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Business Wire
a day ago
- Health
- Business Wire
(radium-223 dichloride) Data in Metastatic Castration-Resistant Prostate Cancer from Phase III PEACE III Trial Published in
WHIPPANY, N.J.--(BUSINESS WIRE)-- Annals of Oncology published full results from the pivotal investigational Phase III PEACE III trial, evaluating XOFIGO ® (radium-223 dichloride) in combination with enzalutamide, an AR pathway inhibitor (ARPI), versus enzalutamide alone in the first-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. 1 XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. 2 Initially presented as a late-breaking abstract during the Presidential Symposium at ESMO 2024, results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) for 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. 1,3 Patients receiving XOFIGO in combination with enzalutamide had a median rPFS of 19.4 months (95% CI, 17.1-25.3 months) compared to 16.4 months (95% CI, 13.8-19.2 months) with enzalutamide, a 3-month difference in median rPFS. 1,3 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). Additionally, at a preplanned interim analysis the results demonstrated statistically significant overall survival (OS), with a 31% reduction in the risk of death (HR=0.69; 95% CI 0.52-0.90; p=0.0031), with a median OS of 35.0 months (95% CI 28.8-38.9) in the enzalutamide arm compared to 42.3 months (95% CI 36.8-49.1) for XOFIGO plus enzalutamide. 1 The study will continue to the final OS analysis. XOFIGO is the first and only alpha emitting radiopharmaceutical that treats bone metastases in mCRPC approved by the U.S. Food and Drug Administration (FDA). 'PEACE III is the first major Phase III trial to combine an ARPI with radiopharmaceutical that showed statistical significance in meeting the primary endpoint,' said Denis Lacombe, Chief Executive Officer, EORTC. 'The EORTC is proud to be at the forefront of this groundbreaking trial, helping to redefine the development of clinical trials and supporting patient care for difficult to treat diseases.' The results were consistent with the established safety profile of XOFIGO, although authors noted the importance of administering bone protective agents (BPAs) to avoid fractures. Following the release of the ERA-223 results, the PEACE III study was amended in March 2018 making BPAs mandatory at the monthly skeletal-related-event dose. The observed reduction in fractures following this amendment underlined the importance of using a BPA in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastasis also in the era of ARPI's. 4 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. 1 The most frequent Grade 3 or higher TEAEs were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%), and neutropenia (5%). 1 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 13.4% of patients in the enzalutamide arm. 1 These results demonstrate the potential for this combination to be a new treatment option for patients with mCRPC and bone metastases who have experienced disease progression on androgen deprivation therapy (ADT). 'There remains an unmet patient need for people living with metastatic castration-resistant prostate cancer who have bone metastases,' said Christine Roth, Global Head of Product Strategy and Commercialization at Bayer's Pharmaceuticals Division. 'The PEACE III trial underscores our dedication to advancing therapies for patients with prostate cancer and exploring the full potential of XOFIGO.' Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for XOFIGO for the treatment of patients with mCRPC and who have bone metastases in combination with enzalutamide based on positive results from the Phase III PEACE trial. Bayer will submit applications for marketing authorizations of XOFIGO to additional health authorities as well. The trial is supported by Astellas and Pfizer who manufacture enzalutamide (Xtandi) in collaboration with 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 Xofigo ® (radium-223 dichloride) Injection 2 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 concomitant chemotherapy 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 dichloride, 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 Ra 223 dichloride). About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and XOFIGO are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Tombal. B., et al. Enzalutamide plus Radium-223 in Metastatic Castration-Resistant Prostate Cancer: Results of the EORTC 1333/PEACE-3 trial. Annals of Oncology. May 30, 2025. DOI: 10.1016/ Gillessen, S., et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. European Society of Medical Oncology 2025 (ESMO) LBA1. September 9, 2024. Xofigo ® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019. Gillessen S, et al. Decrease in Fracture Rate with Mandatory Bone-protecting Agents in the EORTC 1333/PEACE-3 Trial Comparing Radium-223 Combined with Enzalutamide Versus Enzalutamide Alone: A Safety Analysis. Eur Urol. 2025 Mar;87(3):285-288.
Globe and Mail
3 days ago
- Business
- Globe and Mail
Meningioma Pipeline Appears Robust With 5+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'Meningioma Pipeline Insight 2025' report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Meningioma pipeline landscape. It covers the Meningioma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Meningioma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Meningioma Pipeline. Dive into DelveInsight's comprehensive report today! @ Meningioma Pipeline Outlook Key Takeaways from the Meningioma Pipeline Report In May 2025, European Organisation for Research and Treatment of Cancer - EORTC conducted a LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand. In May 2025, Baptist Health South Florida announced a phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma. DelveInsight's Meningioma Pipeline report depicts a robust space with 5+ active players working to develop 5+ pipeline therapies for Meningioma treatment. The leading Meningioma Companies such as NX Development Corp., Clarity Pharmaceutical Ltd., Bristol-Myers Squibb, Biosynthema Inc., and others. Promising Meningioma Pipeline Therapies such as Nivolumab, Cabozantinib, Abemaciclib, SOM230C, Bevacizumab, 177Lu-DOTATATE, Pembrolizumab and others. Stay ahead with the most recent pipeline outlook for Meningioma. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Meningioma Treatment Drugs Meningioma Emerging Drugs Profile Gleolan: NX Devolopment Corp NX development corp.'s drug, Gleolan also known as Aminolevulinic acid is an orally administered small molecule in development for the treatment and real time detection of meningioma. Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The exogenous application of ALA leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light. It is a photosensitizer molecule which can utilize the energy to induce photochemical reactions to produce lethal toxic agents; ultimately results in cell death and tissue destruction. Nivolumab: Bristol-Myers Squibb Bristol-Myers Squibb 'breakthrough' drug nivolumab is currently being evaluated for the treatment of Meningioma and has demonstrated good safety and efficacy profile in phase II trials. Nivolumab is a human immunoglobin (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks the interaction with PD-L1 and PD-L2, releasing anti-tumor response. The Meningioma Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Meningioma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Meningioma Treatment. Meningioma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Meningioma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Meningioma market Explore groundbreaking therapies and clinical trials in the Meningioma Marketed and Pipeline Drugs. Access DelveInsight's detailed report now! @ New Meningioma Drugs Meningioma Companies NX Development Corp., Clarity Pharmaceutical Ltd., Bristol-Myers Squibb, Biosynthema Inc., and others. Meningioma Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Subcutaneous Intravenous Oral Intramuscular Molecule Type Meningioma Products have been categorized under various Molecule types such as Small molecules Natural metabolites Monoclonal antibodies Product Type Unveil the future of Meningioma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Meningioma Market Drivers and Barriers Scope of the Meningioma Pipeline Report Coverage- Global Meningioma Companies- NX Development Corp., Clarity Pharmaceutical Ltd., Bristol-Myers Squibb, Biosynthema Inc., and others. Meningioma Pipeline Therapies- Nivolumab, Cabozantinib, Abemaciclib, SOM230C, Bevacizumab, 177Lu-DOTATATE, Pembrolizumab and others. Meningioma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Meningioma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Meningioma Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Meningioma Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary Meningioma: Overview Pipeline Therapeutics Therapeutic Assessment Meningioma – DelveInsight's Analytical Perspective In-depth Commercial Assessment Meningioma Collaboration Deals Late Stage Products (Phase III) Gleolan: Nx Development Corp. Drug profiles in the detailed report….. Mid Stage Products (Phase II) Nivolumab: Bristol-Myers Squibb Drug profiles in the detailed report….. Pre-clinical and Discovery Stage Products Drug profiles in the detailed report….. Inactive Products Meningioma Key Companies Meningioma Key Products Meningioma- Unmet Needs Meningioma- Market Drivers and Barriers Meningioma- Future Perspectives and Conclusion Meningioma Analyst Views Meningioma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
