Sermonix Pharmaceuticals to Share Longer Patient Follow-up Results for ELAINE-2 in Poster Presentation at ASCO 2023
26 May 2023 - 7:00AM
Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical
company developing innovative therapeutics to specifically treat
metastatic breast and gynecological cancers harboring ESR1
mutations, today shared an abstract to be presented at the 2023
American Society of Clinical Oncology (ASCO) Annual Meeting
detailing the results of its ELAINE-2 clinical study with longer
patient follow-up. ASCO 2023 will be held June 2-6 at McCormick
Place in Chicago.
ELAINE-2 (NCT04432454), an open-label, Phase 2 Evaluation of
Lasofoxifene in ESR1 Mutations (ELAINE) study of Sermonix’s lead
investigational drug, lasofoxifene, in combination with Eli Lilly
and Company’s CDK4/6 inhibitor abemaciclib, evaluated 29 women with
ER+/HER- metastatic breast cancer and an ESR1 mutation. The primary
endpoint was safety/tolerability, with secondary endpoints
including progression-free survival (PFS) and overall response rate
(ORR). Earlier ELAINE-2 results were shared at ASCO 2022.
With patient follow-up through Jan. 31, 2023, the combination of
lasofoxifene and abemaciclib continued to be well-tolerated, with
clinically meaningful efficacy in women with ER+/HER- metastatic
breast cancer and an ESR1 mutation. The previously reported PFS, a
median of 13 months, and ORR of 50% were promising, with longer
term follow-up to be provided at ASCO 2023. Encouraging Phase 2
monotherapy and combination results in ELAINE-1 and ELAINE-2
respectively led Sermonix in March to initiate ELAINE-3, a
confirmatory Phase 3 randomized study. Enrolling 400 patients,
ELAINE-3 will again assess the efficacy of the combination of
lasofoxifene and abemaciclib compared to the combination of
fulvestrant and abemaciclib.
“Sermonix is pleased that the combination of lasofoxifene and
abemaciclib, which demonstrated compelling anti-tumor activity in
ELAINE-2, continued to be well-tolerated when observed through a
longer patient follow-up,” said Dr. David Portman, founder and
chief executive officer of Sermonix. “The results solidify our
team’s excitement for ELAINE-3 enrollment and continue to point to
a potential therapy with a favorable safety profile and the ability
to address a critical unmet need for women confronted with
metastatic breast cancer. We look forward to further discussing the
results at ASCO 2023.”
Details of Sermonix’s ASCO 2023 poster presentation are as
follows:
Abstract Title: Lasofoxifene (LAS) plus
abemaciclib (Abema) for treating ESR1-mutated ER+/HER2- metastatic
breast cancer (mBC) after progression on prior therapies: ELAINE 2
study update.
- Session Title: Breast Cancer—Metastatic
- Session Date and Time: June 4, 2023, 8-11 a.m.
CT
Sermonix will also convene meetings of its ELAINE-3 Steering
Committee and ELAINE-3 Translational Committee while at ASCO.
To learn more about Sermonix Pharmaceuticals and lasofoxifene,
visit https://sermonixpharma.com.
About LasofoxifeneLasofoxifene is an
investigational novel endocrine therapy in clinical development
which has demonstrated robust target engagement as an ESR1
antagonist in the breast, particularly in the presence of ESR1
mutations. Lasofoxifene has demonstrated anti-tumor activity as
monotherapy and in combination with abemaciclib in Phase 2 studies
and has unique tissue selectivity distinguishing it from other
current and investigational endocrine therapies, with beneficial
effects seen on vagina and bone in previous clinical studies.
Lasofoxifene, which Sermonix licensed globally from Ligand
Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous
comprehensive Phase 1-3 non-oncology clinical trials in more than
15,000 postmenopausal women worldwide. Lasofoxifene’s
bioavailability and activity in mutations of the estrogen receptor
could potentially hold promise for patients who have acquired
endocrine resistance due to ESR1 mutations, a common finding in the
metastatic setting and an area of high unmet medical need.
Lasofoxifene’s novel activity in ESR1 mutations was discovered at
Duke University and Sermonix has exclusive rights to develop and
commercialize the product in this area. Lasofoxifene, a novel
targeted and tissue selective oral endocrine therapy could, if
approved, play a critical role in the precision medicine treatment
of advanced ER+ breast cancer.
About SermonixSermonix Pharmaceuticals Inc. is
a privately held biopharmaceutical company focused on the
development of female-specific oncology products and is currently
undertaking two Phase 2 clinical studies of lasofoxifene, its lead
investigational drug. The Sermonix management team, led by founder
Dr. David Portman, has significant experience in all stages of the
drug development, regulatory and commercialization processes. Paul
Plourde, M.D., vice president of oncology clinical development, has
many decades of experience at AstraZeneca in the breast cancer drug
development arena. Barry Komm, Ph.D., chief scientific officer, is
recognized for his expertise in nuclear receptor biology. Miriam
Portman, M.D., is co-founder and chief operating officer, with
expertise in clinical trial conduct and patient recruitment.
Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development
officer, has extensive experience in pharmaceutical drug
commercialization. Simon Jenkins, Ph.D., vice president of
operations, has over 30 years of experience in global drug
development leadership. Sermonix non-executive chairman of the
board is Anthony Wild, Ph.D., former president of both Parke-Davis
Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn
more at SermonixPharma.com.
Sermonix Contact:Monica Kozlowski, MSPHSermonix
Product Managermkozlowski@sermonixpharma.com860-692-8548
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