AnaptysBio- and GSK-partnered immuno-oncology agent JEMPERLI (dostarlimab-gxly) meets primary endpoint in Phase 3 RUBY trial in primary advanced or recurrent endometrial cancer
03 December 2022 - 01:00AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced that GSK’s RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3
trial of JEMPERLI (dostarlimab) plus standard of care chemotherapy
compared to chemotherapy plus placebo in patients with primary
advanced or recurrent endometrial cancer, met its primary endpoint
of investigator-assessed progression-free survival (PFS). The
JEMPERLI regimen showed a statistically significant and clinically
meaningful benefit in the prespecified mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H) patient subgroup and
in the overall population. A clinically relevant benefit in PFS was
also observed in the mismatch repair proficient
(MMRp)/microsatellite stable (MSS) patient subgroup.
While the overall survival (OS) data were immature at the time
of this analysis, a favorable trend was observed in the overall
population, including both the dMMR/MSI-H and MMRp/MSS
subgroups.
The safety and tolerability profile of dostarlimab plus
chemotherapy was consistent with clinical trials of similar
regimens.
Regulatory submissions based on the trial results are
anticipated in the first half of 2023. GSK expects to publish full
results from the RUBY trial in a medical journal and present at an
upcoming scientific meeting.
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.
“We are encouraged to see AnaptysBio-discovered molecules
continue to deliver differentiated outcomes for patients in
indications with substantial unmet need. We are grateful to our
partners at GSK for enabling broad development of JEMPERLI and to
the patients in the RUBY and other JEMPERLI trials for their
participation,” said Daniel Faga, interim president and chief
executive officer of AnaptysBio. “We believe that potential
first-in-class approvals for JEMPERLI in endometrial cancer and
other indications could over time materially contribute to our
strong capital position as we focus on the R&D of our immune
cell modulator pipeline. This includes our two checkpoint agonists
in clinical-stage development, rosnilimab, a PD-1 agonist, and
ANB032, a BTLA agonist, which act directly on cell types mediating
disease pathology and have the potential to treat a broad range of
autoimmune and inflammatory disorders.”
About RUBY
RUBY is a two-part global, randomised, double-blind, multicentre
study of patients with primary advanced or recurrent endometrial
cancer. Part 1 is evaluating dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab versus placebo plus
carboplatin-paclitaxel 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 primary endpoints are progression-free survival
(PFS), per RECIST v1.1 by investigator assessment, and overall
survival in Part 1, and PFS in Part 2. Secondary endpoints include
PFS per blinded independent central review (BICR), overall response
rate, duration of response, disease control rate, patient-reported
outcomes, and safety and tolerability. RUBY is part of an
international collaboration of European Network of Gynaecological
Oncological Trial groups (ENGOT) and the GOG Foundation.
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 tumours or metastatic cancers.
JEMPERLI is indicated in the US for adult patients with dMMR
recurrent or advanced endometrial cancer, as determined by an
FDA-approved test, that have progressed on or following prior
treatment with a platinum-containing regimen. JEMPERLI is also
indicated in the US for dMMR recurrent or advanced solid tumours,
as determined by an FDA-approved test, that have progressed on or
following prior treatment and who have no satisfactory alternative
treatment options. These indications are approved in the US under
accelerated approval based on tumour response rate and durability
of response. Continued approval for these indications may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s). In the EU, JEMPERLI received conditional
approval for adult patients with dMMR/MSI-H recurrent or advanced
endometrial cancer who have progressed on or following prior
treatment with a platinum-containing regimen.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company focused on
delivering innovative immunology therapeutics. We are developing
immune cell modulators, including two checkpoint agonists in
clinical-stage development, for autoimmune and inflammatory
disease: rosnilimab, our anti-PD-1 agonist program in Phase 2 for
the treatment of moderate-to-severe alopecia areata; and ANB032,
our anti-BTLA agonist program. AnaptysBio is also developing
imsidolimab, our anti-IL-36R antibody in Phase 3 for the treatment
of generalized pustular psoriasis, or GPP. Our preclinical and
research portfolio includes ANB033, an anti-CD122 antagonist
antibody for the treatment of inflammatory diseases. AnaptysBio has
also developed antibodies in an immuno-oncology collaboration with
GSK, 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).
Contact:Dennis MulroyAnaptysBio,
Inc.858.732.0201dmulroy@anaptysbio.com
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