Camizestrant

Frankfurt: Roche's experimental oral drug giredestrant has been shown to cut the risk of recurrence of a common form of breast cancer after surgery, boosting the company's shares and underpinning its traditional credentials in oncology. The Swiss drugmaker said on Tuesday that a scheduled interim analysis of a late-stage trial showed the experimental pill resulted in a clinically meaningful improvement in keeping patients disease-free after surgery compared with standard endocrine therapy. More details are to be published at a medical conference to be announced as Roche works towards regulatory approval, the company added. The prospect of the drug reducing the spread of early-stage disease to other body parts lifted the company's share price by 6.1% to an eight-month high of 304.90 Swiss francs ($383.23) by 0939 GMT, with JPMorgan analysts calling the news a significant positive surprise. If approved, the clinical use explored in the trial could generate about $5 billion in annual revenue, the analysts added. Investors have been concerned that Roche is relying too heavily on its older blockbuster drugs, even as the family controlled company steps up efforts to break into the fast-growing obesity market and diversify away from oncology. The giredestrant pill belongs to a class known as oral selective oestrogen receptor degraders (SERD) to fight tumours that grow in response to oestrogen, which are estimated to account for up to 80% of all breast cancer cases. The market opportunity has also attracted AstraZeneca, which is developing rival compound camizestrant, while Sanofi's development efforts in this area have failed. ($1 = 0.7956 Swiss francs) (Reporting by Ludwig Burger Editing by David Goodman)

Roche said Tuesday that its breast cancer pill beat standard of care when used after surgery. This could set the drug up as a new therapy of choice in this setting, the company added. However, a comparable study of AstraZeneca’s similar pill — both are selective estrogen receptor degraders or SERDs — will report data next year, and it is possible that its results in this setting will turn out to be stronger. An interim data cut from Roche’s Phase 3 lidERA trial showed that giredestrant extended invasive disease-free survival compared with standard-of-care hormone therapy. Around a third of patients given postsurgical hormone therapy, the current standard treatment, see their cancer recur. The lengthening of the time to relapse was statistically significant and clinically meaningful, Roche said , meeting the trial’s primary endpoint. This is the first time a SERD has yielded a significant benefit in a late-stage trial in the adjuvant setting, Roche said. The data could position giredestrant as “a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure,” Roche’s chief medical officer Levi Garraway said in a release. Roche’s stock climbed by as much as 6% on the Swiss exchange on Tuesday morning. The lidERA study signed up more than 4,000 patients with early-stage breast cancer whose tumors were estrogen receptor-positive and HER2-negative. Thanks to screening programs and awareness campaigns, most breast cancer cases are diagnosed at an early stage. Overall survival data were immature, though Roche said there was a positive trend. The drug was well tolerated, with no nasty surprises on safety. Full results will come at a medical meeting, with the San Antonio Breast Cancer Symposium next month being a possible venue, and Roche will take the lidERA data to regulators. Analysts from Jefferies wrote in a same-day note that giredestrant could become a new standard of care in patients at medium risk of disease recurrence, who make up around a quarter of the adjuvant population. As for high-risk patients, a combination of Roche’s drug and a CDK4/6 inhibitor might be a better bet, they wrote. This is based on data from a late-stage trial of Novartis’ CDK4/6 inhibitor Kisqali. Roche’s trial includes a small substudy looking at the combination of giredestrant with a different CDK4/6 inhibitor, Eli Lilly’s Verzenio, but this has not yet reported data. The lidERA data build on results from the Phase 3 evERA trial, which showed giredestrant to work better than standard care in a later breast cancer setting. AstraZeneca will reveal results from a trial of its SERD, camizestrant, in a similar postsurgical setting in 2026. Comparisons with lidERA will be tricky, however, owing to design differences. For example, the CAMBRIA-2 trial allows Verzenio to be added to both the camizestrant and hormone therapy arms, and also enrolled some patients who had endocrine therapy before their surgery, according to the Jefferies analysts. AstraZeneca’s trial is also a lot bigger, at around 5,500 patients, and the primary endpoint, while similar to lidERA’s, has a slightly different definition of time to relapse. The UK pharma is running another adjuvant trial of camizestrant, called CAMBRIA-1, but all patients in that study must have had between two and five years of prior adjuvant endocrine therapy, making it less comparable to lidERA.