ONCTERNAL THERAPEUTICS, INC. Item 8.01 Other Events.
On
As of the data cut-off date of
• Seven of the 12 evaluable patients achieved a complete response, for a
complete response ("CR") rate of 58%, determined by Cheson criteria. One of
the seven patients had a complete metabolic response ("CMR") by PET scan,
with an indeterminant bone marrow biopsy. Responses developed rapidly in
most patients, with four of the seven CRs documented after approximately
three months on the combination of cirmtuzumab and ibrutinib. All seven CRs
were ongoing, including one patient who has remained in CR at over 23 months
on study.
• The overall best objective response rate ("ORR") was 83%, including patients
who achieved a CR and three patients (25%) who achieved a partial response
("PR"). In addition, two patients had stable disease ("SD"), for a total
best clinical benefit rate (including CR, PR and SD) of 100%.
• Median progression-free survival ("PFS") was 17.5 months, with a median
follow-up of 8.3 months.
• Patients had received an average of 2.8 prior therapies (range 1-5) before
participating in this clinical trial, including four patients who had
received prior treatment with ibrutinib. Seven of the 12 evaluable patients
had high or intermediate Mantle Cell Lymphoma International Prognostic Index
("MIPI") risk score at study entry.
• Historical data published for single-agent ibrutinib for patients with MCL,
who had received more than one prior therapy, reported an ORR of 63%, CR
rate of 23% and median PFS of 10.3 months (Rule 2019 Haematologica).
As of the data cut-off date on
• Thirty of the 34 evaluable patients achieved a clinical response, for an
overall best ORR of 88%, including one patient (3%) who achieved a CR, and
29 patients (85%) who achieved a PR. In addition, four patients had stable
disease, for a total clinical benefit rate (including CR, PR, SD) of 100%.
• No patients progressed while in the study, and PFS was 100%, with a median
follow-up of 12.8 months.
• Twelve patients were treatment-naïve and 22 had relapsed/refractory CLL.
Patients with relapsed/refractory CLL had received an average of 2.6 prior
therapies (range 1-9) before participating in this clinical trial.
Cirmtuzumab as a single agent has been well tolerated in this study. The combination of cirmtuzumab plus ibrutinib has also been well tolerated, with adverse events consistent with those reported for ibrutinib alone. There have been no dose-limiting toxicities and no serious adverse events attributed to cirmtuzumab alone. Neutropenia of any grade occurred in six subjects (8.6%).
Cautionary Note Regarding Forward-Looking Statements
Oncternal cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. Forward looking statements include statements regarding Oncternal's beliefs, goals, intentions and expectations, and include: the potential of cirmtuzumab to treat ROR1 expressing cancers, and the potential for interim data results to be replicated or continue to show improved clinical efficacy as the ongoing trial continues. Forward looking statements are subject to risks and uncertainties inherent in Oncternal's business, which include, but are not limited to: the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available, including interim response results may not be confirmed by later assessments; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing product candidates such as cirmtuzumab and
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Oncternal's other product candidates, which could adversely impact the company's
ability to complete clinical trials and obtain regulatory approval for such
product candidates; Oncternal has encountered delays, and may encounter
additional delays or difficulties, in enrolling patients in its clinical trials
as a result of the COVID-19 pandemic; the COVID-19 pandemic may disrupt
Oncternal's business operations, increasing its costs; uncertainties associated
with the clinical development and process for obtaining regulatory approval of
cirmtuzumab and Oncternal's other product candidates, including potential delays
in the commencement, enrollment and completion of clinical trials; Oncternal's
dependence on the success of cirmtuzumab and its other product development
programs; the risk that the regulatory landscape that applies to the development
program for cirmtuzumab and the company's other product; comparisons to
historical ibrutinib data are based on unrelated clinical trials and does not
reflect results that might have been obtained from head-to-head studies,
including due to differences in study protocols, conditions and patient
populations; candidates may change, which could result in delays or termination
of development of such product candidates or unexpected costs in obtaining
regulatory approvals; the risk that competitors may develop technologies or
product candidates more rapidly than Oncternal, or that are more effective than
Oncternal's product candidates, which could significantly jeopardize Oncternal's
ability to develop and successfully commercialize its product candidates;
Oncternal's limited operating history and the fact that it has incurred
significant losses, and expects to continue to incur significant losses for the
foreseeable future; the risk that the company will have insufficient funds to
finances its operations after the third quarter of 2020 and may not be able to
obtain sufficient additional financing when needed or at all as required to
achieve its goals, which could force the company to delay, limit, reduce or
terminate its product development programs or other operations, and other risks
described in the company's prior public periodic filings with the
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