Strong results for AZ’s Lynparza will help in PARP battle

AstraZeneca has announced that its PARP inhibitor cancer treatment Lynparza has recorded strong results in a new phase 3 trial.

Lynparza (olaparib) is already approved in patients with platinum-sensitive relapsed ovarian cancer, but is facing competition from rival drugs in the PARP class, most notably Tesaro’s niraparib.

Tesaro’s drug was one the talking points of the recent ESMO cancer congress, after its data suggested it could be used in a broad population of platinum sensitive ovarian cancer patients who have either germline mutation in breast cancer susceptibility gene 2 (gBRCA) or a tumour with high-grade serious histology.

Now AstraZeneca has responded with its topline news about its phase 3 SOLO-2 trial in a similar BRCA-mutated population.

The company would not reveal much about the results, saying only that the median PFS in the Lynparza arm of SOLO-2 “substantially exceeded” that observed in the phase 2 maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19).

AZ and Tesaro are not the only interested parties.  Medivation, recently acquired by Pfizer, has its own pipeline PARP, talazoparib.  Another player is Clovis, although disappointing results from its molecule rucaparib may make it an also-ran.

Tesaro is also seeking approval of niraparib for a broad second-line maintenance group, without the use of a diagnostic.

Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said the company would work with regulators to gain approval in these patients as swiftly as possible.

The company says it will continue to investigate Lynparza as monotherapy and in combinations and further indications.

AZ said full results of SOLO-2 will be presented at a forthcoming medical meeting, but wouldn’t specify when this would be. 

The new trial also feature a more patient-friendly dosing regime.  The current licensed indication is for eight capsules taken twice a day, but the new trial allowed patients to take just two tablets twice a day.