On May 28, 2025 Thermo Fisher Scientific, the world leader in serving science, reported it will showcase some of the technologies that have helped power precision oncology at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Thermo Fisher Scientific, MAY 28, 2025, View Source [SID1234653466]). Through poster presentations, abstracts, and an end-to-end presence across oncology diagnostics, clinical trials, and drug development, Thermo Fisher will demonstrate how its integrated solutions – from biomarker discovery to commercialization – are improving access to targeted cancer therapies.

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By advancing NGS technologies that prioritize speed, accuracy, and accessibility, the company, through its clinical sequencing business, is helping to ensure that patients in all care settings benefit from the latest innovations. This year marks a significant milestone for Thermo Fisher: a decade of pharma partnership in NGS companion diagnostics development and commercialization, supporting new drug launches globally with decentralized in-country CDx solution.

This commitment extends to its clinical research capabilities. Over the past five years, Thermo Fisher has supported more than 750 hematology and oncology clinical trials, involving over 175,000 patients at more than 35,000 sites in over 100 countries. Through its PPD clinical research business, the company takes a patient-centered approach to trial design and execution, ensuring that studies are not only scientifically rigorous but also more accessible and inclusive.

"Reflecting on the last decade of partnership with pharmaceutical companies and their therapeutic innovations, we’re proud to continue our legacy as a trusted partner and celebrate the impact these collaborations have had on expanding access to precision cancer care," said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. "Behind every test is a patient waiting for answers. That’s what drives us – equipping clinicians with fast, reliable insights so they can make confident, timely treatment decisions that change lives."

Davy will deliver opening remarks at the Canadian Evening at ASCO (Free ASCO Whitepaper) 2025, hosted by Breast Cancer Canada. Held Friday, May 30, at the Marriott Marquis Chicago, this event brings together researchers, clinicians, advocates, and industry leaders to celebrate progress in cancer research.

Research and Abstract Highlights at ASCO (Free ASCO Whitepaper) 2025

At ASCO (Free ASCO Whitepaper) 2025, researchers from Thermo Fisher and its customers will present new data on precision oncology, including:

Assessment of Homologous Recombination Deficiency and BRCA Status (Abstract 3130, Poster presentation) – evaluates a decentralized NGS assay for identifying HRD and BRCA mutations in ovarian cancer.
Combined Genomic Profiling of cfDNA and ctDNA – demonstrates how dual analysis of cfDNA and ctcDNA using a prostate cancer-specific panel can provide complementary molecular insights.
Association between Targeted Therapy and Survival in Patients with AML (Abstract e23283 in collaboration with EVERSANA) – analyzes real-world data showing improved survival in high-risk MDS patients receiving targeted therapies based on genetic mutations.
Attendees can connect with Thermo Fisher experts at booth #12049 to learn more about how the company supports oncology programs from research through commercialization.

On May 28, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that the results from the open label Phase 2 PROSPECT Study of tirabrutinib is to be presented at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Ono, MAY 28, 2025, View Source [SID1234653465]). Patients in the U.S. with relapsed or refractory primary central nervous system lymphoma (R/R PCNSL) who received oral tirabrutinib as a monotherapy achieved an overall response rate (ORR) of 67%.2

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Tirabrutinib is a highly selective irreversible, second generation Bruton’s tyrosine kinase inhibitor discovered by Ono in Japan. In March 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to investigational tirabrutinib for the treatment of PCNSL.3

"PCNSL is a rare and aggressive extranodal non-Hodgkin lymphoma with historically poor survival rates and no approved treatments in the U.S.," said Tracy Batchelor, MD, MPH, Mass General Brigham Chair of Neurology and Coordinating Investigator for the PROSPECT study. "The PROSPECT Study data show tirabrutinib provided a promising response rate in patients with R/R PCNSL, supporting its role as a potentially effective treatment option for patients living with this devastating disease."

Study Results
In the PROSPECT Study, 48 patients with R/R PCNSL received oral tirabrutinib as a monotherapy once daily.2,4 The primary endpoint was ORR, and secondary endpoints included duration of response (DOR), time to response (TTR), and safety.2,4

After a median follow-up of 11.5 months, ORR was 67%, with a complete response rate of 44%.2 Median DOR was 9.3 months, and median TTR was 1.0 months.2 Exploratory endpoints included median overall survival, which was not reached, and median progression-free survival, which was 6.0 months.2

Tirabrutinib demonstrated a generally favorable safety profile.2 At data cutoff, 13 patients (27%) remained on tirabrutinib treatment.2 The main reasons for discontinuation were disease progression (54.2%) and death (8.3%); one patient discontinued due to an adverse event (AE).2 Incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was 56.3%.2 Any-grade treatment-related TEAEs were experienced by 75.0%, and most frequently included anemia (18.8%), rash maculo-papular (16.7%), fatigue (14.6%), neutrophil count decreased (14.6%), lymphocyte count decreased (14.6%), pruritus (14.6%), and rash (14.6%).2 Two patients died of TEAEs, which were considered unrelated to study treatment. 2

"We are deeply grateful to the study investigators and the patients who participated in this study for making this important research possible," said Thomas Lechner, MSc. Ph.D., VP, Medical Affairs, ONO PHARMA USA INC. "Tirabrutinib is approved for relapsed or recurring PCNSL in Japan, Taiwan, and South Korea and our hope is to bring this potential treatment to those living with this hard-to-treat disease in the U.S as soon as possible."

PROSPECT Study data will be included in a regulatory submission to the FDA in the near future.

About PCNSL
PCNSL is a rare and aggressive extra nodal non-Hodgkin lymphoma (NHL) that is confined to the brain parenchyma, spinal cord, eye, or leptomeninges, without systemic involvement. The annual incidence rate of PCNSL is approximately five cases per 1,000,000 people in the U.S. The rate can further increase among immunocompromised people aged 65 years and older. The signs and symptoms presented in patients with PCNSL vary depending on the neuroanatomical site of the lesion, and include cranial neuropathy, neuropsychiatric symptoms, symptoms associated with increased intracranial pressure, seizures, ocular symptoms, headache, dysmotility, cranial neuropathy, and radiculopathy. There are no therapeutic products approved for the treatment of PCNSL in the U.S., and data guiding therapeutic approaches are very limited. Despite recent progress resulting in the improvement of clinical outcomes in newly diagnosed patients with PCNSL after an induction treatment, approximately 20 to 30 percent of patients are refractory to the initial treatment, and up to 60 percent of patients will eventually relapse. To learn more about R/R PCNSL, please visit navigatingpcnsl.com.

About Tirabrutinib
Tirabrutinib, discovered and developed by Ono Pharmaceutical Co., Ltd., is a highly potent selective BTK inhibitor. Signaling through the B-cell receptor (BCR) regulates cellular proliferation and activation, and promotes survival, differentiation, and clonal expansion of B-cells. The BCR signaling pathway plays an important role in a number of B-cell malignancies. In Japan, tirabrutinib was approved in March 2020 for the treatment of relapsed or refractory PCNSL and launched under the tradename of Velexbru in May 2020. It was subsequently approved for the treatment of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma in August 2020.Tirabrutinib was approved for the treatment of relapsed or refractory PCNSL in South Korea in November 2021 and in Taiwan in February 2022.

About the PROSPECT Study
The PROSPECT Study is a Phase 2 trial (NCT04947319) evaluating the safety and efficacy of an investigational oral medicine called tirabrutinib for the potential treatment of newly diagnosed or relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL), which is a type of cancer that either does not improve from treatment (refractory) or improves only for a limited time (relapsed). Current treatment options for R/R PCNSL are limited, and there are no medications specifically approved in the U.S. for the treatment of PCNSL. Learn more about the PROSPECT Study here: theprospectstudy.com.

On May 28, 2025 Nucleai, an AI-powered spatial biomarker and diagnostics company, reported it will showcase its expanded suite of solutions for antibody-drug conjugate (ADC) clinical trials at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held this week from May 30-June 3 in Chicago, IL (Press release, Nucleai, MAY 28, 2025, View Source [SID1234653464]). Recent studies have demonstrated that AI-powered computational pathology and spatial biomarkers can predict ADC treatment response more accurately than standard pathological scores, enabling ADC developers to derisk their drug development programs by designing biomarker-informed clinical trials. Nucleai’s commercially available ADC suite of solutions unlocks unparalleled granularity for ADC developers, including high sensitivity for low levels of biomarker expression as well as detecting subcellular protein expression.

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At ASCO (Free ASCO Whitepaper), Nucleai will demo their OD-based quantitative biomarker scoring solution, which solves the challenges of manual visual scoring of immunohistochemistry (IHC) images by pathologists, which could lead to inconsistent results and an incomplete understanding of drug efficacy. The analysis suite also includes spatial biomarker scoring methods to model a drug’s potential bystander effect, with implications for patient stratification and trial design. In addition to these applications, biopharma partners developing ADC and immunotherapy combination therapy strategies can evaluate tumor immunogenicity and identify specific immune cell subsets in the tumor microenvironment using Nucleai’s multimodal capabilities, which combine IHC data with hematoxylin and eosin (H&E) stained biopsy slides.

Demand has continued to rise for AI-powered quantitative biomarker scoring, especially for ADC development, where the exact mechanism of action (MOA), treatment response, and resistance mechanisms have not been fully established. For example, in some studies, researchers have concluded that high levels of protein expression on the surface of tumor cells are correlated to patient outcomes, but in other studies, treatment response is correlated to higher expression of the protein in the cell’s cytoplasm. On the other hand, in some indications, there is no clear correlation between protein expression levels in the patient and their response to the drug. In addition to supporting drug development, clinicians are also in need of better biomarkers to help guide the sequence of treatment in indications like hormone receptor (HR)-positive breast cancer, where multiple ADCs with similar cytotoxic payloads have been approved in recent years.

Nucleai, which has pioneered the use of AI for spatial biomarker analysis, has been working with leading ADC developers to evaluate their trials with this expanded suite of capabilities. As an add-on to these capabilities, Nucleai will also unveil an AI-driven analysis studio that enables easier extraction of actionable MOA and biomarker insights from complex computational pathology and spatial biology data. With this advancement, biopharma partners now have faster access to actionable insights, which can be applied to clinical trials and companion diagnostics in the future.

The expanded ADC suite also includes a novel spatial proteomics dataset with over 200 tumor and normal samples, across 30 biomarkers and 3 indications to profile ADCs, bispecific antibody targets, the tumor immune microenvironment, and for credentialing potential combination therapy strategies.

"Biomarker exploration often stops at identifying correlations, but the promise of AI-based spatial biomarkers and diagnostics is to move beyond this limited understanding," said Avi Veidman, CEO and co-founder of Nucleai. "With this expanded suite of ADC solutions, researchers can shift from passive observation to active investigation with an interactive interface, helping to bridge the gap from correlation to causality. This approach enables our biopharma partners to accelerate development by deriving clinically meaningful insights from complex data."

Next week at ASCO (Free ASCO Whitepaper) (booth #IH02), the Nucleai team will be sharing specific applications of the ADC solutions suite with demos that cover target identification, credentialing of bispecific targets and combination strategies, OD-based quantitative biomarker scoring, and spatial scoring to model a drug’s potential bystander effect. The demos will show how Nucleai is reducing the burden on bioinformatics and pathology teams by providing intuitive tools for real-time interaction with data.

Poster Presentation: Biomarkers of Immunotherapy Response in Melanoma

Also at ASCO (Free ASCO Whitepaper), Nucleai’s AI-powered spatial biomarker technology combined with Lunaphore (a Bio-Techne brand)’s high-throughput, hyperplex COMET platform will be featured in a poster presentation in collaboration with Dr. Paolo A. Ascierto, Director of the Melanoma and Cancer Immunotherapy Unit at the National Cancer Institute in Naples.

The poster, titled "Application of a novel multiplex imaging-based immunotherapy panel and AI-powered analysis solution for predictive spatial biomarker identification on immunotherapy-treated melanoma patients," will be presented on Sunday, June 1 from 9:00 AM – 12:00 PM CDT in Hall A – Posters and Exhibits.

For more information, visit nucleai.ai/asco2025.

On May 28, 2025 Bayer reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy (Press release, Bayer, MAY 28, 2025, View Source [SID1234653463]).

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"Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that supports our ongoing efforts to develop healthcare solutions that help people living with lung cancer," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "If approved, sevabertinib will provide an additional treatment option for previously treated patients with advanced NSCLC harboring a HER2-activating mutation."

The NDA for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial. Results from patients with advanced NSCLC harboring a HER2-activating mutation, who experienced disease progression after ≥1 systemic therapies for advanced disease and were naïve to HER2-targeted therapy.1

The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.2

In 2024, the FDA granted sevabertinib Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. The Breakthrough Therapy designation was supported by preliminary clinical evidence from the SOHO-01 trial. The FDA grants Breakthrough Therapy designation for the evaluation of investigational medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).3

About sevabertinib (BAY 2927088)4
Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths in the U.S.5 Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases.4 Activating HER2 mutations are found in 2% to 4% of advanced NSCLC.6 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.7 Patients with HER2-mutant NSCLC currently face limited targeted therapies.

On May 28, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review to satricabtagene autoleucel ("satri-cel", CT041)(an autologous CAR T-cell product candidate against protein Claudin18.2), for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy (Press release, Carsgen Therapeutics, MAY 28, 2025, View Source [SID1234653462]).

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About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA.