On June 26, 2023 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat metastatic breast and gynecological cancers harboring ESR1 mutations, reported that an article analyzing its use of both traditional enrollment methods and a just-in-time model for its Phase 2 ELAINE-2 clinical trial was published in JCO Clinical Cancer Informatics (JCO CCI) (Press release, Sermonix Pharmaceuticals, JUN 26, 2023, View Source [SID1234632934]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The article, "Operational Metrics for the ELAINE-2 Study Combining a Traditional Approach with a Just-in-TIME Model," details Sermonix’s use of two distinct enrollment methods for its second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study, which recruited patients from 2020-2021. One method was a traditional approach that included site selection, institutional review board (IRB) and contract approval, and trial activation prior to a patient being identified for enrollment. The second method used the Tempus TIME Trial Network that would rapidly open the trial, at the site of care, after identifying a patient with a mutation of interest and eligibility for the trial. Sermonix was able to leverage Tempus’ network of individual clinical sites that use a pre-approved clinical trial agreement and regulatory process, as well as a central IRB.

"Sermonix’s collaboration with Tempus for ELAINE-2 trial proved to be a great success story, allowing us to more rapidly and efficiently recruit eligible patients from a wider area, rather than relying only on traditional sites," said Paul Plourde, M.D., vice president of oncology clinical development at Sermonix. "Based on these results, we are again thrilled to work with Tempus in our registrational Phase 3 ELAINE-3 study."

ELAINE-2 enrolled 29 patients over 8.5 months, besting its anticipated enrollment period of 12-18 months. Six traditional and 10 TIME Trial sites participated. The duration for full clinical trial agreement execution averaged 200.5 days for traditional sites, compared to 7.6 days for TIME Trial sites. Average IRB approval time was 27.5 days and three days respectively. Average time from study activation to first consent was 33.3 days and 8.8 days respectively. The first seven patients enrolled were at TIME Trial sites and the first patient was on-study 115 days before a traditional site equivalent. Traditional sites consented 23 patients and enrolled 16, while TIME trial sites consented 16 and enrolled 13.

"So many prospective patients want to participate in clinical trials but do not live close enough to the major academic medical centers that traditionally serve as investigational sites," said Plourde. "The just-in-time model provides an important opportunity to a greater diversity of patients. These results demonstrate the value of employing both models for biomarker-driven studies."

Tempus is an industry leader analyzing multimodal data to identify actionable clinical trial options for cancer patients. Through its TIME Trial Network, 1,500 oncologists and their patients have access to a large portfolio of cutting-edge precision medicine trials.

"The ELAINE-2 study is a great example of how Tempus’ platform can identify patients for these biomarker-driven studies and then rapidly activates sites closer to home in a fraction of time it has historically taken," said Matthew Cooney, M.D., vice president of therapeutic development, oncology, at Tempus. "This approach creates greater access to cutting-edge, investigational therapies to patients around the country while also accelerating study times."

ELAINE-3 is a registrational Phase 3 clinical study comparing targeted lasofoxifene, Sermonix’s lead investigational drug, in combination with Eli Lilly and Company’s CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

JCO CCI is an online-only, interdisciplinary journal publishing clinically relevant research based on biomedical informatics methods and processes applied to cancer-related data, information, and images.

Sermonix’s article is an open-access submission. To read the published article, visit JCO CCI’s website. To learn more about the ELAINE studies, visit ElaineStudy.com.

About Lasofoxifene

Lasofoxifene 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.