MINNEAPOLIS, MINNESOTA, May 01, 2026
Celcuity has announced positive topline results from its Phase 3 VIKTORIA-1 trial, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients with PIK3CA-mutant HR+/HER2- advanced breast cancer treated with gedatolisib-based regimens. The findings position gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) pathway inhibitor, as a potential next-generation targeted therapy capable of overcoming limitations of current single-target treatments. The results will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, reinforcing the study’s significance in advancing precision oncology and treatment innovation.
Phase 3 VIKTORIA-1 Trial Demonstrates Superior Efficacy
The VIKTORIA-1 Phase 3 clinical trial evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, compared to standard-of-care therapy using alpelisib plus fulvestrant in patients whose disease progressed after prior CDK4/6 inhibitor and aromatase inhibitor treatment. The study achieved its primary endpoint, with the gedatolisib triplet regimen showing statistically significant improvement in PFS, indicating a clinically meaningful delay in disease progression.
Additionally, the gedatolisib doublet regimen also demonstrated significant PFS improvement, further validating the therapy’s effectiveness across treatment combinations. Importantly, both regimens were generally well tolerated, with manageable safety profiles and no new safety signals, supporting their potential for broad clinical application in advanced breast cancer treatment.
Multi-Target PAM Inhibition Offers Differentiated Approach
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Gedatolisib’s mechanism of action is uniquely designed to simultaneously inhibit all class I PI3K isoforms as well as mTORC1 and mTORC2, enabling comprehensive blockade of the PAM signaling pathway, a key driver of tumor growth and therapeutic resistance in breast cancer. Unlike currently approved therapies that target only a single component of the pathway, gedatolisib addresses adaptive resistance mechanisms that often limit treatment effectiveness.
This multi-target inhibition strategy is expected to deliver enhanced tumor suppression and improved clinical outcomes, particularly in patients with PIK3CA mutations, which are present in approximately 40% of HR+/HER2- breast cancer cases. The ability to target multiple nodes within the pathway represents a significant advancement in targeted oncology therapies, aligning with the industry’s shift toward precision medicine and combination treatment strategies.
Advancing Regulatory Strategy and Oncology Innovation
Following these positive results, Celcuity plans to submit the data to the U.S. Food and Drug Administration (FDA) as part of a supplemental New Drug Application (sNDA), with additional submissions planned for global regulatory authorities. The company has already received Priority Review for its NDA in the PIK3CA wild-type population, with a PDUFA target date of July 17, 2026, highlighting strong regulatory momentum.
From a GxP perspective, the VIKTORIA-1 trial was conducted in compliance with Good Clinical Practice (GCP) standards, ensuring high-quality data, patient safety, and regulatory integrity. Breast cancer remains one of the most prevalent cancers globally, with HR+/HER2- subtypes accounting for approximately 70% of all cases, underscoring the importance of innovative treatment approaches. As resistance to existing therapies continues to challenge clinical outcomes, gedatolisib’s comprehensive pathway inhibition offers a promising solution to improve survival and redefine standard-of-care treatments. This development reinforces Celcuity’s position as a leader in next-generation oncology drug development, driving forward transformative therapies for patients with advanced cancer.
Source: Celcuity press release
