On May 30, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 31-June 4 in Chicago (Press release, Guardant Health, MAY 30, 2024, View Source [SID1234643892]).

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Featured presentations will share data supporting the utility of therapy response monitoring with circulating tumor DNA (ctDNA) using Guardant Infinity and the use of the GuardantINFORM clinical-genomic database to characterize drivers and resistance mechanisms and their association with real-world outcomes in a variety of solid tumor types. Additional studies will present data supporting the application of genomic and epigenomic biomarkers in areas such as minimal residual disease detection and cohort characterization.

"The robust data we present at ASCO (Free ASCO Whitepaper) will further demonstrate the important scientific and clinical developments in cancer care that are possible using liquid biopsy," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Several studies will highlight the tremendous potential of epigenomic analysis using our Guardant Infinity platform to quantify tumor fraction and characterize therapy resistance mechanisms in order to improve treatment response across multiple cancer types."

Featured presentations include:

An oral presentation of a study using the Guardant360 liquid biopsy and exploring racial differences in genomic profiles and targeted treatment use in ER+ HER2- metastatic breast cancer (Abstract 1017, Monday, June 3, 11:30 am – 1:00 pm, Hall D1)
Interim data readout from the collaboration between Guardant Health and the Parker Institute for Cancer Immunotherapy (PICI) to identify genomic and epigenomic biomarkers using Guardant Infinity for quantification of tumor fraction and association with outcomes from the RADIOHEAD real-world advanced pan-cancer cohort (Abstract 2570, Saturday, June 1, 9:00 am – 12:00 pm, Hall A)
Complete list of Guardant Health and collaborator presentations at ASCO (Free ASCO Whitepaper)

Abstract

Title (Hall A unless otherwise noted)

Product

Saturday, June 1 | 9:00 am – 12:00 pm

2570

Use of a tissue-free epigenomic circulating tumor DNA (ctDNA) assay for quantification of tumor fraction (TF) and association with outcomes from RADIOHEAD real-world advanced pan-cancer cohort

Guardant Infinity

3041

Association of KRAS G12D vs. G12V circulating tumor DNA variant allele fraction and real-world overall survival in metastatic non-small cell lung and colorectal cancers

Guardant Infinity

Saturday, June 1 | 1:30 pm – 4:30 pm

LBA3557

A randomized study evaluating tailoring of advanced/metastatic colorectal cancer (mCRC) therapy using circulating tumor DNA (ctDNA): TACT-D

Guardant360 CDx

3519

Candidate molecular alterations associated with potential resistance in KRAS G12D gastrointestinal cancers

Guardant360 & Guardant360/CDx

3602

Characteristics of patients (pts) with disease relapse despite absence of molecular residual disease (MRD) after resection of colorectal oligometastases (CRM): implications from PRECISION study

Guardant360 & Guardant Reveal

3545

Characterization of mutational signatures demonstrating adaptive mutability post anti-EGFR therapy in a real-world metastatic colorectal cancer cohort

GuardantINFORM

Sunday, June 2 | 9:00 am – 12:00 pm

1037

Molecular profiling of serial liquid biopsy specimens utilizing cell free DNA (cfDNA) and circulating tumor cells (CTCs) in TBCRC041: A phase II study of alisertib in endocrine resistant metastatic breast cancer (MBC)

Guardant Infinity

1043

Evaluating metrics of circulating tumor DNA response and progression using a high sensitivity tumor-agnostic assay in metastatic HR+/HER2- breast cancer receiving endocrine therapy and a CDK4/6-inhibitor

Guardant Infinity

1071

Real-world (RW) elacestrant use patterns and therapeutic outcomes in patients (pts) with hormone receptor-positive (HR+)/HER2-negative advanced breast cancer (aBC)

GuardantINFORM

5069

Dynamic androgen receptor alterations (ARa) ctDNA profiles and clinical outcomes in metastatic prostate cancer (mPC)

GuardantINFORM

Monday, June 3 | 9:00 am – 12:00 pm | Hall A

5592

Serial circulating tumor DNA (ctDNA) sequencing to monitor response and define acquired resistance to letrozole/abemaciclib in endometrial cancer (EC)

Guardant Infinity

Monday, June 3 | 11:30 am – 1:00 pm | Hall D1

1017

Rapid Oral Abstract Session: Racial differences in genomic profiles and targeted treatment use in ER+ HER2- metastatic breast cancer

Guardant360

Online only

e13097

Co-occurrence of ESR1 and PIK3CA mutations in HR+/HER2- metastatic breast cancer: Incidence and outcomes with targeted therapy

Guardant360 & Guardant360 CDx

e12566

Molecular profiling in ABC: Is complementary testing with tissue and plasma necessary and clinically relevant?

Guardant360

e13702

Utilization of circulating tumor DNA (ctDNA) testing by race and ethnicity in more than 135,000 patients

GuardantINFORM

e20088

Use of cell-free tumor DNA in early detection of lung cancer

Shield (next generation)

The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting can be found at the ASCO (Free ASCO Whitepaper) website.

For more information and updates from the meeting, follow Guardant Health on LinkedIn and X (Twitter) or visit ASCO (Free ASCO Whitepaper) booth #28115.

On May 30, 2024 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported that it will highlight its latest research insights through more than 145 presentations at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from Friday, May 31 – Tuesday, June 4 in Chicago, Ill (Press release, Sarah Cannon Research Institute, MAY 30, 2024, View Source [SID1234643891]). Over 100 investigators from across SCRI’s network are co-authors on clinical trial updates that will be showcased at the Annual Meeting, including data from more than 65 early-phase clinical trials.

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"We look forward to connecting with colleagues from around the world at ASCO (Free ASCO Whitepaper)’s Annual Meeting to discuss the latest developments in advancing therapies for cancer patients," says Howard A. "Skip" Burris, III, MD, President, SCRI. "The depth and breadth of clinical research being presented by SCRI experts signifies our commitment to accelerating drug development and providing greater access to cutting-edge therapies closer to home."

For a comprehensive list of abstracts and presentations, visit SCRI’s ASCO (Free ASCO Whitepaper) Site. To learn more about our research experts, visit our Leadership Page.

Noteworthy Presentations

Breast Cancer

Erika Hamilton, MD, SCRI, will present "H3B-6545 in Women with Locally Advanced/Metastatic Estrogen Receptor-Positive, HER2 Negative Breast Cancer" in an oral presentation during the Breast Cancer – Metastatic Rapid Oral Abstract Session on Monday, June 3 from 11:30 a.m. – 1:00 p.m. CDT in Hall D1.
Joyce O’Shaughnessy, MD, SCRI at Texas Oncology I The US Oncology Network, will deliver "Association of MammaPrint Index and 3-Year Outcome of Patients with HR+HER2- Early-Stage Breast Cancer Treated with Chemotherapy with or without Anthracycline" in an oral presentation during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. – 4:15 p.m. CDT in E451.
Denise Yardley, MD, SCRI, will give the oral presentation, "Baseline Characteristics and Efficacy Endpoints for Patients with Node-Negative HR+/HER2− Early Breast Cancer: NATALEE Trial" during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. – 4:15 p.m. CDT in E451.
Lung Cancer

David Spigel, MD, SCRI, will discuss "ADRIATIC: Durvalumab as Consolidation Treatment for Patients with Limited-Stage Small-Cell Lung Cancer" in an oral presentation during the Plenary Session on Sunday, June 2 from 1:00 p.m. – 4:00 p.m. CDT in Hall B1.
Clinical Trial Access

Ishwaria Subbiah, MD, MS, SCRI, will present "5-Year Multicenter Analysis of Clinical Trial Participation and Total Cost of Care for Older Adults with Cancer" in an oral presentation during the Quality Care/Health Services Research Rapid Oral Abstract Session on Monday, June 3 from 1:15 p.m. – 2:45 p.m. CDT in S102.
In addition to scientific presentations, SCRI leadership will participate in and lead ASCO (Free ASCO Whitepaper) sessions, including:

Meredith McKean, MD, MPH, SCRI, is a discussant in the Oral Abstract Session, Melanoma/Skin Cancers, on Friday, May 31 from 2:45 p.m. – 5:45 p.m. CDT in Hall D1, where she will present "PD-1–Refractory Advanced Melanoma: How Do We Get to the Finish Line?"
Dr. Burris will deliver the "Presentation and Recognition of Conquer Cancer Top Donors" in the Opening Session on Saturday, June 1 from 9:30 a.m. – 12:00 p.m. CDT in Hall B1.
Dr. Hamilton will chair the Clinical Science Symposium, Next-Generation Antibody-Drug Conjugates: The Revolution Continues, and present "The ABCs of ADCs: What Does the Future Hold?" on Sunday, June 2 from 9:45 a.m. – 11:15 a.m. CDT in Hall D1.
Abdul Naqash, MD, SCRI at OU Health – Stephenson Cancer Center, will chair the Oral Abstract Session, Developmental Therapeutics—Immunotherapy, on Monday, June 3 from 11:30 a.m. – 2:30 p.m. CDT in Hall D2.
Andrew McKenzie, PhD, SCRI & Genospace, and Vivek Subbiah, MD, SCRI, will serve as panelists in the Case-Based Panel, Beyond Tumor Types: Advancing Tumor-Agnostic Drug Development and the Role of the Tumor Microenvironment, on Monday, June 3 from 3:00 p.m. – 4:00 p.m. CDT in Hall D2.
Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute, will present "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma," during the Breaking Ground in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Novel Therapies Beyond PD-L1 Immunotherapy Education Session on Tuesday, June 4 from 8:00 a.m. – 9:15 a.m. CDT in S100a.
Additional Poster Presentations with SCRI First Authors

Saturday, June 1

"Validation of PD-L1 as a Predictive Biomarker of Response in Operable Gastroesophageal Adenocarcinoma: A Meta-Analysis and Meta-Regression of Neoadjuvant Chemoimmunotherapy Trials," Antonella Cammarota, MD, SCRI at HCA Healthcare UK, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"Phase 1 Trial Safety and Efficacy of Ragistomig, a Bispecific Antibody Targeting PD-L1 and 4-1BB, in Advanced Solid Tumors," Gerald Falchook, MD, SCRI at HealthONE, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"NALIRIFOX versus Nab-Paclitaxel and Gemcitabine in Treatment-Naïve Patients with Metastatic Pancreatic Ductal Adenocarcinoma: Updated Overall Survival Analysis with 29-Month Follow-Up of NAPOLI 3," Maen Hussein, MD, SCRI at Florida Cancer Specialists & Research Institute, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"Safety and Preliminary Efficacy of EIK1001 in Combination with Atezolizumab in Participants with Advanced Solid Tumors," & "Preliminary Results from a Phase 1 Study of AC699, an Orally Bioavailable Chimeric Estrogen Receptor Degrader, in Patients with Advanced or Metastatic Breast Cancer," Manish Patel, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Results from Phase 1a/1b Analyses of TTX-080, a First in Class HLA-G Antagonist, in Combination with Cetuximab in Patients with Metastatic Colorectal Cancer and Head and Neck Squamous Cell Carcinoma," Susanna Ulahannan, MD, MMEd, SCRI at OU Health – Stephenson Cancer Center, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Phase 1/2 Study of NGM707, an ILT2/ILT4 Dual Antagonist Antibody, in Advanced Solid Tumors: Interim Results from Dose-Escalation," Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. – 12:00 p.m. CDT, Hall A
Sunday, June 2

"Trastuzumab Deruxtecan vs Trastuzumab Emtansine in Patients with HER2+ Metastatic Breast Cancer: Updated Survival Results of DESTINY-Breast03," Dr. Hamilton, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
Monday, June 3

"Subcutaneous Epcoritamab Administered Outpatient for Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma: Results from Phase 2 EPCORE NHL-6," David Andorsky, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9 a.m. – 12 p.m. CDT, Hall A
"MYTX-011 in Patients with Previously Treated Locally Advanced or Metastatic NSCLC: Initial Dose Escalation Results in The Phase 1 KisMET-01 Study," Melissa Johnson, MD, SCRI, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"Clinical Activity and Safety of Naptumomab Estafenatox and Docetaxel in Patients with Checkpoint Inhibitor –Pretreated Advanced/Metastatic Non-Small Cell Lung Cancer: Preliminary Results of a P2 Trial," Tim Larson, MD, SCRI at Minnesota Oncology I The US Oncology Network, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"Treatment of Acute Myeloid Leukemia with Orca-T," Jeremy Pantin, MD, SCRI at TriStar Centennial, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Safety and Tolerability of Durvalumab + Carboplatin/Paclitaxel Followed by Durvalumab ± Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer in the DUO-E/GOG-3041/ENGOT-EN10 Trial," Jessica Thomes Pepin, MD, SCRI at Minnesota Oncology I The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"OPTec: A Phase 2 Study to Evaluate Outpatient Step-Up Administration of Teclistamab, a BCMA-Targeting Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma," Robert Rifkin, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Clinical Trial Participation and End-of-Life Care Among Older Adults: A Multi-Center Longitudinal Observational Cohort Analysis of 121,717 Patients with Cancer," Dr. I. Subbiah, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Performance of Comprehensive Genomic Profiling versus Single Gene Testing in Guideline-Recommended Biomarker Selection in Non-Small Cell Lung Cancer," Dr. V. Subbiah, 1:30 p.m. – 4:30 p.m. CDT, Hall A.

On May 30, 2024 Akeso, Inc. (HKEX: 9926.HK) ("Akeso," "we," or the "Company") reported that the Phase III clinical trial, HARMONi-2 or AK112-303, met its primary endpoint of progression-free survival (PFS) (Press release, Akeso Biopharma, MAY 30, 2024, View Source [SID1234643890]). HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS >1%). HARMONi-2 is a single region, multi-center, double-blinded Phase III study sponsored by Akeso with data generated and analyzed by Akeso.

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At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab. The PFS benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression (PD-L1 TPS 1-49%), PD-L1 high expression (PD-L1 TPS >50%), squamous and non-squamous histologies, as well as other high-risk patients.

There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

The Phase III HARMONi-2 study, along with the approval of ivonescimab in China in combination with chemotherapy based on the results of the HARMONi-A trial, provides clear evidence supporting the purposefully-engineered, differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics, and its opportunity to improve upon the existing standards of care for solid tumors.

"HARMONi-2 clearly demonstrates that ivonescimab has strong clinical values globally as well as commercial potentials." stated Dr. Michelle Xia , Chairwoman, President and Chief Executive Officer of Akeso. "ivonescimab is the next generation in PD-1 directed immunotherapy, and its potential to make a significant difference in the lives of patients with lung cancer and prospectively other tumors."

Conference Call

Akeso, Inc. (HKEX: 9926.HK) ("Akeso," "we," or the "Company") will host a conference call to discuss recent updates related to ivonescimab on Friday May 31, 2024, before the market opens.

About Ivonescimab

Ivonescimab, known as AK112 is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro.[1] This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days,[1] is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3.

The safety profile of ivonescimab is manageable and consistent with known risks for PD-1 and VEGF inhibiting drugs. In the first Phase III study to be presented at ASCO (Free ASCO Whitepaper), "Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous NSCLC who progressed on EGFR TKI treatment (AK112-301): A randomized, double-blind, multi-center, phase 3 trial," 5.6% of patient discontinues ivonescimab due to adverse events.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to a placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

About Lung Cancer

Lung cancer is believed to impact approximately 600,000 people across the United States, United Kingdom, Spain, France, Italy, Germany, and Japan.[2] NSCLC is the most prevalent type of lung cancer and represents approximately 80% to 85% of all incidences.[3] Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.[4] Patients with squamous histology represent approximately 25% to 30% of NSCLC patients.

On May 30, 2024 InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against tumor-treatment resistance and metastasis, reported results from the Phase Ib/II clinical trial of ifebemtinib, the company’s focal adhesion kinase (FAK) inhibitor, in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation, for the first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation (Press release, InxMed, MAY 30, 2024, View Source [SID1234643889]).

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These results will be featured in a poster presentation (Abstract: 8605 | Poster #469) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL.

As of the cutoff date of May 10, 2024, a total of 33 subjects were enrolled in the study. Among the 31 evaluable patients, the antitumor responses were assessed and summarized as follows:

The objective response rate (ORR) was 90.3% (95% CI: 74.3, 98.0), and the disease control rate (DCR) was 96.8% (95% CI: 83.3, 99.9). A total of 28 partial responses (PRs) and two stable diseases (SDs) were reported. Twenty-six out of 28 PRs were confirmed thus far.
The data for median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) are still maturing.
The overall safety profile of the combination of ifebemtinib with garsorasib is consistent with either ifebemtinib or garsorasib monotherapy. Most treatment-related adverse events (AEs) were Grade 1 or 2, and some Grade 3 AEs were reported.
"The objective responses in patients exceeded our initial expectations. The combination regimen was well tolerated with known, non-overlapping, and manageable AEs from both agents," said Zhengbo Song, M.D., Associate Professor, Director of Phase 1 Unit, Zhejiang Cancer Hospital, University Chinese Academy of Sciences and Principal Study Investigator. "These data warrant further investigation to assess the potential of ifebemtinib to impact the future standard of care for KRAS G12C mutant-driven NSCLC, with or without immunotherapies in the combination regimen."

"We are highly encouraged by the results of the current clinical study of ifebemtinib in NSCLC. RAS mutations account for approximately 30 percent of all cancer patients, and KRAS mutations, including the G12C mutation, wreak havoc in many people with solid tumors, including lung, pancreatic, and colorectal cancers," stated James McLeod, M.D., Chief Medical Officer of InxMed. "With recent rapid advances in KRAS G12C inhibitors comes the need for further improving clinical responses and safety/tolerability profiles of treatment regimens. We have studied FAK tumor biology and designed the combination therapy with KRAS inhibitors based on our deep understanding of FAK’s roles in the tumor defense mechanism. We are pleased to see that ifebemtinib significantly amplifies the clinical responses of the combination regimen."

Dr. McLeod added, "The current data set, albeit early with PFS and DOR data, is still maturing but is consistent with the results from our clinical trials in other tumor types. These initial findings demonstrate the potential of ifebemtinib to become an anchor component in combination regimens with chemotherapies, targeted therapies, or immunotherapies. We will continue further exploring the clinical utility of ifebemtinib in combination therapy and certainly welcome collaborations with global leaders in cancer therapies."

About Ifebemtinib
Ifebemtinib (IN10018, BI853520) is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, ifebemtinib has demonstrated therapeutic synergies with chemotherapy agents, targeted therapies, and immunotherapies. InxMed is currently pursuing a registrational trial in platinum-resistant ovarian cancer in China, and multiple proof-of-concept trials are ongoing in lung, colorectal, melanoma, and pancreatic cancers, with select tumor types to progress into pivotal clinical trials. Thus far, more than 600 patients have been treated with ifebemtinib, and a favorable safety and tolerability profile was observed.

Ifebemtinib was granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track designation from the U.S. Food and Drug Administration (FDA). InxMed plans to submit a New Drug Application to the NMPA in early 2025.

On May 30, 2024 Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer, reported that it will share data demonstrating the power of its DCISionRT test to better predict radiation therapy (RT) benefit in comparison to clinicopathologic risk factors for women with ductal carcinoma in situ (DCIS) at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held on May 31 – June 4, 2024 at the McCormick Place in Chicago (Press release, PreludeDx, MAY 30, 2024, View Source [SID1234643888]).

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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

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Of particular importance, the DCISionRT biosignature identified a low-risk group of patients with no significant benefit from ET or RT after breast-conserving surgery.

"We look forward to sharing the latest data at ASCO (Free ASCO Whitepaper) that reaffirms DCISionRT’s prognostic and predictive value of the test to reclassify recurrence risk based on clinicopathology alone, and that the test’s impact is not altered by use of endocrine therapy," said Dan Forche, President and CEO of PreludeDx.

PreludeDx American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Poster to Be Presented

Title: Identification of DCIS patients with low-risk clinicopathology who benefit from radiation therapy with and without endocrine therapy after breast-conserving surgery assessed with the 7-gene biosignature
Presenter: Pat W. Whitworth, MD, Nashville Breast Center, Nashville, TN
Date: Sunday, June 2, 9:00 a.m. CT

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.