AnaptysBio and GSK-partnered immuno-oncology agents JEMPERLI (dostarlimab-gxly) and cobolimab show positive progress in two separate non-small cell lung cancer trials
October 05 2022 - 8:00AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced that GSK’s study PERLA, a head-to-head trial
of JEMPERLI vs. Keytruda in patients with metastatic non-squamous
non-small cell lung cancer, met its primary endpoint of objective
response rate (ORR) of dostarlimab plus chemotherapy versus
pembrolizumab plus chemotherapy as assessed by blinded independent
central review per RECIST v1.1.
GSK expects to present full results from the PERLA trial,
including the primary endpoint of ORR and the key secondary
endpoint of progression-free survival, with results by programmed
death ligand-1 (PD-L1) expression subgroups, at an upcoming
scientific meeting.
AnaptysBio also announced today that GSK is advancing both arms
of the COSTAR Lung clinical trial from Phase 2 to Phase 3, testing
both doublet and triplet combinations of dostarlimab plus
chemotherapy, and cobolimab plus dostarlimab plus chemotherapy in
advanced non-small cell lung cancer. This decision follows the
recommendation of the trial’s Independent Data Monitoring
Committee, reflecting the achievement of pre-specified efficacy and
safety criteria per the COSTAR protocol.
The COSTAR Lung Phase 3 trial is a randomized, open label 3-arm
trial comparing cobolimab plus dostarlimab plus docetaxel to
dostarlimab plus docetaxel to docetaxel alone in patients with
advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy
and chemotherapy. AnaptysBio expects to receive a $5 million
milestone payment from GSK upon dosing of the first patient
with cobolimab in the Phase 3 portion of COSTAR.
JEMPERLI and cobolimab were discovered at 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 research,
development, commercialization and manufacturing of each of these
monoclonal antibody therapies under the agreement.
“We are encouraged to see immuno-oncology molecules discovered
at Anaptys delivering differentiated outcomes and advancing on
multiple fronts by GSK,” said Daniel Faga, interim president and
chief executive officer of AnaptysBio. “We intend to leverage our
strong capital position, which has been supported in part from the
partial monetization of potential future royalty streams from this
immuno-oncology portfolio, as we focus on the R&D of our novel
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 PERLAThe PERLA phase 2 trial is a global,
randomized, double-blind trial of 243 patients evaluating the
efficacy and safety of dostarlimab plus chemotherapy compared to
pembrolizumab plus chemotherapy in patients with metastatic
non-squamous NSCLC without a known sensitizing epidermal growth
factor receptor, anaplastic lymphoma kinase, or receptor tyrosine
kinase-1 mutation, V600E mutation of the BRAF gene or other genomic
mutation for which an approved targeted therapy is available.
Patients were randomized 1:1 to receive either dostarlimab 500 mg
intravenous (IV) or pembrolizumab 200 mg IV every three weeks in
combination with chemotherapy. Patients were stratified by PD-L1
expression (TPS <1% versus 1%–49% versus ≥50%) and smoking
status (never vs former/current). The primary endpoint was
objective response rate of dostarlimab plus chemotherapy versus
pembrolizumab plus chemotherapy assessed by blinded independent
central review per RECIST v1.1. Secondary endpoints include overall
survival, investigator-assessed progression-free survival per
RECIST v1.1, and safety.
About COSTAR LungThe COSTAR Lung trial
(NCT04655976) is a phase 2/3 global, randomized, open-label trial
of 750 patients. The study evaluates the efficacy and safety of
cobolimab plus dostarlimab plus docetaxel and dostarlimab plus
docetaxel compared to docetaxel in patients with advanced
non-squamous and squamous NSCLC whose disease had progressed on
prior therapy with an anti-PD-(L)1 agent and a platinum
doublet-based chemotherapy given in combination or in sequence. The
study does not include patients with a known sensitizing epidermal
growth factor receptor, anaplastic lymphoma kinase, or receptor
tyrosine kinase-1 mutation, for which an approved targeted therapy
is available. Patients are randomized 2:2:1 to receive either
cobolimab 300 mg plus dostarlimab 500mg plus docetaxel 75 mg/m2
intravenous (IV) every three weeks (Q3W) or dostarlimab 500mg plus
docetaxel 75 mg/m2 IV Q3W or docetaxel 75 mg/m2 IV Q3W. Patients
are stratified by prior line of therapy (1 vs 2), PD-L1 expression
(TPS ≥50% versus <50%) and histology (non-squamous vs squamous).
The primary endpoint at interim analysis 1 (IA1) was objective
response rate between arms as assessed by blinded independent
central review per RECIST v1.1 and evaluated by an independent data
monitoring committee (IDMC). The primary endpoint at final analysis
is overall survival.
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.vii 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. JEMPERLI is not
approved anywhere in the world in combination with chemotherapy in
first-line patients with metastatic non-squamous NSCLC or in
combination with other agents to treat patients with advanced NSCLC
who have progressed on prior anti-PD-L1 therapy and
chemotherapy.
About CobolimabCobolimab is an investigational
monoclonal antibody against the inhibitory receptor, T-cell
immunoglobulin and mucin domain-containing protein 3 (TIM-3), with
potential immune checkpoint inhibitory and antineoplastic
activities.
About AnaptysBioAnaptysBio 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, which
is broadly applicable to human inflammatory diseases associated
with lymphoid and myeloid immune cell dysregulation. AnaptysBio is
also developing imsidolimab, our anti-IL-36R antibody in Phase 3
for the treatment of generalized pustular psoriasis, or GPP.
AnaptysBio’s antibody pipeline has been developed using our
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).
Contacts:Dennis MulroyAnaptysBio,
Inc.858.732.0201dmulroy@anaptysbio.com
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