A combination of hormonal therapy and breast cancer by Celcuity has met the primary endpoints of the phase 3 trial, significantly beating its benchmark to fully succeed in helping it file with the FDA to approve it in the fourth quarter.
The trial was designed to check on doublet and triplet combinations of gedatolisib tested by Celcuity, a PI3K and mTOR inhibitor used in second-line PIK3CA wild-type breast cancer. The doublet paired with gedatolisib fulvestrant, a drug to treat breast cancer sold by AstraZeneca under the brand name Faslodex. The triplet included palbociclib (sold by Pfizer as Ibrance) to the equation. One of the controls was given fulvestrant in monotherapy.
Celcuity stated that the triplet prevented disease progression or death by 76 percent when compared to fulvestrant alone. The value of the doublet was 67 percent. Triplet progression-free survival was 9.3 months, and for the doublet, it was 7.4 months, compared to 2 months in the control arm.
Triplet and doublet had hazard ratios of 0.24 and 0.33. Appearing at a TD Cowen conference in May, Celcuity CEO Brian Sullivan noted that a hazard ratio of 0.5 or lower was a hazard ratio that would be thought of as very compelling. Research on imlunestrant by Eli Lilly, with a hazard ratio of 0.55, and Orserdu by Menarini, with a hazard ratio of 0.62, was noted by Sullivan. The CEO disagreed that the Serena-6 of AstraZeneca is a comparative study, asserting that the study is a modified first-line indication due to its switching design conformation.
Upon the view of the Gedatolisib data, Celcuity heralded the findings as new horizons to the treatment of the HR-positive, HER2-negative advanced breast cancer. The results were put into context by Fred Hutchinson Cancer Center’s Sara Hurvitz.
And the results of both the group topline data of the two regimens of topline data of both the regimens of gedatolisib from the VIKTORIA-1 are possibly practice-changing. This is the first time I have seen the phase 3 outcomes in patients with HR-positive/HER2-negative advanced breast cancer, in which the probability of survival without disease progression increased by a factor of four compared to the control group included in the study.
Celcuity said the discontinuation rate due to adverse events related to treatment was less in the doublet and triplet populations than in phase 3 studies of existing mix-and-match combinations. It also proved to have a lower figure compared to a cohort of phase 1b, which had been treated with palbociclib, fulvestrant, and gedatolisib.
The biotech would be releasing additional data during a medical convention this year. The 2025 calendar of Celcuity also involves publicity of top-line data of a group of phase 3 PIK3CA mutation patients, and an application to the FDA
