Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq:
OLMA), a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of targeted therapies
for women’s cancers, today announced interim results from an
ongoing Phase 1b/2 clinical study of palazestrant (OP-1250) in
combination with CDK4/6 inhibitor ribociclib, a Poster Spotlight
Session on interim Phase 2 clinical data of palazestrant in
combination with palbociclib, and a trials-in-progress poster for
the OPERA-01 monotherapy Phase 3 pivotal trial at the San Antonio
Breast Cancer Symposium (SABCS) at the Henry B. Gonzalez Convention
Center in San Antonio, Texas. This disclosure was originally
planned for December 7, 2023. However, on December 5, 2023, the
2023 San Antonio Breast Cancer Symposium (SABCS) published the
posters ahead of schedule. These full data are scheduled to be
presented on December 7, 2023, and copy of the posters are
available now on Olema’s website under the Science section.
“We believe the results we are presenting at SABCS demonstrate
that palazestrant has key characteristics that make it a potential
best-in-class endocrine therapy for ER+/HER2- breast cancer:
complete antagonism of the estrogen receptor, favorable
tolerability and tumor response, and attractive combinability with
CDK4/6 inhibitors,” said Sean P. Bohen, M.D., Ph.D., President and
Chief Executive Officer of Olema Oncology. “OPERA-01, our Phase 3
monotherapy pivotal trial of palazestrant, has initiated, with
multiple trial sites now activated and patient dosing started. The
data we are gathering in our Phase 2 combination studies with
CDK4/6 inhibitors, ribociclib and palbociclib, support the
potential initiation of a pivotal first-line combination trial as
early as the end of 2024, bringing us closer to achieving our goal
of transforming the standard of care for women’s cancers.”
Palazestrant Phase 1b/2 Study in Combination with
Ribociclib: A poster titled “A Phase 1b/2 study of
palazestrant (OP-1250) in combination with ribociclib in patients
with estrogen receptor-positive, human epidermal growth factor
receptor 2-negative, advanced and/or metastatic breast cancer” will
be presented at SABCS. A more recent data cut, as of November 1,
2023, highlights the following:
- Across 19 patients who had completed
at least one cycle of treatment as of the data cutoff date, the
combination of up to 120 mg of palazestrant with 600 mg of
ribociclib daily was well tolerated, with no safety signals or
enhancement of toxicity and an overall safety profile remains
consistent with the expected safety profile of ribociclib plus an
endocrine therapy.
- Palazestrant did not affect
ribociclib drug exposure in patients, and ribociclib had no
clinically meaningful effect on palazestrant drug exposure.
- There were no dose-limiting
toxicities, the maximum tolerated dose was not reached, and the
majority of treatment-emergent adverse events were grade 1 or 2,
with no grade 4 events observed. Neutropenia was reversible in all
patients, and the timing was generally consistent with
ribociclib-related neutropenia.
- Findings from this study support the
continued use of palazestrant at the recommended Phase 2 dose of
120 mg in combination with 600mg of ribociclib, and enrollment in
the dose-expansion portion of the study is ongoing.
Palazestrant Phase 1b/2 Study in Combination with
Palbociclib: A poster titled “A Phase 1b/2 study of
palazestrant (OP-1250), an oral complete estrogen receptor
antagonist (CERAN) and selective ER degrader (SERD), with
palbociclib in ER-positive, HER2-negative, advanced or metastatic
breast cancer patients”, will be presented in a Poster Spotlight
Session by Prof. Arlene Chan, FRACP, MMed, Breast Cancer Research
Centre-WA, Curtin University, Breast Clinical Trials Unit,
Hollywood Private Hospital, Nedlands, Australia. The presentation
will highlight that:
- Across 46 patients as of the cutoff
date of September 15, 2023, the combination of palazestrant (120
mg) with palbociclib (125 mg) daily was well tolerated, with an
overall safety profile consistent with the expected safety profile
of palbociclib plus an endocrine therapy.
- There was no observed drug-drug
interaction between palazestrant and palbociclib, and there was no
induced metabolism or increase in exposure of either palbociclib or
palazestrant when administered in combination. Most
treatment-emergent adverse events were grade 1 or 2. Neutropenia
incidence was similar to the PALOMA-3 study; it was reversible in
all patients and the timing was generally consistent with the
palbociclib-related neutropenia.
- Tumor responses and prolonged
disease stabilization were observed in this patient group,
including in those previously exposed to CDK4/6 inhibitors, in both
ESR1 mutant and ESR1 wild-type tumors. Partial responses were
observed in seven patients, with two confirmed partial responses
and five unconfirmed partial responses. The clinical benefit rate
was 46% in all patients and 60% in patients with an ESR1 mutation
at baseline. In patients naïve to prior CDK4/6 inhibitor treatment,
the CBR was 71%. 53% of patients had any reduction in target lesion
size.
- Twenty-two (48%) patients remain on
treatment, and efficacy data are still maturing. Findings from this
study are consistent with previously reported data and support the
ongoing clinical development of palazestrant in combination with
CDK4/6 inhibitors for the treatment of ER+/HER2− metastatic breast
cancer.
OPERA-01 Phase 3 Monotherapy Trial: Olema will
present a poster titled “OPERA-01: A randomized, open-label, phase
3, study of palazestrant (OP-1250) vs standard-of-care treatment
for ER+, HER2- advanced or metastatic breast cancer after endocrine
and CDK4/6 inhibitor therapy”, that detailed the ongoing clinical
trial design, inclusion/exclusion criteria, and trial endpoints.
Please find more details at www.opera-01.com or
at clinicaltrials.gov (NCT06016738).
Company Investor Webcast and Conference
Call
Olema will host a webcast and conference call for analysts and
investors to review data presented at SABCS 2023 as well as other
ongoing studies tomorrow, Wednesday, December 6, 2023, at 8:00 a.m.
ET (7:00 a.m. CT). Please register for the webcast by visiting the
Investors & Media section of Olema’s website at olema.com.
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 3 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.
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, the potential of palazestrant to become a best-in-class
endocrine therapy in the treatment of ER+/HER2- metastatic breast
cancer or transform 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
September 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.
Contact:Geoffrey Mogilner, Vice President, Investor Relations
and Communicationsir@olema.com
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