Latest news with #Capdevila
Time of India
02-05-2025
- Sport
- Time of India
Gerd Muller and Capdevila arrive as new Prime League Exchange players in EA FC Mobile
Gerd Muller and Joan Capdevila just received their new EA FC Mobile Prime cards EA Sports has officially added Icon Gerd Muller (108 OVR, ST) and Hero Joan Capdevila (106 OVR, LB) to the Limited League Star Player segment. These two high-impact cards bring both attacking and defensive power, giving players more reasons to grind League Tokens in one of the most underrated sections of the game. With the Team of the Season (TOTS) hype in full swing, these two elite-level cards offer an excellent upgrade path for players looking to solidify both attack and defense without relying on pure pack luck. But don't wait too long, as these cards are available for a limited time, although EA hasn't revealed the expiration date yet. This article provides detailed information on how to claim these cards and what their statistical in-game advantages are. Gerd Muller and Capdevila are now available in League Exchange: How to claim and full stats 120819064 League Tokens are the main currency of this mode and can be earned through League Tournaments, League Quests, and League Season Rewards. These tokens accumulate steadily for active players, making the new Prime cards a realistic target for those committed to daily gameplay. To claim these Muller and Capdevila player cards, fans will need to head over to the Store > Exchange > League Exchange tab. Following are the costs to unlock them: by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 2025 Top Trending local enterprise accounting software [Click Here] Esseps Learn More Undo Gerd Muller (108 OVR, ST - Icon): 60,000 League Tokens Joan Capdevila (106 OVR, LB - Hero): 30,000 League Tokens Gerd Müller's 108 OVR Icon card is an offensive powerhouse. Known as 'Der Bomber,' Müller's card lives up to his legacy with some outrageous stats - 117 Pace , 122 Shooting , and 112 Dribbling . He can burst past defenders and finish from nearly any angle. While his Passing (87) and Physical (95) are decent for a striker, his Defending is understandably low at 51 . This card also comes with a 4-star Weak Foot and 5-star Strong Foot , making him clinical with either foot in front of goal. He possesses the traits Finesse Shot and Outside Foot Shot , his default skill move is Roulette , and he celebrates goals with a signature Cartwheel. On the other hand, Capdevila's 106 OVR Hero card is perfect for players looking to strengthen their defensive flanks. With 117 Pace , 110 Defending , and 106 Dribbling , the Spanish left-back brings a balanced profile to both stop attackers and support forward plays. His 104 Passing allows for accurate long balls and crosses, while his 82 Shooting gives him the edge in finishing rare chances. Although his 3-star Weak Foot may limit his ability to cut inside, the 5-star Strong Foot makes him a brilliant crosser from the flanks. Capdevila's free-kick abilities are top-notch too, reflected in traits like Powerful Driven Free Kick and Long Shot Taker . The card comes with the Heel to Heel Flick skill move and a stylish Roll and Fist Pump celebration. These new additions join the already available McTominay (107 OVR, CM) for 60,000 tokens and Udogie (105 OVR, LB) for 30,000 tokens in the League Exchange section. However, with no official expiry date announced for Müller and Capdevila, it's best to grab these cards sooner rather than later.
Yahoo
06-03-2025
- Business
- Yahoo
ITM Presents Positive Topline Phase 3 COMPETE Trial Data with n.c.a. 177Lu-edotreotide (ITM-11), a Targeted Radiopharmaceutical Therapy, in Patients with Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumors at the ENETS 2025 Conference
Trial met primary endpoint, demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus Median PFS was 23.9 months on n.c.a. 177Lu-edotreotide v. 14.1 months on everolimus; p value=0.022 Company plans for U.S. New Drug Application (NDA) submission in 2025 Krakow, Poland March 6, 2025 - ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today presented positive topline data from its Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial results demonstrated that n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint and significantly prolonged progression-free survival in patients when compared to everolimus, a standard of care cancer treatment. The data were presented by study investigator Jaume Capdevila, MD, PhD, at the 22nd Annual European Neuroendocrine Tumor Society (ENETS) 2025 Conference, held in Krakow, Poland from March 5-7, 2025. 'COMPETE is the first pivotal trial comparing a radiopharmaceutical drug candidate to a targeted molecular therapy without the routine use of accompanying somatostatin analogues in this GEP-NET patient population. These data show unequivocal support for 177Lu-edotreotide's potential benefit in extending PFS,' said Dr. Capdevila, senior medical oncologist at Vall d'Hebron University Hospital, Barcelona. 'Additionally, 177Lu-edotreotide's convenient dosing schedule and favorable safety results reinforce its potential as a compelling new treatment option.' COMPETE is a prospective, randomized, controlled, open-label Phase 3 trial that enrolled 309 patients with inoperable, progressive, Grade 1 or Grade 2 somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin (Ki-67 ≤20%) in Europe, the United States, Australia and South Africa. The study objectives were to evaluate the efficacy and safety of 177Lu-edotreotide compared to everolimus. 177Lu-edotreotide is comprised of non-carrier-added (n.c.a.) lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a somatostatin receptor agonist. It is the first radiopharmaceutical to be tested in the GEP-NET patient population using non-carrier-added lutetium, which has a higher isotopic purity than carrier-added lutetium. Patients were randomized 2:1 to receive 7.5 GBq of 177Lu-edotreotide with a nephroprotective amino acid solution every three months for up to four cycles, or everolimus 10 mg daily for up to 30 months, or until disease progression. There were 207 patients on the 177Lu-edotreotide arm and 102 on the everolimus arm. Dosimetry was used to assess the absorbed dose in tumors compared to that in healthy tissue to enhance safety and efficacy monitoring of the study drug in patients. Topline Clinical Results Summary Primary endpoint Median progression-free survival (PFS) was significantly longer with 177Lu-edotreotide v. everolimus (23.9 vs 14.1 months); stratified*p value = 0.022; HR 0.67, 95% CI [0.48, 0.95] Secondary endpoint Interim median overall survival (OS)** was numerically higher, but not conclusive for 177Lu-edotreotide v. everolimus (63.4 vs 58.7 months); p value=0.206; HR 0.78, 95% CI [0.5, 1.1] Safety A lower proportion of patients experienced treatment-emergent adverse events (TEAEs) related to study medication with 177Lu-edotreotide v. everolimus (82.5% vs 97.0%); one grade 2 serious TEAE of MDS related to 177Lu-edotreotide was reported No unforeseen TEAEs *Stratification factors: primary tumour origin [GE-NETs vs P-NETs] and by prior medical therapy [1st line vs 2nd line]**OS data will continue to matureStatistical analysis methods: Log-rank for PFS and OS; two-sided Fisher exact test and Mantel-Haenszel test for ORR 'The COMPETE results represent a major step forward in the development of new treatment options for people living with progressive, inoperable GEP-NETs. By extending progression-free survival by almost ten months compared to standard of care in this trial, 177Lu-edotreotide showed the potential to significantly improve the treatment paradigm for physicians and their patients,' said Jonathan Strosberg, MD, past president, North American Neuroendocrine Tumor Society and chair, GI Research Program, Moffitt Cancer Center and Research Institute in Tampa, FL. The median overall survival as of January 21, 2025 was 63.4 months for the 177Lu-edotreotide arm and 58.7 months for the everolimus arm. While not statistically significant, the interim analysis showed a favorable trend for 177Lu-edotreotide. Patients were permitted to start an alternative therapy after disease progression, potentially confounding the overall survival data. Overall survival data will continue to be updated. 177Lu-edotreotide was observed to be well-tolerated and there were no unforeseen treatment-emergent adverse events. Additional data, including objective response rate, subgroup analyses, quality of life assessments and dosimetry, are currently being evaluated and expected to be submitted for presentations at future medical meetings. ITM is planning to submit a New Drug Application (NDA) to the FDA in 2025. 'These successful results validate our decision to design a pivotal Phase 3 trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy in Grade 1/2 GEP-NETS, underscoring our commitment to improving the lives of people living with this challenging cancer,' said Andrew Cavey, MD, PhD, chief executive officer, ITM. 'With this successful readout, 177Lu-edotreotide becomes the first drug candidate in ITM's broad portfolio of early- to late-stage radiopharmaceuticals to deliver positive Phase 3 results and progress towards NDA submission and commercial launch preparations. Together, with our global isotopes manufacturing business, robust supply chain, and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry.' ENETS Oral Presentation DetailsTitle: 'Efficacy and safety of [177Lu]Lu-edotreotide vs. everolimus in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours: COMPETE phase 3 trial' Date and Time: March 6, 2025; 10:05 am – 10:12 am CET Session and Room Number: Clinical science, Session 1: Theranostics in NENs – Integrating experience for a brighter future; Auditorium Hall (S1) Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona Additional n.c.a.177Lu-edotreotide Clinical Trials177Lu-edotreotide is also being evaluated in a Phase 3 trial (COMPOSE) in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. The COMPOSE trial is a prospective, randomized, controlled, open-label trial evaluating the efficacy, safety and patient-reported outcomes of 177Lu-edotreotide as first- or second-line treatment compared to physician's choice standard of care chemotherapy. Additional clinical programs with 177Lu-edotreotide include a Phase 1 pediatric trial in SSTR-positive tumors (KinLET) and a Phase 3 investigator-sponsored trial in lung and thymus neuroendocrine tumors (LEVEL). About GEP-NETS Neuroendocrine tumors (NETs) are a rare form of cancer, with an estimated 8 new cases per 100,000 individuals diagnosed each year in the U.S. and 9 cases per 100,000 in Europe. The incidence of NETs has steadily increased over recent decades, resulting, in part, from improved diagnosis. Gastroenteropancreatic neuroendocrine tumors (GEP-NETS) originate in the neuroendocrine system and are made up of nerve cells and hormone-producing cells. They can occur anywhere in the GI tract and pancreas, including the stomach, small intestine, colon, rectum, and appendix. There is still a high unmet medical need for treatment options, as many patients are asymptomatic and diagnosed at a late stage with metastatic disease. About n.c.a. 177Lu-edotreotide177Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177Lu-edotreotide was granted orphan drug designation in the EU and the US, and fast track designation in the US for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with 177Lu-edotreotide. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company's high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcomes and quality of life. ITM Contacts:Media Corporate Communications Kathleen Noonan/Julia Westermeir Phone: +49 89 329 8986 1500 Email: communications@ Investor Relations Ben Orzelek Phone: +49 89 329 8986 1009 Email: investors@ References: Baum RP, Kluge AW, Kulkarni H, et al. [(177)Lu-DOTA](0)-D-Phe(1)-Tyr(3)-Octreotide ((177)Lu-DOTATOC) For Peptide Receptor Radiotherapy in Patients with Advanced Neuroendocrine Tumours: A Phase-II Study. Theranostics. 2016;6(4):501-510. Attachment 03062025_ITM Announces Positive Topline Results of Phase 3 COMPETE Trial with ITM-11 at ENETSSign in to access your portfolio
