On May 18, 2021 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the presentation of data from a systematic literature review characterizing the burden and unmet medical needs associated with Cremophor-based cancer treatments at the 2021 Virtual International Society for the Pharmacoeconomic and Outcomes Research (ISPOR) conference (Press release, Elevar Therapeutics, MAY 18, 2021, View Source [SID1234580356]).
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"Cremophor EL is an additive used to improve the solubility of paclitaxel, an effective and widely used chemotherapy for the treatment of a variety of cancers such as lung, breast and ovarian cancer. Unfortunately, many patients experience increased adverse events and hypersensitivity reactions caused by the additive rather than the active drug," said Diana I. Brixner, R.Ph., Ph.D., FAMCP, executive director of the Pharmacotherapy Outcomes Research Center at University of Utah Health. "While the clinical burden of Cremophor EL is well documented, this literature review confirms that it is also associated with a high economic and quality of life burden, demonstrating the need for non-Cremophor containing therapy."
The systematic literature review evaluated 31 studies that met the eligibility criteria for a qualitative synthesis of literature on the safety, humanistic, and economic burden of burden of treatment with Cremophor EL (CrEL) among patients with ovarian cancer, triple negative breast cancer, pancreatic cancer, and cervical cancer. Key findings include:
Safety and tolerability associated with CrEL-containing therapy on cancer patients, specifically ovarian cancer patients, result in significant patient burden across clinical and humanistic metrics
Most patients need substantial medication to preemptively, or during chemotherapy, mitigate adverse events (AEs) associated with CrEL-containing therapy
Despite pre-medication, patients reported experiencing these AEs with CrEL-containing therapy
Additionally, the published literature describes challenges associated with infusion of CrEL-containing therapy, including longer infusion times and the need for specialized medical devices to handle the viscous medications.
"Today, healthcare providers must consider not only the direct clinical impact of treatment options for patients, but also the potential impact to a patient’s quality of life and the healthcare costs and resources required to manage treatment with Cremophor-based agents," said Mark Gelder, M.D., chief medical officer of Elevar Therapeutics. "This systematic literature review is the first to evaluate the current evidence on the clinical, economic, and humanistic burdens related to Cremophor EL based therapies among multiple tumor types. We are pleased to share these results with the global oncology community which we hope promote a better understanding of the impact of Cremophor EL on patients and help inform optimal treatment selection."
About Ovarian Cancer
Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs 1. Globally, it is the third most common cancer among women and has the highest mortality rate 2,3. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly 4,5. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis 6.
About Apealea (paclitaxel micellar)
Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers.Cremophor EL, is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel, and is known to cause serious hypersensitive allergic reactions.
In December 2020, Elevar Therapeutics announced that it had entered into an exclusive agreement with Inceptua Group for the distribution and commercialization of Apealea (paclitaxel micellar) in Europe. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Apealea has been authorized by European regulatory authorities for use in the European Economic Area in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. It has also been granted Orphan Drug Designation by the U.S. Food and Drug Administration.