Sermonix Pharmaceuticals Shares ASCO Poster Presentation on Longer Patient Follow-up Results for ELAINE-2 Study in ESR1-mutated Metastatic Breast Cancer
05 June 2023 - 11:01PM
Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical
company developing innovative therapeutics to specifically treat
metastatic breast cancers harboring ESR1 mutations, today broadly
shared a poster presentation detailing the results of its ELAINE-2
clinical study with longer patient follow-up. The poster was
initially presented yesterday at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting.
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+/HER2- locally advanced or 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+/HER2- metastatic
breast cancer and an ESR1 mutation. The PFS, a median of 13 months,
and ORR of 56% were promising.
“No new safety signals were noted when looking at lasofoxifene
and abemaciclib with longer patient follow-up,” said Paul Plourde,
M.D., vice president of oncology clinical development at Sermonix.
“The combination demonstrated meaningful antitumor activity, and
observed decreases in ESR1 ctDNA suggest potent target engagement.
We look forward to ELAINE-3 and the continued investigation of this
potentially practice-changing option for treating ESR1 mutations in
women with metastatic breast cancer.”
Noteworthy safety results:
- Lasofoxifene/abemaciclib was well tolerated with primarily
grade 1/2 treatment-emergent adverse events (TEAEs), most commonly
diarrhea, nausea, fatigue, and vomiting.
- Three patients (10.3%) had venous thromboembolic events, all
occurring after patients had achieved clinical benefit.
- One patient discontinued treatment due to grade 2 diarrhea, and
no deaths on treatment occurred.
- Abemaciclib underwent dose reduction once in 6 (20.7%)
patients; there were no dose reductions for lasofoxifene.
- There was no clinical evidence of any drug-drug interactions,
and no pK impact of lasofoxifene on abemaciclib or abemaciclib on
lasofoxifene exposure identified (data not shown).
Noteworthy efficacy results:
- Median PFS was 56.0 wks (~13 mos), CBR was 65.5%, and ORR was
55.6%; median overall survival was not estimable at the time.
- PFS rate (95% CI) was 76.1%, 56.1%, and 38.8% at 6, 12, and 18
mos respectively; 8 (27.6%) patients achieved PFS over 96
weeks.
- Of the four patients who had prior abemaciclib exposure, two
achieved clinical benefit, and one with RECIST progression at week
16 remained on study with stable disease until week 40.
- In 26 patients with evaluable baseline and week 4 ctDNA, ESR1
mutant allele fractions (MAF) decreased at week 4 in 21 (80.8%)
patients, including 14 (53.8%) whose ESR1 MAF were
undetectable.
- Antitumor activity of lasofoxifene/abemaciclib was not
compromised by co-occurring alterations that confer endocrine
resistance.
Sermonix in March initiated ELAINE-3, a registrational Phase 3
study of 400 patients assessing the efficacy of lasofoxifene and
abemaciclib. Enrollment will begin soon.
The company also convened meetings of its ELAINE-3 Steering
Committee and ELAINE-3 Translational Committee at ASCO 2023.
To learn more about Sermonix Pharmaceuticals and lasofoxifene,
visit https://sermonixpharma.com. To learn more about the ELAINE
studies, visit https://elainestudy.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 a CDK4/6 inhibitor 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, MSPH
Sermonix Product Manager
mkozlowski@sermonixpharma.com
860-692-8548
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