On May 27, 2025 REVEAL GENOMICS, S.L., a biotechnology company advancing precision oncology through biomarker innovation, reported the presentation of four independent studies at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, REVEAL GENOMICS, MAY 27, 2025, View Source [SID1234653421]). The studies, involving more than 800 patients, evaluated the clinical utility of its flagship test, HER2DX, in early-stage HER2-positive (HER2+) breast cancer.

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 four studies, CompassHER2 pCR, BionHER, RESPECT and DFCI, validate HER2DX as a powerful genomic tool for predicting response to therapy and long-term prognosis, addressing critical questions. The findings, which provide valuable insights for optimizing treatment strategies in early-stage HER2+ breast cancer and metastatic breast cancer, will be shared in oral and poster sessions led by academic investigators from the U.S., Europe, and Japan.

CompassHER2 pCR or EA1181 (U.S.): HER2DX determining response to THP-based de-escalated therapy

This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1,400 member institutions in the U.S. and around the world.

HER2DX was evaluated as a secondary aim as part of a pre-specified, prospectively planned analysis embedded in the CompassHER2 pCR trial, also known as EA1181 (NCT04266249). This large, prospective multicenter phase II trial is assessing neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in more than 2,000 patients with stage II–III HER2+ breast cancer, without the use of anthracyclines, cyclophosphamide, and carboplatin. The HER2DX assay was defined as a key secondary endpoint, with profiling of all available baseline samples planned.

Among 569 patients assessed to date for the HER2DX pathologic complete response (pCR) score, those with higher scores achieved significantly greater pCR rates, independent of estrogen receptor (ER) status. These findings confirm the ability of HER2DX to identify tumors more likely to respond to THP. Importantly, additional results are expected from this trial, as patients continue to be followed for the primary endpoints of 3-year survival outcomes, and the study team plans to profile many more baseline samples.

"The ability to predict response to THP is extremely valuable," said Dr. Nadine Tung, Director of Breast Medical Oncology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and Principal Investigator of the CompassHER2 pCR (EA1181) trial. "HER2DX provides a biology-driven tool that contributes to the selection of patients who can safely reduce chemotherapy, something we’ve long needed in HER2-positive early breast cancer."

"It is encouraging to see the assay’s performance in both ER-positive and ER-negative subgroups," added Dr. Tung. "The plan is to profile all available samples from the trial, and these early data already provide valuable insights for guiding treatment selection."

BionHER trial (Spain): Validation of HER2DX-guided de-escalation strategy

The BionHER phase II trial (NCT05912062) evaluated HER2DX in 83 patients with stage I–III HER2+ breast cancer treated with neoadjuvant THP for up to 15 weeks at the Catalan Institute of Oncology (ICO L’Hospitalet, Barcelona, Spain). HER2DX was successfully performed in all baseline FFPE tumor samples.

The HER2DX pCR score was significantly associated with pCR with a performance AUC of 0.835. Patients classified by HER2DX pCR score into low, medium, and high groups had increasing pCR rates of 13.3%, 51.6%, and 81.8%, respectively. HER2DX outperformed traditional biomarkers, such as ER, Ki-67, and tumor-infiltrating lymphocytes, in predicting pCR.

"HER2DX is transforming the way we approach treatment selection in HER2-positive disease," said Dr. Sònia Pernas, head of the breast cancer unit at ICO L’Hospitalet, and Principal Investigator of the BionHER study. "By identifying tumors more likely to respond to dual HER2 blockade with a single taxane, we are increasingly able to personalize treatment intensity without compromising efficacy."

RESPECT trial (Japan): a response for an unrepresented population

Trans-RESPECT is a prespecified translational analysis within the Japanese RESPECT non-inferiority trial (NCT01104935), in which 266 patients aged 70–80 years with stage I-III HER2+ breast cancer were randomized to receive adjuvant trastuzumab with or without chemotherapy (Sawaki et al. J Clin Oncol 2020). HER2DX was assessed in 154 of these patients, with a median follow-up of 9.1 years. The HER2DX risk score effectively stratified patients by 10-year relapse-free survival (86.6% in the low-risk group vs. 68.4% in the high-risk group) and overall survival (94.5% vs.72.5%). Notably, chemotherapy conferred an overall survival benefit only in tumors classified as pCR-high by HER2DX, with a significant interaction p-value of 0.045.

"HER2DX provided clear long-term prognostic information in this elderly population," said Dr. Kazuki Nozawa, Lead Investigator of Trans-RESPECT, from the Department of Advanced Clinical Research and Development and the Department of Breast Surgery at Nagoya City University Graduate School of Medical Sciences. "Importantly, its ability to help identify which patients may benefit from adjuvant chemotherapy is highly relevant to clinical decision-making. Older patients with HER2DX low-risk scores, particularly those classified as pCR-low or -medium, appear to be ideal candidates for trastuzumab alone, without chemotherapy."

DFCI T-DXd study (U.S.): predicting survival outcome to T-DXd

Dana-Farber Cancer Institute (DFCI) conducted a retrospective analysis of 41 patients with metastatic breast cancer (25 HER2-positive, 16 HER2-negative) treated with trastuzumab deruxtecan (T-DXd) monotherapy between 2017 and 2023. The HER2DX HER2 signature score was significantly associated with time to next treatment (p=0.001). When stratified into tertiles, patients in the highest tertile had a median time to next treatment of 12.03 months compared to 4.7 months in the lowest tertile (p=0.02).

"Quantitative measurement of HER2 amplicon expression by HER2DX is a key determinant of T-DXd activity in metastatic breast cancer," said Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. She added, "Further evaluation of this genomic test in ongoing T-DXd trials is warranted."

HER2DX makes a significant impact at ASCO (Free ASCO Whitepaper) 2025

"ASCO 2025 marks a pivotal milestone for HER2DX," said Dr. Aleix Prat, Chief Scientific Officer and co-founder of REVEAL GENOMICS. "This test is demonstrating clinical value in real-world practice across continents and care settings, assisting in the tailoring of chemotherapy intensity in the neoadjuvant setting and supporting chemotherapy-free decisions in the adjuvant setting."

Patricia Villagrasa, CEO and co-founder, added, "HER2DX was developed with HER2+ disease at its core, and these four high-quality, independent studies reinforce its clinical value. As we continue to grow globally, this is a clear example of how REVEAL GENOMICS is turning cutting-edge science into meaningful solutions that advance personalized cancer care worldwide."

About HER2DX

HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.

On May 27, 2025 BostonGene, a leader in AI-powered solutions for drug discovery and development, reported that six abstracts have been accepted at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), scheduled to take place May 31 – June 3, 2025, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, MAY 27, 2025, View Source [SID1234653420]). BostonGene will also exhibit at booth #15147.

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!

BostonGene will showcase the impact of its validated, multimodal AI platform, which combines deep molecular profiling, immune system characterization and advanced analytics to accelerate and de-risk oncology drug development. Across six accepted studies—conducted independently and in collaboration with leading academic institutions—BostonGene will demonstrate how its platform uncovers novel biomarkers, refines patient stratification and predicts therapeutic response across a range of tumor types. Presentations will highlight advancements in transcriptomic analysis, immune microenvironment profiling, histomolecular subtyping and blood-based predictors—key tools for improving clinical trial design and driving precision treatment strategies.

Details about the abstracts selected for presentation can be found below:

Abstract number: 11536
Title: Molecular subtyping and insights into sarcoma biology and prognosis
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Nikita Kotlov, BostonGene

In this study, BostonGene’s multiomic Tumor PortraitTM test was used to identify distinct molecular patterns in various sarcoma subtypes that correlated with survival outcomes. These findings demonstrate the potential clinical impact of advanced analytics paired with molecular sequencing in diverse diseases such as sarcoma.

Abstract number: 1049
Title: Macroscale Genomic Alterations in Histomolecular Invasive Lobular Carcinoma Compared to Other Breast Cancer Subtypes
Date & time: June 2 | 9:00 AM – 12:00 PM
Presenter: Jason Mouabbi, MD, The University of Texas MD Anderson Cancer Center

In collaboration with MD Anderson, BostonGene used its advanced analytic platform to identify unique histologic and molecular findings in invasive lobular carcinoma (ILC), a subtype of breast cancer for which treatment options are often inferred. Profiling of over 600 patients resulted in the discovery of biologic mechanisms and alterations that could direct future therapeutic and drug development strategies.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 11561
Title: Detecting hotspots of intra- and transchromosomal fusions in liposarcomas by RNA sequencing
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Lev Bedniagin, MD, BostonGene

Leveraging BostonGene’s extensive internal cohort and advanced sequencing technologies, this study conducted transcriptome analysis of Liposarcoma (LPS) samples, revealing novel hotspots of gene fusions in LPS patients. These discoveries can be used to improve diagnostic accuracy and the development of novel therapeutics in LPS and similar diseases.

Abstract number: 4198
Title: Uncovering the Tumor Microenvironment (TME): Exploring survival and immunotherapy (IO) response in Cancer of Unknown Primary (CUP)
Date & time: May 31 | 9:00 AM – 12:00 PM
Presenter: Joelle Allam, MD, The Texas University MD Anderson Cancer Center

In this study, BostonGene utilized its Tumor PortraitTM test to characterize Cancer of Unknown Primary (CUP). The analysis revealed correlations of clinical factors, the tumor microenvironment and immunotherapy response with survival outcomes, offering new insights into this challenging and poorly defined cancer.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 2634
Title: Tertiary lymphoid structures and their association with immune checkpoint inhibitor response and survival outcomes in patients with non-small cell lung cancer
Date & time: June 2 | 1:30 PM – 4:30 PM
Presenter: Lev Bedniagin, MD, BostonGene

Leveraging BostonGene’s AI-driven Kassandra deconvolution algorithm to analyze transcriptomic data from patients with non-small cell lung cancer, this study identified unique tertiary lymphoid structures within the tumor microenvironment that may serve as predictive and prognostic biomarkers, enhancing the efficacy of immune checkpoint inhibitor therapy.

ONLINE ONLY:
Title: The impact of PTEN deletion, TMPRSS2:ERG fusion, and androgen receptor variant 7 (AR-V7) on resistance to novel hormone therapies (NHTs) in castrate-resistant prostate cancer

This study demonstrated the clinical utility of the BostonGene Tumor PortraitTM test in guiding treatment selection for castrate-resistant prostate cancer based on tumor microenvironment-related gene signatures. These findings underscore the importance of precision medicine in managing cancer subtypes that are resistant to traditional interventions.

For more information, please visit the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

On May 27, 2025 Bayer reported new post-hoc analyses from the investigational Phase III ARANOTE trial showed a clinically meaningful improvement in health-related quality of life (HRQoL) and delayed pain progression for metastatic castration-sensitive prostate cancer (mCSPC) patients treated with NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) versus patients treated with placebo plus ADT (Press release, Bayer, MAY 27, 2025, View Source [SID1234653419]). The results will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois on June 3, 2025.

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!

NUBEQA extended the time to deterioration in the Functional Assessment of Cancer Therapy–Prostate (FACT-P) total score, a prespecified exploratory endpoint acting as a measure of overall well-being, by 5.1 months compared to placebo, with a median of 16.6 months versus 11.5 months (HR 0.76, 95% CI 0.61–0.93).1 Deteriorations in FACT-P subscales by ≥3 points were analyzed post hoc. The analysis showed that the clinically meaningful delay in deterioration of mCSPC patients HRQoL was driven by a longer time to deterioration in social and family well-being (HR 0.79, 95% CI 0.64–0.98), functional well-being (HR 0.78, 95% CI 0.63–0.96) and urinary symptoms (HR 0.78, 95% CI 0.61–0.99).1 NUBEQA also extended the time to pain progression compared to placebo (HR 0.72, 95% CI 0.54–0.96), as assessed using the Brief Pain Inventory-Short Form (BPI-SF) with pain progression defined as an increase of ≥2 points in BPI-SF worst pain score (WPS) observed at two consecutive evaluations or an initiation of opioid use for ≥7 consecutive days. Results were consistent with the established safety profile, with similar incidences of treatment-emergent adverse events versus placebo.1

NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2

Prostate cancer is the second most common cancer in men.3 Only 30% of those diagnosed with mCSPC will survive five years or more after diagnosis.4 Most people with mCSPC eventually progress to mCRPC, a condition with limited long-term survival.5,6

"These results from the ARANOTE trial highlight the potential of darolutamide to not only extend radiographic progression-free survival for patients with metastatic castration-sensitive prostate cancer, but to do so while creating clinically meaningful delays in deterioration of quality of life compared to ADT alone," said Alicia K. Morgans, M.D., Dana-Farber Cancer Institute, Boston. "The ability to maintain social, family, and functional well-being, along with managing urinary symptoms and delaying pain progression, are important to patients with metastatic castration-sensitive prostate cancer."

"These findings underscore the ability of NUBEQA to extend radiographic progression free survival and support quality of life for patients facing metastatic castration-sensitive prostate cancer," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "These results reflect our unwavering commitment to redefining prostate cancer care and enhancing patient outcomes at various stages of the disease. By focusing on innovative therapies that address the comprehensive needs of cancer patients, we aim to improve their overall treatment experience."

About the ARANOTE Trial7
The ARANOTE trial (NCT04736199) is a Phase III, randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of NUBEQA in combination with standard ADT in patients with mCSPC. A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (n=446) or placebo (n=223) twice daily in addition to ADT.

The primary endpoint of the ARANOTE trial was rPFS, measured as the time from randomization to the first documented radiological disease progression or death due to any cause, whichever occurs first. The results from this pivotal Phase III ARANOTE trial demonstrated a statistically significant improvement in rPFS with a 46% reduction in the risk of radiologic progression or death (HR 0.54; 95% CI: 0.41-0.71; P<0.0001) compared to placebo plus ADT.8

About NUBEQA (darolutamide)2
NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions
Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mCSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions
In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions
Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Castration-Sensitive Prostate Cancer
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3,9 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.10,11

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this castration-sensitive disease. Approximately 10% of men will already present with mCSPC when first diagnosed.12,13,14 Men with mCSPC will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mCSPC will eventually progress to mCRPC, a condition with limited survival.

On May 27, 2025 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, reported that the Company will be participating in the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 30 to June 2, McCormick Place, Chicago, IL, USA (Press release, MEDIAN Technologies, MAY 27, 2025, View Source [SID1234653418]).

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!

Median’s team will be hosting interested parties at booth #11046, South Building, Hall A, McCormick Place, from May 31 to June 2 (exhibit dates), from 9:00 am to 5:00 pm CT, where it will share the most recent advances for its central and AI-powered imaging services for oncology clinical trials.

Median Technologies’ abstracts selected for online publication are available on the ASCO (Free ASCO Whitepaper) platform:

Abstract e24073: Technical Performance of the L3 Skeletal Muscle Index in CT

Abstract e13590: Using tumor growth modeling and informed neural networks as early predictive clinical endpoints

Median will host two 30-minute presentation sessions on how the Company’s new solution for radiopharmaceutical image processing is advancing oncology research. Sessions will take place at booth #11046 on Saturday, May 31 and Sunday, June 1, 11:30 am -12:00 pm CT.

The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s premier oncology conference, organized by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the largest oncology society in the world. Each year, the ASCO (Free ASCO Whitepaper) conference brings together more than 35,000 oncologists from all around the globe, and is attended by all medical, educational and industrial stakeholders involved in the field of oncology worldwide. More about the ASCO (Free ASCO Whitepaper) Annual Meeting: View Source

On May 27, 2025 Global pharma major Lupin Limited (Lupin) reported it will present data from its Phase 1a clinical trial evaluating LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois, from May 30 to June 3, 2025 (Press release, Lupin, MAY 27, 2025, View Source;annual-meeting-2025-302465586.html [SID1234653417]). The presentation titled ‘A phase 1 dose escalation study of LNP7457 (PRMT5 inhibitor) in patients with advanced or metastatic solid tumors,’ will be featured in the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session. It can be viewed at Poster Board #422 on June 2, 2025, from 1.30 pm to 4.30 pm (CDT).

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!

Key findings from the study include:

LNP7457 is generally safe and well tolerated in patients with advanced or metastatic solid tumors, with desirable PK/PD profile and no impact of food on the pharmacokinetics.
The maximum tolerated dose, recommended phase 2 dose was determined based on safety, efficacy, PK/PD data, aligning with preclinical findings and the known safety profile of PRMT5 inhibitors.
"We are delighted to share the initial results from Phase I study of our PRMT5 Inhibitor, a novel epigenetic onco-therapeutic targeted for monotherapy. We are committed to innovation and advancing cutting-edge science to offer meaningful therapeutic options for patients with difficult-to-treat cancers," said Vinita Gupta, CEO, Lupin.

Current data from Lupin indicates that LNP7457 is unique within its field and appears to be safe and well-tolerated as a SAM-competitive PRMT5 inhibitor. Lupin will continue to study the efficacy of LNP7457 in its phase 1b trial in India and explore its potential for treatment of cancers with significant unmet medical needs.

Details of the Presentation:

Date and time: June 2, 2025, 1:30 pm – 4:30 pm (CDT)
Location: Hall A – Posters and Exhibits | McCormick Place, Chicago, IL
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Sub Track: Small Molecules
Clinical Trial Registration Number: CTRI/2023/07/054753
Doi: 10.1200/JCO.2025.43.16_suppl.3107
Abstract Number: 3107
Poster Board Number: 422
Abstract link: View Source