Voluntis and AstraZeneca have extended their partnership to evaluate a mobile app, called eCO (eCediranib/Olaparib), to help women with platinum-resistant ovarian cancer report and manage their side effects.
The approach is being developed for women receiving a combination of cediranib plus Lynparza (olaparib), and will be tested in the GY005 Phase 2/3 clinical trial (NCT02502266), which started in 2015 and is sponsored by the National Cancer Institute (NCI).
The study aims to evaluate the efficacy of cediranib and Lynparza, given alone or in combination, in fighting cancers in the ovaries, fallopian tube, or peritoneum, a membrane lining the abdominal cavity and covering the abdominal organs.
Lynparza, by AstraZeneca, works by preventing cancer cells from repairing damaged DNA, which causes them to die. The medicine is approved for ovarian cancer patients who responded to prior platinum-based chemotherapy, or for those with BRCA mutations who received three or more prior chemotherapies.
Cediranib, also by AstraZeneca, is being developed to block the formation of new blood vessels required for a tumor to grow.
Only patients whose disease did not respond to platinum-based chemotherapy or stopped responding to such medications will be admitted in the study. The results will be compared to patients treated with standard chemotherapy.
Primary endpoints of the study include the time a patient lives without disease progression and overall survival. Secondary endpoints include objective response rate and incidence of adverse events, among others, all to be assessed up to five years post-treatment.
Women enrolled in the study will be given eCO along with their treatment to help them manage their symptoms of high blood pressure and diarrhea, sometimes associated with these therapies, with the goal of enabling them to stay longer on treatment.
While patients can receive real-time recommendations for their symptoms, physicians will have access to a corresponding web portal to follow patients and adjust symptom management plans accordingly.
Under terms of the agreement, eCO will be transferred to Theraxium Oncology, Voluntis’ new platform developed to provide digital therapeutics to cancer patients, and help them manage their own symptoms. The platform was announced earlier this year.
“We are delighted to build upon the promising results of our first clinical trial, begun in 2015, and take our innovative partnership with AstraZeneca one step further to study the impact of our eCO solution on a larger scale, using our state-of-the-art Theraxium platform,” Pierre Leurent, chief executive officer of Voluntis, said in a press release.
“Digital therapeutics, like eCO, are at the forefront of a new generation of digital solutions, developed in conjunction with medications as early as Phase 2/3 trials. Through this new phase of our collaboration, we look forward to providing access to this solution to more patients and, hopefully, help them enjoy a better quality of life and treatment outcome,” Leurent added.