Recently, Celcuity announced that its self-developed pan-PI3K/mTOR inhibitor gedatolisib achieved a clinically meaningful improvement in progression-free survival (PFS) in the Phase 3 clinical trial codenamed Viktoria-1 for advanced breast cancer.
This Viktoria-1 clinical trial focused on patients with PIK3CA wild-type advanced breast cancer and employed a highly compelling head-to-head controlled design. The experimental group received triple therapy consisting of gedatolisib, AstraZeneca's fulvestrant (Faslodex), and Pfizer's palbociclib (Ibrance), while the control group received the current clinical standard of care—Novartis' Piqray in combination with fulvestrant.
had a statistically and clinically significant improvement in progression-free survival (PFS) . Furthermore, the dual therapy regimen of gedatolisib and fulvestrant also performed well in the key secondary endpoint compared to Piqray plus fulvestrant, validating its therapeutic advantage in this patient population.
The release of this significant data quickly generated a positive response in the capital market. Following the announcement, Celcuity's stock price surged nearly 40% in pre-market trading , reaching a peak of $145 per share, demonstrating the market's high regard for its research and development achievements.
The success of Gedatolisib is no accident. As a multi-target PI3K/AKT/mTOR (PAM) pathway inhibitor, it potently targets all four class I PI3K subtypes, as well as mTORC1 and mTORC2, thereby achieving comprehensive blockade of the PI3K/AKT/mTOR pathway . This unique mechanism of action aims to overcome the adaptive cross-activation of pathways commonly encountered when targeting only a single node, thus overcoming endocrine resistance.
In fact, gedatolisib was originally developed by Pfizer but was shelved due to tolerability issues. In 2021, Celcuity acquired a license for it with a $10 million upfront payment and eventually revived it through optimized combination therapy. The success in the Viktoria-1 trial, especially the remarkable efficacy demonstrated in the PIK3CA wild-type patient cohort, is considered a significant turning point in PI3K/mTOR pathway drug development.
According to Celcuity's plan, the company will submit a supplemental New Drug Application (NDA) to the U.S. FDA based on this positive result. Currently, the FDA is reviewing the marketing application for gedatolisib for PIK3CA wild-type breast cancer, with an approval decision expected on July 17. If all goes smoothly, the drug is expected to rapidly expand its target population to include PIK3CA-mutant patients upon approval. Simultaneously, the company plans to submit a marketing application to Europe in the fourth quarter of this year and advance global commercialization collaborations.
In conclusion , the success of the Viktoria-1 trial not only makes gedatolisib a promising new treatment option for advanced breast cancer, but also breaks through the development bottleneck of PI3K/mTOR pathway drugs in wild-type patients. From being shelved to being restarted, this breakthrough demonstrates the value of research and innovation and brings new hope to patients. Its subsequent approval and commercialization are highly anticipated.

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