Preliminary Ongoing Results with CYT-0851 in Combination with Capecitabine or Gemcitabine in Advanced Solid Tumors Show Early Clinical Activity and Generally Well Tolerated Safety Profile
June 03 2023 - 9:00AM
Business Wire
- CYT-0851 has demonstrated early activity in
combination with capecitabine or gemcitabine in advanced solid
tumors and a generally well tolerated safety profile in a heavily
pretreated population of patients
- Overall disease control rate was 71.4% with
the capecitabine combination and 87.5% with the gemcitabine
combination
- Enrollment in the Phase 1 dose escalation
study continues with preliminary data expected in mid-2023
Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a clinical
stage oncology company, today presented results from a Phase 1
study with CYT-0851 in combination with capecitabine or gemcitabine
in a poster titled “Phase 1 Results of CYT-0851, a Monocarboxylate
Transporter (MCT) Inhibitor, in Combination with Capecitabine or
Gemcitabine in Advanced Solid Tumors” (Abstract: 3099, Poster: 297)
at the 2023 American Society of Clinical Oncology (ASCO) annual
meeting in Chicago, Illinois.
“We are encouraged by the preliminary data from the Phase 1 dose
escalation study with CYT-0851 in combination with capecitabine and
gemcitabine and are pleased that the safety profile of CYT-0851
continues to be generally tolerable even when combined with these
standard chemotherapy agents,” said Markus Renschler, MD, President
and Chief Executive Officer of Cyteir. “The Cyteir team is
diligently executing on the clinical development of CYT-0851 as a
potential combination therapy, and we look forward to sharing
preliminary data for all patients in these cohorts mid-year.”
Phase 1 Study Objectives
The primary objective of the ongoing Phase 1 study is to
determine the recommended Phase 2 dose and maximum tolerated dose
of CYT-0851 in combination with capecitabine or gemcitabine. Key
secondary objectives include evaluation of safety and tolerability,
determination of the pharmacokinetic parameters, optimal dosing
regimen for each combination and characterization of preliminary
anti-tumor activity of the combinations.
Phase 1 Study Preliminary Findings
The data presented in the poster are the first report of
preliminary results of an ongoing study.
As of the May 1, 2023 data cutoff, 22 patients were enrolled in
the capecitabine cohort across four dose-escalation cohorts from
100 mg to 400 mg once daily dose and 13 patients were enrolled in
the gemcitabine cohort across three dose-escalation cohorts from
100 mg to 300 mg once daily dose. Fourteen patients in the
capecitabine arm were response evaluable and eight patients in the
gemcitabine arm were response evaluable.
The recommended Phase 2 dose in the capecitabine combination is
400 mg once a day with no dose limiting toxicities observed. The
maximum tolerated dose in the combination of CYT-0851 with
capecitabine was not identified. The dose escalation of CYT-0851 in
combination with gemcitabine is ongoing and the study has cleared
the 200 mg dose.
Combination of CYT-0851 with capecitabine
- Seven ovarian cancer patients and seven pancreatic cancer
patients were response evaluable with RECIST measurements
available.
- There was one partial response in an ovarian cancer patient
with treatment ongoing in cycle 12 and nine patients had stable
disease (five pancreatic cancer patients and four ovarian cancer
patients).
- The overall disease control rate in the capecitabine
combination was 71.4%.
Combination of CYT-0851 with gemcitabine
- Five sarcoma patients, two pancreatic cancer patients and one
ovarian cancer patient were response evaluable.
- There was one confirmed partial response in a sarcoma patient
at month two and six patients with stable disease (three sarcoma
patients, two pancreatic patients and one ovarian cancer
patient).
- The overall disease control rate was 87.5%.
Safety:
- To date, CYT-0851 has exhibited a generally well tolerated
safety profile without unanticipated toxicities observed at
clinically active doses, and without exacerbation of the expected
toxicity from the chemotherapy combination partners.
- In the capecitabine cohort, 45.5% of patients reported adverse
events with 9.1% being grade 3/4. The most common treatment-related
adverse events were fatigue (27.3%), decreased appetite (13.6%) and
nausea (13.6%).
- In the gemcitabine cohort, 69.2% of patients reported adverse
events with 46.2% being grade 3/4. The most common
treatment-related adverse events were fatigue (38.5%), anemia
(23.1%) and neutropenia (23.1%).
- No dose-limiting toxicities were observed in any patients
treated with the combination of CYT-0851 and capecitabine.
- In the CYT-0851 plus gemcitabine combination cohorts, one
patient at the 300 mg level had dose-limiting hyperglycemia with
starvation ketoacidosis that resolved upon treatment interruption
and has not recurred upon rechallenge at a lower dose.
- No treatment related deaths have been reported, and no patients
experienced a treatment related adverse event that led to
discontinuation of CYT-0851.
About Cyteir Therapeutics, Inc.
Cyteir is a clinical-stage oncology company that is focused on
the development of CYT-0851, an oral investigational drug that
inhibits monocarboxylate transporters. Cyteir’s current priority in
CYT-0851 development is in combination with capecitabine and
gemcitabine in a Phase 1/2 clinical study, including patients with
advanced ovarian cancer. Follow Cyteir on social media: LinkedIn
and Twitter and at www.cyteir.com.
Forward-Looking Statements
This press release contains “forward-looking statements” about
Cyteir’s strategy, future plans, and prospects, including
statements regarding the development of CYT-0851, regulatory
strategy and path for CYT-0851, and the expected timing and
reporting of data for CYT-0851. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “likely,”
“may,” “might,” “plan,” “potential,” “project,” “seek,” “will,”
“would,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to: that Cyteir’s
clinical trials may fail to demonstrate adequately the safety and
efficacy of CYT-0851; that preclinical testing of CYT-0851 may not
be predictive of the results or success of clinical trials; that
the clinical development of CYT-0851 may be delayed or otherwise
take longer and/or cost more than planned; that Cyteir may be
unable to initiate, enroll or complete clinical development of
CYT-0851; that preliminary data may change as more patient data
become available and are subject to audit and verification
procedures that could result in material changes in the final data;
that the continuing global outbreak of COVID-19 (including any
resurgences or variants) may result in development or manufacturing
delays, supply shortages, or shortages of qualified healthcare
personnel; that synthetic lethality, as an emerging class of
precision medicine targets, could result in negative perceptions of
the efficacy, safety or tolerability of this class of targets,
which could adversely affect our ability to conduct our business,
advance our drug candidates or obtain regulatory approvals; and
that Cyteir’s compounds may not receive regulatory approvals or
become commercially successful products. These and other risks and
uncertainties are identified under the heading “Risk Factors” in
Cyteir’s most recent Annual Report on Form 10-K and other filings
Cyteir has made and may make with the Securities and Exchange
Commission ("SEC") in the future, available on the SEC's website at
www.sec.gov.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Cyteir does not undertake and specifically disclaims any obligation
to update any forward-looking statements.
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