Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, or the
“Company”, Nasdaq: OLMA), a clinical-stage biopharmaceutical
company focused on the discovery, development and commercialization
of targeted therapies for women’s cancers, today announced results
from a Phase 2 clinical study of palazestrant (OP-1250), the
Company’s complete estrogen receptor (ER) antagonist (CERAN) and
selective ER degrader (SERD), for the treatment of metastatic
ER+/HER2- breast cancer. These results were presented in an oral
presentation at the European Society for Medical Oncology (ESMO)
Congress 2023 in Madrid, Spain, on October 22, 2023.
The presentation, titled “Results from the phase 1/2 study of
OP-1250, an oral complete estrogen receptor (ER) antagonist (CERAN)
and selective ER degrader (SERD) in patients (pts) with advanced or
metastatic ER-positive, HER2-negative breast cancer”, highlighted
that:
- Across 86 heavily pretreated
patients, where 42% of patients were 4th line or later at study
entry, 120 mg once-daily, monotherapy palazestrant was well
tolerated and achieved a median progression-free survival (PFS) of
4.6 months and clinical benefit rate (CBR) of 40%, and a median PFS
of 5.6 months and CBR of 52% in patients with ESR1 mutations at
baseline.
- In a subset analysis of 49 second-
or third-line patients with or without prior chemotherapy (the
EMERALD trial eligibility criteria), the median PFS was 7.2 months
and CBR was 48% across all patients, and the median PFS was 7.3
months and CBR was 59% ESR1-mutant patients.
“These Phase 2 monotherapy study results demonstrate that
palazestrant (OP-1250) has the potential to become a best-in-class
endocrine therapy and improve upon current standard of care
treatments for women living with metastatic breast cancer. In
addition to being well-tolerated, palazestrant has demonstrated
compelling progression-free survival as monotherapy in a heavily
pretreated patient population,” said Sean P. Bohen, M.D., Ph.D.,
President and Chief Executive Officer of Olema Oncology. “Going
forward, we are in the process of initiating OPERA-01, our first
pivotal Phase 3 clinical trial testing palazestrant as monotherapy
in second- and third-line metastatic breast cancer.”
Phase 2 Clinical Study Results
Enrollment
As of the data cut-off of July 7, 2023, 86 patients with
recurrent, locally advanced or metastatic ER+/HER2- breast cancer
were treated at the Recommended Phase 2 Dose (RP2D) of 120 mg. The
group was heavily pretreated with 42% of patients being fourth-line
or later at study entry, 65% of patients having received two or
more prior lines of endocrine therapy for metastatic disease, and
31% having received prior chemotherapy. Almost all patients (97%)
received prior treatment with a cyclin-dependent kinase 4/6
(CDK4/6) inhibitor, and 66% received prior treatment with
fulvestrant. Of 75 patients whose circulating tumor DNA (ctDNA) was
assessed, 48% had activating mutations in ESR1 at baseline.
Pharmacokinetics
Palazestrant demonstrated favorable pharmacokinetics
characterized by high oral bioavailability, dose proportional
exposure and a long half-life of eight days, with steady-state
plasma levels showing minimal peak-to-trough variability, enabling
consistent inhibition of the ER for the full dosing interval.
Safety and Tolerability
Treatment with palazestrant at the RP2D of 120 mg was well
tolerated with no dose-limiting toxicities, and the maximum
tolerated dose (MTD) was not reached. The majority of
treatment-emergent adverse events (TEAEs) were Grade 1 or 2. Of the
86 patients treated, events of Grade 4 neutropenia were observed in
six patients, occurring approximately 4–6 weeks into therapy. Of
these patients, three had a dose interruption with recovery and
subsequent dose reduction (two continued at 90 mg and one continued
at 60 mg) without any recurrence, and three had dose
discontinuation followed by recovery. All six patients had prior
exposure to CDK4/6 inhibitors.
Efficacy
Across all 86 patients, the median PFS was 4.6 months and the
CBR was 40% with a 6-month PFS rate of 38%. In patients with an
ESR1 mutation, the median PFS was 5.6 months and the CBR was 52%
with a 6-month PFS rate of 46%. In ESR1 wild-type patients, the
median PFS was 3.5 months and the CBR was 32% with a 6-month PFS
rate of 35%.
In a subset analysis of 49 patients that received palazestrant
as a second- or third-line therapy with or without prior
chemotherapy (the EMERALD trial eligibility criteria), the median
PFS was 7.2 months and the CBR was 48% across all patients with a
6-month PFS rate of 54%. In patients with an ESR1 mutation, the
median PFS was 7.3 months and CBR was 59% with a 6-month PFS rate
of 62%. In ESR1 wild-type patients the median PFS was 5.5 months
and the CBR was 38% with a 6-month PFS rate of 44%.
Anti-tumor activity was observed in this heavily pretreated
population, with 40% of patients demonstrating reduction in target
lesions and evidence of activity in both ESR1 wild-type and
ESR1-mutant patients. Given the advanced and heavily pretreated
nature of the patients, many of these patients are expected to be
resistant to monotherapy endocrine treatment.
Company Investor Webcast and Conference
Call
Olema will host a webcast and conference call for analysts and
investors to review data presented at ESMO 2023 on Monday, October
23, 2023, at 8:00 a.m. ET (5:00 a.m. PT). Dr. Nancy Lin, Associate
Chief of the Division of Breast Oncology, Susan F. Smith Center for
Women’s Cancers, at the Dana-Farber Cancer Institute in Boston, MA,
will join Olema management for the call. Please register for the
webcast by visiting the Investors & Media section of Olema’s
website at olema.com.
A copy of the oral presentation is available on Olema’s website
under the Science section of the Olema website.
About Olema OncologyOlema Oncology is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of targeted therapies for women’s
cancers. Olema’s lead product candidate, palazestrant (OP-1250), is
a proprietary, orally-available small molecule with dual activity
as both a complete estrogen receptor (ER) antagonist (CERAN) and a
selective ER degrader (SERD). It is currently being evaluated both
as a single agent in an ongoing Phase 2 clinical trial, and in
combination with CDK4/6 inhibitors (palbociclib and ribociclib) and
a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally
advanced or metastatic ER-positive (ER+), human epidermal growth
factor receptor 2-negative (HER2-) breast cancer. Palazestrant has
been granted FDA Fast Track designation for the treatment of
ER+/HER2- metastatic breast cancer that has progressed following
one or more lines of endocrine therapy with at least one line given
in combination with a CDK4/6 inhibitor. Olema is headquartered in
San Francisco and has operations in Cambridge, Massachusetts. For
more information, please visit us at www.olema.com, or follow us on
Twitter and LinkedIn.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Words such as
“anticipate,” “expect,” “will,” “may,” “goal,” “potential” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These statements
include those related to the potential beneficial characteristics,
safety, tolerability, efficacy, and therapeutic effects of
palazestrant, the development of palazestrant, the initiation and
timing of clinical trials, palazestrant’s combinability with other
drugs, and the potential of palazestrant to become a best-in-class
endocrine therapy in the treatment of ER+/HER2- metastatic breast
cancer or improve upon the standard of care treatments for women
living with ER+/HER2- metastatic breast cancer. Because such
statements deal with future events and are based on Olema’s current
expectations, they are subject to various risks and uncertainties,
and actual results, performance or achievements of Olema could
differ materially from those described in or implied by the
statements in this press release. These forward-looking statements
are subject to risks and uncertainties, including, without
limitation, those discussed in the section titled “Risk Factors” in
Olema’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2023, and future filings and reports that Olema makes from time
to time with the U.S. Securities and Exchange Commission. Except as
required by law, Olema assumes no obligation to update these
forward-looking statements, including in the event that actual
results differ materially from those anticipated in the
forward-looking statements.
IR Contact:Geoffrey Mogilner, Vice President, Investor Relations
and Communicationsir@olema.com
Media Contact:Ignacio Guerrero-Ros, Ph.D., Russo
Partners646-942-5604ignacio.guerrero-ros@russopartnersllc.com
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