AstraZeneca's $2B oncology contender shows promise in prostate cancer

AstraZeneca's headquarters in London--Courtesy of AstraZeneca

AstraZeneca's ($AZN) ovarian cancer-treating olaparib may also have a beneficial effect on prostate cancer, researchers said, potentially increasing the value of a key drug in the company's self-appraised $12 billion oncology pipeline.

As Reuters reports, the Institute of Cancer Research's Johann de Bono touted "encouraging" results from an early clinical trial pitting olaparib against prostate cancer. De Bono and his colleagues are running a Phase II trial to determine whether the drug has potential beyond the ovarian, breast and gastric cancers against which AstraZeneca has tested it, and the group is optimistic as it rolls into the second stage of the study.

The drug, which AstraZeneca plans to market as Lynparza, is a poly ADP-ribose polymerase (PARP) inhibitor, the first of a new class of treatments designed to stand in the way of cancer cells' efforts to repair themselves.

Johann de Bono

In keeping with competing therapies from Clovis Oncology ($CLVS) and AbbVie ($ABBV), olaparib's development has largely focused on cancers tied to mutations in the BRCA gene, but "these exciting new trials could give (PARP inhibitors) a whole other lease of life in advanced prostate cancer and other tumors with DNA repair mutations," de Bono said.

The company believes its treatment can bring in $2 billion a year in sales, a figure unveiled earlier this year as the U.K. drugmaker worked to fend off unwelcome advances from Pfizer ($PFE). AstraZeneca has even higher hopes for MEDI4736, a PD-L1 therapy the company said can top out at $6.5 billion a year; and AZD9291, a Phase I lung cancer treatment tabbed to peak at $3 billion.

Olaparib is the nearest to market among the three contenders, in line for European approval in the next few months thanks to an October vote of confidence from the European Medicines Agency. The EMA's recommendation drew from Phase II data in which olaparib led to progression-free survival (PFS) of 11.2 months versus 4.3 months on placebo.

However, the drug faces a less certain path to market in the U.S., as those results weren't enough to sway an FDA panel considering an early approval. Over the summer, a group of agency experts picked apart olaparib's potential, taking issue with the its failure to significantly improve overall survival, pointing to a few alarming adverse events and expressing doubts in the reliability of its PFS data. The committee voted 11-2 against recommending an early approval for the drug, meaning AstraZeneca will mosty likely have to complete its ongoing Phase III study on olaparib before it can make its way to the U.S. market.

- read the Reuters story