Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study
The drug, gedatolisib, in combination with Pfizer's (PFE.N), opens new tab Ibrance and AstraZeneca's (AZN.L), opens new tab endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients in a late-stage study.
HR+/HER2- breast cancer accounts for about 70% of all breast cancers.
The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex.
Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' (NOVN.S), opens new tab Afinitor and AstraZeneca's Truqap.
The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details.
The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex.
Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year.
It expects to apply for U.S. marketing approval in the fourth quarter.
Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell.
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