On May 20, 2021 Flatiron Health reported eight abstracts have been accepted for presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8 (Press release, Flatiron Health, MAY 20, 2021, View Source [SID1234580397]).

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"Flatiron’s research continues to demonstrate the important applications of real-world data and the insights of real-world evidence," said Michael Vasconcelles, MD, Chief Medical Officer at Flatiron. "The research abstracts being presented at ASCO (Free ASCO Whitepaper) 2021 include work illuminating racial disparities in treatment among breast cancer patients, advancing our understanding of the COVID-19 pandemic’s impact on cancer treatment, and matching patients to clinical trials through an AI-based point-of-care tool."

This year’s accepted abstracts again reflect Flatiron’s many collaborations and partnerships in pursuit of its mission to improve lives by learning from the experience of every cancer patient.

Highlights include:

an investigation of racial disparities in treatment patterns among breast cancer patients, aligned with the 2021 ASCO (Free ASCO Whitepaper) theme of "Equity: Every Patient. Every Day. Everywhere."
a machine-learning tool that can ultimately improve patients’ access to clinical trials by improving the efficiency of patient ascertainment and thereby removing a barrier for practices to take part in studies of rare populations
a deep learning algorithm that automates the extraction of dates of key clinical events from unstructured chart notes, reducing the need for human curation in real-world data (RWD) research
leveraging the Flatiron Health-Foundation Medicine Clinico-Genomic Database to understand implications of NGS-defined biomarkers in patients with breast cancer and gastroesophageal cancers
an illustration of the power of a nationwide RWD network in aggregating clinical information to study treatment patterns and outcomes in patients with Castleman disease, a rare lymphoproliferative disorder
a description of the evolving impact of the COVID-19 pandemic on cancer treatment.
Flatiron collaborated on the accepted research with: Beth Israel Deaconess Medical Center, Birmingham Hematology Oncology (Alabama Oncology), Cancer Partners of Nebraska, Dana-Farber Cancer Institute, Foundation Medicine, Fox Chase Cancer Center, Massachusetts General Hospital, Moffitt Cancer Center, Penn Medicine, University of Alabama at Birmingham and Yale University.

Full abstracts will be posted at rwe.flatiron.com post-ASCO embargo on May 29.

Poster Presentations

Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi)
First author: Felipe Batalini (Beth Israel Deaconess Medical Center)
Abstract: 10512

Clinical characteristics, treatment patterns, and overall survival of real-world patients with idiopathic multicentric Castleman disease
First author: Aaron B. Cohen (Flatiron Health)
Abstract: 7048

Concordance of HER2+ status by IHC/ISH and ERBB2 status by NGS in a real-world clinicogenomic database and analysis of outcomes in patients (pts) with metastatic breast cancer (mBC)
First author: Cheryl D. Cho-Phan (Flatiron Health)
Abstract: 1036

ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA)
First author: Samuel J. Klempner (Massachusetts General Hospital)
Abstract: 4045

Extracting non-small cell lung cancer (NSCLC) diagnosis and diagnosis dates from electronic health record (EHR) text using a deep learning algorithm
First author: Alexander S. Rich (Flatiron Health)
Abstract: 1556

Racial disparities in second-line (2L) treatment and overall survival among patients (pts) with hormone receptor positive HER2 negative (HR+HER2-) metastatic breast cancer (mBC) treated in routine practice
First author: Xiaoliang Wang (Flatiron Health)
Abstract: 6541

Impact of COVID-19 pandemic on time to treatment initiation for patients with advanced cancer
First author: Samuel U. Takvorian (Perelman School of Medicine at the University of Pennsylvania)
Abstract: 1528

An automated EHR-based tool to facilitate patient identification for biomarker-driven trials
First author: Shailendra Lakhanpal (Birmingham Hematology Oncology/Alabama Oncology)
Abstract: 1539

On May 20, 2021 OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) and its development partner Boehringer Ingelheim reported that acceptance of an upcoming poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 4 – 8, 2021, covering promising initial data from Phase 1 dose escalation of selective SIRPα inhibitor BI 765063 in patients with advanced solid tumors (Abstract #2623) (Press release, OSE Immunotherapeutics, MAY 20, 2021, View Source [SID1234580464]).

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The data to be presented at ASCO (Free ASCO Whitepaper) 2021 indicate that OSE Immunotherapeutics’ first-in-class signal regulatory protein α (SIRPα) inhibitor BI 765063 was well-tolerated, showed sustained receptor occupancy (RO) saturation and monotherapy activity. Clinical benefit was observed in 45% of patients evaluable per RECIST* criteria. A durable partial response was observed in an advanced hepatocellular carcinoma (HCC) patient, and the on-treatment biopsy of the responder showed an increase in CD8 T-cell infiltration and activation. Furthermore, the on-treatment biopsy also showed an increase in PD-L1 expression on tumor cells. A BI 765063 dose escalation study in combination with Ezabenlimab (PD-1 antagonist) is ongoing and will help determine the recommended dose for further Phase 2 clinical development in patients with advanced solid tumors.

Alexis Peyroles, CEO of OSE Immunotherapeutics commented: "OSE Immunotherapeutics is moving forward to deliver highly innovative, first-in-class and best-in-class compounds. The promising data presented at ASCO (Free ASCO Whitepaper) includes no serious dose limiting toxicities, as well as early evidence of efficacy, suggesting that selective myeloid cell targeting of SIRPα to modulate CD47-dependent inhibition of anti-tumor immunity including the ‘Don’t Eat Me’ axis is a sound therapeutic strategy in solid tumors. These promising data presented at ASCO (Free ASCO Whitepaper) 2021 on BI 765063 confirm the quality of our science and we look forward to continuing to accelerate our clinical development and pipeline diversification over the coming years."

*RECIST: Response Evaluation Criteria in Solid Tumours

PRESENTATION DETAILS

Title: "Safety, pharmacokinetics, efficacy, and preliminary biomarker data of first-in class
BI 765063, a selective SIRPα inhibitor: results of monotherapy dose escalation in phase 1 study in patients with advanced solid tumors"

The abstract #2623 was posted on ASCO (Free ASCO Whitepaper).org on May 19, 2021 at 5:00PM ET and 11:00PM CEST

From June 4th at 3:00PM CEST:
Virtual poster presentation on demand
Poster session: Developmental Therapeutics – Immunotherapy
Presenting Author: Stéphane Champiat, MD, PhD, Institut de Cancérologie, Gustave Roussy, Villejuif

On May 20, 2021 AbbVie (NYSE: ABBV) reported that it will participate in the UBS Global Healthcare Virtual Conference on Tuesday, May 25, 2021. Michael Severino, M.D., vice chairman and president, Robert A. Michael, executive vice president and chief financial officer, and Jeffrey R. Stewart, executive vice president, commercial operations, will present virtually at 11:00 a.m. Central time (Press release, AbbVie, MAY 20, 2021, View Source [SID1234580349]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On May 20, 2021 Incyte (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of June (Press release, Incyte, MAY 20, 2021, View Source [SID1234580365]):

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William Blair 41st Annual Growth Stock Conference (Virtual) on Thursday, June 3, 2021 at 1:00 pm (EDT)
BioPharma Sustainability Roundtable’s CEO Investor Forum on Monday, June 7, 2021 at 1:35 pm (EDT)
Goldman Sachs 42nd Annual Global Healthcare Conference (Virtual) on Tuesday, June 8, 2021 at 8:00 am (EDT)
Guggenheim’s "Biopharma’s Next Decade: Views from the Top on Global Strategy and Innovation" Series on Monday, June 28, 2021 at 11:00 am (EDT)
The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay.

On May 20, 2021 H3 Biomedicine Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the presentation of four posters providing updated investigational data on its H3B-6545 clinical program for breast cancer and its H3B-6527 clinical program for hepatocellular carcinoma at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually June 4–8, 2021 (Press release, H3 Biomedicine, MAY 20, 2021, View Source [SID1234580398]).

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"We continue to be encouraged by the insights gained through our evaluation of genomically and clinically defined patient populations in these two oncology programs in areas of tremendous unmet medical need," said Antonio Gualberto, MD, PhD, Chief Medical Officer of H3. "We look forward to further highlighting our innovative, data-driven approach to precision oncology research and to showcasing the potential clinical benefit of our product candidates for patients with cancer at ASCO (Free ASCO Whitepaper) 2021."

The investigational clinical data abstracts published online today for the H3B-6545 and H3B-6527 studies reflect data as of March 31, 2021 and Jan 04, 2021, respectively. Updated results from both studies will be presented at ASCO (Free ASCO Whitepaper).

H3’s ASCO (Free ASCO Whitepaper) abstract titles are as follows:

H3B-6545

Abstract Number: 1018
Title: Phase I/II Study of H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist (SERCA), in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer
Poster Discussion Session: Breast Cancer – Metastatic
Presenter: Erika P. Hamilton, Sarah Cannon Research Institute, Tennessee Oncology

Abstract Number: e13025
Title: Phase 1b Study of H3B-6545 in Combination with Palbociclib in Women with Metastatic Estrogen Receptor–positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative Breast Cancer
Poster Session: Breast Cancer – Metastatic (Online Publication Only)
Presenter: Stephen R.D. Johnston

Abstract Number: e13022
Title: Relative Bioavailability of H3B-6545 Tablets vs Capsules and Drug-Drug Interaction between H3B-6545 and Pantoprazole
Poster Session: Breast Cancer – Metastatic (Online Publication Only)
Presenter: Alan Xiao

H3B-6527

Abstract Number: 4090
Title: Phase 1 Study of H3B-6527 in Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC)
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Presenter: Teresa Macarulla

About H3B-6545

Estrogen receptor alpha (ERα) plays an important oncogenic role in the genesis and progression of luminal breast cancers and historically has been a target of endocrine therapies. However, recently, hotspot mutations in ERα have been detected in nearly 30% of endocrine-therapy resistant metastases. Functional studies have shown that these ERα mutations can confer ligand-independent activation of the ERα pathway and can promote partial resistance to existing classes of ER-directed therapies. H3B-6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα. H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies.

About H3B-6527

Receptor tyrosine kinases (RTKs) can be dysregulated in cancer cells and can frequently promote abnormally rapid tumor growth and development. Hepatocellular carcinoma (HCC) can be driven in this way by hyperactivation of the fibroblast growth factor 19 (FGF19)/fibroblast growth factor receptor 4 (FGFR4) pathway. H3B-6527 is a selective, orally bioavailable, and covalent inhibitor of FGFR4 that has demonstrated tumor regression in several preclinical models of HCC. H3B-6527 is being tested specifically in patients with FGFR4-dysregulated advanced HCC.

The abstracts discuss investigational uses of agents in development and are not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.