Data Demonstrating Potential in AML and BPDCN Presented During
Oral Presentation; Dose and Schedule Selected for Further
Development
Preclinical Combination Data Also Presented; Support Further
Evaluation of IMGN632 Doublets and Triplet in AML
ImmunoGen, Inc., (Nasdaq: IMGN) a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that new safety and efficacy findings from the dose
escalation and expansion of the first-in-human trial of IMGN632 in
patients with relapsed/refractory acute myeloid leukemia (AML) and
blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented
in an oral session at the 61st American Society of Hematology (ASH)
Annual Meeting in Orlando, Florida. Preclinical data related to
IMGN632 in combination with Vidaza® (azacitidine) and Venclexta®
(venetoclax), and two “trial in progress” posters were also
presented at the conference.
“The data presented at ASH demonstrate the potential of IMGN632
to offer a new treatment option for patients with AML and BPDCN,”
said Anna Berkenblit, MD, Senior Vice President and Chief Medical
Officer of ImmunoGen. “With the benefit of a comprehensive
assessment of IMGN632’s safety and efficacy across a wide range of
doses and two schedules, we have selected a dose and schedule that
demonstrate significant anti-tumor activity, favorable
tolerability, and the convenience of a short infusion that can be
administered in an outpatient setting. Together with the
preclinical data on combining IMGN632 with azacitidine and
venetoclax presented by our collaborators from MD Anderson, these
updated clinical results provide a strong foundation for our
ongoing expansion of IMGN632 monotherapy studies in BPDCN, AML, and
ALL, and the recent initiation of our trial to evaluate IMGN632
combinations with azacitidine and venetoclax in relapsed and
frontline AML, as well as IMGN632 as a monotherapy in minimal
residual disease positive AML patients.”
“We are particularly encouraged by the activity and tolerability
of IMGN632 in heavily pre-treated patients, including a 40% ORR in
relapsed and refractory de novo AML patients treated at the
recommended phase 2 dose, and the responses in relapsed or
refractory BPDCN patients previously treated with Elzonris®
(tagraxofusp-erzs) and intensive chemotherapy,” said Naval Daver,
MD, Associate Professor in the Department of Leukemia at MD
Anderson Cancer Center. “We look forward to continuing to evaluate
IMGN632 as a monotherapy and in combination with azacitidine and
venetoclax in doublet and triplet regimens in relapsed/refractory
AML and frontline older AML.”
PHASE 1 DATA ON IMGN632 AS A MONOTHERAPY IN AML AND BPDCN
Oral Presentation, Abstract #734 Updated key findings from the
Phase 1 study of IMGN632 include the following:
Safety
- IMGN632 was administered to 95 patients over dose levels
ranging from 0.015 to 0.45 mg/kg intravenously on the every 3 week
schedule and 0.015 to 0.06 mg/kg on the fractionated day 1, 4, and
8 schedule every 3 weeks.
- IMGN632 displays a well tolerated safety profile and activity
at doses up to and including 0.09 mg/kg per cycle.
- The most common treatment-related adverse event was
infusion-related reactions (24% all grades, 8% grade 3); none
required IMGN632 discontinuation.
- Single dose-limiting toxicities were seen at the highest dose
levels tested (0.18-0.45 mg/kg): three reversible cases of
veno-occlusive disease and one prolonged neutropenia; no patterns
of hepatotoxicity or cytopenias occurred with doses below 0.18
mg/kg.
- Although no maximum tolerated dose was determined on either
schedule, based on the efficacy, safety, and pharmacokinetic data
generated, the dose and schedule of 0.045 mg/kg given on day 1
every 3 weeks has been selected as the monotherapy recommended
Phase 2 dose.
AML Efficacy
- Across all dose levels and both schedules, of the patients
assessable for efficacy (n=71), 38 (54%) had a reduction in bone
marrow blasts and 13 (18%) achieved an objective response,
including 2 complete remissions (CR) and 10 with incomplete
recovery (CRi) and one morphologic leukemia free state (MLFS) in
heavily pretreated patients. The vast majority of these responders
(92%) had failed prior intensive therapies, including 3 with prior
transplant, 69% had failed 2-3 prior lines of therapy, and 54% had
an adverse risk classification.
- At the dose and schedule selected as the recommended Phase 2
dose (0.045 mg/kg Q3W), a 40% response rate was seen in relapsed
and refractory patients with de novo AML, including 1 CR, 4 CRi,
and 1 MLFS (with subsequent conversion to CRi).
BPDCN Efficacy
- 3 of 9 (33%) evaluable relapsed/refractory BPDCN patients
achieved a response after a 1-2 doses of 0.045 mg/kg IMGN632 (1 CR,
1 CRi, and 1 partial remission); all three patients had received
prior SL-401 (tagraxofusp-erzs), two had received intense
multi-agent chemotherapy, and one had prior stem cell
transplant.
PRECLINICAL DATA ON IMGN632 IN COMBINATION WITH AZACITIDINE
AND VENETOCLAX Poster Presentation, Abstract 1375 IMGN632 was
evaluated in combination with azacitidine, and as a triplet with
azacitidine and venetoclax in AML models, including patient derived
xenografts (PDX). The addition of IMGN632 to azacitidine alone or
to azacitidine plus venetoclax consistently led to reductions in
tumor burden and to improved survival in these murine models. These
data support clinical testing of the addition of IMGN632 to
standard of care therapy including azacitidine, and azacitidine
plus venetoclax in AML patients.
Additional information, including abstracts, can be found at
www.hematology.org.
ABOUT IMGN632 IMGN632 is a CD123-targeting ADC in Phase I
testing for hematological malignancies, including acute myeloid
leukemia (AML), blastic plasmacytoid dendritic cell neoplasm
(BPDCN), and acute lymphocytic leukemia (ALL). IMGN632 uses one of
ImmunoGen's novel indolino-benzodiazepine (IGN) payloads, which
alkylate DNA without crosslinking. IGNs have been designed to have
high potency against AML blasts, while demonstrating less toxicity
to normal marrow progenitors than other DNA-targeting payloads.
ABOUT ACUTE MYELOID LEUKEMIA (AML) AML is a cancer of the
bone marrow cells that produce white blood cells. It causes the
marrow to increasingly generate abnormal, immature white blood
cells (blasts) that do not mature into effective infection-fighting
cells. The blasts quickly fill the bone marrow, impacting the
production of normal platelets and red blood cells. The resulting
deficiencies in normal blood cells leave the patient vulnerable to
infections, bleeding problems, and anemia. It is estimated that, in
the U.S. alone, 21,380 patients will be diagnosed with AML this
year and 10,590 patients will die from the disease.
ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM
(BPDCN) BPDCN is a rare form of blood cancer that has features
of both leukemia and lymphoma, with characteristic skin lesions,
lymph node involvement, and frequent spread to the bone marrow.
This aggressive cancer requires intense treatment often followed by
stem cell transplant. Despite the recent approval of a
CD123-targeting therapy, the unmet need remains high in the
relapsed/refractory setting.
ABOUT CD123 CD123, the interleukin-3 alpha chain, is
expressed on multiple myeloid and lymphoid cancers including AML,
BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative
neoplasms. With limited expression on normal hematopoietic cells,
rapid internalization, and expression on AML leukemia stem cells,
CD123 is a validated therapeutic target, with the recent approval
of a CD123-targeting therapy for BPDCN.
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By generating targeted therapies with enhanced
anti-tumor activity and favorable tolerability profiles, we aim to
disrupt the progression of cancer and offer our patients more good
days. We call this our commitment to “target a better now.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Vidaza®, Venclexta® and Elzonris® are registered trademarks of
their respective owners.
FORWARD-LOOKING STATEMENTS This press release includes
forward-looking statements based on management's current
expectations. For these statements, ImmunoGen claims the protection
of the safe harbor for forward-looking statements provided by the
Private Securities Litigation Reform Act of 1995. Various factors
could cause ImmunoGen's actual results to differ materially from
those discussed or implied in the forward-looking statements, and
you are cautioned not to place undue reliance on these
forward-looking statements, which are current only as of the date
of this release. It should be noted that there are risks and
uncertainties related to the development of novel anticancer
products, including risks related to preclinical and clinical
studies, their timings and results, and the potential that earlier
clinical studies may not be predictive of future results. A review
of these risks can be found in ImmunoGen's Annual Report on Form
10-K for the fiscal year ended December 31, 2018 and other reports
filed with the Securities and Exchange Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20191209005068/en/
INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting
Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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