Celcuity Inc. reported that its Phase 3 VIKTORIA‑1 trial of the PI3K/AKT/mTOR inhibitor gedatolisib showed a dramatic improvement in progression‑free survival for patients with hormone‑receptor positive, HER2‑negative, PIK3CA wild‑type advanced breast cancer who had progressed after a CDK4/6 inhibitor and aromatase inhibitor. In the PIK3CA wild‑type cohort, the triplet regimen of gedatolisib, fulvestrant, and palbociclib produced a median PFS of 12.4 months (hazard ratio 0.17) versus 1.9 months for fulvestrant alone, while the doublet regimen achieved 10.0 months (HR 0.19).
The results underscore the drug’s potential to fill a critical unmet need in the post‑CDK4/6 inhibitor setting. The safety profile was also favorable: no clinically relevant hyperglycemia was observed, dose reductions were rare, and Grade 2–3 stomatitis resolved quickly. These data suggest that gedatolisib can deliver meaningful clinical benefit without adding significant toxicity, a key differentiator in a crowded therapeutic landscape.
In a geographically diverse subgroup that included the U.S., Canada, Western Europe, and Asia Pacific, the triplet regimen achieved a 16.6‑month median PFS (HR 0.14) and the doublet 7.1 months (HR 0.36), both compared with 1.9 months for fulvestrant alone. Patient‑reported outcomes also highlighted a 23.7‑month median time to definitive deterioration for the triplet, indicating a substantial extension of quality‑of‑life duration for patients on the combination.
Chief Medical Officer Igor Gorbatchevsky emphasized the clinical significance of the data, noting that the combination “offers paradigm‑shifting results for patients with HR‑positive, HER2‑negative, PIK3CA wild‑type advanced breast cancer” and that patients experienced “nearly two years of delay in definitive deterioration of their well‑being.” The quote reflects the company’s confidence that the efficacy and safety profile will translate into a competitive advantage in the market.
Analysts responded by raising price targets for Celcuity, citing the robust efficacy data and the drug’s favorable safety profile as key drivers. The strong performance in both the overall and regional cohorts, coupled with the extended patient‑reported outcomes, reinforced expectations of commercial potential for gedatolisib in the post‑CDK4/6 inhibitor setting.
Celcuity’s broader context supports the clinical findings: the company reported $455 million in cash and short‑term investments, providing a runway through 2027, and has submitted a New Drug Application to the U.S. FDA. The company’s competitive landscape includes established CDK4/6 inhibitors and endocrine therapies, but gedatolisib’s dual PI3K/AKT/mTOR inhibition offers a novel mechanism to overcome resistance. The updated trial results strengthen Celcuity’s position as a leading contender in this therapeutic space and set the stage for future regulatory and commercial milestones.
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