Review of Data from First 10 Patients Demonstrates Significant
Activity and Favorable Tolerability in Both De Novo BPDCN Patients
and Those with a Prior or Concomitant Hematologic Malignancy
(PCHM)
Following Discussion with FDA, CADENZA Patients to be Segmented
into De Novo and PCHM BPDCN Patients; Aligned with FDA on Efficacy
Analysis in De Novo Patients
Additional De Novo Patients to be Enrolled with Top-line Data
Expected in 2024
Continuing to Enroll Patients with PCHM to Further Explore the
Potential Benefit of Pivekimab in this Population
Conference Call to be Held at 8:00 a.m. ET Today
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today provided an update on the pivotal Phase 2 CADENZA study of
pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic
cell neoplasm (BPDCN).
The CADENZA study is enrolling frontline BPDCN patients,
including patients with de novo disease and those with a prior or
concomitant hematologic malignancy (PCHM). Although complete
responses have been observed in BPDCN patients who present with
PCHM, most will not achieve full hematologic recovery due to the
impact of their prior or concomitant malignancy. For these
patients, achieving a complete response with partial hematological
recovery (CRh) is a potentially important measure of clinical
benefit.
In data from the first ten patients in the pivotal CADENZA
frontline cohort, the Company observed:
- 2 of 4 de novo patients achieved CR (complete response)/CRc
(clinical complete response); and
- 4 of 6 PCHM patients achieved CR/CRc/CRh.
In addition, in three frontline patients (2 de novo, 1 PCHM)
enrolled prior to the opening of the pivotal cohort, all three
patients achieved CR/CRc.
In conjunction with a recent Type B meeting regarding these
initial data from the CADENZA study, the Company has aligned with
FDA that the efficacy analysis will be conducted in de novo BPDCN
patients with CR/CRc as the primary endpoint and the key secondary
endpoint of duration of CR/CRc. The Company will also continue to
enroll PCHM patients in CADENZA to further explore the potential
benefits of pivekimab in this population. Based upon this guidance
from FDA, the Company will enroll up to 20 de novo patients for
purposes of the efficacy analysis. To date, a total of 6 de novo
BPDCN patients have enrolled in CADENZA. Given this is an
ultra-rare disease, the Company now expects to report top-line data
on the primary and key secondary endpoints in 2024.
“We believe these initial frontline data from the CADENZA study
further support the potential of pivekimab as an important
treatment option for patients with BPDCN,” said Anna Berkenblit,
MD, Senior Vice President and Chief Medical Officer of ImmunoGen.
“With Breakthrough Therapy designation, we have had productive
discussions with FDA. Based on the initial frontline data observed
to date, we will continue to explore the benefit of pivekimab in
both de novo and PCHM patients. We look forward to sharing
additional details of pivekimab in frontline BPDCN at an upcoming
medical meeting.”
"With limited treatment options for this rare and aggressive
cancer, I am encouraged by the data generated thus far for
pivekimab in frontline BPDCN,” said Kendra Sweet, MD, Associate
Member in the Department of Malignant Hematology at Moffitt Cancer
Center. “BPDCN patients with PCHM are increasingly recognized as
having significant unmet need as there are no therapies specific
for this population. BPDCN patients with PCHM are most likely to
die of the aggressive BPDCN component, which requires urgent
treatment, while the second malignancy is typically chronic and may
not even require treatment. What has been observed is that patients
with PCHM who’ve cleared their marrow of BPDCN with pivekimab may
not fully recover counts, likely due to the underlying concurrent
heme malignancy. Despite partial count recovery, complete clearance
of BPDCN allows these patients to bridge to transplant, when
eligible, the only curative option for BPDCN.”
CONFERENCE CALL INFORMATION ImmunoGen will hold a
conference call today at 8:00 a.m. ET to discuss these results. To
access the live call by phone, please register here. A dial-in and
unique PIN will be provided to join the call. The call may also be
accessed through the Investors and Media section of the Company’s
website, www.immunogen.com. Following the call, a replay will be
available at the same location.
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 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 U.S. 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® and Venclexta® 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, ImmunoGen’s expectations related to: the occurrence,
timing, and outcome of potential preclinical, clinical, and
regulatory events related to, and the potential benefits of, the
Company’s product candidates, including, but not limited to the
enrollment of patients in the CADENZA study and the potential full
approval of pivekimab sunirine in BPDCN; the timing and
presentation of preclinical and clinical data on the Company’s
product candidates, including top-line data from the CADENZA study;
and the Company’s business and product development strategies.
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; 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 interactions with regulatory authorities; 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 February 28, 2022, the Company’s Quarterly Reports on
Form 10-Q filed with the Securities and Exchange Commission on May
6, 2022 and August 1, 2022, 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. We undertake 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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version on businesswire.com: https://www.businesswire.com/news/home/20220831005279/en/
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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