Niraparib Tosylate

Oral Presentation to be Featured on Initial Results of a First-in-Human Study for a Promising Targeted Therapy for Advanced/Metastatic Solid Tumors. ESMO 2025 abstracts featuring FCS research: 965P, 967P, 981P, 1014eP, 1031eTiP, 1068P, 1070P, 1073P, 1073P, 1113P, 1153P, 1166P, 1172P, 1196P, 1221TiP, 1239eTiP, 1349P, 158P, 2604P FORT MYERS, Fla., Oct. 18, 2025 /PRNewswire/ -- Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors. Continue Reading 23 Florida Cancer Specialists & Research Institute abstracts are being presented at the European Society of Medical Oncology Congress 2025 in Berlin, Germany including one oral presentation by FCS Director of Drug Development Manish R. Patel, MD, and four additional poster presentations by FCS first-authors. "FCS is engaged in significant and transformative scientific discoveries that are driving new possibilities and better outcomes for patients everywhere," said Lucio N. Gordan, MD, FCS president & managing physician. The following physician leader is first author of an oral presentation at the ESMO Congress: Manish R. Patel, MD, FCS director of drug development, will participate in an oral presentation followed by expert discussion and perspectives of initial results of a first-in human study: A tumor-associated Mucin 1 (TA-MUC1)–directed Antibody–drug Conjugate (ADC), in Patients (pts) with Advanced/Metastatic (adv/met) Solid Tumors. The following physician leaders are first authors of poster presentations at the ESMO Congress: Bradley Monk, MD, FCS medical director of late-phase clinical research, will present the following abstracts: Post hoc survival outcomes based on initial and subsequent treatment in patients (pts) with mismatch repair proficient/microsatellite stable (MMRp/MSS) primary advanced or recurrent endometrial cancer (pA/R EC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. Tisotumab Vedotin Plus Carboplatin or Pembrolizumab in Recurrent or Metastatic Cervical Cancer: 5-Year Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. Cesar Augusto Perez, MD, FCS, director of drug development, Sarah Cannon Research Institute (SCRI) at FCS, will review and discuss in a poster presentation, Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours. Judy S. Wang, MD, FCS associate director of drug development will present and discuss the findings of the following abstract: Histological biomarker analysis of nonclinical and baseline tumor samples from the phase 1 dose escalation study assessing micvotabart peliodotin (MICVO) in advanced solid tumors. Dr. Patel, who oversees early phase research at FCS' three drug development units, said, "Our team is proud to be at the forefront of oncology research, leading first-in-human studies and advancing cutting-edge targeted therapies." Dr. Monk leads initiatives to expand and deploy late-phase clinical trials. He noted, "By pushing the boundaries of what's possible, we're helping bring the next generation of treatments to patients who need them most and are dedicated to increasing clinical trial accessibility to patients worldwide." FCS researchers have also co-authored numerous abstracts that will also be featured in poster presentations throughout the annual international symposium: Barry Berman, MD, MS: Clinical and biomarker results from E7386 study 102: Global dose-expansion cohort of E7386 + envatinib in patients with advanced/recurrent endometrial cancer that progressed on platinum-based chemotherapy and an anti−PD-(L)1 immunotherapy Bradley Monk, MD: Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. (Simultaneous publication in the Annals of Oncology.) Human papillomavirus integration site mapping in advanced cervical cancer: The NRG Oncology/GOG-0240 NIH Cancer Moonshot. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy (ICC): Phase III MIRASOL trial. 5-year progression-free survival (PFS) with rucaparib (RUCA) maintenance in patients with newly diagnosed advanced ovarian cancer in ATHENA-MONO (GOG-3020/ENGOT-ov45). (Simultaneous publication in the Annals of Oncology.) The relationship between patient-reported outcomes and clinician-rated toxicity in participants with locally advanced cervix cancer in the OUTBACK trial. GOG-3119/ENGOT-en29/TroFuse-033: A Phase 3, Randomized Study of Sacituzumab Tirumotecan Plus Pembrolizumab vs Pembrolizumab Alone as First-Line Maintenance Therapy for Mismatch Repair-Proficient Endometrial Cancer. BELLA: A Phase 2 Study of Relacorilant Plus Nab-Paclitaxel +/- Bevacizumab in Patients with Gynecologic Cancers. Manish R. Patel, MD: A phase 1 study of the next-generation farnesyltransferase inhibitor (FTI) KO-2806 as monotherapy in advanced solid tumors. COM701 in ovarian cancer: A pooled analysis of 3 phase I clinical trials. Farnesyltransferase inhibitor (FTI) KO-2806 in combination with cabozantinib (cabo) in renal cell carcinoma (RCC): Preliminary results from FIT-001 Phase 1 trial. Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors. Cesar Augusto Perez, MD: Tipifarnib (TIP) and alpelisib (ALP) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 1 results from KURRENT-HN. Phase 1 global study of Iza-Bren (BL-B01D1), an EGFR × HER3 bispecific antibody–drug conjugate (ADC), in patients with metastatic or unresectable NSCLC and other solid tumours. Judy S. Wang, MD: First- in- Human Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), MICVO, in Patients with Select Solid Tumors. Phase 1 Expansion Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), Micvotabart Pelidotin (MICVO), in Patients with Select Advanced Solid Tumors. FCS provides access to advanced clinical trial options across 29 locations in Florida, bringing promising therapies closer to home for cancer patients. Over 110 new early-phase and 40 late-phase studies are launched annually. FCS has played a vital role in the development of numerous cancer drugs approved by the U.S. Food and Drug Administration (FDA). A longstanding partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, provides patients with access to a comprehensive listing of clinical trials available in the U.S. Additionally, a partnership with Paradigm Health, Inc. helps streamline and accelerate matching patients to available clinical trials. Representing more than 45,000 members globally, ESMO is a reference for oncology education and information. The ESMO Congress is a globally influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. All of the accepted abstracts will be published online at ESMO. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. 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Takeda’s (Japan) Zejula (niraparib) was one of among six innovative anti-cancer medicines across 20 indications that were considered in this study. Credit: Melnikov Dmitriy / Shutterstock. Amgen is hopeful that Phase III data will cement the validity of its recently approved widened label for cholesterol-lowering drug Repatha (evolocumab). In August 2025, the US Food and Drug Administration (FDA) approved the use of Repatha in adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C). Now, the VESALIUS-CV trial (NCT03872401) has proved its long-term efficacy in these patients after meeting both its primary endpoints, proving that Repatha can significantly reduce the risk of MACE in patients without a prior history of heart attack or stroke. The primary endpoints were time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke, and time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularisation. The trial enrolled more than 12,000 high-risk patients who were followed for 4.5 years. Of those enrolled, approximately 85% were maintained on a high-intensity or moderate LDL-C reducing therapy. Amgen R&D executive vice-president Dr Jay Bradner said: “The benefit across endpoints and established safety profile underscore Repatha’s role as a cornerstone therapy in comprehensive lipid management. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Repatha is known as a highly effective LDL-C-lowering treatment and is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke. These additional data demonstrate that Repatha has the potential to reach tens of millions more patients earlier in their journey, before a life-altering event occurs.” Amgen has not yet released data from the trial; however, this is set to be presented at the American Heart Association Scientific Sessions on 8 November. Repatha was first approved in the US for adults with high cholesterol who require further LDL-C reduction on 27 August 2015. This came after European approval, making it the first PCSK9 inhibitor to receive regulatory clearance worldwide. Its long market presence means it is coming close to the end of its patent-protected period, due to end in 2030, opening up an opportunity for biosimilars. GlobalData predicts this will dent Amgen’s market dominance, with peak sales for the drug reaching $3.87bn in 2029 before slowly dropping, with a 2031 sales forecast of $3.32bn. GlobalData is the parent company of Clinical Trials Arena . Repatha’s main market competition comes from Praluent (alirocumab), a PCSK9 inhibitor developed by Regeneron and Sanofi, which gained US approval before Repatha, but EU approval came later. Praluent sales are set to reach $880m in 2031, according to GlobalData. After Praulent’s approval, Regeneron and Sanofi, and Amgen were embroiled in a patent dispute over the two therapies, with Amgen emerging victorious . Amgen also faces competition from Novartis’ Leqvio (inclisiran), a long-acting small-interfering RNA (siRNA) that degrades PCSK9. GlobalData predicts sales will rise sharply, from $754m in 2024 to $3.98bn in 2031. A number of LDL-C-lowering drugs have also recently shown promise, including LIB Therapeutics’ lerodalcibep, AstraZeneca’s AZD0780 and NewAmsterdam Pharma’s obicetrapib. GlobalData predicts the total dyslipidemia (high cholesterol) market will reach $15.53bn across seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by 2032. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now