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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Fintech PR
Hastee reaches profitability as Earned Wage Access solutions become the norm for top employers
LONDON, Oct. 16, 2024 /PRNewswire/ — Hastee, one of Europe’s leading providers of earned wage access (EWA) and financial wellbeing solutions, is proud to announce that it has reached profitability. This marks a significant milestone in its journey to empower employees with greater financial flexibility and control. The achievement comes amid rising demand for on-demand pay solutions, with destination employers now frequently citing these as a necessary benefit to attract, retain, and engage staff.
Founded with a mission to improve the financial resilience of workers, Hastee has grown rapidly since its launch and now has over 350 employer clients spanning nearly all sectors. Notable customers include global leaders in hospitality (such as McDonald’s, Domino’s and Taco Bell), top international retailers (such as IKEA, Mediamarkt and DIA), major healthcare organisations (such as Bupa and the NHS), and many more of the world’s leading employers (such as Unilever, PayPal, Iberia Express and EY).
Hastee operates in 4 of the 5 largest European markets for earned wage access: UK, Spain, Ireland, and Portugal. In 2020, Hastee acquired Typs, one of Southern Europe’s leading financial wellbeing solutions, enabling Hastee to build a unique multi-language, multi-currency, and flexible platform ready for further international scaling. Hastee is majority-owned by IDC, a multi-fund platform with $2.2B AUM, through its innovation vertical IDC Ventures.
Hastee’s solution is built on 3 pillars of financial wellbeing: Earn, Learn, and Grow. Employees can use the award-winning Hastee app to track their earnings, access earned pay flexibly, receive personalized bite-sized financial education and save directly from their payroll. The app is one of the most popular financial wellbeing apps in the Apple App Store and Google Play Store, with a user rating of 4.7 in each.
“We are extremely proud to be among the very first EWA providers globally to reach profitability,” commented Hastee CEO Jaime Jimenez. “The combination of rapid growth of our customer base alongside a cautious approach to spending has paid off: we have built a highly sustainable business that can service its clients without the need for further external funding.”
Jimenez continued: “Financial wellbeing has risen to the very top of the agenda among HR leaders, and we are honoured to have a role to play in supporting employees improve their financial health, while also helping our clients reach their ambitious ESG targets.”
“We are thrilled to support Hastee in reaching this pivotal moment,” shared Alejandro Rodriguez, co-founder and Managing Partner at IDC Ventures. “Hastee’s focus on financial wellbeing aligns perfectly with IDC Ventures’ mission of backing impactful companies that make a positive difference. We’re excited to be part of this journey, providing real value to both the end users and our partners. This achievement reflects the strength of Hastee’s model and the growing importance of solutions that empower individuals to take control of their financial health.”
About Hastee
Hastee is a financial wellness platform that allows employees to access a portion of their earned wages before payday, helping them manage cash flow and avoid debt. The platform integrates with employers’ payroll systems and provides users with flexible, on-demand access to their earnings. Hastee currently has over 350 employer clients spanning nearly all sectors. Learn more by visiting Hastee.com.
About IDC Ventures
IDC Ventures (IDCV) is a venture capital platform within IDC Network, a global multi-fund asset manager. Serving as the Partner of Choice for over 150 family offices across 30 countries, IDCV offers a diverse range of venture capital opportunities including proprietary funds, co-investments, and co-managed funds in collaboration with industry-leading managers. With $500M in assets under management, IDCV typically leads funding rounds and holds board seats, offering founders guidance drawn from deep expertise in entrepreneurship, banking, law, and consulting. Since its inception in 2019, IDCV has backed transformative founders from Series A to growth stages, with a primary focus on fintech and marketplaces in Europe, the US, and Latin America—particularly Brazil and Mexico. For more information, visit IDCVentures.com.
Media Contact:
Ernesto Bernado
[email protected]
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OSLO, Norway, Oct. 16, 2024 /PRNewswire/ — Akastor ASA invites investors and analysts to a webcast presentation of the third quarter 2024 financial results on Wednesday, 30 October 2024.
Date and time:
Wednesday, 30 October 2024, at 15:00 CET
Presenters:
- Akastor: Karl Erik Kjelstad, CEO, and Øyvind Paaske, CFO
- HMH: Thomas McGee, CFO, and David Bratton, SVP FP&A and Operational Finance
Link to webcast:
https://akercreativehub.eventcdn.net/events/akastor-audiocast-q3-2024
Questions can be submitted throughout the streaming event. The presentation material will be published on www.akastor.com and www.newsweb.no at 07:00 CET on 30 October.
For further information, please contact:
Øyvind Paaske
Chief Financial Officer
Mob: +47 917 59 705
E-mail: [email protected]
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act
This information was brought to you by Cision http://news.cision.com
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LONDON, Oct. 16, 2024 /PRNewswire/ — Greenbrook, the specialist communications advisor, is pleased to announce the appointment of former European Commissioner and Lead non-exec director at HM Treasury, Lord Hill, and the return of the City advisor, David Trenchard, as advisors to the firm.
Lord Hill is the former European Commissioner for Financial Stability, Financial Services and Capital Markets Union. He was Leader of the House of Lords and Chancellor of the Dutchy of Lancaster from 2013 to 2014. He has been Lead non-executive director at HM Treasury and is Chairman of the Ditchley Foundation. He carried out the UK Listings Review for the then Chancellor of the Exchequer in 2021.
David Trenchard, who was an advisor to Greenbrook from 2014 to 2022, brings over four decades of experience in finance. Most recently, he was Engagement Director at Elliott Advisors. David began his career at Morgan Stanley, rising to become a Managing Director in Equity Capital Markets and Head of Corporate Broking.
Andrew Honnor, Managing Partner of Greenbrook, commented: “We are delighted to welcome both Jonathan and David to our team. Their considerable experience across policy, markets and finance will provide deep insight to our clients as they navigate the evolving challenges and opportunities in the current macro-economic environment.”
Lord Hill commented: “I’ve known Andrew for two decades, and have looked with admiration at what he has achieved at Greenbrook. I look forward to joining his team and hope I can add something to the firm’s growing success.”
David Trenchard commented: “It is a pleasure to return as an advisor to Greenbrook, a leader in complex communications issues. I look forward to working with Greenbrook’s clients across various situations.”
Lord Hill and David Trenchard join Michelle Pinggera, Simon Walker and Piers Dennison as advisors to Greenbrook. Michelle joined Greenbrook in July 2018 and is the former International Chief of Staff and Partner at Goldman Sachs. Simon joined Greenbrook in March 2017 and was previously Director General of the Institute of Directors, Communications Secretary to HM Queen Elizabeth II, advisor to former Prime Minister John Major, and Chief Executive of the British Private Equity & Venture Capital Association. Piers joined Greenbrook in July 2021 and is a former Partner and Head of Investor Relations at Park Square Capital.
Contact details:
Ksenia Galouchko / Demi Kurban
Greenbrook
+44 20 7952 2000 / [email protected]
About Greenbrook:
Greenbrook provides strategic communications advisory services to the investment industry. We work with clients across the following asset classes: private equity, venture capital, private debt, hedge funds, activist funds, infrastructure and real estate, and traditional fund management.
We advise our clients on all aspects of their business through the lens of reputation, helping to build and protect value.
Greenbrook has advised on over $58 billion of corporate and sovereign debt restructurings over the last 12 months. Greenbrook was ranked by Bloomberg as the #1 advisor in Europe for engaged shareholder communications in 2023. The firm ranked among the top #5 in Europe by Mergermarket and the #1 PR and communications firm in Europe by Private Equity Wire.
For more information, please visit www.greenbrookadvisory.com or follow Greenbrook on LinkedIn.
View original content:https://www.prnewswire.co.uk/news-releases/greenbrook-appoints-lord-hill-and-david-trenchard-as-advisors-302276721.html
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