MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical
company focused on discovering, developing, manufacturing and
commercializing innovative antibody-based therapeutics for the
treatment of cancer, today provided an update on the Phase 2
TAMARACK study of vobramitamab duocarmazine (vobra duo, previously
known as MGC018) in patients with metastatic castration-resistant
prostate cancer (mCRPC).
As previously disclosed, safety data from the Company’s ongoing
TAMARACK Phase 2 study was submitted in early February to the
American Society of Clinical Oncology (ASCO) for presentation
at the upcoming Annual Meeting that begins May 31. The abstract
containing this early interim data, based on a January 4, 2024 data
cut-off, was not accepted. The submitted abstract is provided
below.
“While the TAMARACK data will not be presented at the ASCO
Annual Meeting, we intend to maintain our previously disclosed plan
to share further TAMARACK interim data, including updated safety
and preliminary efficacy, by the end of May,” said Scott Koenig,
M.D., Ph.D., President and Chief Executive Officer. “This updated
information will be based upon a future data cut-off. In addition,
we still anticipate presenting updated clinical data – including
radiographic progression-free survival, or rPFS, the study’s
primary endpoint – in the Fall of 2024.”
Abstract as submitted on February 6, 2024:
“TitleVobramitamab
duocarmazine (vobra duo), a B7-H3 directed antibody drug conjugate
(ADC) in metastatic castration resistant prostate cancer (mCRPC):
Early data from the Phase 2 TAMARACK study.
BackgroundVobra duo
(MGC018) is an ADC with a duocarmycin-based DNA-alkylating payload.
Vobra duo targets B7-H3, which is highly expressed in multiple
tumor types including prostate cancer and has limited expression in
normal tissue. Phase 1 testing (NCT03729596) of vobra duo at 3.0
mg/kg Q3W demonstrated anti-tumor activity in mCRPC, although
adverse events resulted in high rates of dose modifications and
early treatment discontinuation. Lowering the starting dose may
improve tolerability, extend treatment duration, and enhance
effectiveness.
MethodsTAMARACK is
an ongoing randomized, open-label, Phase 2 dose selection study
assessing the efficacy, safety, and tolerability of two dose levels
of vobra duo (2.0 mg/kg and 2.7 mg/kg IV Q4W). The study enrolled
patients (pts) with mCRPC previously treated with abiraterone,
enzalutamide, or apalutamide; prior docetaxel was allowed. The
primary endpoint is investigator-assessed PFS at 6 months.
ResultsAt data
cutoff (Jan 4, 2024), 182 pts with mCRPC enrolled on TAMARACK, of
which 177 received vobra duo. Enrolled pts were 46 to 89 years of
age (median 70.5) with ECOG performance status ≤ 2. Thirty (16.5%)
had visceral disease at baseline, 109 (59.9%) had RECIST-evaluable
disease, and 98 (53.8%) received prior docetaxel. At this early
data cut, pts have received a median of 3 (range 1 to 7) cycles of
vobra duo; treatment is ongoing in 156 (85.7%). A summary of
treatment-emergent adverse events (TEAEs) is presented below.
|
Vobra duo 2.0 mg/kg (n=91) |
Vobra duo 2.7 mg/kg (n=86) |
Any TEAE |
85 (93.4%) |
82 (95.3%) |
TEAE Grade ≥ 3 |
23 (25.3%) |
27 (31.4%) |
Serious AE |
11 (12.1%) |
17 (19.8%) |
Drug Interruption due to AE |
10 (11.0%) |
16 (18.6%) |
Drug Discontinuation due to AE |
4 (4.4%) |
2 (2.3%) |
Fatal AE |
0 |
0 |
The most common (≥10%) TEAEs
regardless of dose were asthenia (40.7%), nausea (27.7%), fatigue
(20.3%), decreased appetite (19.2%), anemia (17.5%), constipation
(16.4%), diarrhea (14.7%), headache (13.0%), neutropenia (12.4%),
and peripheral edema (10.7%). In the subset (n = 95) of TAMARACK
pts on treatment for ≥ 12 weeks or who discontinued study treatment
within 12 weeks, TEAEs led to drug interruption in 12 (12.6%) and
discontinuation in 5 (5.3%) pts. This compares favorably to the
rate of drug interruption (58.5%) and discontinuation (14.6%)
observed at 12 weeks in pts with mCRPC who received vobra duo at
3.0 mg/kg Q3W on the Phase 1 study. Following the pre-specified
interim analysis for futility on both arms, the IDMC recommended
continuing the study as planned without modification.
Conclusions
Preliminary safety data from TAMARACK suggest that reducing the
dose and frequency of vobra duo improves its safety and
tolerability in men with mCRPC. The authors anticipate sharing
preliminary efficacy data and updated safety data at the
conference. Clinical trial information: NCT05551117.”
MacroGenics would like to thank the abstract authors, including:
Johann S. De Bono, Carole Helissey, Karim Fizazi, Eric Voog, Pablo
Maroto-Rey, Guilhem Roubaud, Emmanuel S. Antonarakis, Shahneen
Sandhu, Neal D. Shore, Raffaele Ratta, Begoña Pérez Valderrama,
Christof Vulsteke, Galina Marr, Ashley Ward, Enxu Zhao, Josep M.
Piulats, on behalf of the TAMARACK Investigators.
About MacroGenics, Inc.MacroGenics (the
Company) is a biopharmaceutical company focused on discovering,
developing, manufacturing and commercializing innovative monoclonal
antibody-based therapeutics for the treatment of cancer. The
Company generates its pipeline of product candidates primarily from
its proprietary suite of next-generation antibody-based technology
platforms, which have applicability across broad therapeutic
domains. The combination of MacroGenics' technology
platforms and protein engineering expertise has allowed the Company
to generate promising product candidates and enter into several
strategic collaborations with global pharmaceutical and
biotechnology companies. For more information, please see the
Company's website at www.macrogenics.com. MacroGenics and
the MacroGenics logo are trademarks or registered
trademarks of MacroGenics, Inc.
Cautionary Note on Forward-Looking
StatementsAny statements in this press release about
future expectations, plans and prospects
for MacroGenics (“Company”), including statements about
the Company’s strategy, future operations, clinical development of
the Company’s therapeutic candidates, including initiation and
enrollment in clinical trials, expected timing of results from
clinical trials, discussions with regulatory agencies, commercial
prospects of or product revenues from MARGENZA and the Company’s
product candidates, if approved, manufacturing services revenue,
milestone or opt-in payments from the Company’s collaborators, the
Company’s anticipated milestones and future expectations and plans
and prospects for the Company, as well as future global net sales
of TZIELD and the Company’s ability to achieve the milestone
payments set forth under the terms of the agreement with DRI (or
its successors or assigns with respect to such agreement), and
other statements containing the words “subject to”, "believe",
“anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,”
“project”, “may”, “will”, “should”, “would”, “could”, “can”, the
negatives thereof, variations thereon and similar expressions, or
by discussions of strategy constitute forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ,
MARGENZA or any other product candidate’s revenue, expenses and
costs may not be as expected, risks relating to TZIELD,
vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any
other product candidate’s market acceptance, competition,
reimbursement and regulatory actions; our ability to provide
manufacturing services to our customers; the uncertainties inherent
in the initiation and enrollment of future clinical trials; the
availability of financing to fund the internal development of our
product candidates; expectations of expanding ongoing clinical
trials; availability and timing of data from ongoing clinical
trials; expectations for the timing and steps required in the
regulatory review process; expectations for regulatory approvals;
expectations of future milestone payments; the impact of
competitive products; our ability to enter into agreements with
strategic partners and other matters that could affect the
availability or commercial potential of the Company's product
candidates; business, economic or political disruptions due to
catastrophes or other events, including natural disasters,
terrorist attacks, civil unrest and actual or threatened armed
conflict, or public health crises such as the novel coronavirus
(referred to as COVID-19 pandemic); and other risks described in
the Company's filings with the Securities and Exchange
Commission. In addition, the forward-looking statements included in
this press release represent the Company's views only as of the
date hereof. The Company anticipates that subsequent events and
developments will cause the Company's views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so, except as may be required by
law. These forward-looking statements should not be relied upon as
representing the Company's views as of any date subsequent to the
date hereof.
CONTACTS:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com
MacroGenics (NASDAQ:MGNX)
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