Latest news with #MIRASOL
Yahoo
17-03-2025
- Business
- Yahoo
AbbVie reports final analysis from Phase III trial of Elahere for ovarian cancer
US-based pharmaceutical company AbbVie has reported the final analysis from the Phase III MIRASOL trial, which assessed its antibody-drug conjugate (ADC) Elahere against chemotherapy for treating platinum-resistant ovarian cancer (PROC). The randomised trial assessed the therapy's safety and efficacy when given to women with folate receptor alpha (FRα) positive PROC. Its primary endpoint was progression-free survival (PFS), with its secondary endpoints being objective response rate (ORR) and overall survival (OS). The study enrolled 453 subjects who had received up to three previous therapies and exhibited high-grade serous epithelial PROC expressing high FRα levels. The median follow-up of 30.5 months showed that ADC treatment led to a median PFS of 5.59 months compared to 3.98 months for investigator's choice (IC) chemotherapy, decreasing the tumour progression or mortality risk by 37%. In addition, it achieved an ORR of 41.9%, significantly higher than the 15.9% achieved with chemotherapy. Subjects treated with Elahere also experienced a superior median OS of 16.85 months against 13.34 months for those receiving IC chemotherapy, marking a 32% decrease in mortality risk. The drug's safety profile and duration of response were consistent with the primary data analysis at a median follow-up of 13.1 months. AbbVie oncology medical affairs vice-president Svetlana Kobina said: "Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. 'The data presented today reinforce the importance of Elahere as a transformative therapy for patients with limited options.' Elahere received full approval from the US Food and Drug Administration in March 2024 and from the European Commission last November. Several other nations are currently reviewing applications for marketing authorisation submitted by AbbVie for the drug. Last June, AbbVie released positive topline data from the Phase II PICCOLO trial, which investigated Elahere as a single agent in heavily pre-treated platinum-sensitive ovarian cancer subjects. "AbbVie reports final analysis from Phase III trial of Elahere for ovarian cancer" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-03-2025
- Business
- Yahoo
AbbVie (NYSE:ABBV) Reports ELAHERE Success in Phase 3 Trials for Platinum-Resistant Ovarian Cancer
AbbVie has recently seen promising developments with the release of favorable final results from the MIRASOL trial of ELAHERE, demonstrating significant improvements for women with platinum-resistant ovarian cancer. Over the last quarter, the company's share price rose by 23%, bolstered by this promising news and other product-related announcements, including ELAHERE's prior full FDA approval and regulatory progress in other regions. This positive momentum contrasts with AbbVie's mixed financial performance, which revealed a net loss for the last quarter despite an increase in sales. Meanwhile, AbbVie's declaration of a generous cash dividend might have further supported investor confidence. The broader market remained volatile, influenced by macroeconomic concerns and significant movements in major indexes. Still, AbbVie's advancements in its oncology segment offered a strong narrative amid these conditions, setting a positive tone for investor sentiment compared to the market's generally downward trend over the same period. Understand AbbVie's track record by examining our performance history report. Uncover 15 companies that survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Over the last five years, AbbVie's total shareholder returns surged 279.78%, a testament to strong capital gains and consistent dividends. This period includes increased sales across various quarters, highlighted by the Q1 2022 revenue of US$13.54 billion. Notably, during the same timeframe, regulatory successes, like the EMA's approval of ELAHERE in November 2024, significantly impacted growth. Product-related advancements also played a crucial role, such as the FDA's approval of RINVOQ for ankylosing spondylitis in April 2022. Despite challenges like declining net income and ongoing legal issues, AbbVie outperformed its sector in the past year, with its returns surpassing the US Biotechs industry, which saw a 5% decline. The company's current undervaluation relative to its fair value estimation also suggests potential capital growth. Over the last year, positive momentum sustained by clinical progress and dividend increases has further supported long-term investor sentiment. Are you invested in AbbVie already? Keep abreast of every twist and turn by setting up a portfolio with Simply Wall St, where we make it simple for investors like you to stay informed and proactive. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:ABBV. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
