Sunesis Pharmaceuticals Announces Data from Ongoing Phase 1b/2 Trial of Vecabrutinib in Patients with CLL and Other B-Cell Ma...
06 December 2019 - 3:41AM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced
data from the Company’s Phase 1b/2 clinical trial of its
non-covalent BTK inhibitor vecabrutinib in adults with
relapsed/refractory chronic lymphocytic leukemia (CLL) and other
B-cell malignancies. The results will be presented on Sunday,
December 8, from 6:00-8:00 p.m. ET in a poster session
titled “CLL: Therapy, excluding Transplantation: Poster II” at the
60th American Society of Hematology (ASH) Annual Meeting
in Orlando, Florida. The poster, titled “Ongoing Results
of a Phase 1b/2 Dose Escalation and Cohort-Expansion Study of
the Selective, Noncovalent, Reversible Bruton’s Tyrosine Kinase
Inhibitor, Vecabrutinib, in B-Cell Malignancies,” Abstract No.
3041, will be available at www.sunesis.com on Sunday.
The data are being disclosed in advance of the
ASH meeting due to an unauthorized disclosure of the poster on
social media this morning.
“The data are encouraging, with vecabrutinib
showing evidence of clinical activity in high-risk patients
resistant to covalent BTK inhibitors, in both wild-type and
C481-mutated BTK disease,” said Dayton Misfeldt, Interim Chief
Executive Officer of Sunesis. “Vecabrutinib is very well tolerated
at the dose levels studied thus far, with patients now being
treated in the 400 mg cohort. We are prepared for Phase 2
expansion, which will focus on BTK inhibitor-resistant CLL/SLL
patients and those with prior intolerance to other BTK
inhibitors.”
Data reported today were from 29
relapsed/refractory patients treated in Cohorts 1 to 5 (25 mg to
300 mg). These included 23 patients with CLL, three with
Waldenstrom macroglobulinemia (WM), two with mantle cell lymphoma
(MCL), and one with marginal zone lymphoma (MZL). Patients had
received an average of 4 lines of prior therapy, and all had
progressed on prior BTK inhibitor therapy; 61% of the CLL patients
had a BTK C481 mutation.
The poster builds vecabrutinib’s profile in four key areas:
- Safety: The most common
treatment-emergent adverse events (TEAEs) of any grade were anemia
(35%), headache (28%), and night sweats (24%). Headache and nausea
(both 10%) were the two most common drug-related TEAEs. To date, no
drug-related Grade 3 or Grade 4 TEAEs have been observed at dose
levels higher than 50 mg.
- Activity: Clinical benefit has been observed
in covalent BTK inhibitor-resistant patients with poor prognostic
features and in both wild-type and C481-mutated BTK disease. In the
300mg dose group (Cohort 5), stable disease was observed in 3 of 5
patients, and two remain on treatment in Cycle 5 and Cycle 6,
including a wild-type BTK CLL patient with -40% change in tumor
burden at first scan. In addition, one patient from Cohort 3
remains on study in Cycle 12, having been dose escalated twice from
their initial dose of 100 mg to their current dose of 300 mg.
- Pharmacokinetics: Vecabrutinib showed
sustained exposure over the dosing interval with both exposure and
median steady-state minimum blood plasma concentration (Cmin)
increasing with dose. On Day 8, steady-state median Cmin values
were 75 ng/mL (Cohort 1, n=3), 451 ng/mL (Cohort 2, n=10), 873
ng/mL (Cohort 3, n=4), 1124 ng/mL (Cohort 4, n=4), and 1950 ng/mL
(Cohort 5, n=5).
- Pharmacodynamics: Vecabrutinib’s
pharmacodynamic effects (reductions in chemokines CCL3 and CCL4)
increased with dose in CLL patients and indicate increased impact
on BTK signaling as dose is escalated.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company
developing novel targeted inhibitors for the treatment of
hematologic and solid cancers. Sunesis has built an experienced
drug development organization committed to improving the lives of
people with cancer. The Company is focused on advancing its novel
kinase inhibitor pipeline, with an emphasis on its oral
non-covalent BTK inhibitor vecabrutinib. Vecabrutinib is currently
being evaluated in a Phase 1b/2 study in adults with chronic
lymphocytic leukemia and other B-cell malignancies that have
progressed after prior therapies.
For additional information on Sunesis, please
visit www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements related to Sunesis’ continued
development of vecabrutinib, including the timing of Phase 1b/2
trial of vecabrutinib and the therapeutic potential of
vecabrutinib, further development and potential of its kinase
inhibitor pipeline, and sufficiency of its cash resources and
financial position. Words such as “expect,” “will,” “look forward,”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
Sunesis' current expectations. Forward-looking statements involve
risks and uncertainties. Sunesis' actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties. These and other risk factors are discussed under
"Risk Factors" in Sunesis' Quarterly Report on Form 10-Q for the
quarter ended September 30, 2019 and Sunesis' other
filings with the Securities and Exchange Commission. Sunesis
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Sunesis' expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
Investor and Media Inquiries: Maeve Conneighton Argot Partners
212-600-1902 |
Willie Quinn Sunesis Pharmaceuticals Inc. 650-266-3716 |
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