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Home News U.S. FDA approves Phase 3 Study Design for Zilovertamab in the
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U.S. FDA APPROVES PHASE 3 STUDY DESIGN FOR ZILOVERTAMAB IN THE TREATMENT OF
MANTLE CELL LYMPHOMA
By
Editorial Team
-
January 4, 2022
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Following a successful End-of-Phase 2 meeting Oncternal Therapeutics, a
clinical-stage biopharmaceutical company, and U.S. Food and Drug Administration
(FDA) reached a consensus on the design and major details of the Phase 3
superiority Study ZILO-301, to treat patients with relapsed or refractory mantel
cell lymphoma (MCL) with zilovertamab (previously known as cirmtuzumab and
UC-961) plus ibrutinib (Imbruvica®; Pharmacyclics/Janssen Biotech)
Zilovertamab is an investigational, potentially first-in-class monoclonal
antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1.
The drug is currently being evaluated in a Phase 1/2 clinical trial in
combination with ibrutinib for the treatment of MCL or chronic lymphocytic
leukemia (CLL), in a collaboration with the University of California San Diego
(UC San Diego) School of Medicine and the California Institute for Regenerative
Medicine (CIRM). In addition, Oncternal Therapeutics is supporting two
investigator-sponsored studies being conducted at the UC San Diego School of
Medicine, including a Phase 1b clinical trial of zilovertamab in combination
with paclitaxel for the treatment of women with HER2-negative metastatic or
locally advanced, unresectable breast cancer, and a Phase 2 clinical trial of
zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with
relapsed/refractory CLL.
Unmet medical need
Mantel cell lymphoma and chronic lymphocytic leukemia are cancers of B-cells
that can cause disabling constitutional symptoms including lymph node and/or
spleen/liver enlargement, and bone marrow infiltration. In turn, this causes
marrow failure, immune deficiency, morbidity, and early mortality.
In the United States approximately 4,200 and 21,000persons respectively are
diagnosed with MCL and CLL annually. There are currently no curative therapies.
Patients with MCL or CLL generally require successive rounds of therapy and
often develop refractory disease.
Advertisement #3
Ibrutinib (IMBRUVICA®) is an orally administered inhibitor of Bruton’s tyrosine
kinase, that has become a standard of care in the modern treatment of CLL and
MCL. However, most patients with CLL achieve only a partial response with
ibrutinib, which then must be administered continuously, resulting in a greater
potential for side effects, which is an enhanced health care burden for
patients, and substantial therapeutic costs. The proportion of patients with CLL
who achieve a complete response to ibrutinib after 12 months of therapy is below
10%.
In previously treated patients with MCL, rates of complete response range from
12.5% to 23%, even with long-term, continuous therapy. Resistance to ibrutinib
eventually develops in many patients with CLL and the great majority of patients
with MCL. Hence, a new therapeutic agent that increases the complete response
rate of CLL and MCL to ibrutinib is urgently needed.
Fig 1.0 – Zilovertamab (formerly called cirmtuzumab or UC-961) Mechanism of
Action.
Attractive target
ROR1 is a potentially attractive target for cancer therapy because it is an
onco-embryonic antigen – not usually expressed on adult cells, and its
expression confers a survival and fitness advantage when reactivated and
expressed by tumor cells. Researchers at the UC San Diego School of Medicine
discovered that targeting a critical epitope on ROR1 was key to specifically
target ROR1 expressing tumors. This led to the development of zilovertamab,
which binds this critical epitope of ROR1, which is highly expressed on many
different cancers but not on normal tissues.[1][2]
Preclinical data showed that when zilovertamab bound to ROR1, it blocked Wnt5a
signaling, inhibited tumor cell proliferation, migration, and survival, and
induced differentiation of the tumor cells. The FDA has granted Orphan Drug
Designations to zilovertamab for the treatment of patients with MCL and
CLL/small lymphocytic lymphoma.[1]
Consensus
Oncternal Therapeutics and the FDA agreed on key elements of the company’s
potentially pivotal Phase 3 clinical trial of zilovertamab for the treatment of
patients with relapsed or refractory mantle cell lymphoma (MCL). The FDA has
also reviewed and agreed upon the key design features and operational details of
the company’s Phase 3 clinical trial protocol and Statistical Analysis Plan,
which is being finalized based on the FDA’s input.
“The completion of End-of-Phase 2 meetings and consensus on clinical trial
design and other program elements mark a meaningful and encouraging milestone
for Oncternal Therapeutics,” said James Breitmeyer, MD, Ph.D., Oncternal’s
President and Chief Executive Officer.
“The agreement underscores our productive dialogue with the FDA on key elements
of our program and the Phase 3 clinical trial design as we align on the
potential path to commercialization for zilovertamab, which offers potential
advantages to patients suffering from aggressive lymphomas such as MCL. The
positive data from our ongoing Phase 1/2 CIRLL study recently presented at ASH
2021 underscore those advantages and are supportive of our registration
strategy,” Breitmeyer added.
Phase 3 Study: ZILO-301
Michael Wang MD, Endowed Professor in the Department of Lymphoma & Myeloma at MD
Anderson Cancer Center, will serve as the U.S. Principal Investigator and
Chairman of the steering committee for the new phase 3 superiority study
ZILO-301. The study randomizes patients with relapsed or refractory MCL who have
experienced stable disease or partial response after receiving four months of
oral ibrutinib therapy to receive either blinded zilovertamab or placebo, and
all patients will continue receiving oral ibrutinib.
The primary endpoint, intended to support submission of a Biologics License
Application (BLA) seeking regular FDA approval, will be progression-free
survival (PFS). An interim analysis potentially supporting submission of a BLA
seeking accelerated FDA approval will be conducted with a primary endpoint of
Overall Response Rate (ORR) plus Duration of Response (DOR). The FDA previously
provided positive feedback on the sufficiency of the preclinical and
pharmacology studies of zilovertamab needed to support a BLA submission.
The ZILO-301 study will be conducted internationally in at least 50 centers with
demonstrated expertise treating MCL, with initiation expected in the second
quarter of 2022. Sample size calculations are being finalized for this novel
enrichment study, based on input from the FDA.
Oncternal Therapeutics is also planning to conduct Study ZILO-302, an open-label
companion study of zilovertamab plus ibrutinib for patients who have progressive
disease during the initial four months of ibrutinib monotherapy from Study
ZILO-301.
Clinical trials
Extension Study of UC-961 (Cirmtuzumab) for Patients With Chronic Lymphocytic
Leukemia Treated Previously With UC-961 – NCT02860676
UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia –
NCT02222688
Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced,
Unresectable Breast Cancer – NCT02776917
A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid
Malignancies – NCT03088878
Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of
Zilovertamab (A ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in
Patients with Relapsed or Refractory Mantle Cell Lymphoma (ZILO-301)
Highlights of prescribing information
Ibrutinib (Imbruvica®; Pharmacyclics/Janssen Biotech)(Perscription Information)
Reference
[1] Zhang S, Zhang H, Ghia EM, Huang J, Wu L, Zhang J, Lam S, Lei Y, He J, Cui
B, Widhopf GF 2nd, Yu J, Schwab R, Messer K, Jiang W, Parker BA, Carson DA,
Kipps TJ. Inhibition of chemotherapy resistant breast cancer stem cells by a
ROR1 specific antibody. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1370-1377.
doi: 10.1073/pnas.1816262116. Epub 2019 Jan 8. PMID: 30622177; PMCID:
PMC6347692.
[2] Balakrishnan A, Goodpaster T, Randolph-Habecker J, Hoffstrom BG, Jalikis FG,
Koch LK, Berger C, Kosasih PL, Rajan A, Sommermeyer D, Porter PL, Riddell SR.
Analysis of ROR1 Protein Expression in Human Cancer and Normal Tissues. Clin
Cancer Res. 2017 Jun 15;23(12):3061-3071. doi: 10.1158/1078-0432.CCR-16-2083.
Epub 2016 Nov 16. PMID: 27852699; PMCID: PMC5440207.
Featured image: Low magnification micrograph of mantle cell lymphoma of the
terminal ileum. Endoscopic biopsy. H&E stain. Photo Courtesy: 2020. Nephron.
This file is licensed under the Creative Commons Attribution-Share Alike 3.0
Unported license.
WE RECOMMEND
1. U.S. FDA approves Phase 3 Study Design for Zilovertamab in the Treatment of
Mantle Cell Lymphoma
Editorial Team, Onco'Zine, 2022
2. Oncternal Therapeutics Announces Closing of an $18.4 million Series B
Financing.
Peter Hofland, ADC Review, 2017
3. Combination of Ibrutinib + Venetoclax Effective in Treatment of Mantle Cell
Lymphoma - Onco'Zine
Peter Hofland et al., Onco'Zine, 2023
4. Merck to Acquire VelosBio and Strengthens Oncology Pipeline with
Investigational Antibody-Drug Conjugates
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5. Study Confirms Ibrutinib Significantly Delays Disease Progression and
Extends Survival for Patients with Resistant or Relapsed CLL - Onco'Zine
Editorial Team et al., Onco'Zine, 2014
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