Gedatolisib Regimens Show Promising Results in Advanced Breast Cancer

In a significant advancement for cancer treatment, gedatolisib-based regimens have demonstrated substantial improvements in progression-free survival (PFS) for patients with hormone receptor-positive (HR+)/HER2-negative advanced breast cancer, according to recent findings from the VIKTORIA-1 trial. The trial, which assessed the efficacy of gedatolisib combined with palbociclib and fulvestrant, revealed a remarkable 76% reduction in the risk of disease progression or death compared to fulvestrant alone.

The VIKTORIA-1 trial (NCT05501886), a phase 3, open-label, randomized study, specifically targeted patients whose cancer had progressed following treatment with CDK4/6 inhibitors. These patients typically experience limited benefits from subsequent endocrine therapies. According to Dr. Sara Hurvitz, senior vice president of the Clinical Research Division at Fred Hutchinson Cancer Center and co-principal investigator for the trial, these results could be transformative for patients facing this challenging cancer subtype.

The topline data indicates that the gedatolisib triplet regimen not only improved PFS significantly—median PFS increased from just 2.0 months with fulvestrant alone to 9.3 months with the triplet—but also reduced the risk of disease progression or death by 76% (hazard ratio [HR] 0.24; 95% CI, 0.17-0.35; p < 0.0001). In a doublet regimen involving gedatolisib and fulvestrant, the risk reduction was 67% with a median PFS of 7.4 months.

These findings underscore the potential impact of gedatolisib as a novel treatment option. "To my knowledge, we have not seen phase 3 results in patients with hormone receptor-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control," Dr. Hurvitz explained.

The trial enrolled patients who had confirmed histological or cytological evidence of metastatic or locally advanced disease, with documented radiological disease progression on or after their last line of therapy. They were also required to have adequate organ function and a life expectancy of at least three months.

The safety profile of the gedatolisib regimens was also favorable, with lower rates of treatment discontinuations and adverse effects compared to previous studies. Notably, the incidence of hyperglycemia and stomatitis was reduced relative to results from past phase 1b trials.

Celcuity, the pharmaceutical company behind gedatolisib, plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, aiming to bring this promising treatment to patients as soon as possible.

The upcoming presentation of full results at a medical congress in 2025 is eagerly anticipated as researchers continue to explore the implications of these findings for clinical practice in oncology. The integration of gedatolisib into treatment regimens holds potential not only for improving outcomes in HR+/HER2- advanced breast cancer but also for reshaping the therapeutic landscape for patients with limited options following CDK4/6 inhibitor therapy. As the field of oncology evolves, the results from the VIKTORIA-1 trial may pave the way for new standards in managing advanced breast cancer, offering hope for improved patient care and outcomes.

In conclusion, the promising results of gedatolisib in combination with palbociclib and fulvestrant highlight a significant milestone in the treatment of advanced breast cancer, reinforcing the need for continued research and innovation in oncological therapies. As Celcuity prepares for regulatory submissions and researchers prepare to share detailed findings, the medical community remains optimistic about the future of treatment for this challenging cancer type.