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Business Wire
28-05-2025
- Business
- Business Wire
ASCO 2025: XOFIGO ® (radium-223 dichloride) Combination Data Showcases Clinical Benefits in Metastatic Castration-Resistant Prostate Cancer with Bone Metastases
WHIPPANY, N.J.--(BUSINESS WIRE)--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) 2025 Annual Meeting on June 3, 2025. The studies in prostate cancer treatment with XOFIGO, offer potential new insights for patients with mCRPC with bone metastases. 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 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 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) Injection 1 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). 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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and XOFIGO are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: 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 XOFIGO ® (radium-223) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019. Choudhury A, et al. PSA and alkaline phosphatase changes in the EORTC-1333 PEACE-3 study evaluating the addition of six cycles of radium 223 in metastatic castration-resistant prostate cancer (mCRPC) starting enzalutamide. Abstract 5062. Presented at ASCO 2025. 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. McKay RR, et al. A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis. Abstract 5007. Presented at ASCO 2025.
Time of India
20-05-2025
- Time of India
All 7 prime accused in Hangal gangrape case granted bail
Haveri: The Hangal gangrape case took a dramatic turn 17 months after the gruesome crime, with all the seven prime suspects granted bail by the additional district and sessions (FTSC-1) court of Haveri on Tuesday, following the survivor's inability to identify the suspects in court. The seven prime suspects — identified as Aftab Chandanakatt, Madarasab Mandakki, Samiulla Lalanavar, Mohammad Sadiq Agasimani, Sohib Mulla, Tousif Choti, and Riyaz Saviker — had their bail pleas rejected multiple times in the past. Of the 19 suspects initially arrested, including the seven prime suspects, 12 were granted bail and released from Haveri sub-jail 10 months ago. The 26-year-old survivor had previously complained to the media that she was gang-raped by seven men. She had made the same statement before a magistrate under CRPC section 164, and even identified the suspects during an identification parade in the presence of Hangal tahsildar. However, public prosecutor Vijaykumar Patil confirmed that the survivor's reluctance to maintain her previous statements led to the court granting bail to all seven primary suspects. C Gopal, the then additional SP of Haveri, had prepared a chargesheet that included statements from around 80 witnesses, including forensic experts, doctors, staff members and the owner of the private lodge where the survivor and her male companion were residing before the crime, and others. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like [Click Here] - 2025 Top Trending Search - Local network access Esseps Learn More Undo The documenting of evidence spans roughly 1,000 pages, detailing the accused persons' involvement established through DNA samples, hair strands, blood samples, undergarments recovered from the crime scene, identification parade, and CCTV footage. Moral policing turns into gangrape Initially, a case of moral policing was filed, involving an interfaith couple residing at a private lodge. However, later, police added the gangrape charge after the survivor confirmed the crime before the magistrate on January 11, 2023. The survivor, who was with her male companion at the time of the crime, said she was dragged to a forested area near Nalkuru Cross and sexually assaulted by the seven prime accused, who were later arrested from Akkialuru village. During the course of the inquiry, 12 others were arrested who had allegedly assaulted the victim and turned facilitator to the prime accused.
India Gazette
16-05-2025
- Politics
- India Gazette
IYC protests in Delhi against Bihar Government over FIR on Rahul Gandhi
New Delhi [India], May 16 (ANI): Indian Youth Congress workers staged a protest in Delhi against the Bihar government on Friday following an FIR filed by the Darbhanga district administration against Congress MP and Lok Sabha Leader of Opposition Rahul Gandhi. The FIR was filed against Rahul Gandhi for allegedly organising an event at the Ambedkar hostel in Darbhanga without official permission. The protesters condemned the action, terming it an attempt to suppress political activities. Earlier on Thursday, Congress MP Rahul Gandhi alleged that Bihar Police tried to stop him on his way to Ambedkar Hostel, Darbhanga district administration on Thursday said that they will take action against him for the violation of Section 163 of the Code of Criminal Procedure (CrPC). The District Magistrate of Darbhanga told ANI, 'Darbhanga district administration to take action against Lok Sabha LoP and Congress MP Rahul Gandhi for violation of CRPC 163.' Earlier today, calling the NDA government in Bihar a 'Double Engine Dhokebaaz Sarkaar', Congress leader Rahul Gandhi alleged that the Bihar Police stopped him on his way to the Ambedkar hostel in Darbhanga. 'The Bihar Police tried to stop me. But they could not stop me because your power (minority community) is watching over me. We told PM Narendra Modi that you have to conduct a census... Under your pressure, PM Narendra Modi announced a caste census in the country. Scared of your pressure, he placed the Constitution on his forehead. But their government is against democracy, the Constitution, and the minorities. This is the government of Adani-Ambani and not yours,' Rahul Gandhi said, addressing the gathering in Darbhanga. 'I guarantee that the moment our government forms in India and in Bihar, and implements everything that you deserve,' he added. In a post on X, Rahul Gandhi, following his allegations, asked Bihar Chief Minister Nitish Kumar since when the dialogue became a 'crime in the state.' 'NDA's 'Double Engine Dhokebaaz Sarkaar' in Bihar is preventing me from interacting with Dalit and backward students in Ambedkar Hostel. Since when has dialogue become a crime? Nitish ji, what are you afraid of? Do you want to hide the state of education and social justice in Bihar?' the Lok Sabha LoP said. (ANI)
India Gazette
16-05-2025
- Politics
- India Gazette
Union Minister Giriraj Singh attacks Rahul Gandhi, says he can't tolerate Narendra Modi as PM
New Delhi [India], May 16 (ANI): Union Minister Giriraj Singh on Friday took a jibe at Leader of Opposition Rahul Gandhi, claiming he cannot tolerate that someone like Narendra Modi, a backward class leader and former tea vendor holds the post of Prime Minister. Responding to Rahul Gandhi's call for implementing reservation in private institutions, Union Minister Giriraj Singh said the Leader of Opposition should have questioned his father and grandmother---both former Prime Ministers of India on why they failed to introduce such measures during their time in power. 'Rahul Gandhi thinks that nobody can become the Prime Minister except him, or without the leadership of the Gandhi family. He can't tolerate that someone like Narendra Modi, the son of a backwards class, poor tea vendor, be the PM. That is why he is creating all this drama,' Singh told ANI. 'He should have asked his father and grandmother why they didn't implement reservations. Shedding crocodile tears is not going to help him accomplish anything now,' he added. This comes after, Gandhi in his address in Bihar's Darbhanga, advocated for implementing reservation laws in private colleges and universities, ensuring equal opportunities for marginalised communities. '...I talked about the caste census there (at the college hostel) and also said that the law which is there - reservation in private colleges and universities - that law should be implemented. Also, the 50% barriers in the reservation should be removed. These are our demands and we will fulfil them,' he said. Ahead of this, the Darbhanga district administration said on Thursday that they would take action against him for the violation of Section 163 of the Code of Criminal Procedure (CRPC). The District Magistrate of Darbhanga told ANI, 'Darbhanga district administration to take action against Lok Sabha LoP and Congress MP Rahul Gandhi for violation of CRPC 163.' The action came after Gandhi reached Ambedkar Hostel in Darbhanga despite being denied of permission by Bihar Police. (ANI)
India Gazette
15-05-2025
- Politics
- India Gazette
"Only went there to do politics because there are elections in Bihar this year": JDU MP Sanjay Jha criticises Rahul Gandhi's intentions
Patna (Bihar) [India], May 15 (ANI): JDU MP Sanjay Jha on Thursday questioned Lok Sabha LoP Rahul Gandhi's visit to a hostel in Darbhanga, accusing him of using the issue of reservation and caste census for political gain, particularly in the context of upcoming elections in Bihar. Criticising Gandhi's intentions and highlighting Bihar Chief Minister Nitish Kumar's efforts in Bihar, Jha contrasted this with the permission granted for a meeting at the town hall. 'In Darbhanga, where he (Rahul Gandhi) had sought permission, the administration did not give permission because is any political meeting ever held in a hostel? But when his party later sought permission in the town hall, they were given permission... He (Rahul Gandhi) did not care about any poor student or the backwards. He only went there to do politics because there are elections in Bihar this year...,' Jha told ANI. This comes amid Rahul Gandhi's allegations that Bihar Police tried to stop him on his way to Ambedkar Hostel in Darbhanga. Highlighting the JDU's commitment to social justice, Jha took a dig at the previous RJD-Congress alliance and highlighted Nitish Kumar's initiative in conducting a caste-based survey in Bihar and releasing its data. 'When the RJD-Congress were together in the government, those Dalits, backwards people did not have reservations even in the Panchayat...,' Jha credited Kumar's government with providing reservations to Dalits and Backward classes in panchayats, a move he claimed was lacking during the RJD-Congress government's tenure. 'Reservation is being given after Nitish Kumar came to power... As far as the caste census is concerned, Nitish Kumar is the only leader of this country who got a caste-based survey done in Bihar and released its data. Even when we (JDU) were in the INDIA alliance, we repeatedly put forward the proposal, but they did not accept it...' Meanwhile, Darbhanga district administration on Thursday said that they will take action against Rahul Gandhi for the violation of Section 163 of the Code of Criminal Procedure (CrPC). The District Magistrate of Darbhanga told ANI, 'Darbhanga district administration to take action against Lok Sabha LoP and Congress MP Rahul Gandhi for violation of CRPC 163.' Notably, Rahul Gandhi is in Bihar to launch 'Shiksha Nyay Samvad' in Darbhanga (ANI)
