April 7, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Colorado-based Clovis Oncology , announced on April 6 that its monotherapy treatment for advanced ovarian cancer has received Breakthrough Therapy designation. Investigational agent rucaparib showed positive results in an ongoing treatment study known as ARIEL2. Following the news, shares of Clovis rose more than 5 percent in late-day trading on April 6.
Rucaparib is an oral inhibitor of PARP1 and PARP2, and it’s being developed for the treatment of platinum-sensitive ovarian cancer patients with BRCA mutations. Updates from the ARIEL2 study were presented last week at the 2015 Annual Meeting on Women’s Cancer. The data showed that 70 percent of evaluable BRCA-mutant patients received a Response Evaluation Criteria in Solid Tumors and/or Cancer Antigen-125 response, and 65 percent achieved a RECIST response.
“In the case of rucaparib, we believe it is in recognition of the encouraging response rate observed in women with BRCA-mutated advanced ovarian cancer treated with rucaparib, and this designation reinforces the unique profile of rucaparib among PARP inhibitors, as well as our leadership in the differentiated clinical development of a PARP inhibitor,” said Patrick Mahaffy, president and CEO of Clovis Oncology.
ARIEL2 was recently expanded into a registration study. It will include an additional 300 women, bringing the total to more than 500 subjects.
Preparing for ARIEL3
ARIEL3 is a pivotal randomized, double blind study that is designed to compare the effects of the drug to a placebo. It is also meant to determine whether the drug could be used as a maintenance therapy and improve disease control.
Patients in the ARIEL3 study will be given either rucaparib or placebo, with two-thirds of the participants receiving the investigational drug. Researchers would like to recruit around 540 patients for ARIEL3 to compile their results.
Prior to the release of positive data on April 6, Clovis had already begun to see optimal results from rucaparib in the ARIEL2 study. In November 2014, the company debuted information from the trial, which showed that the drug was well-tolerated. No patients had been dismissed from the trial due to adverse side effects.
“I am delighted to be involved in this study, which may ultimately lead to an additional treatment option for women with relapsed ovarian cancer, not only those with germline BRCA mutations but also the much larger numbers of patients, with somatic BRCA mutations or BRCA-like signatures for whom few options exist today, and for whom new treatments are very much needed,” said Iain McNeish, a principal investigator on the ARIEL2 study, at the time of the announcement.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
