Strand Therapeutics Announces Initial First-in-human Phase 1 Data for STX-001 in Patients with Advanced Solid Tumors at The 2025 ASCO Annual Meeting

On May 28, 2025 Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, reported exciting preliminary Phase 1 clinical data for its lead investigational candidate, STX-001, in patients with advanced solid tumors (Press release, Strand Therapeutics, MAY 28, 2025, View Source [SID1234653470]). The study marks the first clinical evidence of Strand’s proprietary programmable mRNA technology platform and represents a major milestone in the company’s mission to bring next-generation mRNA therapies to patients with cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In the ongoing first-in-human Phase 1, open-label, dose-escalation clinical trial, STX-001 demonstrated a favorable safety profile and encouraging signs of anti-tumor activity as a monotherapy in patients with immune checkpoint inhibitor-refractory solid tumors, including melanoma and other solid tumor indications. As of the April 3rd, 2025 data cutoff, the trial had enrolled 22 patients across multiple sites in the United States and Australia. All patients were treated with STX-001 as a monotherapy (without combination with immune checkpoint inhibitors, etc.) with injections to surface accessible lesions.

The data will be presented at The 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on June 1 by Sarina Piha-Paul, M.D., professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

"This investigational therapy has the potential to address an important unmet need in patients with checkpoint inhibitor-refractory advanced cancers," said Dr. Piha-Paul. "We’re observing systemic immune activation and antitumor responses, including in non-injected lesions, across multiple tumor types, which is encouraging and supports continued evaluation."

Key highlights from the Phase 1 trial include:

Preliminary Clinical Activity: Multiple RECIST responses were observed, including a confirmed complete response and multiple partial responses. Furthermore, there were multiple cases of prolonged disease stabilization.
Safety and Tolerability: STX-001 was well-tolerated up to 300 µg. Treatment-related adverse events were consistent with STX-001’s intended mechanism of action of immune activation.
Pharmacodynamic Activity: Biomarker analysis confirmed dose-dependent increase in plasma IL-12 and IFN-γ, as well as infiltration of immune cells within the tumor microenvironment.
"This is a transformative moment for Strand and for the field of synthetic mRNA therapeutics," said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. "The Phase 1 data for STX-001 provide early clinical validation of our platform’s ability to deliver programmable, tumor-localized immunotherapy safely and effectively. Our mRNA medicines as a therapeutic modality offer the potential capability to broaden pathways to treatment for patients while seamlessly integrating into the existing healthcare ecosystem."

STX-001 encodes IL-12, an immunomodulatory protein, which the company has designed such that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand’s approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity.

The company is currently conducting dose expansion in the Phase 1 trial. Upon completion, the company plans to transition into a Phase 2 trial of STX-001 as a monotherapy. The company also plans to initiate dose escalation of STX-001 in combination with checkpoint inhibitors and expand into additional solid tumor indications. In addition, Strand is advancing a broader pipeline powered by the company’s first-in-class cell-type specific mRNA engineering platform, including advancing STX-003, an intravenously administered version of STX-001, to patients in 2026.

ASCO Poster Presentation Information:
Abstract Title: Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors.
Session Type: Poster
Date and Time: June 1, 9:00 AM-12:00 PM CDT
Abstract Number: 9556
Location: Hall A
Full abstract is available on the ASCO (Free ASCO Whitepaper) Annual Meeting Website.

The study, an open-label, dose escalation trial, evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of STX-001 in patients with advanced solid tumors. STX-001 was well-tolerated up to 300 µg, with dose-dependent and manageable treatment-related adverse events. Promising early clinical activity was observed, including multiple RECIST responses and durable disease stabilization. Findings support the further development of STX-001 as a monotherapy and in combination with checkpoint inhibitors for the treatment of solid tumors.

Additional Commentary

Professor Georgina Long AO, BSc, PhD, MBBS, FRACP, FAHMS, AAHMS, FAA, Medical Director of Melanoma Institute Australia (MIA), and Chair of Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, The University of Sydney: "I am encouraged by this early data. While intratumoral therapies offer a promising approach by initiating immune activation at the injected tumor site, they have historically struggled to generate robust systemic responses. STX-001 may represent a meaningful step forward, with early clinical evidence showing cases of regression of non-injected lesions, a sign of systemic immune engagement."

Tasuku Kitada, PhD, Co-Founder, President, and Head of R&D at Strand Therapeutics: "Patients who are refractory to immune checkpoint inhibitors urgently need new treatment options. While IL-12 has long been recognized as a powerful immune stimulator, its clinical potential has been limited by toxicity, and to date, no IL-12–based therapies have been approved by the FDA. STX-001 is designed to overcome these challenges, delivering localized IL-12 expression to activate the tumor microenvironment and drive systemic immune responses, all while seeking to minimize toxicities. These early data suggest we may finally be able to realize the promise of IL-12 in cancer therapy."

About STX-001

STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly injected into the tumor microenvironment in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, and announced its first patient dosed just before the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting. Additional study details can be found at clinicaltrials.gov, using identifier: NCT06249048.

NeoGenomics Debuts PanTracer Family of Genomic Profiling Tests at ASCO 2025

On May 28, 2025 NeoGenomics, Inc. ("NeoGenomics" or the "Company") (NASDAQ:NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported it will debut its PanTracer Family, a comprehensive suite of genomic profiling tests for advanced solid tumors, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 30–June 3, 2025 (Press release, NeoGenomics Laboratories, MAY 28, 2025, View Source [SID1234653469]). The company will also unveil Paletrra, its new AI-driven spatial proteomics platform designed to provide clear, actionable insights from tissue samples.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The debut of the PanTracer Family and Paletrra represents a significant milestone for NeoGenomics and a step forward in precision oncology," said Warren Stone, President & Chief Operating Officer at NeoGenomics. "By equipping clinicians and drug developers with the tools to make faster, more informed decisions, we’re helping transform cancer care and accelerate innovation across the continuum of oncology diagnostics."

The PanTracer Family is designed to provide oncologists with timely and actionable genomic insights, supporting treatment decisions for patients with advanced-stage solid tumors. The portfolio includes PanTracer Tissue for comprehensive profiling from Formalin-Fixed, Paraffin-Embedded tissue, PanTracer LBx for liquid biopsy applications where tissue is unavailable or insufficient, and PanTracer Tissue + HRD, which adds homologous recombination deficiency testing to enhance therapy stratification. These assays can be used independently or as complementary tools, allowing clinicians to tailor their approach based on patient-specific needs. It also ensures fast, reliable access to the data needed to explore targeted therapies or clinical trials.

Paletrra is an AI-powered spatial proteomics platform that transforms precious tissue into high-plex, image-based insights. Built for translational research teams, Paletrra combines deep pathology expertise with integrated multimodal analysis to decode the tumor microenvironment and validate mechanisms of action. Paletrra provides a scalable, high-touch solution that enables both large biopharma and emerging biotech companies to make more informed therapeutic decisions—helping teams see the biology more clearly, faster, and with confidence.

NeoGenomics will showcase both solutions at Booth #11093 at the meeting, including an interactive experience, "Hey Neo," to help attendees explore how PanTracer supports therapy selection in real-world settings.

The company will also present a scientific poster at ASCO (Free ASCO Whitepaper) 2025, along with two abstracts published online. These achievements reinforce the company’s role as a research-driven partner to the biopharma community, supporting oncology drug development and clinical trials through cutting-edge diagnostics and scientific insight. The abstracts include:

Abstract #5568/Poster Board #466 (poster presentation): Real-world analysis of folate receptor alpha (FRα; FOLR1) expression in pan-tumor samples from over 6000 patients in the US
Abstract #e15180 (online publication): The cancer fusionome and overexpressed druggable oncogenic signals in K-RAS wild-type pancreatic cancer
Abstract #e15047 (online publication): Analytical validation and clinical performance of a plasma-based CGP assay, NEO | PanTracer LBx

Sarah Cannon Research Institute Announces Strategic Alliance With AbbVie to Advance Novel Cancer Therapies

On May 28, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a strategic alliance with AbbVie (Press release, Sarah Cannon Research Institute, MAY 28, 2025, View Source [SID1234653468]). The alliance aims to accelerate the development of innovative therapies for patients with cancer through collaborative scientific engagement and operational synergies to enhance the delivery of clinical trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"By combining SCRI’s scientific and operational expertise in conducting clinical trials in the community with AbbVie’s innovative drug development approach, we can further strengthen our mission to advance novel therapies for patients," said Dee Anna Smith, Chief Executive Officer, SCRI. "Working together, we can expedite the development of more treatment options and transform clinical trial delivery, providing greater access to cutting-edge therapies for patients close to home."

SCRI’s research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Through the alliance, SCRI and AbbVie will enhance scientific connectivity, enabling collaboration with SCRI’s physician leadership and contract research organization, SCRI Development Innovations, to drive clinical development.

"We are encouraged about the opportunity to establish a strategic scientific alliance with SCRI as we work together on initiatives aimed to address high unmet needs for patients battling cancer," said Svetlana Kobina, MD., PhD., Vice President of AbbVie Oncology, Global Medical Affairs. "Through close collaboration with SCRI and its community sites, we hope to gain a more comprehensive understanding of the treatment paths and health needs of patients living with cancer to provide tailored, patient-centered scientific solutions. This partnership enables us to delve deeper into the challenges faced by medical oncologists, hematologists, patients and caregivers to help us design clinical studies that more accurately represent all patient communities."

The collaboration will leverage SCRI’s advanced research operational capabilities through its Accelero model, which maximizes site contributions, optimizes site activation timelines, and synchronizes end-to-end clinical research management. The Accelero model utilizes SCRI’s robust Personalized Medicine program, including centralized screening services to enable more seamless identification and enrollment of patients on studies. Additionally, through SCRI’s streamlined data delivery solutions, SCRI can ensure timely access to data to inform drug development and optimize clinical trial delivery.

ASCO 2025: XOFIGO® (radium-223 dichloride) Combination Data Showcases Clinical Benefits in Metastatic Castration-Resistant Prostate Cancer with Bone Metastases

On May 28, 2025 Bayer reported new data from two clinical trials evaluating XOFIGO (radium-223 dichloride) in patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting on June 3, 2025 (Press release, Bayer, MAY 28, 2025, View Source [SID1234653467]). The studies in prostate cancer treatment with XOFIGO, offer potential new insights for patients with mCRPC with bone metastases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

XOFIGO is indicated for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease.1 It is the first and only alpha emitting radiopharmaceutical that treats bone metastases in mCRPC approved by the U.S. Food and Drug Administration (FDA).

An analysis from the pivotal Phase III PEACE III trial, evaluating XOFIGO in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), showed that adding six cycles of XOFIGO to enzalutamide improved prostate-specific antigen (PSA) and alkaline phosphatase (ALP) response rates.2 Notably, PSA response rates ≥90% at 6 and 12 months were 50.5% and 54.9%, respectively, in the combination arm compared to 34.1% and 37.6%, respectively, in the enzalutamide arm alone.2 The analysis also showed that for XOFIGO in combination with enzalutamide the median time to ALP normalization was 1.97 months compared to 4.47 months in the enzalutamide arm (HR 1.42; 95% CI, 1.13-1.80).2

The analysis follows the presentation of the full results from the PEACE III trial, presented as a late-breaking abstract during the Presidential Symposium at ESMO (Free ESMO Whitepaper) 2024.3 The results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) among patients with mCRPC with bone metastases, with a 31% reduction in the risk of progression or death (HR 0.69; 95% CI, 0.54-0.87; p=0.0009) compared to enzalutamide alone.3 At the preplanned interim analysis conducted at 80% of the overall survival (OS) events, the hazard ratio (HR) for OS was 0.69 (95% CI 0.52-0.90; p=0.0031). The safety results were consistent with the established safety profile of XOFIGO, although authors noted the importance of administering bone protective agents (BPAs) to avoid fractures.3 The trial was a collaboration between the European Organization for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG).

The results were consistent with the established safety profile of XOFIGO. Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 65.6% of patients in the combination arm compared to 55.8% of patients who received enzalutamide alone.2 The most frequent Grade 3 or higher TEAEs in the combination arm were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%) and neutropenia (5%).2 Fractures (either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without BPA use) were reported in 24.3% of patients in the combination arm and in 13.4% of patients in the enzalutamide arm.2

"The PEACE III trial has provided us with valuable insights into the benefits of combining XOFIGO with enzalutamide for patients with metastatic castration-resistant prostate cancer with bone metastases," said Dr. Murilo Luz, Urologic Oncologist, The Mount Sinai Hospital, New York and trial investigator. "This analysis highlights that the combination therapy achieved improvements on PSA and ALP, beyond the known radiographic progression free survival benefit. We are encouraged by these results with this potential compelling therapeutic option, which could provide an additional treatment option for patients."

Data from the Phase II COMRADE trial were also presented at the ASCO (Free ASCO Whitepaper) 2025 Annual Meeting. Results demonstrated that the combination of olaparib with XOFIGO significantly improved radiographic progression-free survival (rPFS) in mCRPC patients compared to XOFIGO alone, with a median of 8.6 months versus 4.0 months (HR 0.51; 80% CI, 0.37-0.70; 2-sided p=0.005).4 56% of patients in the olaparib with XOFIGO and 35% of patients in the XOFIGO arms had grade ≥3 treatment-related adverse events, the most common adverse events on the olaparib with XOFIGO and XOFIGO arms were anemia (22.0%/18.0%), lymphocyte decrease (30.5%/9.1%), platelet decrease (6.8%/3.6%), and neutrophil decrease (5.1%/7.3%), respectively.4

"The results from the PEACE III and COMRADE trials underscore our dedication to exploring combinations, such as XOFIGO with enzalutamide or olaparib. We are hopeful these results will introduce another treatment option for patients with mCRPC and bone metastases who have not progressed viscerally," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

About PEACE III (EORTC GUCG-1333)

The PEACE III trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. A total of 446 patients were randomized 1:1 to receive either XOFIGO 55 kBq/kg as an intravenous injection monthly for six cycles in combination with enzalutamide 160mg orally daily or enzalutamide 160mg orally daily.

The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. This trial was a collaboration with several cancer cooperative groups: EORTC, CTI, CUOG, LACOG, and GETUG.

About COMRADE II

COMRADE is an open-label, randomized Phase II investigator-initiated trial in patients with metastatic castration resistant prostate cancer with bone metastases treated with a combination of olaparib, a PARP inhibitor, and XOFIGO compared to XOFIGO alone, 120 patients were randomized 1:1 to receive either olaparib plus XOFIGO or XOFIGO alone. The primary endpoint was radiographic progression-free survival (rPFS).

About XOFIGO (radium-223 dichloride) Injection1

XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information for Xofigo (radium-223 dichloride) Injection

Warnings and Precautions:

Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.

Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure

Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care

Concomitant Use With Chemotherapy: Safety and efficacy of concomitantchemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued

Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established

Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo
Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on

placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).

Please see the full Prescribing Information for Xofigo (radium 223 dichloride).

Thermo Fisher Scientific Celebrates Precision Oncology Advancement at ASCO 2025

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.