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AstraZeneca says Lynparza/abiraterone combo delayed disease progression in mCRPC

PBR Staff Writer Published 05 June 2018

AstraZeneca has reported that Lynparza (olaparib) in combination with abiraterone succeeded in a phase II trial by delaying disease progression in metastatic castration-resistant prostate cancer (mCRPC) patients.

Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor co-developed by AstraZeneca with Merck. Abiraterone is the standard-of-care treatment in mCRPC.

The combination of Lynparza and abiraterone was evaluated in comparison to abiraterone monotherapy in a phase II trial named Study 08 in patients with previously-treated mCRPC, irrespective of homologous recombination repair (HRR) mutation status.

AstraZeneca said that the combination could demonstrate clinical improvement in median radiologic progression-free survival (rPFS), which was the primary endpoint of the trial. Median rPFS for the Lynparza and abiraterone arm was 13.8 months, in comparison to 8.2 months seen in the abiraterone monotherapy arm.

AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “A previous trial demonstrated improvements in response rates with Lynparza monotherapy in metastatic castration-resistant patients with HRR mutations.

“The Study 08 combination data suggests that regardless of their mutation status, men with metastatic castration-resistant prostate cancer may potentially benefit from Lynparza in combination with abiraterone.”

Secondary endpoints of the Study 08 included time to second progression or death (PFS2), overall survival (OS) and also health-related quality of life, which were all met by the trial.

MSD Research Laboratories global clinical development senior vice president and head and chief medical officer Roy Baynes said: “There is a significant unmet medical need for patients with metastatic castration-resistant prostate cancer as they are a high-risk group with limited treatment options.

“Lynparza is the first PARP inhibitor to demonstrate activity in combination with standard-of-care treatment in prostate cancer. These data from Study 08 represent another important milestone in the clinical development of Lynparza.”

Earlier, this year, Lynparza was approved by the US Food and Drug Administration for the treatment of germline BRCA-mutated metastatic breast cancer.

Lynparza functions by exploiting tumor DNA repair pathway deficiencies to selectively kill cancer cells. This mode of action gives the drug the potential for activity across various tumor types with DNA repair deficiencies.

Image: AstraZeneca’s Lynparza in combination with abiraterone succeeded in a phase 2 trial. Photo: courtesy of AstraZeneca.