AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced that GSK has received U.S. Food and Drug
Administration (FDA) approval for JEMPERLI (dostarlimab-gxly) plus
carboplatin and paclitaxel (chemotherapy) for the treatment of
adult patients with mismatch repair deficient (dMMR)/microsatellite
instability-high (MSI-H) primary advanced or recurrent endometrial
cancer. The supplemental Biologics License Application (sBLA)
supporting this new indication received Priority Review and was
approved ahead of the Sept. 23, 2023 Prescription Drug User Fee Act
action date.
This approval is supported by interim analysis results from Part
1 of GSK’s Phase 3 RUBY trial. The dual-primary endpoints in Part 1
are investigator-assessed progression-free survival (PFS) and
overall survival (OS). The statistical analysis plan included
pre-specified analyses of PFS in the dMMR/MSI-H and intent-to-treat
(ITT) populations and OS in the overall population. Part 1 of the
RUBY trial continues to assess the dual-primary endpoint of OS in
the ITT population.
“We are excited that JEMPERLI plus chemotherapy has been
FDA-approved as the first new frontline treatment option in decades
for patients with dMMR/MSI-H primary advanced or recurrent
endometrial cancer,” said Daniel Faga, interim president and chief
executive officer of AnaptysBio. “We believe that royalties of
JEMPERLI from this approval, as well as its potential in first-line
ovarian cancer, in combination with Zejula and in second-line
NSCLC, in combination with cobolimab, if GSK's ongoing Phase 3
clinical trials lead to approvals, could over time contribute to
our strong capital position as we focus on the development of our
immune cell modulator pipeline, including our two checkpoint
agonists in clinical-stage development, rosnilimab, a PD-1 agonist,
and ANB032, a BTLA agonist.”
JEMPERLI was discovered by AnaptysBio and licensed to TESARO,
Inc., now a part of the GSK group of companies, under a
Collaboration and Exclusive License Agreement signed in March 2014.
GSK is responsible for the ongoing development and
commercialization of JEMPERLI. AnaptysBio is entitled to receive
milestones and tiered royalties of 8% for net sales of JEMPERLI
below $1 billion and 12% up to 25% of net sales above $1 billion.
In 2021, AnaptysBio monetized with Sagard Healthcare Royalty
Partners certain commercial milestones and royalties for net sales
of JEMPERLI below $1 billion up to a certain amount of receivables
before such receivables revert back to AnaptysBio.
The sBLA supporting this new indication was reviewed under the
FDA Oncology Center of Excellence Project Orbis Framework, which
allowed for concurrent submission to and review by US and other
international regulatory authorities. As part of Project Orbis, the
application remains under review in Australia, Canada, Switzerland,
Singapore and the United Kingdom. A marketing authorization
application is also under review by the European Medicines Agency.
About RUBY
RUBY is a two-part global, randomized, double-blind, multicenter
Phase 3 trial of patients with primary advanced or recurrent
endometrial cancer. Part 1 is evaluating dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab versus
carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is
evaluating dostarlimab plus carboplatin-paclitaxel followed by
dostarlimab plus niraparib versus placebo plus
carboplatin-paclitaxel followed by placebo.
The dual-primary endpoints in Part 1 are investigator-assessed
PFS based on the Response Evaluation Criteria in Solid Tumors v1.1
and OS. The statistical analysis plan included pre-specified
analyses of PFS in the dMMR/MSI-H and ITT populations and OS in the
overall population. Pre-specified exploratory analyses of PFS in
the mismatch repair proficient (MMRp)/microsatellite stable (MSS)
population and OS in the dMMR/MSI-H populations were also
performed. RUBY Part 1 included a broad population, including
histologies often excluded from clinical trials and had
approximately 10% of patients with carcinosarcoma and 20% with
serous carcinoma. In Part 2, the primary endpoint is
investigator-assessed PFS. Secondary endpoints in Part 1 and Part 2
include PFS per blinded independent central review, overall
response rate, duration of response, disease control rate,
patient-reported outcomes, and safety and tolerability.
About JEMPERLI (dostarlimab-gxly)
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking
antibody that binds to the PD-1 receptor and blocks its interaction
with the PD-1 ligands PD-L1 and PD-L2. JEMPERLI is being
investigated in registrational enabling studies, as monotherapy and
as part of combination regimens, including in women with recurrent
or primary advanced endometrial cancer, women with stage III or IV
non-mucinous epithelial ovarian cancer, and in patients with other
advanced solid tumors or metastatic cancers.
In the U.S., JEMPERLI is indicated for 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 a prior platinum-containing regimen in any setting
and are not candidates for curative surgery or radiation, and in
combination with carboplatin and paclitaxel for the treatment of
adult patients with primary advanced or recurrent endometrial
cancer that is dMMR, as determined by an FDA-approved test, or
microsatellite instability-high (MSI-H). The sBLA supporting this
new indication received Breakthrough Therapy designation from the
FDA. JEMPERLI is also indicated in the U.S. for patients with dMMR
recurrent or advanced solid tumors, as determined by an
FDA-approved test, that have progressed on or following prior
treatment and who have no satisfactory alternative treatment
options. The latter indication is approved in the U.S. under
accelerated approval based on tumor response rate and durability of
response. Continued approval for this indication in solid tumors
may be contingent upon verification and description of clinical
benefit in a confirmatory trial(s).
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company focused on
delivering innovative immunology therapeutics. It is developing
immune cell modulators, including two checkpoint agonists in
clinical-stage development, for autoimmune and inflammatory
disease: rosnilimab, its PD-1 agonist, in a planned Phase 2b trial
for the treatment of moderate-to-severe rheumatoid arthritis; and
ANB032, its BTLA agonist, currently in a Phase 2b trial for the
treatment of moderate-to-severe atopic dermatitis. Its preclinical
immune cell modulator portfolio includes ANB033, an anti-CD122
antagonist antibody for the treatment of autoimmune and
inflammatory diseases. In addition, AnaptysBio has developed two
cytokine antagonists available for out-licensing: imsidolimab, an
anti-IL-36R antagonist, in Phase 3 for the treatment of generalized
pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist
for the treatment of respiratory disorders that is Phase 2/3 ready.
AnaptysBio has also discovered multiple therapeutic antibodies
licensed to GSK in a financial collaboration for immune-oncology,
including an anti-PD-1 antagonist antibody (JEMPERLI
(dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab,
GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).
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 timing of initiation of the company’s clinical
trials, including rosnilimab’s clinical trial in rheumatoid
arthritis; whether the company will receive any future royalties
from JEMPERLI sales; and the company’s ability to find a licensing
partner for imsidolimab or etokimab and the timing of any such
transaction. 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 its
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:Nick MontemaranoSenior Director,
Investor Relations and Strategic Communications AnaptysBio, Inc.
858.732.0178investors@anaptysbio.com
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