On May 24, 2024 Foundation Medicine, Inc., reported that 22 new pieces of research from its robust oncology diagnostics portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 to June 4 in Chicago (Press release, Foundation Medicine, MAY 24, 2024, View Source [SID1234643703]).

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Emerging Applications of Liquid Biopsy Using FoundationOneLiquid CDx and FoundationOneTracker

Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer (Abstract #1042)
Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO (Abstract #TPS3644)
Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (Abstract #5020)
Prognostic value of baseline circulating tumor DNA (ctDNA) tumor fraction (TF) in metastatic hormone-sensitive prostate cancer (mHSPC) (Abstract #5085)
BRCA1/2 reversion mutations (BRCArev) in advanced prostate cancer in the absence of prior PARP inhibitor (PARPi) therapy (Abstract #5056)
Utility of CGP in Earlier Stages of Disease, Rare Cancers, and Using RNA Sequencing

Preliminary results of the Lung Cancer Mutation Consortium LCMC4 evaluation of actionable drivers in early-stage lung cancer (LEADER) screening trial (Abstract #8068)
Impact of alterations in tumor suppressor genes (TSG-alt) on survival outcomes in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC) receiving androgen deprivation therapy (ADT) with androgen receptor pathway inhibition (ARPI) or docetaxel (Abstract #5091)
On the right TRACK: Providing comprehensive genomic profiling (CGP) and molecular tumor board (MTB) for patients (pts) with rare cancers (Abstract #3127)
New soft tissue sarcoma (STS) transcriptomic clusters to unveil STS subsets with unique biological characteristics and refine the accuracy of overall survival (OS) prediction (Abstract #11545)
New CGP Biomarkers, Including Homologous Recombination Deficiency (HRD) Signature and Methyl Thioadenosine Phosphorylase (MTAP) Genomic Loss

Pathological complete response (pCR) association with a novel homologous recombination deficiency HRD signature (HRDsig) in patients with triple-negative breast cancer (TNBC) receiving neoadjuvant therapy (Tx) (Abstract #591)
Characterization of diverse targetable ERBB2 alterations in 512,993 patients with solid tumors (Abstract #3129)
Nature and distribution of methyl thioadenosine phosphorylase (MTAP) genomic loss in human tumors (Abstract #3067)
Genomic alterations (GA) in ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) patients (pts) with metastatic breast cancer (MBC): Co-occurrence and prevalence along treatment course (Abstract #1060)
Impact of Ancestry on the Genomic Alteration Landscape

Genetic ancestry-associated differences in genomic profiling and treatment patterns in pancreatic ductal adenocarcinoma (PDAC) (Abstract #4138)
Endometrial cancer (EC) by ERBB2 amplification (ERBB2amp) status: Differences in molecular subtypes, ancestry, and real-world outcomes (Abstract #5614)
"Our data at this year’s ASCO (Free ASCO Whitepaper) annual meeting reflects Foundation Medicine’s progress in making genomic profiling indispensable to cancer care and research, particularly in lung, breast and prostate cancers where there is an increasing number of targeted therapies for health care providers to consider for these patients," says Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. "We are also excited to demonstrate our new RNA sequencing capabilities and spotlight the expanding utility of ctDNA to inform treatment decision making through a simple blood sample."

The following is a complete list of Foundation Medicine abstracts that will be presented. To access the abstracts being presented at ASCO (Free ASCO Whitepaper), please visit ASCO (Free ASCO Whitepaper).org/abstracts.

Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO24 and visit us in person at Booth #22031.

Abstract #

Title

Collaborator

Products

Posters

Abstract #3127
6/1/2024 9:00 AM-
12:00 PM

On the right TRACK: Providing comprehensive genomic profiling (CGP) and molecular tumor board (MTB) for patients (pts) with rare cancers

TargetCancer Foundation, UC San Diego Moores Cancer Center, University of California, San Diego, Medical College of Wisconsin (MCW) Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins Hospital, The University of Texas MD Anderson Cancer Center, Department of Pharmacy, Rutgers New Jersey Medical School, Medication Acquisition, Inc., Sarah Cannon Research Institute, University of Nebraska, WIN Consortium for Precision Medicine

FoundationOneCDx
FoundationOneLiquid CDx

Abstract #3129
6/1/2024 9:00 AM-
12:00 PM CDT

Characterization of diverse targetable ERBB2 alterations in 512,993 patients with solid tumors

Memorial Sloan Kettering Cancer Center

FoundationOneCDx
FoundationOneLiquid CDx

Abstract #4138
6/1/2024 1:30 PM-
4:30 PM CDT

Genetic ancestry-associated differences in genomic profiling and treatment patterns in pancreatic ductal adenocarcinoma (PDAC)

Yale Cancer Center, New York University Perlmutter Cancer Center

FoundationOneCDx
Flatiron Health-Foundation
Medicine Clinico-Genomic
Database (CGDB)

Abstract #TPS3644
6/1/2024 1:30 PM-
4:30 PM CDT

Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO

University of Pisa, Italy

FoundationOneTracker

Abstract #11545
6/1/2024 1:30 PM-
4:30 PM CDT

New soft tissue sarcoma (STS) transcriptomic clusters to unveil STS subsets with unique biological characteristics and refine the accuracy of overall survival (OS) prediction

Universitario Lisboa Norte, Institute Portugues de Oncologia de Lisboa Francisco Gentil, Institute Superior Tecnico, Universidade de Lisboa, Institute de Medicina Molecular Joao Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, F. Hoffmann-La Roche AG, Institute Superior Tecnico (1ST), Universidade de Lisboa, Hospital CUF Descobertas

FoundationOneRNA for
research use

Abstract #3067

6/1/2024 9:00 AM-
12:00 PM CDT

Nature and distribution of methyl thioadenosine phosphorylase (MTAP) genomic loss in human tumors

San Raffaele Hospital and Scientific Institute, Italy

FoundationOne
FoundationOneCDx

Abstract #1060
6/2/2024 9:00 AM-
12:00 PM CDT

Genomic alterations (GA) in ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) patients (pts) with metastatic breast cancer (MBC): co-occurrence and prevalence along treatment course

Emory University

FoundationOneCDx
FoundationOneLiquid CDx
Flatiron Health-Foundation
Medicine Clinico-Genomic
Database (CGDB)

Abstract #591
6/2/2024 9:00 AM-
12:00 PM CDT

Pathological complete response (pCR) association with a novel homologous recombination deficiency HRD signature (HRDsig) in patients with triple-negative breast cancer (TNBC) receiving neoadjuvant therapy (Tx)

Stanford University

FoundationOneCDx
Flatiron Health-Foundation
Medicine Clinico-Genomic
Database (CGDB)

Abstract #5056
6/2/2024 9:00 AM-
12:00 PM CDT

BRCA1/2 reversion mutations in advanced prostate cancer in the absence of prior PARP inhibitor (PARPi) therapy

Cedars-Sinai Medical Center, Upstate University Medical Center, University of California – San Diego

FoundationOneLiquid CDx

Abstract #1042
6/2/2024 9:00 AM-
12:00 PM CDT

Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer

Johns Hopkins University School of Medicine, Vanderbilt University Medical Center, Allegheny Health Network, Weill Cornell Medicine and New York-Presbyterian Hospital

FoundationOneLiquid CDx

Abstract #5091
6/2/2024 9:00 AM-
12:00 PM CDT

Impact of alterations in tumor suppressor genes (TSG-alt) on survival outcomes in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC) receiving androgen deprivation therapy (ADT) with androgen receptor pathway inhibition (ARPI) or docetaxel

Huntsman Cancer Institute, Masonic Cancer Center

Flatiron Health-Foundation
Medicine Clinico-Genomic
Database (CGDB)

Abstract #5085
6/2/2024 9:00 AM-
12:00 PM CDT

Prognostic value of baseline circulating tumor DNA (ctDNA) tumor fraction (TF) in metastatic hormone-sensitive prostate cancer (mHSPC)

Rogel Comprehensive Cancer Center, University of Michigan, Karmanos Cancer Institute, Wayne State University

FoundationOneLiquid CDx

Abstract #5020
6/2/2024 9:00 AM-
12:00 PM CDT

Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Peter MacCallum Cancer Centre, Department of Medical Oncology, Institut Gustave Roussy, University of Paris-Saclay, Pfizer Inc., National Cancer Center Hospital East, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, The Urology Center of Colorado, National Cancer Center, Tom Baker Cancer Centre, University of Calgary, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Huntsman Cancer Institute (NCI-CCC), University of Utah

FoundationOneLiquid CDx
FoundationOneMonitor for
Research Use

Abstract #3626
6/2/2024 9:00 AM-
12:00 PM CDT

Contrasting comprehensive genomic profiles of adenocarcinomas of the appendix in younger versus older patients

Upstate Medical University

FoundationOne
FoundationOneCDx

Abstract #4588
6/2/2024 9:00 AM-
12:00 PM CDT

FGFR3-mutated urothelial carcinoma of bladder and upper tract including ureter and renal pelvis: A comparative genomic profiling study

Upstate Medical University, University of California – Los Angeles, University of Washington, Huntsman Cancer Center, Moffitt Cancer Center, MD Anderson Cancer Center, Cleveland Clinic, San Rafael University

FoundationOne
FoundationOneCDx

Abstract #8032
6/2/2024 9:00 AM-
12:00 PM CDT

Retrospective analysis of change in frequency of STK11 mutation in lung adenocarcinomas over a 10-year period

Upstate Medical University

FoundationOne
FoundationOneCDx

Abstract #1092
6/2/2024 9:00 AM-
12:00 PM CDT

Impact of HER2 low status on genomic signatures in triple negative breast cancer (TNBC)

Yale University

FoundationOne
FoundationOneCDx

Abstract #11575
6/2/2024 9:00 AM-
12:00 PM CDT

Intimal sarcomas (ISarc) of the cardiac chambers (CC) of the heart and great vessels (GV): A comprehensive genomic profiling (CGP) study

Upstate Medical University

FoundationOne
FoundationOneCDx

Abstract #6036
6/2/2024 9:00 AM-
12:00 PM CDT

Clinical, molecular, and immunologic profiling of brain metastases (BM) in head and neck squamous cell carcinoma (HNSCC)

Dana-Farber Cancer Institute, University of California – San Diego, Phase Genomics

Abstract #5614
6/3/2024 9:00 AM-
12:00 PM CDT

Endometrial cancer (EC) by ERBB2 amplification (ERBB2amp) status: Differences in molecular subtypes, ancestry, and real-world outcomes

University of Colorado Health, Mount Sinai

FoundationOneCDx

Abstract #8068
6/3/2024 1:30 PM-
4:30 PM CDT

Preliminary results of the Lung Cancer Mutation Consortium LCMC4 evaluation of actionable drivers in early-stage lung cancer (LEADER) screening trial

Baylor College of Medicine, Harvard University, University of Michigan, University of Missouri, University of Washington, University of California – Los Angeles, University of Colorado, Memorial Sloan Kettering

FoundationOneCDx
FoundationOneLiquid CDx

Abstract #8532
6/3/2024 1:30 PM-
4:30 PM CDT

Molecular profiling across histologies in lung cancer: Time to change WHO nomenclature?

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, Papardo Hospital, Roche Sequencing Solutions

FoundationOneCDx

On May 24, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of the combination of avutometinib, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, for adult patients with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy (Press release, Verastem, MAY 24, 2024, View Source [SID1234643702]). The rolling review process allows the Company to submit completed sections of an application for review by the FDA before all sections become available. The initial sections of the application will include the nonclinical and quality sections. In discussions with the FDA, Verastem reached agreement to submit a primary efficacy analysis based on the RAMP 201 study with 12 months of follow up. Based on discussions with the FDA, we understand that the proposed indication for final submission of the clinical module can be expanded in the event Verastem provides data that demonstrates a substantial improvement over available therapy in the KRAS wild-type (KRAS wt) population. FDA has accepted Verastem’s plan to submit the clinical module in the second half of 2024 to complete the NDA application. Previously, the FDA granted Breakthrough Therapy Designation (BTD) for the combination for treatment of patients with recurrent LGSOC, regardless of KRAS status, following one or more previous lines of therapy and Orphan Drug Designation (ODD) for the combination in certain LGSOC indications. The Company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC.

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"The initiation of our rolling NDA submission of the avutometinib and defactinib combination for accelerated approval, is an important step towards addressing the significant unmet needs that patients face living with KRAS mutant low-grade serous ovarian cancer,"​ said Dan Paterson, president and chief executive officer of Verastem Oncology. "The data from our ongoing RAMP 201 trial continues to support our belief that the avutometinib and defactinib combination has the potential to be a new standard of care in patients with recurrent low-grade serous ovarian cancer, if approved. In the second half of this year, we anticipate completing our NDA submission with the mature data from the RAMP 201 trial and discussing with the FDA a path forward for patients with KRAS wild-type disease. We also expect to present the mature dataset at a medical meeting in the second half of 2024."​

RAMP 201 is a Phase 2 registration-directed study evaluating avutometinib and defactinib combination in patients with recurrent LGSOC. The enrollment in RAMP 201 is completed, with 115 patients being treated at the recommended Phase 2 dose (RP2D) of avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily for 3 out of every 4 weeks, and follow-up continues. Verastem expects to complete the NDA submission after obtaining mature safety and efficacy data from the RAMP 201 trial, including 12 months of follow-up, anticipated in the second half of 2024. Verastem also plans to further discuss the KRAS wt data with FDA to inform the potential path forward for approval for this patient population. The Company plans to present the mature dataset from RAMP 201 at a medical meeting in the second half of 2024.​ As of February 2024, the interim data continued to show robust overall response rates (ORR) and durable responses with low discontinuation rates due to adverse events (AEs) in patients from RAMP 201 Parts A, B, C, who had a minimum follow-up of five (5) months.

The FDA granted Breakthrough Therapy Designation of the investigational combination of avutometinib and defactinib for the treatment of all patients with recurrent LGSOC regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy in May 2021. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC in March 2024. The Company believes that this Orphan Drug Designation signifies that LGSOC is a rare ovarian cancer that is a distinct and different disease from other forms of ovarian cancer such as high-grade serous ovarian cancer (HGSOC). LGSOC is highly recurrent and fatal, with no FDA-approved treatment options, and the current standard of care treatments include hormonal therapy or chemotherapy, which have demonstrated an ORR between 6-13% with discontinuation due to AEs of 17-30%. ​

The Company is currently enrolling patients and activating sites for RAMP 301, an international confirmatory Phase 3 trial, evaluating the avutometinib and defactinib combination versus standard of care chemotherapy or hormonal therapy for the treatment of patients with KRAS mt and KRAS wt recurrent LGSOC.

Conference Call and Webcast Information

Verastem will hold an investor conference call and webcast on Friday, May 24 at 8:00 am EDT, to review the initiation of the NDA submission and limited, topline data from the RAMP 201 trial, with a minimum follow-up of five (5) months and the RAMP 205 data. The call will feature members of Verastem’s management team. To access the conference call, please dial (844) 763-8274 (local) or (412) 717-9224 (international) at least 10 minutes prior to the start time and ask to be joined into the Verastem Oncology conference call. A live audio webcast of the call, along with accompany slides, will be accessible here. The Company expects to file an 8-K pertaining to this update.

About RAMP 201

RAMP 201 (ENGOTov60/GOG3052) is an adaptive, two-part multicenter, parallel cohort, randomized, open-label trial to evaluate the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent low-grade serous ovarian cancer. The first part of the study (Part A) determined the selection of the go forward regimen, which was the combination of avutometinib and defactinib versus avutometinib alone, based on overall response rates. The expansion phases of the trial (Parts B and C) are evaluating the safety and efficacy of the go forward regimen of avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily. The Part D portion of the trial is evaluating a low dose of avutometinib in combination with defactinib to inform individualized dose reduction.

About RAMP 301

RAMP 301 (GOG-3097; ENGOT-ov81/NCRI) is an international collaboration between The GOG Foundation, Inc. (GOG) and the European Network of Gynaecological Oncological Trial groups (ENGOT) sponsored by Verastem Oncology. The trial is expected to enroll a total of 270 patients in the U.S., Canada, the United Kingdom, Europe, Australia and South Korea, who will be randomized to either the combination of avutometinib and defactinib or investigator’s choice chemotherapy (pegylated liposomal doxorubicin, paclitaxel, topotecan) or hormone therapy (letrozole, anastrozole). The primary endpoint is progression free survival (PFS) by Blinded Independent Central Review. Secondary endpoints include ORR, duration of response​, disease control rate, safety and tolerability, patient reported outcomes, and overall survival.

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a rare ovarian cancer that is insidious, persistent and ultimately fatal. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. The majority of patients report negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life. The current standard of care for this disease includes hormone therapy and chemotherapy, but there are no treatments specifically approved by the U.S. Food and Drug Administration to treat LGSOC.

About the Avutometinib and Defactinib Combination

Avutometinib is a n investigational RAF/MEK clamp that is designed to induce inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. Avutometinib is designed to block both MEK kinase activity and the ability of RAF to phosphorylate MEK. This differentiated proposed mechanism potentially allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other MEK-only inhibitors. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation of the investigational combination of avutometinib and defactinib, a selective FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC.

Verastem Oncology is currently conducting clinical trials with avutometinib in RAS/MAPK driven tumors as part of its Raf And Mek Program or RAMP. RAMP 301 (NCT06072781) is an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 (NCT04625270) is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and enrollment has been completed in each of the dose optimization and expansion phases and the low-dose evaluation.

Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) in combination with avutometinib and defactinib and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively. The RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/Nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by a PanCAN Therapeutic Accelerator Award.

On May 24, 2024 Agendia, Inc., reported that new data on its comprehensive genomic tests will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place May 31st – June 4th, 2024, in Chicago, Illinois (Press release, Agendia, MAY 24, 2024, View Source [SID1234643701]).

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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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The presented data underscores Agendia’s commitment to advancing individualized management of breast cancer and to providing support throughout a patient’s treatment journey. These studies add to the already robust library of clinical studies demonstrating Agendia’s MammaPrint and BluePrint effectiveness in providing reliable guidance for therapeutic considerations in early-stage breast cancer.

The two abstracts that have been selected by ASCO (Free ASCO Whitepaper) for oral discussion will 1) feature an investigation of underlying biology that mediates immune therapy response and, 2) will provide an evaluation of the MammaPrint Index and 3-year recurrence-free interval in patients treated with CT, with and without anthracycline. Both presentations utilize whole transcriptome data from the prospective, observational real-word evidence FLEX Study (NCT03053193).

The following are details of the abstracts that have been accepted at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting:

Oral Discussion

Association of MammaPrint index and 3-year outcome of patients with HR+HER2- early-stage breast cancer treated with chemotherapy with or without anthracycline
Authors: O’Shaughnessy, J., et al.
Presenter: Joyce O’Shaughnessy, MD | Baylor-Sammons Cancer Center, Texas Oncology
Session: Rapid Oral Abstract – Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Friday, May 31, 2024 | 2:45 PM – 4:15 PM CDT
Abstract #: 511
Elucidating the immune active state of HR+HER2- MammaPrint High 2 early breast cancer
Authors: Cobain, E., et al.
Presenter: Erin Cobain, MD | University of Michigan Rogel Cancer Center
Session: Oral Abstract Session – Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 3, 2024 | 3:00 PM – 6:00 PM CDT
Abstract #: 506
Poster sessions

Cost consequence model of the MammaPrint (70-gene signature) and 21-gene signature in patients with primary HR+ HER2-, N1 early-stage breast cancer in Germany
Authors: Lux M.P., Sandor M. F., Hofmann V., Pronin D., Klinkhamer J.C., Müller-Huesmann H.
Presenter: Harald Müller-Huesmann | St. Josef Brothers Hospital Paderborn, Germany
Session Date & Time: Sunday, June 2, 2024 | 9:00 AM – 12:00 PM CDT
Abstract #: 534
Other Investigator Initiated Abstracts Utilizing MammaPrint + BluePrint:

Correlation of hormone receptor positive HER2-negative/MammaPrint high-2 breast cancer with triple negative breast cancer: Results from gene expression data from the ISPY2 trial.
Authors: Alejandro Rios-Hoyo; Lajos Pusztai
Session Date & Time: Sunday, 2, 2024 | 9:00AM-12:00PM CDT
Abstract #: 573
Genomic profile in Mexican women with early-stage breast cancer using Mammaprint + Blueprint assay: A retrospective study.
Authors: Valdez, et al.
Abstract #: e12541
More information about the program can be found at the ASCO (Free ASCO Whitepaper) 2024 website.

On May 24, 2024 Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ: FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, reported that Phase 1 clinical data on its lead therapeutic development candidate, FID-007, to treat Head and Neck cancer, will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2024 in Chicago, Illinois (Press release, Fulgent Pharma, MAY 24, 2024, View Source [SID1234643700]).

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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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Details of the presentation are as follows:

Abstract Title: Efficacy from the phase 1 study of FID-007, a novel nanoparticle paclitaxel formulation, in patients with head and neck squamous cell carcinoma
Session: Head and Neck Cancer
Presentation Date and Time: June 2, 2024, from 9:00 a.m. to 12:00 p.m. Central Time
Presentation Type: Poster Session
Abstract #6042, Poster Board #345

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.

On May 24, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, reported new findings from a biomarker study in non-small cell lung cancer (NSCLC) patients with exon 20 insertion (exon20ins) mutations, highlighting sunvozertinib as an effective treatment for this patient population (Press release, Dizal Pharma, MAY 24, 2024, View Source [SID1234643699]). The findings have been published in an abstract (#8563) available on the official website of the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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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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A total of 121 patients with EGFR exon20ins mutations treated with sunvozertinib were included in this biomarker study. Serial plasma ctDNA samples were collected from baseline until disease progression (PD). The key findings of the analysis were as follows:

Anittumor efficacy of sunvozertinib was observed in patients regardless of baseline EGFR exon20ins status in plasma ctDNA.

There was a positive correlation between detectable EGFR exon20ins in baseline plasma ctDNA and higher number of metastasis sites.
Higher abundance of EGFR exon20ins in baseline plasma ctDNA was positively correlated with more metastasis sites and brain metastasis (BM).
Patients with baseline negative EGFR exon20ins in plasma ctDNA achieved a higher objective response rate (ORR) (68.0% vs. 45.8%) and longer median progression free survival (PFS) (7.4 months vs. 5.5 months) than those with positive EGFR exon20ins.
Sunvozertinib could effectively clear EGFR exon20ins in plasma ctDNA, confirming its direct effect on EGFR pathway.

Decrease of EGFR exon20ins mutant allele was observed in 85.7% of patients with sunvozertinib treatment.
The earliest clearance of EGFR exon20ins occurred after one week of sunvozertinib treatment.
The resistance to sunvozertinib could be through EGFR-dependent and EGFR-independent mechanisms and combination of golidocitinib, a JAK1 inhibitor, with chemotherapy could be a potential approach to overcome sunvozertinib resistance.

Acquired EGFR C797S and other genetic aberrations in EGFR downstream signaling pathway may be associated with resistance to sunvozertinib.
In vitro and in vivo experiments suggested that combination of golidocitinib, a JAK1 inhibitor, with chemotherapy could be a potential approach to overcome sunvozertinib resistance.
"This biomarker study selected for poster presentation at 2024 ASCO (Free ASCO Whitepaper) Annual Meeting helps us further optimize treatment options for NSCLC patients with EGFR exon20ins mutations, and at the same time validates sunvozertinib’s efficiency of clearance of EGFR exon20ins mutations." said Xiaolin Zhang, PhD, CEO of Dizal, "Supported by positive findings from the WU-KONG6 study, a pivotal study with patients from China, sunvozertinib was approved in China in relapsed or refractory setting, making it the world’s first and only oral drug for the treatment of NSCLC patients with EGFR exon20ins mutations. The latest data from WU-KONG1 Part B, the equivalent study with patients worldwide, will be unveiled at the upcoming ASCO (Free ASCO Whitepaper) meeting. The study met its predefined primary end point and was statistically significant, providing substantial evidence for successful NDA submissions of sunvozertinib in the US, the EU and other overseas markets."

WU-KONG1 Part B is a multinational pivotal study, currently being conducted across ten countries and regions in Asia, Europe, North America, and South America. The primary analysis showed that sunvozertinib demonstrated promising antitumor efficacy in relapsed or refractory NSCLC with EGFR exon20ins, with a tolerable safety profile. The updated data will be presented orally at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #8513).