AstraZeneca Plc (NYSE:AZN) has recently released encouraging data from SOLO-2, a phase 3 clinical trial evaluating the efficacy of Lynparza (olaparib) as a monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed, BRCA-mutated ovarian cancer.
Generally, the results show a meaningful improvement of progression-free survival (PFS) among subjects administered with Lynparza. Specifically, the median PFS has significantly exceeded that of the Phase 2 clinical trial.
The safety profile of Lynparza for the said indication has also been proven consistent with the results of previous clinical trials.
AstraZeneca’s announcement follows the Fast Track Designation granted by the US Food and Drug Administration (FDA) to Lynparza as a monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed, BRCA-mutated ovarian cancer. The company will publish further details from the clinical trial soon.
“We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine,” boasted Sean Bohen, AstraZeneca Chief Medical Officer (CMO) and Executive Vice President (EVP) of Global Medicines Development.
SOLO-2 Clinical Trial
SOLO-2 was conducted together with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour I’Étude des Cancers de I’Ovaire et du sein (GINECO). Nearly 300 subjects who had received at least two prior lines of platinum-based chemotherapy have been enrolled in the clinical trial, each of whom were randomly administered with 300 mg of Lynparza twice a day or placebo until disease progression.
Ovarian cancer is currently the seventh most diagnosed cancer and the eighth most common cause of cancer death among women globally.
Presently, Lynparza is approved for the treatment of patients with BRCA-mutated ovarian cancer patients in the US and Europe.
New Drug Application (NDA) for Sodium Zirconium Cyclosilicate (ZS-9)
Last week, the company also revealed that the US FDA has accepted its resubmission of the NDA for a potential drug candidate for the treatment of hyperkalaemia, ZS-9.
ZS-9 is an insoluble, non-absorbed compound with a structure designed to capture potassium ions. The company’s NDA resubmission is backed by three double-blind, placebo-controlled clinical trials and in an ongoing 12-month, open-label clinical trial.
On Wednesday, AstraZeneca has closed at $29.59.