Celcuity announced on Monday that its experimental three-drug combination slowed the spread of a type of advanced breast cancer. This news caused the biotech company’s stock to more than double in premarket trading.
The treatment combines Celcuity’s gedatolisib, Pfizer’s Ibrance, and AstraZeneca’s Faslodex. In a late-stage study, it cut the risk of cancer progression or death by 76% compared to using Faslodex alone. The study focused on patients with HR+/HER2- advanced breast cancer who had been treated before.
HR+/HER2- breast cancer makes up about 70% of all breast cancers.
Patients on the three-drug combo lived an average of 9.3 months without their cancer getting worse. Those taking only Faslodex had just about two months of such survival.
Gedatolisib is a PAM inhibitor. Other drugs in this class include Novartis’ Afinitor and AstraZeneca’s Truqap.
Celcuity said the three-drug combo was better tolerated in this late-stage trial than in an earlier study. Fewer patients had high blood sugar or mouth inflammation. No more details were given.
The study also tested a two-drug combo: gedatolisib plus Ibrance. This pair reduced the risk of progression or death by 67% compared to Faslodex. It also extended average progression-free survival to 7.4 months, versus about two months with Faslodex alone.
Celcuity plans to release full results from this late-stage study later this year. It will also share data from another trial, which looks at patients with tumors that have certain gene changes.
The company hopes to apply for U.S. marketing approval in the fourth quarter.
Shares of the Minnesota-based firm jumped nearly 114% to $29.40 in premarket trading.
Related topics:
Expanded mastectomies could cut UK breast cancer by 11%
Mediterranean Diet Adherence Doubles in Breast Cancer Survivors
