Roche shares jump over 6% after early breast cancer drug trial success

Investing.com -- Roche (SIX:ROG) shares rose more than 6% on Tuesday after the Swiss drugmaker reported an unexpected interim success in its lidERA study of the breast cancer drug giredestrant. 

The study, conducted in early-stage, estrogen receptor–positive breast cancer, showed a proven benefit at the interim analysis, a development the note described as arriving far earlier than expected.

Kepler Cheuvreux said in a note said the adjuvant setting represents a “multi-billion USD” market.

The trial had not been anticipated to read out at this stage, making the finding a significant development for the company. 

Roche, one of the world’s largest pharmaceutical groups, is the first to show a benefit for a selective estrogen receptor degrader in early breast cancer. 

Roche carried out the trial in a broad patient population compared with competitors. 

“Overall survival data were immature at the time of interim analysis, but a clear positive trend was observed,” the brokerage said. 

It added that such a result was the strongest signal possible this early because the last patient entered the study in the third quarter of 2023.

Roche said giredestrant was well tolerated and that adverse events were consistent with the drug’s known safety profile, with “no unexpected safety findings observed.” 

Details of the study are expected to be presented at a future medical conference, and Roche plans to share the data with regulators.

The lidERA result arrived while attention had been centered on the company’s other major trial, persevERA, which evaluates giredestrant in first-line metastatic breast cancer. 

That study is expected to report results in early 2026. Kepler Cheuvreux wrote that the lidERA outcome could influence expectations for the metastatic trial as well.

Before the interim readout, the analysts had included a “token” forecast of a 30% probability of CHF2.5 billion in peak adjuvant sales for giredestrant, valued at CHF2 per share in their Roche model. 

This translated to roughly CHF1.5 billion after risk adjustment, similar to the $1.6 billion consensus expectation for 2032. The analysts said they plan to review their forecasts and expect consensus changes to follow.

Roche described adjuvant ER-positive breast cancer as a large treatment area and said the early success in lidERA strengthens Roche’s position in the competitive SERD field. 

It also outlined an open question on whether giredestrant might be used alongside Novartis’ CDK4/6 inhibitor Kisqali, which is emerging as a standard option for medium- to high-risk adjuvant breast cancer.

Kepler Cheuvreux said that the development could also affect broader views of Roche’s research capabilities following a series of mixed outcomes in recent years.