Results from Oasmia Pharmaceutical’s phase III study have been presented at ASCO annual meeting
June 5, 2018
During Monday Oasmia Pharmaceutical AB presented the follow-up results from the completed phase III study with Apealea® for treatment of ovarian cancer.
The 2018 ASCO Annual Meeting is ongoing in Chicago with 33,000 international attendees interested in clinical oncology. Oasmia presented the follow-up results from the study including 789 patients with platinum-sensitive recurrent ovarian cancer during Monday. Patients with disease relapse is a group that could benefit from further treatment options. The study results show that Apealea in combination with carboplatin has a similar effect as standard treatment with regard to overall survival. The patients in the Apealea group survived in average 25.7 months and the patients with standard treatment survived 24.8 months from study start. Also, the time to progression was similar between the Apealea group and standard treatment group (hazard ratio 0.86 [95% confidence interval: 0.72-1.03] in favour for Apealea). The results are further strengthened by sub-group analyses in the study showing similar effects.
ASCO (American Society of Clinical Oncology) is an organization for clinical oncologists and provides recommendations for clinical practices and publishes the scientific journal Journal of Clinical Oncology among other things.
”Our presentation at the ASCO Annual Meeting gave opportunity to many fruitful discussions especially with US oncologists who recognized the advantages of Apealea compared to Taxol and today’s standard treatment regime,” says Nina Heldring, Head of Clinical Development at Oasmia.
For more information, please contact:
Nina Heldring, Head of Clinical Development
Tel: +46 18 50 54 40
Notes to editors:
Apealea is a Cremophor EL- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17. Paclitaxel is one of the most widely used anticancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved in conventional solutions for infusion. It has orphan drug designation in the EU and the US.
About the phase III clinical study of Apealea
The phase III open, randomized, multi-center study, which included 789 patients in total, was designed to compare the efficacy and safety between Apealea and Taxol, which is also a paclitaxel-based product. Both Apealea and Taxol were administered in combination with carboplatin.
Paclitaxel in combination with carboplatin, or any other platinum containing compound, has become a standard in first-line setting in patients with epithelial ovarian cancer. It is also used as second-line treatment, providing that the patient had a response time of at least 6 months. These patients are defined as platinum sensitive.
The phase III study included patients who relapsed at least six months after end of first-line or second-line treatment including platinum-based therapy. Apealea was administered as a one-hour intravenous infusion at its recommended dose of 250 mg/m2. Taxol was administered as a three-hour intravenous infusion at its recommended dose of 175 mg/m2. Both drugs were dosed in six three-weeks cycles.
Patients treated with Taxol received systemic pre-treatment with corticosteroids, antihistamines and H2-receptor antagonists. Patients treated with Apealea did not receive such treatment to the same extent. Carboplatin was given as an intravenous infusion starting 30 minutes after the end of the paclitaxel infusion. Both treatment groups received the same carboplatin dose (“5-6 AUC”).
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Capital Markets (OASM.US), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).
This information is information that Oasmia Pharmaceutical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on June 5, 2018.