine: Hypoparathyroidism
- Other (Hematologic/Immune): Haemolytic anaemia, aplastic
anaemia, hemophagocytic lymphohistiocytosis, systemic inflammatory
response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi
lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ
transplant rejection
Infusion-Related Reactions
- Severe or life-threatening infusion-related reactions have been
reported with PD-1/PD-L1–blocking antibodies. Severe
infusion-related reactions (Grade 3) occurred in 0.2% (1/444) of
patients receiving JEMPERLI. All patients recovered from the
infusion-related reactions.
- Monitor patients for signs and symptoms of infusion-related
reactions. Interrupt or slow the rate of infusion or permanently
discontinue JEMPERLI based on severity of reaction.
Complications of Allogeneic HSCT after
PD-1/PD-L1–Blocking Antibody:
- Fatal and other serious complications can occur in patients who
receive allogeneic hematopoietic stem cell transplantation (HSCT)
before or after treatment with a PD-1/PD-L1–blocking antibody.
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 Toxicity and Lactation:
- Based on its mechanism of action, JEMPERLI can cause fetal
harm. Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to use effective
contraception during treatment with JEMPERLI and for 4 months after
their last dose. Because of the potential for serious adverse
reactions from JEMPERLI in a breastfed child, advise women not to
breastfeed during treatment with JEMPERLI and for 4 months after
their last dose.
Common Adverse Reactions
- The most common adverse reactions (Grades 1-4) in ≥10% of 104
dMMR endometrial cancer patients who received JEMPERLI as
monotherapy were fatigue (48%), nausea (30%), diarrhoea (26%),
anaemia (24%), constipation (20%), vomiting (18%), pruritus (14%),
cough (14%), decreased appetite (14%), urinary tract infection
(13%), and myalgia (12%).
- JEMPERLI was permanently discontinued due to adverse reactions
in 5 (4.8%) patients, including transaminases increased, sepsis,
bronchitis, and pneumonitis. Dosage interruptions due to an adverse
reaction occurred in 23% of patients who received JEMPERLI. Adverse
reactions that required dosage interruption in ≥1% of patients who
received JEMPERLI were anaemia, diarrhoea, increased lipase, and
pyrexia.
Please see full Prescribing
Information
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing
first-in-class antibody product candidates focused on unmet medical
needs in inflammation. The Company’s proprietary anti-inflammatory
pipeline includes imsidolimab, its anti-IL-36R antibody, previously
referred to as ANB019, for the treatment of dermatological
inflammatory diseases, including generalized pustular psoriasis, or
GPP, EGFRi skin toxicity, ichthyosis, hidradenitis suppurativa and
acne; its anti-PD-1 agonist program, ANB030, for treatment of
certain autoimmune diseases where immune checkpoint receptors are
insufficiently activated; and its BTLA modulator program, ANB032,
which is broadly applicable to human inflammatory diseases
associated with lymphoid and myeloid immune cell dysregulation.
AnaptysBio’s antibody pipeline has been developed using its
proprietary somatic hypermutation, or SHM platform, which uses in
vitro SHM for antibody discovery and is designed to replicate key
features of the human immune system to overcome the limitations of
competing antibody discovery technologies. AnaptysBio has also
developed multiple therapeutic antibodies in an immuno-oncology
collaboration with GSK, including an anti-PD-1 antagonist antibody
(JEMPERLI (dostarlimab-gxly) GSK4057190), an anti-TIM-3 antagonist
antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist
antibody (GSK4074386), and an inflammation collaboration with
Bristol-Myers Squibb, including an anti-PD-1 checkpoint agonist
antibody (CC-90006) currently in clinical development.
Forward-Looking Statements
This press release contains 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: the milestones and royalty payments to be received
under the GSK partnership and the timing of the release of data
from our clinical trials. Statements including words such as
“plan,” “continue,” “expect,” or “ongoing” and statements in the
future tense are forward-looking statements. These forward-looking
statements involve risks and uncertainties, as well as assumptions,
which, if they do not fully materialize or prove incorrect, could
cause our results to differ materially from those expressed or
implied by such forward-looking statements. Forward-looking
statements are subject to risks and uncertainties that may cause
the company’s actual activities or results to differ significantly
from those expressed in any forward-looking statement, including
risks and uncertainties related to the company’s ability to advance
its product candidates, obtain regulatory approval of and
ultimately commercialize its product candidates, the timing and
results of preclinical and clinical trials, the company’s ability
to fund development activities and achieve development goals, the
company’s ability to protect intellectual property and other risks
and uncertainties described under the heading “Risk Factors” in
documents the company files from time to time with the Securities
and Exchange Commission. These forward-looking statements speak
only as of the date of this press release, and the company
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date
hereof.
Contact:Dennis MulroyAnaptysBio,
Inc.858-732-0201dmulroy@anaptysbio.com
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