AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced that GSK has shared interim results from Part 1 of
the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial investigating
Jemperli (dostarlimab-gxly) plus standard-of-care chemotherapy
(carboplatin-paclitaxel) followed by dostarlimab-gxly alone
compared to chemotherapy plus placebo followed by placebo in adult
patients with primary advanced or recurrent endometrial cancer.
These data from GSK’s RUBY clinical trial are being shared in a
European Society for Medical Oncology (ESMO) Virtual Plenary,
presented at the Society of Gynecologic Oncology (SGO) Annual
Meeting on Women’s Cancer (25-28 March) in Tampa, Florida and
published simultaneously in The New England Journal of Medicine.
“We continue to be encouraged in the differentiated outcomes
delivered by immuno-oncology antibodies discovered at AnaptysBio as
GSK advances their development to treat multiple advanced solid
tumors. The positive results from the RUBY trial represent a
potential breakthrough for patients with primary advanced or
recurrent endometrial cancer,” said Daniel Faga, interim
president and chief executive officer of AnaptysBio. “There is
a potential significant royalty opportunity over time to AnaptysBio
from Jemperli if this indication is approved, as well as from GSK’s
ongoing Phase 3 trials, including of dostarlimab in first line
ovarian cancer and, in combination with cobolimab, a TIM-3
antagonist, in second line NSCLC.”
For specific details on the results of Part 1 of the RUBY trial,
please reference the GSK stock-exchange announcement here. The
safety and tolerability profile of dostarlimab-gxly in combination
with carboplatin/paclitaxel in the RUBY phase 3 trial was generally
consistent with the known safety profiles of the individual
agents.
GSK stated in its press release that its “ambition is for
dostarlimab to become the backbone of the Company’s ongoing
immuno-oncology-based research and
development program when used alone and in combination
with standard of care and future novel cancer therapies,
particularly for patients who currently have limited treatment
options. Dostarlimab is being investigated in registrational
enabling studies as monotherapy and as part of combination
regimens, including in patients with recurrent or primary advanced
endometrial cancer, patients with Stage III or IV non-mucinous
epithelial ovarian cancer, and patients with other advanced
solid tumors or metastatic cancers.”
GSK also has advanced, in Q3 2022, both arms of the COSTAR Lung
clinical trial to Phase 3, testing both doublet and triplet
combinations of dostarlimab-gxly plus chemotherapy, and cobolimab
(TIM-3 antagonist) plus dostarlimab-gxly plus chemotherapy in
advanced non-small cell lung cancer.
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 annual net
sales of Jemperli below $1 billion and 12% up to 25% of
annual net sales above $1 billion. In
2021, AnaptysBio monetized with Sagard Healthcare
Royalty Partners certain commercial milestones and royalties
for annual net sales of Jemperli below $1 billion up to a
certain amount of receivables before such receivables revert back
to AnaptysBio.
About Endometrial Cancer
Endometrial cancer is found in the inner lining of the uterus,
known as the endometrium. Endometrial cancer is the most common
gynecologic cancer globally, with approximately 417,000 new cases
reported each year worldwide[i], and incidence rates are expected
to rise by almost 40% by 2040.[ii][iii] Approximately 15-20% of
patients with endometrial cancer will be diagnosed with advanced
disease at the time of diagnosis.[iv]
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-gxly plus
carboplatin-paclitaxel followed by dostarlimab-gxly versus
carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is
evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by
dostarlimab-gxly plus niraparib versus placebo plus
carboplatin-paclitaxel followed by placebo. The 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 MMRp/MSS
population and OS in the dMMR/MSI-H populations were also
performed. Part 1 RUBY 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.[v]
Jemperli is not approved anywhere in the world for use in
combination with standard-of-care chemotherapy
(carboplatin-paclitaxel) followed by dostarlimab-gxly for primary
advanced or recurrent endometrial cancer. In the US, Jemperli is
indicated for adult patients with mismatch repair-deficient (dMMR)
recurrent or advanced endometrial cancer, as determined by a US
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. Jemperli is also indicated in
the US for patients with dMMR recurrent or advanced solid tumors,
as determined by a US 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 US
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).
Please see full Prescribing Information
here.
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, in a planned 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 regulatory submissions for Jemperli in
this indication; 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
i Sung H, Ferlay J, Siegel R et al. Global cancer statistics
2020: GLOBOCAN estimates of incidence and mortality worldwide for
36 cancers in 185 countries. CA Cancer J Clin. 2021.
doi:10.3322/caac.21660.ii Braun MM, et al. Am Fam Physician.
2016;93(6):468-474.iii International Research on Cancer. Global
Cancer Observatory. Cancer Tomorrow.
https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed 13 July 2022.iv
Kantar Health, Cust Study (2018).v Laken H, Kehry M, Mcneeley P, et
al. Identification and characterization of TSR-042, a novel
anti-human PD-1 therapeutic antibody. European Journal of Cancer.
2016;69,S102. doi:10.1016/s0959-8049(16)32902-1.
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