Interim Analysis from Phase 2 Trial Demonstrates Compelling
Anti-Tumor Activity in Patients with Frontline and
Relapsed/Refractory BPDCN; No New Safety Signals Identified
Enrollment Continues in Frontline CADENZA Cohort; Top-Line
Pivotal Data Expected in 2024
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced updated data from an interim analysis of the Phase
2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with
frontline and relapsed/refractory (R/R) blastic plasmacytoid
dendritic cell neoplasm (BPDCN). The data will be presented in an
oral session on Sunday, June 11 at the European Hematology
Association (EHA) 2023 Congress in Frankfurt, Germany.
The CADENZA trial is enrolling frontline BPDCN patients,
including those with de novo disease and those with a prior or
concomitant hematologic malignancy (PCHM). As announced in August
2022, ImmunoGen aligned with the US Food and Drug Administration
(FDA) that the efficacy analysis will be conducted in de novo BPDCN
patients with CR/CRc as the primary endpoint. The secondary
endpoint is duration of CR/CRc. With enrollment in the R/R cohort
complete, ImmunoGen expects to complete enrollment in the pivotal
frontline de novo cohort this year and report top-line data in
2024.
"BPDCN is a rare and aggressive blood cancer characterized by
extremely low survival rates and limited treatment options that are
often associated with significant toxicities," said Naveen
Pemmaraju, MD, Associate Professor of Leukemia at The University of
Texas MD Anderson Cancer Center and co-investigator of the Phase 2
study. "We are encouraged by these updated data in a larger
population of patients, which demonstrated impressive anti-tumor
activity and durable responses in both frontline and R/R patients.
These efficacy data, coupled with outpatient administration,
reinforce the potential of pivekimab as a promising, novel option
for this challenging disease. I look forward to its continued
evaluation in the trial."
INTERIM ANALYSIS OF A REGISTRATION-ENABLING STUDY OF
PIVEKIMAB SUNIRINE, A CD123-TARGETING ANTIBODY-DRUG CONJUGATE, IN
PATIENTS WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM Lead
Author: Naveen Pemmaraju, MD Presentation ID: S139 Session Date:
Sunday, June 11 Session Time: 11:30am-12:45pm CEST / 5:30am-6:45am
EDT
Pivekimab is administered at 0.045 mg/kg on day 1 of a 21-day
cycle as an outpatient infusion of approximately 30 minutes. As of
the May 19, 2023 data cutoff, data were available for 79 BPDCN
patients (30 frontline, 49 R/R). Key interim and updated safety and
efficacy findings include:
Efficacy
- In frontline-treated patients including those with de novo and
PCHM, the objective response rate (ORR [CR, CRc, CRh, CRi, PR]) is
80% (24/30 patients) with a composite complete remission (CCR [CR,
CRc, CRh, CRi]) rate of 73% (22/30 patients), and an additional
patient achieving a CR post-transplant.
- Median duration of response (DOR) for all responders in
frontline-treated patients was 12.7 months.
- In R/R patients, the ORR was 33% (16/49 patients), with a CCR
rate of 20% (10/49 patients), including those who previously failed
intensive chemotherapy and/or transplant.
- Median DOR for all responders in R/R patients was 7.1
months.
Safety
- Pivekimab continues to exhibit manageable safety; no new safety
signals were observed.
- The most common treatment-emergent adverse events (TEAEs) (all
grades [grade 3+ events]) occurring in 15% or more of patients were
peripheral edema (46% [10%]), thrombocytopenia (27% [19%]), fatigue
(25% [4%]),infusion-related reactions (25% [4%]), constipation (23%
[0%]), nausea (22% [0%]) anemia (20% [8%]), headache (19% [4%]),
neutropenia (18% [17%]), diarrhea (17% [0%]), hypokalemia (17%
[3%]), dyspnea (15% [1%]), hyperglycemia (15% [6%]) and pyrexia
(15% [1%]).
- No capillary leak syndrome or cytokine release syndrome are
reported.
- Discontinuations due to pivekimab-related adverse events are
3%.
- 30-day mortality is 0% in frontline-treated patients and 4% (2
deaths due to disease progression) in R/R patients.
"We look forward to completing enrollment in CADENZA this year
and are pleased with the interim data in frontline BPDCN,
particularly the 73% CCR rate observed in this population, as well
as the responses seen in those patients with more advanced R/R
disease," said Anna Berkenblit, MD, Senior Vice President and Chief
Medical Officer of ImmunoGen. "With promising anti-tumor activity,
manageable safety including no observed capillary leak or cytokine
release syndrome, and the convenience of potential outpatient
administration, we believe pivekimab could serve as a critical
option for BPDCN patients."
Additional information can be found at www.ehaweb.org.
ABOUT PIVEKIMAB SUNIRINE
Pivekimab sunirine is a CD123-targeting ADC in clinical
development for hematological malignancies, including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid
leukemia (AML), and other CD123+ hematologic malignancies.
Pivekimab is currently being evaluated as monotherapy for patients
with BPDCN and in combination with Vidaza® (azacitidine) and
Venclexta® (venetoclax) for patients with untreated and
relapsed/refractory AML. Pivekimab uses one of ImmunoGen's novel
indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause
single strand breaks without crosslinking. IGNs are designed to
have high potency against tumor cells, while demonstrating less
toxicity to normal marrow progenitors than other DNA-targeting
payloads. The European Medicines Agency (EMA) granted orphan drug
designation to pivekimab for the treatment of BPDCN in June 2020.
Pivekimab also holds this designation in the US. In October 2020,
the FDA granted pivekimab Breakthrough Therapy designation in
relapsed/refractory BPDCN.
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 approval of a CD123-targeting therapy,
the unmet need remains high for patients, both in the frontline and
in the relapsed/refractory setting.
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. These
statements include, but are not limited to, the potential clinical
benefits of pivekimab in BPDCN and AML and the potential for
regulatory approval of pivekimab. 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.
Factors that could cause future results to differ materially from
such expectations include, but are not limited to: the timing and
outcome of the Company's preclinical and clinical development
processes; top-line data may change as more patient data become
available and are subject to audit and verification procedures; the
timing and outcome of the Company's preclinical and clinical
development processes; the difficulties inherent in the development
of novel pharmaceuticals, including uncertainties as to the timing,
expense, and results of preclinical studies, clinical trials, and
regulatory processes; the timing and outcome of the Company's
anticipated interactions with regulatory authorities; the risk that
the Company may not be able to obtain adequate price and
reimbursement for any approved products, including the potential
for delays or additional difficulties for ELAHERE in light of the
FDA granting accelerated approval; risks and uncertainties
associated with the scale and duration of the COVID-19 pandemic and
the resulting impact on ImmunoGen's industry and business; and
other factors as set forth in the Company's Annual Report on Form
10-K filed with the Securities and Exchange Commission on March 1,
2023, the Company's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commision on April 28, 2023, and other
reports filed with the Securities and Exchange Commission. The
forward-looking statements in this press release speak only as of
the date of this press release. ImmunoGen undertakes no obligation
to update any forward-looking statement, whether as a result of new
information, future developments, or otherwise, except as may be
required by applicable law.
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INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600
anabel.chan@immunogen.com
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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