On September 30, 2025 RefleXion Medical, an external‑beam theranostic oncology company, reported first results from the PREMIER Registry (NCT05406167) evaluating its SCINTIX biology-guided radiotherapy, or BgRT, platform in patients with lung and bone tumors (Press release, RefleXion, SEP 30, 2025, View Source [SID1234656359]). The findings, presented at the 2025 ASTRO Annual Meeting, showed local control of 100 percent at nine months post-treatment with no reported Grade 2 or higher adverse events. The data represent the first prospective, multi-institutional evidence of SCINTIX therapy’s clinical impact.

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 PREMIER Registry findings mark a milestone for our field," said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. "We are beginning to see the clinical translation of a technology that can autonomously guide radiation based on real-time biology. Achieving 100% local control in both lung and bone tumors with imaging up to nine months after treatment, without significant toxicity, represents an important step forward in expanding the reach of radiotherapy for patients with advanced cancer."

By Feb. 25, 2025, five cancer centers had enrolled 45 patients in the registry, with 28 providing follow-up imaging for analysis. Fifteen patients were treated for lung tumors, including early-stage and metastatic disease, and 13 for bone metastases. The median patient age was 69.5 years, with 39% female.

Across 39 follow-up scans, investigators reported a local control rate – defined as complete response (CR), partial response (PR), or stable disease (SD) – of 100% across available follow-up imaging. Tumor response rates (CR+PR) were 41% overall, including 47% for bone metastases and 35% for lung tumors. No Grade 2 or higher treatment-related adverse events were observed.

RefleXion plans to expand registry enrollment and continue long-term follow-up to strengthen the dataset and evaluate correlations between treatment parameters, imaging metrics and patient outcomes.

These early results underscore RefleXion’s goal of establishing SCINTIX therapy as a first-in-class treatment option for both localized and metastatic disease. As the registry grows, the company expects the evidence to further support BgRT’s integration into routine cancer care.

RefleXion (booth #1433) is also presenting early results characterizing performance of its future, next-generation platform1 that offers a 20-fold increase in PET sensitivity, which may increase patient eligibility for SCINTIX therapy. Presentations will be held every 30 minutes in the RefleXion booth during exhibit hours.

On September 30, 2025 Accuray Incorporated (NASDAQ: ARAY) and the University of Wisconsin School of Medicine and Public Health (UW SMPH) reported the signing of a memorandum of understanding (MOU) to advance online adaptive radiotherapy (OART) on the Accuray helical radiation treatment delivery platform (Press release, University of Wisconsin, SEP 30, 2025, View Source [SID1234656357]). As part of the MOU, the two parties outlined their intent to collaborate on clinical research, education and training, and adaptive technology development, to help empower medical care teams to raise the bar in the personalization and precision of cancer care.

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!

"I couldn’t be prouder to announce this proposed collaboration with the University of Wisconsin and the renowned team at their Department of Human Oncology. We share a mutual goal to expand the curative power of radiotherapy with technologies that not only help extend survivorship but also quality of life―and we believe OART can help to do just that. The proposed collaboration aims to leverage our respective strengths to reshape the overall OART experience for providers so that ultimately, clinical departments of all sizes can find it feasible to incorporate this advanced treatment option into their practice," said Mu Young Lee, SVP, Research & Product Development at Accuray.

University of Wisconsin–Madison researchers invented the first helical radiation delivery platform, the TomoTherapy System. It ushered in a new era in radiation medicine that enabled clinicians, for the first time, to leverage a system specifically designed for integrated 3D daily image-guidance with intensity-modulated radiation therapy (IG-IMRT) to increase the precision and accuracy of treatments and help better control patients’ cancer. Since the TomoTherapy System’s introduction, Accuray has continued to evolve the helical platform with the purpose of further enhancing its precision and accuracy, as well as introducing advances in the areas of image quality, speed, versatility, and workflow efficiencies.

"The origins of the TomoTherapy System began right here at UW–Madison, and our clinical researchers have deep experience in bringing future innovations from bench to bedside," said Nita Ahuja, MD, MBA, Dean of the school and Vice Chancellor for Medical Affairs at the University of Wisconsin–Madison. "This MOU focused on online adaptive radiotherapy for personalized, precision cancer care signifies our commitment to keeping patients at the center of our research efforts, while also allowing important translational medicine training opportunities for the next generation of clinical researchers and physician-scientists."

On September 30, 2025 AbbVie (NYSE: ABBV) reported submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (Press release, AbbVie, SEP 30, 2025, View Source;an-investigational-antibody-drug-conjugate-adc-to-treat-rare-cancer-with-limited-treatment-options-302570103.html [SID1234656356]). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer that has features of both leukemia and lymphoma. Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant. The need for additional and innovative treatment is high for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory disease.

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!

PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in clinical development for hematological malignancies (blood cancers), including BPDCN and acute myeloid leukemia (AML). ADCs are designed to deliver potent cancer cell death-inducing agents called ‘payloads’ directly to the cancer cells expressing a specific protein. CD123 (IL-3Rα) is a protein overexpressed in BPDCN, making it an ideal target for therapy.

"Meaningful innovations in cancer research and treatment are happening every day. It is important that these innovations reach patients who desperately need them, including those with rare cancers who have limited options," said Roopal Thakkar, executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to next steps in the regulatory process for our latest Antibody-Drug Conjugate (ADC), our first ADC in blood cancer, and how it may advance treatment for those living with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)."

About the CADENZA Trial
CADENZA is a Phase 1/2 multicenter, open-label study designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing schedule for PVEK monotherapy and to assess the safety, tolerability, PK, immunogenicity, and antileukemia activity of PVEK when administered to subjects with CD123+ hematologic malignancies (including subjects with BPDCN, AML, and others).

About Pivekimab Sunirine (PVEK)
PVEK is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). PVEK is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML. In October 2020, the FDA granted PVEK Breakthrough Therapy designation in relapsed/refractory BPDCN.

On September 30, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present ten abstracts from our portfolio and advancing pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress taking place from 17-21 October 2025, including new data for PADCEV (enfortumab vedotin) plus pembrolizumab in muscle-invasive bladder cancer (MIBC) which will be presented in an ESMO (Free ESMO Whitepaper) Presidential Symposium on 18 October (Press release, Astellas, SEP 30, 2025, View Source [SID1234656355]). In prostate cancer, we are sharing final best-in-class overall survival data for XTANDI (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone sensitive disease, plus encouraging data for our next-generation bispecific T cell engager ASP2138 in solid tumors, demonstrating continued leadership in CLDN18.2-targeted precision medicine.

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!

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"Astellas focuses on some of the most complex and devastating cancers. These ESMO (Free ESMO Whitepaper) data demonstrate our ‘bench to bedside’ approach in action – from deep disease biology to measurable improvements in patient outcomes. We’re proud to share breakthrough new survival data in muscle-invasive bladder cancer and overall survival data in hormone sensitive prostate cancer, which reflect potentially practice-changing advances that could transform outcomes for patients who need them most. We also continue to advance innovation in gastric and gastroesophageal junction cancer with new clinical data for our next-generation investigational bispecific T cell engager."

Highlights from Astellas at ESMO (Free ESMO Whitepaper) 2025 will include:

Data from the Phase 3 EV-303 (also known as KEYNOTE-905) clinical trial which will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium, evaluating enfortumab vedotin in combination with pembrolizumab as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy.
Long-term follow-up data from the EV-302 clinical trial exploring the utility of enfortumab vedotin in combination with pembrolizumab for patients with challenging baseline characteristics, including older patients with locally advanced or metastatic urothelial cancer and those with comorbidities such as diabetes and chronic kidney disease.
Final data from the Phase 3 EMBARK trial assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence.
First clinical data from Astellas’ investigational CLDN18.2-targeted, next-generation bispecific CD3 T cell engager ASP2138, both as a monotherapy and in combination with standard of care therapy.
Astellas Presentations at ESMO (Free ESMO Whitepaper) Congress 2025

Enfortumab vedotin

Presentation Title

Presenter

Presentation Details

Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study

C. Vulsteke

Type: Presidential Symposium 1

Abstract Number: LBA2

Date: October 18,
16:52 – 17:04 CEST

Enfortumab vedotin and pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer: An exploratory analysis in older patients and those with comorbidities from EV-302

N. Mar

Type: Poster

Abstract Number: 3073P

Date: October 18,
12:00-12:45 CEST

Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: Results from a cohort of the EV-202 trial

P.L. Swiecicki

Type: Mini oral

Abstract Number: 1329 MO

Date: October 19,
17:38-17:43 CEST

EV-103 Cohort K: Efficacy and safety of enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible pts with previously untreated locally advanced or metastatic urothelial cancer with a median follow-up of ≈3.5 y

T.W. Friedlander

Type: Poster

Abstract Number: 3074P

Date: October 18,
12:00-12:45 CEST

Real-world use of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy in France

A. Fléchon

Type: ePoster

Abstract Number: 3111eP

Date: October 18, 12:00-12:45 CEST

Enzalutamide

Presentation Title

Presenter

Presentation Details

Overall survival in EMBARK, a phase 3 randomised trial of enzalutamide or placebo plus leuprolide and enzalutamide monotherapy in patients with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis

S.J. Freedland

Type: Proffered Paper

Abstract Number: LBA87

Date: October 19,
10:55-11:05 CEST

Baseline features and metastasis-free survival by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis

N.D. Shore

Type: Poster

Abstract Number: 2461P

Date: October 18,
12:00-12:45 CEST

Pipeline

Presentation Title

Presenter

Presentation Details

ASP2138 monotherapy in patients with (CLDN18.2)+, advanced solid tumors: Phase 1/1b trial

K. Shitara

Type: Poster

Abstract Number: 2137P

Date: October 19,
12:00-12:45 CEST

ASP2138 monotherapy or in combination with pembrolizumab and mFOLFOX6 or with ramucirumab and paclitaxel in (CLDN18.2)+ locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: Phase 1/1b trial

F. Dayyani

Type: Poster

Abstract Number: 2136P

Date: October 19,
12:00-12:45 CEST

Phase 1 trial of ASP5541 (PRL-02), a long-acting intramuscular depot injection of abiraterone decanoate, in patients with advanced prostate cancer

J. Avitia

Type: Poster

Abstract Number: 2443P

Date: October 18,
12:00-12:45 CEST

On September 30, 2025 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and European leader in epigenetics, reported that the European Patent Office (EPO) has issued a Decision to Grant for its patent application EP20712594.9, entitled "Combinations of iadademstat for cancer therapy" (Press release, Oryzon, SEP 30, 2025, View Source;utm_medium=email&utm_campaign=NdP.30+2025-10-01+EPO+allowance+combos+ICI+ENG784 [SID1234656354]).

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 allowed claims protect the use of iadademstat in combination with PD1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). Once formally granted, the patent will remain in force until at least 2040, excluding potential patent term extensions. Corresponding patents have already been allowed or granted in Australia and Russia, with additional applications pending in the United States, Japan, China, and other territories.

"We are delighted to have secured this grant, which strengthens protection for iadademstat in combination with immune checkpoint inhibitors such as atezolizumab and durvalumab, a therapeutic approach we are actively pursuing in clinical trials", said Neus Virgili, Oryzon’s Chief IP Officer.

Iadademstat is currently being investigated in combination with PD-L1 inhibitors (atezolizumab or durvalumab) in first line, extensive-disease SCLC patients in a Phase I/II trial conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon. More than 30 sites accross the U.S. participate in the trial, including leading institutions such as Memorial Sloan Kettering Cancer Center, Johns Hopkins, City of Hope, Yale University and the University of Chicago, among others.