Roche Breast Cancer Prospect Fails First-Line Test

 

Roche’s shares tumbled nearly 5% on news that a key pillar in the five-pronged clinical plan for the breast cancer asset giredestrant was unsuccessful.

Roche’s ambitious breast cancer prospect giredestrant has failed to improve progression-free survival in a key Phase 3 trial that could have granted the Swiss pharma access to the first-line treatment setting in the disease.

Instead, Roche will fall back on earlier trials that confirmed the benefit of the selective estrogen receptor degrader in second-line and advanced disease.

The news sent Roche’s shares falling nearly 5% to 324.40 CHF ($416.40).

Roche’s Genentech unit was testing giredestrant in the late-stage persevERA trial of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer. The study combined the therapy with Pfizer’s Ibrance, a common treatment for breast cancer.

The trial failed to meet the primary endpoint of achieving a statistically significant improvement in progression-free survival as compared to an arm of the study that featured letrozole and Ibrance, according to a Monday morning press release. However, Genentech noted that “a numerical improvement was observed.”

Genentech did not provide specific data in the release but when reporting full-year earnings in January, Roche Pharmaceuticals CEO Teresa Graham said that a 20% benefit “would be considered clinically meaningful.” The company promised to reveal more details from the persevERA readout at an upcoming medical meeting.

Analysts on the full-year earnings call had been worried about a potential delay in the persevERA trial that could signal problems. They also wondered if the study population of 992 people would be enough to hit statistical significance. But Graham insisted all was well.

Giredestrant has already been filed with the FDA based on the successful evERA trial, in which the drug was tested as a second-line treatment. Roche also celebrated positive results from the lidERA study in the adjuvant setting. Data from that test will also be submitted to the agency soon, Roche said.

“While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer,” said Levi Garraway, chief medical officer and head of Global Product Development. “The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development program.”

In addition, Roche executives say they still believe giredestrant could find success as a first-line therapy in some treatment settings. The five-pronged clinical program—which includes evERA, lidERA and persevERA—includes two more first-line trials that have yet to read out.

In pionERA, the pharma is testing a combination of giredestrant plus physician’s choice of a CDK4/6 inhibitors. The class includes Ibrance as well as Novartis’ Kisqali and Eli Lilly’s Verzenio. The trial features the same population as persevERA with a readout due in 2027. Finally, the heredERA study in first-line disease will examine the drug as part of a combination in the maintenance setting.

https://www.biospace.com/drug-development/roche-breast-cancer-prospect-fails-first-line-test-sending-shares-down