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 European Commission has granted conditional marketing
authorization for JEMPERLI (dostarlimab) for use in women with
mismatch repair deficient (dMMR)/microsatellite instability-high
(MSI-H) recurrent or advanced endometrial cancer who have
progressed on or following prior treatment with a platinum
containing regimen. The approval makes dostarlimab the first
anti-PD-1 therapy available for endometrial cancer in Europe.
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
regulatory approval.
“We are delighted that JEMPERLI is the first
AnaptysBio-generated antibody to be approved in Europe and look
forward to meaningful potential future milestone and royalty
revenue from our collaboration with GSK,” said Hamza Suria,
president and chief executive officer of AnaptysBio. “These
revenues will continue to support AnaptysBio’s primary
value-creation strategy, which is focused on advancing wholly-owned
first-in-class therapeutic antibodies through multiple upcoming
clinical catalysts in 2021 and 2022.”
JEMPERLI is indicated as a monotherapy for
treatment of adult patients with recurrent or advanced dMMR/MSI-H
endometrial cancer, who have progressed on, or are being dosed
following, prior treatment with a platinum-containing regimen, and
is the first indication approved by the European Commission for
JEMPERLI. AnaptysBio has earned a $10.0 million milestone payment
as a result of this approval. Earlier this month, AnaptysBio earned
a $20.0 million milestone payment as a result of approval by the
U.S. Food and Drug Administration for JEMPERLI in endometrial
cancer. 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.
Earlier this year, FDA 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 $35 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 net 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 Information for JEMPERLI in the
EU
IndicationJEMPERLI is indicated as
monotherapy for the treatment of adult patients with mismatch
repair deficient (dMMR)/microsatellite instability-high (MSI-H)
recurrent or advanced endometrial cancer (EC) that has progressed
on or following prior treatment with a platinum-containing
regimen.
Immune-Mediated Adverse Reactions
Immune-related adverse reactions, which may be severe or fatal, can
occur in patients treated with antibodies blocking the programmed
cell death protein-1 / programmed death-ligand 1 (PD-1/PD-L1)
pathway, including JEMPERLI. While immune-related adverse reactions
usually occur during treatment with PD-1/PD-L1 blocking antibodies,
symptoms can also manifest after discontinuation of treatment.
Immune-related adverse reactions may occur in any organ or tissue
and may affect more than one body system simultaneously. Important
immune-related adverse reactions listed in this section are not
inclusive of all possible severe and fatal immune-related
reactions.
Early identification and management of
immune-related adverse reactions are essential to ensure safe use
of PD-1/PD-L1 blocking antibodies. Patients should be monitored for
symptoms and signs of immune-related adverse reactions. Clinical
chemistries, including liver tests and thyroid function tests,
should be evaluated at baseline and periodically during treatment.
For suspected immune-related adverse reactions, adequate evaluation
including specialty consultation should be ensured.
Based on the severity of the adverse reaction,
treatment with JEMPERLI should be withheld or permanently
discontinued and corticosteroids (1 to 2 mg/kg/day prednisone
or equivalent) or other appropriate therapy administered. Upon
improvement to Grade ≤1, corticosteroid taper should be
initiated and continued for 1 month or longer. Based on
limited data from clinical studies in patients whose immune-related
adverse reactions could not be controlled with corticosteroid use,
administration of other systemic immunosuppressants can be
considered. Hormone replacement therapy for endocrinopathies should
be instituted as warranted.
Treatment with JEMPERLI should be permanently
discontinued for any Grade 3 immune-related adverse reaction
that recurs and for any Grade 4 immune-related adverse
reaction toxicity, except for endocrinopathies that are controlled
with replacement hormones and unless otherwise specified in the
Summary of Product Characteristics (SmPC).
Immune-Related Pneumonitis
Pneumonitis has been reported in patients receiving JEMPERLI.
Patients should be monitored for signs and symptoms of pneumonitis.
Suspected pneumonitis should be confirmed with radiographic imaging
and other causes excluded. Patients should be managed with JEMPERLI
treatment modifications and corticosteroids.
Immune-related pneumonitis occurred in 7 (1.4%) of
515 patients, including Grade 2 (1.2%) and Grade 3
(0.2%) pneumonitis. Pneumonitis led to discontinuation of JEMPERLI
in 3 (0.6%) patients. Systemic corticosteroids (prednisone ≥ 40 mg
per day or equivalent) were required in all 7 patients experiencing
pneumonitis. Pneumonitis resolved in 6 (85.7%) patients.
Immune-Related ColitisJEMPERLI can
cause immune-related colitis. Patients should be monitored for
signs and symptoms of colitis and managed with treatment
modifications, anti-diarrhoeal agents and corticosteroids.
Colitis occurred in 8 (1.6%) patients, including
Grade 2 (1.0%) and Grade 3 (0.6%) colitis. Colitis did
not lead to discontinuation of JEMPERLI in any patients. Systemic
corticosteroids (prednisone ≥ 40 mg per day or
equivalent) were required in 2 (28.6%) patients. Colitis resolved
in 6 (75.0%) patients experiencing colitis.
Immune-Related HepatitisJEMPERLI
can cause immune-related hepatitis. Patients should be monitored
for changes in liver function periodically as indicated, based on
clinical evaluation and managed with JEMPERLI treatment
modifications and corticosteroids.
Hepatitis occurred in 1 (0.2%) patient, which was
Grade 3. Systemic corticosteroids (prednisone
≥ 40 mg per day or equivalent) were required. Hepatitis
did not lead to discontinuation of JEMPERLI and resolved.
Immune-Mediated
Endocrinopathies
Hypothyroidism occurred in 37 (7.2%) patients, all
of which were Grade 2. Hypothyroidism did not lead to
discontinuation of JEMPERLI and resolved in 13 (35.1%)
patients.
Hyperthyroidism occurred in 10 (1.9%) patients,
including Grade 2 (1.7%) and Grade 3 (0.2%).
Hyperthyroidism did not lead to discontinuation of JEMPERLI and
resolved in 8 (80%) patients.
Thyroiditis occurred in 2 (0.4%) patients; both
were Grade 2. Neither event of thyroiditis resolved; there
were no discontinuations of JEMPERLI due to thyroiditis.
Adrenal insufficiency occurred in 7 (1.4%)
patients, including Grade 2 (0.8%), and Grade 3 (0.6%).
Adrenal insufficiency resulted in discontinuation of JEMPERLI in 1
(0.2%) patient and resolved in 2 (28.6%) patients.
Immune-Mediated Nephritis
Nephritis, including tubulointerstitial nephritis, occurred in 3
(0.6%) patients; all were Grade 2. Systemic corticosteroids
(prednisone ≥ 40 mg per day or equivalent) were required
in 2 (66.7%) patients experiencing nephritis. Nephritis led to
discontinuation of JEMPERLI in 1 (0.2%) patient and resolved in 2
of 3 (66.7%) patients.
Immune-Related RashImmune-related
rash occurred in 17 (3.3%) patients, including Grade 3 in 6
(1.2%) patients receiving JEMPERLI. The median time to onset of
rash was 41 days (range 2 days to 407 days). Systemic
corticosteroids (prednisone ≥ 40 mg per day or
equivalent) were required in 5 (29%) patients experiencing rash.
Rash did not lead to discontinuation of JEMPERLI and resolved in 13
(76.5%) patients.
Immune-Related
ArthralgiaImmune-related arthralgia occurred in 21 (4.1%)
patients. Grade 3 immune-related arthralgia was reported in 3
(0.6%) patients receiving JEMPERLI. The median time to onset of
arthralgia was 87 days (range 1 day to 783 days).
Systemic corticosteroids (prednisone ≥ 40 mg per day or
equivalent) were required in 2 (9.5%) patients experiencing
arthralgia. Arthralgia did not lead to discontinuation of JEMPERLI
and resolved in 8 (38%) patients experiencing arthralgia.
Other Immune-Related Adverse
ReactionsGiven the mechanism of action of JEMPERLI other
potential immune-related adverse reactions may occur, including
potentially serious events [e.g. myositis, myocarditis,
encephalitis, demyelinating neuropathy (including Guillain Barré
syndrome), sarcoidosis].
Clinically significant immune-related adverse
reactions reported in less than 1% of patients treated with
JEMPERLI as monotherapy in clinical studies include autoimmune
haemolytic anaemia, pancreatitis, iridocyclitis, uveitis and
diabetic ketoacidosis. Patients should be monitored for signs and
symptoms of immune-related adverse reactions and managed as
described in the SmPC.
Solid organ transplant rejection has been reported
in the post-marketing setting in patients treated with PD-1
inhibitors. Treatment with JEMPERLI may increase the risk of
rejection in solid organ transplant recipients. The benefit of
treatment with JEMPERLI versus the risk of possible organ rejection
should be considered in these patients.
Fatal and other serious complications can occur in
patients who receive allogeneic haematopoietic 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 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.
Infusion-Related Reactions
Infusion-related reactions including hypersensitivity occurred in 7
(1.4%) patients, including Grade 2 (1.2%) and Grade 3
(0.2%) infusion-related reactions. All patients recovered from the
infusion-related reaction.
ImmunogenicityAnti-drug antibodies
(ADA) were tested in 315 patients who received JEMPERLI and
the incidence of JEMPERLI treatment-emergent ADAs was 2.5%.
Neutralising antibodies were detected in 1.3% of patients. In the
patients who developed anti-JEMPERLI antibodies, there was no
evidence of altered efficacy or safety of JEMPERLI.
Elderly populationOf the
515 patients treated with JEMPERLI monotherapy, 50.7% were
under 65 years, 37.9% were 65-75 years, and 11.5% were
75 years or older. No overall differences in safety were
reported between elderly (≥ 65 years) and younger
patients (< 65 years).
Pregnancy, Lactation and
FertilityJEMPERLI is not recommended during pregnancy and
in women of childbearing potential not using contraception.
JEMPERLI should not be used during breast-feeding and
breast-feeding should be avoided for at least 4 months after
the last dose of JEMPERLI. Fertility studies have not been
conducted with JEMPERLI.
COMMON ADVERSE REACTIONSJEMPERLI
is most commonly associated with immune-related adverse reactions.
Most of these, including severe reactions, resolved following
initiation of appropriate medical therapy or withdrawal of
JEMPERLI.
In patients with advanced or recurrent solid
tumours (N = 515), the most common adverse reactions
(> 10%) were anaemia (25.6%), nausea (25.0%), diarrhoea
(22.5%), vomiting (18.4%), arthralgia (13.8%), pruritus (11.5%),
rash (11.1%), pyrexia (10.5%) and hypothyroidism (10.1%). JEMPERLI
was permanently discontinued due to adverse reactions in 17 (3.3%)
patients; most of them were immune-related events. Adverse
reactions were serious in 8.7% of patients; most serious adverse
reactions were immune-related adverse reactions.
Refer to the JEMPERLI Prescribing
Information for a full list of adverse events and the complete
important safety 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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