Roche’s shares declined after the company reported that a late-stage clinical trial evaluating its breast cancer drug candidate giredestrant did not achieve its primary objective. The Phase 3 persevERA study was designed to support the use of the therapy in the first-line treatment setting for certain breast cancer patients.
The trial, conducted by Roche’s Genentech unit, studied giredestrant in combination with Pfizer’s breast cancer drug Ibrance in patients with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. The study compared this treatment combination with another arm that used letrozole and Ibrance.
According to Roche, the trial did not demonstrate a statistically significant improvement in progression-free survival, which was the primary endpoint of the study. The company said the results therefore did not provide reliable evidence that the giredestrant combination slowed disease progression compared with the regimen of letrozole and Ibrance. However, Genentech noted that a numerical improvement in progression-free survival was observed.
The company did not provide detailed results in its announcement but said further information from the persevERA trial would be presented at an upcoming medical meeting.
Following the announcement, Roche’s share price declined. At one stage on Monday, the stock fell more than 7%, representing its largest drop in nearly a year. By 1335 GMT, shares were down 4.1% at 327.20 Swiss francs, their lowest level in about two months. Earlier reports also noted that the stock had dropped nearly 5% to 324.40 Swiss francs after the trial outcome became public.
Despite the trial missing its primary endpoint, Roche indicated that giredestrant could still be used in other treatment settings based on results from earlier studies.
One of those studies, the evERA trial, tested giredestrant as a second-line treatment and found that the oral therapy reduced the risk of tumour recurrence in breast cancer patients who had previously received treatment. Roche has already applied for potential approval of the drug from the U.S. Food and Drug Administration based on the evERA data.
Another study, called lidERA, examined the drug as an adjuvant treatment in patients with early-stage breast cancer and also produced positive results. Roche said data from that study will be submitted to the FDA as well.
Levi Garraway, Roche’s chief medical officer and head of Global Product Development, commented on the outcome of the persevERA study while highlighting results from the other trials in the company’s clinical program. “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,” Garraway said.
Giredestrant belongs to a class of medicines known as oral selective oestrogen receptor degraders, or SERDs, which are designed to target tumours that grow in response to oestrogen. These cancers account for up to 80% of breast cancer cases.
Roche’s clinical program for the drug includes five studies. In addition to evERA, lidERA, and persevERA, two other trials are ongoing in the first-line treatment setting.
The pionERA trial is testing giredestrant in combination with a physician’s choice of CDK4/6 inhibitors, a class of medicines that includes Ibrance, Novartis’ Kisqali, and Eli Lilly’s Verzenio. The study involves the same patient population as the persevERA trial and is expected to report results in 2027.
Another study, heredERA, is evaluating the drug as part of a combination therapy used in the maintenance setting for first-line disease.
Analysts also commented on the trial results. Barclays analyst James Gordon said the share decline represented a buying opportunity and estimated that the drug could reach peak annual revenue of $6.5 billion in add-on treatment settings. Jefferies analyst Michael Leuchten said the outcome was consistent with concerns that the trial may have been underpowered and said the result challenges more optimistic expectations surrounding the drug’s potential.
What the Giredestrant Trial Results Showed
The study compared giredestrant plus palbociclib against a standard treatment of hormonal therapy combined with palbociclib. Although giredestrant showed some positive trends, the data did not demonstrate a clear advantage in delaying disease progression or death.
Following the announcement, Roche shares dropped as much as 7–8% in early trading, reflecting investor concerns about the commercial potential of giredestrant as a first-line breast cancer therapy.
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