October 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WALTHAM, Mass. – Riding high off of positive Phase III data for its PARP inhibitor, Niraparib, Tesaro Inc. is not looking for anyone to burst its bubble, including Myriad Genetics , which developed the companion diagnostic test Tesaro used in the Phase III trial.
Tesaro filed a lawsuit against Myriad over a press release the Utah-based company had intended on releasing a statement calling into question the clinical significance of the tests, Endpoints reported this morning. In its complaint, Tesaro claimed a press release Myriad intended to release a statement that included “false and misleading statements” about the data. Additionally, Endpoints reported Tesaro made objections to Myriad’s comments about toxicity profile and also questioned some of the critical quotes the company intended to use in the statement, claiming those individuals did not have access to the data.
However, the judge who heard the arguments ultimately sided with Myriad, saying Tesaro intended to release the data and the company would not suffer irreparable harm, Endpoints reported.
In an email, a Tesaro spokesperson told Endpoints the two companies were able to settle their disagreements over the language Myriad intended to use. The spokesperson said the complaint was filed in order to give the companies time to come to an agreement over the statements.
“Once the content was agreed upon, the news release was issued, and the suit was dropped,” the spokesperson told Endpoints.
The latest statement released by Myriad touts that the company’s myChoice HRD test identified more than double the number of patients who may benefit from treatment with niraparib than were identified by germline BRCA testing alone. Tesaro and Myriad have been in partnership since 2014. If Niraparib is approved by the U.S. Food and Drug Administration, both companies stand to benefit financially.
The release followed Tesaro’s presentation about niraparib at the European Network for Gynecological Oncological Trial groups in Denmark. Company data showed the drug could benefit 70 percent of all ovarian cancer patients who received previous chemotherapy treatments. Tesaro said niraparib increased progression free survival in different cohorts of a 553-patient trial–whether they had the BRCA gene or homologous recombination deficient (HRD) tumors. Trial data showed patients with the BRCA gene had 21 months of progression free survival–15 months longer than the control group. Additionally, patients in the non-germline BRCA mutant cohort showed progression free survival of 9.3 months, compared to 3.9 months for control.
Following the presentation, RBC analyst Adnan Butt told Investors Business Daily that the results of the trial mean niraparib is “the PARP inhibitor to beat.”
Other companies developing PARP inhibitors include Colorado-based Clovis Oncology and rucaparib, a PARP inhibitor developed for the treatment of patients with platinum-sensitive, high-grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer. The FDA accepted rucaparib for priority review in August. In September, the U.S. FDA opted to not hold an advisory committee meeting to discuss rucaparib. Niraparib and rucaparib are possible contenders for AstraZeneca ’s Linparza, the first PARP inhibitor approved for women with BRCA-positive advanced ovarian cancer.
Tesaro is expected to file for approval with the U.S. Food and Drug Administration (FDA) by the end of this year, with a final decision expected in 2017.
