Mechelen, Belgium; June 14, 2024, 22:01
CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced
that it will present encouraging new data from the ongoing Phase
1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101, in
relapsed/refractory non-Hodgkin lymphoma (R/R NHL) at the annual
European Hematology Association (EHA) 2024 Hybrid Congress.
Galapagos' product candidate GLPG5101 is produced using the
company's innovative, decentralized T-cell manufacturing
platform.
The oral presentation includes updated safety
and efficacy data for GLPG5101 in patients with diffuse large
B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone
lymphoma (MZL) and mantle cell lymphoma (MCL). The presentation
also includes durability and cellular kinetics data. At the data
cut-off date of December 20, 2023, no unexpected safety findings
were observed and treatment with GLPG5101 resulted in high complete
response rates in all indications in this heavily pretreated
patient population.
GLPG5101 was administered as a fresh product in
94% of patients with a median vein-to-vein time of seven days,
eliminating the need for bridging therapy. T-cell subsets were
assessed in the apheresis starting material and final CAR-T
product. There was a higher proportion of early phenotypes of CD4+
and CD8+ CAR T cells (naive/stem cell memory and central memory T
cells) in the final product compared with starting material,
indicating an increase of those populations during the
manufacturing process. This demonstrates the feasibility of
Galapagos’ decentralized manufacturing platform to deliver a
high-quality CAR T-cell product to patients.
The new data will be presented by Marie José
Kersten, M.D., Professor of Hematology and Head of the Department
of Hematology at the Amsterdam University Medical Center.
“We are committed to accelerating breakthrough
innovations to extend the reach of CAR-T therapies to patients with
rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of
Clinical Development Oncology at Galapagos. “We are delighted to
present promising new data for GLPG5101 at the EHA congress. The
high complete response rates, combined with low-grade CRS and
ICANS, demonstrates the potential of GLPG5101 in addressing the
critical needs of this patient population. The data also confirm
the feasibility of our innovative decentralized T-cell
manufacturing platform in delivering fresh, fit cells with a median
vein-to-vein time of just seven days.”
Key new data from the ongoing Phase 1/2
ATALANTA-1 study include:As of the data cut-off date of
December 20, 2023, 34 patients (17 in Phase 1 and 17 in Phase 2)
received GLPG5101 with a median vein-to-vein time of seven days.
Overall, safety results were available for 33 patients and efficacy
results were available for 31 patients. The data are summarized
below:
- GLPG5101 showed an encouraging
safety profile with most TEAEs1 of Grade 1 or 2; the majority of
Grade ≥ 3 events were hematological. Two cases of CRS2 Grade 3 were
observed in Phase 1 and one case of ICANS3 Grade 3 was observed in
Phase 2.
- In Phase 1, 14 of 16
efficacy-evaluable patients responded to treatment (objective
response rate, ORR 87.5%), with 12 patients achieving a complete
response (CR) (CR rate, CRR 75%). In Phase 2, 14 of 15
efficacy-evaluable patients responded to treatment (ORR 93.3%), and
all responders achieved a complete response (CRR 93.3%).
- High ORR and CRR were observed in
the pooled Phase 1 and Phase 2 efficacy analysis set, split by
indication:
- In patients with
DLBCL, 7 of 9 efficacy-evaluable patients responded to treatment
(ORR 78%), with 5 patients achieving a complete response (CRR
56%).
- In patients with
FL or MZL, objective and complete responses were observed in 16 of
17 efficacy-evaluable patients (ORR and CRR 94%).
- In patients with MCL, all 5 of 5
efficacy-evaluable patients responded to treatment (ORR and CRR
100%).
- Durable responses were observed in
the majority of responding patients:
- 71% of patients in Phase 1 had an
ongoing response at data cut-off with median follow-up of 13.1
months.
- 100% of patients in Phase 2 had an
ongoing response at data cut-off with median follow-up of 4.2
months.
- Strong and consistent in vivo CAR-T
expansion levels and products consisting of early phenotype T cells
were observed in all doses tested.
Presentation details:
Abstract number/title |
Authors/Presenter |
Presentation date/time |
Abstract #S243Seven-Day Vein-to-Vein Point-of-Care Manufactured
CD19 CAR T Cells (GLPG5101) in Relapsed/Refractory Non-Hodgkin
Lymphoma: Results from the Phase 1/2 Atalanta-1 Trial |
Marie José Kersten, Kirsten Saevels, Sophie Servais, Evelyne
Willems, Marte C. Liefaard, Stavros Milatos, Margot J. Pont, Claire
Vennin, Eva Santermans, Anna D.D. Van Muyden, Maria T. Kuipers,
Sébastien Anguille, Joost S.P. Vermaat |
Saturday, June, 1512:15- 12:30 pm CET Session s422:
Aggressive lymphoma – CAR-T cell therapyHall Dali 2 |
About the ATALANTA-1 study (EudraCT
2021-003272-13)ATALANTA-1 is an ongoing Phase 1/2,
open-label, multicenter study to evaluate the safety, efficacy and
feasibility of decentralized manufactured GLPG5101, a CD19 CAR-T
product candidate, in patients with relapsed/refractory non-Hodgkin
lymphoma (R/R NHL). GLPG5101 is a second generation anti-CD19/4-1BB
CAR-T product candidate, administered as a single fixed intravenous
dose. The primary objective of the Phase 1 part of the study is to
evaluate the safety and preliminary efficacy to determine the
recommended dose for the Phase 2 part of the study. Secondary
objectives include assessment of efficacy and feasibility of near
the point-of-care manufacturing of GLPG5101. The dose levels that
were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2)
and 250×106 (DL3) CAR+ viable T cells. The primary objective
of the Phase 2 part of the study is to evaluate the objective
response rate (ORR), while the secondary objectives include
complete response rate (CRR), duration of response, progression
free survival, overall survival, safety, pharmacokinetic profile,
and the feasibility of decentralized manufacturing. Each enrolled
patient will be followed for 24 months.
About non-Hodgkin
lymphomaNon-Hodgkin lymphoma is a cancer originating from
lymphocytes, a type of white blood cell which is part of the body’s
immune system. Non-Hodgkin lymphoma can occur at any age although
it is more common in adults over 50 years old. Initial symptoms
usually are enlarged lymph nodes, fever, and weight loss. There are
many different types of non-Hodgkin lymphoma. These types can be
divided into aggressive (fast-growing) and indolent (slow growing)
types, and they can be formed from either B lymphocytes (B cells)
or in lesser extent from T lymphocytes (T cells) or Natural Killer
cells (NK cells). B-cell lymphoma makes up about 85% of non-Hodgkin
lymphomas diagnosed in the US. Prognosis and treatment of
non-Hodgkin lymphoma depend on the stage and type of disease.
About Galapagos’ T-cell manufacturing
platformGalapagos’ decentralized, innovative T-cell
manufacturing platform has the potential for the administration of
fresh, fit cells within a median vein-to-vein time of seven days,
greater physician control and improved patient experience. The
platform consists of an end-to-end xCellit® workflow management and
monitoring software system, a decentralized, functionally closed,
automated manufacturing platform for cell therapies (using Lonza’s
Cocoon®) and a proprietary quality control testing and release
strategy.
About GalapagosWe are a
biotechnology company with operations in Europe and the U.S.
dedicated to developing transformational medicines for more years
of life and quality of life. Focusing on high unmet medical needs,
we synergize compelling science, technology, and collaborative
approaches to create a deep pipeline of best-in-class small
molecules, cell therapies, and biologics in oncology and
immunology. With capabilities from lab to patient, including a
decentralized T-cell manufacturing network, we are committed to
challenging the status quo and delivering results for our patients,
employees and shareholders. For additional information, please
visit www.glpg.com or follow us
on LinkedIn or X.
For further information, please
contact:
Media
inquiries:Marieke Vermeersch +32 479 490
603 media@glpg.com Jennifer Wilson + 44 7444
896759media@glpg.com |
Investor
inquiries:Sofie Van Gijsel +1 781 296
1143ir@glpg.comSandra Cauwenberghs +32 495 58 46
63ir@glpg.com |
Forward-looking statementsThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended. These statements are often, but are not always, made
through the use of words or phrases such as “anticipate,” “expect,”
“plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,”
“potential,” “could,” “indicate,” “forward,” as well as similar
expressions. Forward-looking statements contained in this release
include, but are not limited to, statements regarding new data from
the ATALANTA-1 Phase 1/2 study and other analyses related to
Galapagos’ CD19 CAR-T program, statements related to Galapagos’
plans, expectations and strategy with respect to the ATALANTA-1
study, and statements regarding the potential benefits of GLPG5101.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors which might cause Galapagos’ actual
results to be materially different from those expressed or implied
by such forward-looking statements. These risks, uncertainties and
other factors include, without limitation, the risk that
preliminary or interim clinical results may not be replicated in
ongoing or subsequent clinical trials; the risk that ongoing and
future clinical studies with GLPG5101 may not be completed in the
currently envisaged timelines or at all, the inherent uncertainties
associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from ongoing and planned clinical research
programs may not support registration or further development of
GLPG5101 due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties (including its
collaboration partner Lonza) and that Galapagos’ estimations
regarding its GLPG5101 development program and regarding the
commercial potential of GLPG5101 may be incorrect, as well as those
risks and uncertainties identified in Galapagos’ Annual Report on
Form 20-F for the year ended 31 December 2023 filed with the U.S.
Securities and Exchange Commission (SEC) and its subsequent filings
with the SEC. All statements other than statements of historical
fact are statements that could be deemed forward-looking
statements. The forward-looking statements contained herein are
based on management’s current expectations and beliefs and speak
only as of the date hereof, and Galapagos makes no commitment to
update or publicly release any revisions to forward-looking
statements in order to reflect new information or subsequent
events, circumstances or changes in expectations.
1 Treatment Emergent Adverse Events2 Cytokine
Release Syndrome3 Immune effector Cell-Associated Neurotoxicity
Syndrome
- Press release GLPG EHA 2024_ENG_FINAL
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