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Arcus Biosciences to Present First Combination Data for HIF-2a Inhibitor Casdatifan Plus Cabozantinib in an Oral Presentation at the 2025 ASCO Annual Meeting

On April 23, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that data from the ARC-20 study will be presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3, 2025 (Press release, Arcus Biosciences, APR 23, 2025, View Source [SID1234652074]).

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The oral presentation will highlight the first safety and efficacy data for the ARC-20 expansion cohort evaluating the HIF-2a inhibitor casdatifan plus cabozantinib, an anti-vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor (VEGFR2-TKI), in patients with ccRCC that had previously been treated with immunotherapy alone or in combination with anti-VEGFR2-TKI therapies.

"We are thrilled to be presenting the first combination data evaluating our HIF-2a inhibitor, casdatifan, in combination with cabozantinib in an oral presentation at ASCO (Free ASCO Whitepaper)," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The data being presented support our rapidly advancing and differentiated development program for casdatifan, which includes the initiation of our Phase 3 trial, PEAK-1, that will evaluate the same combination as this cohort. The development plan also includes our clinical collaboration to evaluate casdatifan in combination with AstraZeneca’s PD-1/CTLA-4 bispecific antibody, volrustomig, in immuno-oncology-naive ccRCC patients. We look forward to presenting additional data from the ARC-20 study throughout the year."

Study

Title

Abstract Number

Session Type & Title

Session Date & Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Combination Casdatifan Plus Cabozantinib Expansion Cohort of Phase 1 ARC-20 Study in Previously Treated Patients with Clear Cell Renal Cell Carcinoma

4506

Oral Abstract Session – Genitourinary Cancer—Kidney and Bladder

6/01/2025,

9:45 AM – 12:45 PM CT

Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 446724 on Monday, June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2⍺, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

Ono Pharma Announces an Oral Presentation on Phase 2 Data for Tirabrutinib and a Poster Session on ONO-4578 (EP4 Antagonist) at the American Society of Clinical Oncology (ASCO) Annual Meeting

On April 23, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "ONO") reported that it will present positive results from the Phase 2 PROSPECT study of tirabrutinib (ONO-4059) for the treatment of relapsed or refractory primary central nervous system lymphoma during an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held May 30 to June 3, 2025, in Chicago, Illinois (Press release, Ono, APR 23, 2025, View Source [SID1234652073]). The company will also present data on ONO-4578, an investigational EP4 antagonist, for the treatment of locally advanced resectable rectal cancer, during a poster presentation.

"We are fully committed to developing innovative drugs for cancer patients. This announcement is an important step forward in demonstrating that we can potentially provide new value to patients," said Tatsuya Okamoto, Corporate Officer / Executive Director, Clinical Development at ONO. "We aim to offer new treatment options in cancer care globally and contribute to improving patients’ quality of life."

Details for both studies and data to be presented are as follows:

Tirabrutinib (ONO-4059)
Abstract Title: Tirabrutinib for the treatment of relapsed or refractory primary central nervous system lymphoma: Efficacy and safety from the phase II PROSPECT study.
Abstract Submission ID: 487376
Session Type and Title: Rapid Oral Abstract – Central Nervous System Tumors
Session Date and Time: May 31, 2025, 3:00-4:30 PM CDT
Presenter: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

ONO-4578
Abstract Title: Neoadjuvant ONO-4578, an EP4 antagonist, in combination with nivolumab after chemoradiation therapy in locally advanced resectable rectal cancer.
Session Type and Title: Poster Session Gastrointestinal Cancer – Colorectal and Anal
Abstract Number for Publication: 3588
Poster Board: 257
Session Date and Time: May 31, 2025, 9:00 AM-12:00 PM CDT
Presenter: Yusuke Takahashi, Lower Gastrointestinal Surgery, National Hospital Organization Osaka National Hospital

OncoHost to Showcase Plasma Proteomics Research in NSCLC at AACR 2025

On April 23, 2025 OncoHost, a technology company transforming the approach to precision medicine for improved cancer patient outcomes, reported its acceptance to present a scientific poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25–30, 2025, in Chicago, IL (Press release, OncoHost, APR 23, 2025, View Source [SID1234652072]).

The abstract, titled "Clinical and biological implications of plasma proteomic patterns in NSCLC patients treated with immune checkpoint inhibitors," investigates the proteins involved in the PROphetNSCLC model. PROphetNSCLC serves as a treatment guidance tool for patients with advanced stage non-small cell lung cancer (NSCLC). The study is the result of an international collaboration between academic institutions and leading cancer centers including The Ohio State University, UC Davis, Baylor University Medical Center, Roswell Park Comprehensive Cancer Center, and others.

"This research provides a deeper understanding of the biological underpinnings driving resistance to immunotherapy in NSCLC," said Dr. Michal Harel, Director of Science and Innovation at OncoHost and lead author of the study. "Our analysis of resistance-associated proteins (RAPs) identifies key proteomic signatures that not only explain clinical outcomes but can also help stratify patients and identify new therapeutic targets."

PROphetNSCLC is based on 388 plasma proteins, collectively termed RAPs. The study uncovered five distinct expression patterns across healthy individuals, NSCLC patients with clinical benefit (CB), and those with no clinical benefit (NCB) from immunotherapy. These patterns revealed mechanistic insights into treatment resistance that can be monitored in the plasma, highlighting processes such as angiogenesis, immune modulation, chemoresistance, and cell proliferation. In addition, the findings shows that 17.5% of the RAPs identified could be targeted with existing or investigational drugs. These findings suggest that RAPs can serve as a pool of novel targets for intervention, further strengthening the potential clinical significance of these RAPs.

"Being selected to present at AACR (Free AACR Whitepaper) reinforces the scientific and clinical relevance of our work," said Ofer Sharon, MD, CEO of OncoHost. "We are moving beyond predictive diagnostics into an era where understanding the ‘why’ behind treatment resistance is critical to driving real-world precision medicine. This study brings us closer to realizing the full potential of proteomics in oncology."

Poster Presentation Details
Title: Clinical and biological implications of plasma proteomic patterns in NSCLC patients treated with immune checkpoint inhibitors
Session Title: Predictive Biomarkers 3
Poster Board #: 27
Presenter: Michal Harel, PhD, Director of Science and Innovation, OncoHost
Date & Time: Monday, April 28, 2025, 9:00 AM – 12:00 PM CDT

Novita Pharmaceuticals Announces Oral Presentation of Phase 2 NP-G2-044 Data at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting

On April 23, 2025 Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported that additional data from its Phase 2 Study of NP-G2-044 combined with anti-PD-1 therapy will be presented in an oral presentation as part of a Rapid Oral Session at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 30 to June 3, 2025, in Chicago, IL (Press release, Novita Pharmaceuticals, APR 23, 2025, View Source [SID1234652071]).

Details of the presentation are as follows:

Abstract Title: Durable responses in ICI-refractory or acquired resistance: Phase 2 study of NP-G2-044 combined with anti-PD-1 therapy.
Abstract Number: 2513
Session Type: Rapid Oral Abstract
Session Title: Developmental Therapeutics—Immunotherapy
Date and Time: June 1, 2025; 11:15 AM-12:45 PM CDT

Nuvalent to Present Trial in Progress Posters for the ALKAZAR Trial of Neladalkib and HEROEX-1 Trial of NVL-330 at the 2025 American Society of Clinical Oncology Annual Meeting

On April 23, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported two "Trial in Progress" poster presentations for its novel ALK-selective inhibitor, neladalkib, and novel HER2-selective inhibitor, NVL-330, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 30 – June 5, 2025, in Chicago (Press release, Nuvalent, APR 23, 2025, View Source [SID1234652070]). Posters will be archived on the Nuvalent website at www.nuvalent.com.

The first "Trial in Progress" poster will include background and study design for ALKAZAR (NCT06765109), a global, randomized, controlled Phase 3 trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive non-small cell lung cancer (NSCLC). Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA (alectinib) monotherapy. The company plans to initiate the ALKAZAR trial in the first half of 2025.

The second poster will include background and study design for the ongoing HEROEX-1 Phase 1a/1b clinical trial (NCT06521554) evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Details of the poster presentations are as follows:

Title: Neladalkib (NVL-655), a highly selective anaplastic lymphoma kinase (ALK) inhibitor, compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer: The Phase 3 ALKAZAR study
Authors: Sanjay Popat*1, Benjamin J. Solomon2, Thomas E. Stinchcombe3, Geoffrey Liu4, Gilberto Lopes5, Melissa Johnson6, Misako Nagasaka7, Ece Cali Daylan8, Christina Baik9, James D’Olimpio10, Tzu-Chuan Huang11, Alexander Spira12, Daniel Haggstrom13, Benjamin Creelan14, Tina Kehrig15, Junwu Shen15, Rachel DeLaRosa15, Viola W. Zhu15, Alexander Drilon16, Alice T. Shaw17
Abstract Number: TPS8666
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: May 31, 2025, from 1:30 p.m.– 4:30 p.m. CDT
Poster Board Number: 136b

*Presenter, corresponding author; 1Royal Marsden Hospital NHS Foundation Trust and The Institute of Cancer Research, London, UK; 2Peter MacCallum Cancer Centre, Melbourne, Australia; 3Duke Cancer Center, Durham, NC, USA; 4Princess Margaret Hospital, Toronto, ON, Canada; 5Sylvester Comprehensive Cancer Center, Miami, FL, USA; 6Sarah Cannon Research Institute Oncology Partners, Nashville, TN, USA; 7University of California Irvine School of Medicine, Orange, CA, USA; 8Washington University School of Medicine, St. Louis, MO, USA; 9Fred Hutchinson Cancer Center, Seattle, WA, USA; 10Clinical Research Alliance Inc., Westbury, NY, USA; 11University Cancer and Blood Center, LLC, Athens, GA, USA; 12Virginia Cancer Specialists (Fairfax) – USOR, Fairfax, VA, USA; 13Carolinas Medical Center, Charlotte, NC, USA; 14H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA; 15Nuvalent, Inc., Cambridge, MA, USA; 16Memorial Sloan Kettering Cancer Center, New York, NY, USA; 17Dana-Farber Cancer Institute, Boston, MA, USA

Title: NVL-330, a selective HER2 tyrosine kinase inhibitor, in patients with advanced or metastatic HER2-altered non-small cell lung cancer: The Phase 1 HEROEX-1 study
Authors: Xiuning Le*1, Zofia Piotrowska2, Alexander Spira3, Christina Baik4, Maria Q. Baggstrom5, Gerald Falchook6, Joel Neal7, Shirish Gadgeel8, Gilberto Lopes9, Melissa Johnson10, Jonathan W. Riess11, Danny Nguyen12, Lisa Morelli13, Danieska Sandino13, Steven Margossian13, Vivek Upadhyay13, Fernando C. Santini14
Abstract Number: TPS8665
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: May 31, 2025, from 1:30 p.m.– 4:30 p.m. CDT
Poster Board Number: 136a

*Presenter, corresponding author; 1University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Massachusetts General Hospital, Boston, MA, USA; 3NEXT Oncology, Fairfax, VA, USA; 4Fred Hutchinson Cancer Center, Seattle, WA, USA; 5Washington University School of Medicine, St. Louis, MO, USA; 6Sarah Cannon Research Institute at HealthONE, Denver, CO, USA; 7Stanford Cancer Institute, Stanford, CA, USA; 8Henry Ford Cancer Institute, Detroit, MI, USA; 9Sylvester Comprehensive Cancer Center, Miami, FL, USA; 10Sarah Cannon Research Institute Oncology Partners, Nashville, TN, USA; 11University of California Davis, Davis Comprehensive Cancer Center, Sacramento CA, USA; 12City of Hope-Lennar, Irvine, CA, USA; 13Nuvalent, Inc., Cambridge, MA, USA; 14Memorial Sloan Kettering Cancer Center, New York, NY, USA

About Neladalkib
Neladalkib is a novel brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About NVL-330
NVL-330 is a novel brain-penetrant HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-mutant tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases.