Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical
biopharmaceutical company focused on the discovery, development and
commercialization of drugs for the treatment of cancer, today
announced data from its CLOVER WaM pivotal study, evaluating
iopofosine I 131, a potential first-in-class, targeted radiotherapy
candidate for the treatment of relapsed/refractory Waldenstrom’s
macroglobulinemia (WM) patients that have received at least two
prior lines of therapy, including Bruton tyrosine kinase inhibitors
(BTKi). CLOVER WaM is the largest study to date in relapsed or
refractory WM patients post-BTKi therapy and represents the most
refractory population ever tested in clinical studies based upon a
review of published literature.
The CLOVER WaM study met its primary endpoint
with a major response rate (MRR) of 61% (95% confidence interval
[44.50%, 75.80%, two-sided p value < 0.0001]). The overall
response rate (ORR) in evaluable patients was 75.6%, and 100% of
patients experienced disease control. Responses were durable, with
median duration of response not reached and 76% of patients
remaining progression free at a median follow-up of eight months.
These outcomes exceed real world data, which demonstrate a 4-12%
MRR and a duration of response of approximately six months or less
despite continuous treatment in a patient population that is less
pretreated and less refractory to multiple classes of drugs.
Notably, iopofosine monotherapy achieved an 8% stringent complete
remission (sCR) in this highly refractory WM population.
"There is a critical need for new therapies with
novel mechanisms of action to treat WM. There are no approved
treatments for patients post BTKi therapy, where currently the
expected response rate to salvage treatments is approximately 10%,
and the expected duration of response in those patients is less
than six months,” said Sikander Ailawadhi, M.D., professor of
medicine at Mayo Clinic, and lead investigator in the CLOVER WaM
study. “The results from this pivotal study utilizing just four
doses of iopofosine monotherapy in heavily pretreated patients are
very compelling, demonstrating deep and durable remissions. The
combination of the safety profile and deep durable responses with a
high proportion of patients remaining treatment free is
impressive."
CLOVER WaM is a single-arm registration study with
a target enrollment of 50 patients. The study is fully enrolled and
topline safety data is being reported on 45 patients meeting
criteria for modified intent to treat (mITT) with a data cut-off
date of January 3, 2024. Topline efficacy evaluable population (41)
is defined as patients who have received a total administered dose
of greater than 60 mCi and had follow up of at least 60 days post
last dose. Among mITT patients, median age was 71 years, median IgM
level prior to treatment with iopofosine was 2,185, 90% were
refractory to either a BTKi (18/36 50%) or anti-CD20 therapy (18/41
40%), with 26.7% multiclass refractory, and 80% of patients were
previously treated with a BTKi therapy.
Newton Guerin, International Waldenstrom’s
Macroglobulinemia Foundation (IWMF) president and CEO, said, “These
inspiring topline data represent important and exciting news for
the entirety of the WM community battling this challenging disease.
WM patients need new, clinically meaningful treatment modalities
and currently, there are limited options for patients who have
received prior BTKi therapy. Iopofosine’s product profile is
notable because of its novel mechanism of action, fixed four-dose
course of treatment completed within 75 days and the promise of an
enhanced quality of life for patients, including a prolonged
treatment-free interval.”
Iopofosine I 131 was well tolerated and its
toxicity profile was consistent with the Company's previously
reported safety data. There were no treatment-related adverse
events (TRAEs) leading to discontinuation. The rates of Grade 3 or
greater TRAEs observed in more than 10% of patients included
thrombocytopenia (55%), neutropenia (37%), and anemia (26%). All
patients recovered from cytopenias with no reported aplastic
sequalae. Importantly, there were no clinically significant
bleeding events, and the rate of febrile neutropenia was 2%. There
were no treatment related deaths in the study.
“We are most grateful to the patients and their
families, participating study sites, their staff and our dedicated
employees for the successful completion of this study. Their
respective contributions may provide a meaningful new treatment
option for patients where there currently are no approved
therapies," said James Caruso, president and CEO of Cellectar.
“Iopofosine’s high major response rate and achievement of the
study’s primary endpoint in highly refractory, Waldenstrom’s
macroglobulinemia patients exhibits its potentially
practice-changing clinical profile. We believe the currently
impressive response rates and the duration of responses will
continue to improve as the data matures. We plan to include these
outcomes in our NDA submission and will be requesting an
accelerated approval based upon our WM Fast Track Designation.”
Conference Call & Webcast
DetailsCellectar management will host a conference call
for investors today, January 8, 2024, beginning at 8:00 am ET /
5:00 am PT. Dial-in: 1-888-886-7786. Webcast Link: Click
HERE
About Cellectar Biosciences,
Inc.Cellectar Biosciences is a late-stage clinical
biopharmaceutical company focused on the discovery and development
of proprietary drugs for the treatment of cancer, independently and
through research and development collaborations. The company’s core
objective is to leverage its proprietary Phospholipid Drug
Conjugate™ (PDC) delivery platform to develop the next-generation
of cancer cell-targeting treatments, delivering improved efficacy
and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset
iopofosine I 131, a small-molecule PDC designed to provide targeted
delivery of iodine-131 (radioisotope), proprietary preclinical PDC
chemotherapeutic programs and multiple partnered PDC assets.
For more information, please
visit www.cellectar.com and www.wmclinicaltrial.com or
join the conversation by liking and following us on the company’s
social media channels: Twitter, LinkedIn,
and Facebook.
About Waldenstrom’s
MacroglobulinemiaWM is a B-cell malignancy characterized
by bone marrow infiltration of clonal lymphoplasmacytic cells that
produce a monoclonal immunoglobulin M (IgM) that remains incurable
with available treatments. The prevalence in the US is
approximately 26,000 with 1,500-1,900 patients being diagnosed
annually. Approximately 10,000 patients require treatment in the
relapsed or refractory setting and there are an estimated 4,300
patients requiring 3rd line or greater therapy. There are no FDA
approved treatment options for patients progressing on BTKi
therapy. BTKi therapies do not demonstrate complete response rates
and require continuous treatment. Approximately 50% of 3rd line
patients not receiving treatment are likely to consider new
treatment options. There is an established unmet need for new FDA
approved treatments that provide a novel mechanism of action,
increased deep durable responses, and time limited treatment,
especially in heavily pretreated WM patients.
Forward-Looking Statement
Disclaimer
This news release contains forward-looking
statements. You can identify these statements by our use of words
such as "may," "expect," "believe," "anticipate," "intend,"
"could," "estimate," "continue," "plans," or their negatives or
cognates. These statements are only estimates and predictions and
are subject to known and unknown risks and uncertainties that may
cause actual future experience and results to differ materially
from the statements made. These statements are based on our current
beliefs and expectations as to such future outcomes including our
expectations regarding the WM CLOVER WaM pivotal study. Drug
discovery and development involve a high degree of risk. Factors
that might cause such a material difference include, among others,
uncertainties related to the ability to raise additional capital,
uncertainties related to the disruptions at our sole source
supplier of iopofosine, the ability to attract and retain partners
for our technologies, the identification of lead compounds, the
successful preclinical development thereof, patient enrollment and
the completion of clinical studies, the FDA review process and
other government regulation, our ability to maintain orphan drug
designation in the United States for iopofosine, the volatile
market for priority review vouchers, our pharmaceutical
collaborators' ability to successfully develop and commercialize
drug candidates, competition from other pharmaceutical companies,
product pricing and third-party reimbursement. A complete
description of risks and uncertainties related to our business is
contained in our periodic reports filed with the Securities and
Exchange Commission including our Form 10-K for the year ended
December 31, 2022, and our Form 10-Q for the quarter ended
September 30, 2023. These forward-looking statements are made only
as of the date hereof, and we disclaim any obligation to update any
such forward-looking statements.
Contacts
MEDIA:Claire LaCagninaBliss Bio
Health315-765-1462clacagnina@blissbiohealth.com
INVESTORS:Chad KoleanChief Financial
Officerinvestors@cellectar.com
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