Fintech PR
PharmaMar Announces Positive and Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination in First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
- Jazz plans to submit supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and PharmaMar will submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in first half of the year 2025 for this combination therapy as a first-line maintenance treatment for ES-SCLC.
MADRID, Oct. 15, 2024 /PRNewswire/ — PharmaMar (MSE: PHM) and its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ) have announced today positive top-line results from the Phase 3 clinical trial evaluating Zepzelca® (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq®) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage Small Cell Lung Cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. The combination of lurbinectedin and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.
“Each year, approximately 63,000 to 72,000 new cases of Small Cell Lung Cancer (SCLC) are reported in Europe. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis,[i],[ii],[iii]” said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. “These trial results demonstrate the efficacy of lurbinectedin, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease.”
“The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the lurbinectedin and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting. These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “We are pleased with these clinically meaningful results and plan to submit an sNDA in the first half of 2025 to support this combination in the first-line maintenance setting. We thank the investigators and patients who are involved in this trial, along with our partners at Roche.“
“Lurbinectedin monotherapy is currently the standard of care in 2L SCLC. In Europe, it is only approved in Switzerland and early access and compassionate use programs have already allowed some European patients to benefit from lurbinectedin,” said Javier Jiménez, Chief Medical Officer of PharmaMar.
The combination was generally well-tolerated. The preliminary safety data in the ongoing trial is consistent with the known safety profiles of lurbinectedin and atezolizumab with no new safety signals observed in the combination arm.
Jazz and Roche plan to submit these data for presentation at a future medical meeting.
PharmaMar will submit a marketing authorisation application (MAA) to the EMA in the first half of 2025 to request regulatory approval in the European Union (EU). Lurbinectedin is available for use in 16 territories around the world.
Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
About PharmaMar
PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.
PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (lurbinectedin), in the US; and Aplidin® (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin, ecubectedin, PM534 and PM54. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and The United States. PharmaMar also wholly owns Sylentis, a company dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
About the IMforte Phase 3 Trial
IMforte (NCT05091567) is an ongoing Phase 3, randomized, multicenter maintenance trial evaluating the efficacy, safety and pharmacokinetics of lurbinectedin plus atezolizumab in adults (≥18 years) with ES-SCLC following induction therapy with carboplatin, etoposide and atezolizumab. The primary endpoints for this study are OS and IRF-assessed PFS.
The trial consists of two phases: an induction phase and a maintenance phase. Participants were required to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after the induction phase of four cycles of carboplatin, etoposide, and atezolizumab to be considered for eligibility screening for the maintenance phase. Eligible participants were randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05091567).
About Zepzelca®
Zepzelca® (lurbinectedin), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
please visit our website at www.pharmamar.com
[i] Cancer today. (s. f.). https://gco.iarc.who.int/today/en/fact-sheets-populations#regions
[ii] Alvarado-Lunda G, Morales-Espinosa D. Treatment for small cell lung cancer, where are we now? – A review. Transl Lung Cancer Res. 2016;5(1):26-38.
[iii] SEER Explorer Lung and Bronchus Cancer, Recent Trends in SEER Incidence Rates, 2000-2016, by Age, https://seer.cancer.gov/explorer Updated June 27, 2024. Accessed October 10, 2024.
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Lending revenue dips against backdrop of record-high indices
NEW YORK, Jan. 2, 2025 /PRNewswire/ — The global securities finance industry generated $9.64 billion in revenue for lenders in 2024, according to DataLend, the market data service of fintech EquiLend. The figure represents a 10.3% decrease from the $10.74 billion generated in 2023.
Global broker-to-broker activity, where broker-dealers lend and borrow securities from each other, totaled an additional $2.57 billion in revenue for 2024, a 9.9% decrease from 2023.
Equity lending revenues fell 13% globally, with North America revenue declining 15% and EMEA revenue dropping 24%. In North America, the cause for the revenue decline was a 19% decrease in average fees, while in EMEA, fees and balances decreased 16% and 11%, respectively. Equity lending revenues in APAC were largely flat year-over-year.
Global sovereign debt revenue increased by 8% over 2023, with U.S. treasuries making up the lion’s share of the gains. Treasuries were up 16% year-over-year, driven by a 14% growth in balances.
In corporate debt lending, global revenue declined by 21% as a regression from a record 2023 continued. Fees were the main culprit, with a steep 29% decrease driving the year-over-year decline in revenue.
The top five earning securities in 2024 were Sirius XM Holdings (SIRI US), Lucid Group (LCID US), Beyond Meat Inc. (BYND US), Tempus AI Inc. (TEM US) and Trump Media & Technology Group (DJT US). The five securities in total generated $644 million for lenders over the course of 2024, a significant dip from the $1.11 billion generated by 2023’s top five earners.
Bloomberg Terminal users can subscribe to EquiLend’s exclusive Orbisa securities lending data by entering terminal shortcut APPS ORBISA About DataLend About EquiLend Logo – https://mma.prnewswire.com/media/1060364/EquiLend_Logo.jpg
DataLend, the market data service within EquiLend’s Data & Analytics Solutions group, tracks daily market movements across more than 200,000 securities, covering $35 trillion in lendable assets and $2.6 trillion in on-loan assets for the securities finance market. www.datalend.com
EquiLend is a global financial technology firm offering Trading, Post-Trade, Data & Analytics, RegTech and Platform Solutions for the securities finance industry. EquiLend has offices in North America, EMEA and Asia-Pacific and is regulated in jurisdictions around the globe. www.equilend.com
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NEW YORK, Jan. 2, 2025 /PRNewswire/ — In a dynamic and increasingly complex business environment, small businesses across the USA are experiencing a growing need for expert financial management solutions. Bookkeeping in USA, a critical yet often overlooked business function, is proving essential for companies striving to stay competitive, compliant, and efficient.
Recent studies highlight the importance of tailored bookkeeping solutions to address challenges such as fluctuating tax laws, rising operational costs, and stringent compliance requirements. The demand for professional bookkeeping services in USA has surged, showcasing their role in fostering small business resilience and growth.
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The Role of Bookkeeping in Small Business Success
Bookkeeping in USA offers small business owners’ clarity and control over their financial health. As the business landscape evolves, it is becoming a strategic necessity rather than just a support function. Challenges like tax compliance, cash flow management, and accurate financial reporting require dedicated expertise, which many small business owners find daunting to handle independently.
Insights from Industry Experts
“Small businesses are the backbone of our economy, and they deserve tools that empower them to succeed,” says Ajay Mehta, CEO of IBN Technologies. “Bookkeeping services enable entrepreneurs to focus on their strengths while ensuring their financial bases are secure.”
IBN Technologies has positioned itself as a leader in this space, offering streamlined bookkeeping services that align with industry standards and leverage cutting-edge technology. The company’s solutions are designed to help businesses avoid costly financial missteps, manage cash flow effectively, and maintain compliance with ever-changing regulations.
Modernizing Bookkeeping with Technology
The adoption of cloud-based bookkeeping solutions marks a transformative step forward for small businesses. Real-time access to financial data, enhanced security, and seamless collaboration between business owners and financial experts have made these tools indispensable. IBN Technologies integrates state-of-the-art technology into its services, ensuring clients can monitor their finances anytime, anywhere.
Addressing Tax Compliance and Financial Challenges
One of the most significant challenges for small businesses in the USA is navigating the complex web of federal and state tax laws. IBN Technologies specializes in offering tax-ready to serve bookkeeping in USA that not only mitigate the risk of audits but also identify potential tax savings. This dual approach has enabled many businesses to achieve better financial outcomes while reducing stress.
About IBN Technologies
IBN Technologies LLC, an outsourcing specialist with 25 years of experience, serves clients across the United States, United Kingdom, Middle East, and India. Renowned for its expertise in RPA, Intelligent process automation includes AP Automation services like P2P, Q2C, and Record-to-Report. IBN Technologies provides solutions compliant with ISO 9001:2015, 27001:2022, CMMI-5, and GDPR standards. The company has established itself as a leading provider of IT, KPO, and BPO outsourcing services in finance and accounting, including CPAs, hedge funds, alternative investments, banking, travel, human resources, and retail industries. It offers customized solutions that drive efficiency and growth.
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Fintech PR
CUBE COMPLETES ACQUISITION OF THOMSON REUTERS REGULATORY INTELLIGENCE AND ODEN BUSINESSES
- Acquisition delivers an expanded customer base with a deep global subject matter expertise network that further powers CUBE’s RegBrain AI across its industry proven SaaS RegPlatform™
- CUBE continues to see strong organic customer growth in its well-established enterprise sector whilst also accelerating growth across the mid-market sector
- 2024 was a year of strategic milestones for CUBE including the partnership with Hg, expanding its global footprint across six main hubs, the acquisition of Reg-Room and Thomson Reuters Regulatory Intelligence and Oden businesses, together with pivotal board and executive appointments
LONDON, Jan. 2, 2025 /PRNewswire/ — CUBE, a global leader in Automated Regulatory Intelligence (ARI) and Regulatory Change Management (RCM), has today formally announced the completion of its acquisition of the Thomson Reuters Regulatory Intelligence and Oden businesses on 31 December 2024.
The acquisition of these global businesses is another step forward in CUBE’s growth plans as a leader in regulatory intelligence. It will supplement and enhance CUBE’s ability to deliver significant scale across many of the world’s leading and systemically important financial institutions. CUBE’s global customer base will expand to total approximately 1,000 customers in banking, insurance, asset and investment management, payments and adjacent regulated industries.
CUBE’s Founder and CEO, Ben Richmond, said: “The completion of this acquisition is a major milestone for CUBE in a year that has seen many important milestones including our strategic partnership with Hg, the acquisition of Reg-Room, and the acquisition of Thomson Reuters Regulatory Intelligence and Oden businesses.”
“Thomson Reuters is best known in the industry for providing regulatory analysis and subject matter expertise combined with world-leading journalism and news,” said Ben Richmond. “The powerful combination of CUBE’s AI and the years of human generated content curated by Thomson Reuters Regulatory Intelligence and Oden subject matter experts sets us apart in the industry. This new dimension at CUBE will accelerate innovation and drive further growth and opportunity in 2025 and beyond.”
Following the announcement of its strategic partnership with Hg in March 2024, CUBE has now completed two transformational US-based acquisitions across three businesses whilst continuing to assemble a highly experienced executive team. CUBE’s continued impressive growth saw its presence in the enterprise sector surpassing 200 customers and now represents around 40% of Tier 1 financial institutions globally. In the mid-market sector, serving small and medium sized enterprises, CUBE now has near 800 customers.
With this growth CUBE solidified its global footprint by establishing offices across its six main hubs focused on customer support and implementation; with the number of employees at CUBE doubling to near 700 and a comparable increase in the number of countries where CUBE’s employees are located, which now totals 15 countries.
Ben Richmond said: “We are excited to welcome all of our new colleagues to CUBE – 2025 promises to be yet another significant year for the business as we continue to deliver further innovation focused on automating regulatory compliance and risk management for our customers.”
The definitive agreement was originally announced in May 2024 and terms were not disclosed.
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