AstraZeneca, a global, innovation-driven biopharmaceutical business, announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib.
Voluntis has developed the service in close clinical collaboration with AstraZeneca and the US National Cancer Institute (NCI). It is delivered through a smartphone app paired with a web portal to help clinicians and patients manage side effects of hypertension and diarrhoea sometimes associated with combination therapy with cediranib and olaparib. Such side effects are traditionally described to care teams through manual, time-consuming and non-digitised channels.
The app will be tested as a companion device in three separate clinical trials sponsored by the NCI beginning in the first quarter of 2016, under a Cooperative Research and Development Agreement between the NCI and AstraZeneca. This approach illustrates a clear focus on understanding the patient journey when developing therapeutic solutions. The service will also serve as a pilot within AstraZeneca’s broader strategy of using digital technology to complement treatment and to improve patient outcomes.
Cediranib is a highly potent, selective, orally-administered inhibitor of VEGF-1, -2 and -3 receptors. It has been shown to inhibit angiogenesis and lymphangiogenesis in the vascularization of platinum sensitive tumour types. In July 2015, cediranib filing was accepted by the European Medicines agency and awarded Orphan Drug status for the treatment of platinum sensitive relapse ovarian cancer. Cediranib also in development, in combination with Lynparza (olaparib), for platinum sensitive relapse ovarian cancer and platinum resistant relapse ovarian cancer.
Olaparib is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies. Olaparib is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, and has been launched in the US and Europe, with ongoing regulatory submissions across multiple markets. In addition to ovarian cancer, AstraZeneca is investigating the full potential of olaparib in multiple tumour types, with phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.
Antoine Yver, head of oncology, global medicines development at AstraZeneca, said, “Empowering patients with this smartphone-based app gives them greater control of their treatment and management of their response. The support it provides can further reduce medication dose modification and discontinuation rates and help maintain patients on therapy to improve their treatment outcome.”
Pierre Leurent, chief executive officer of Voluntis, said, “We are delighted to be partnering with AstraZeneca for this project. AstraZeneca has a strong focus on the use of companion devices in drug development. Their approach, combined with our technological, medical and regulatory expertise provides the perfect synergy to create a personalised therapeutic solution that goes beyond the pill to best serve the needs of patients and their health care providers.”