FAETH THERAPEUTICS AND THE GOG FOUNDATION, INC. LAUNCH FIRST PHASE 2 COMBINATION TRIAL FOR SAPANISERTIB-SERABELISIB IN PATIENTS WITH ENDOMETRIAL CANCER
In a groundbreaking development in cancer treatment, Faeth Therapeutics, a clinical-stage biotechnology firm, in partnership with The GOG Foundation, Inc, has initiated a Phase 2 combination trial of two investigational agents, FTH-001 (serabelisib) and FTH-003 (sapanisertib), alongside standard chemotherapy agent paclitaxel. Titled the PIKTOR trial (Evaluation of Sapanisertib and Serabelisib With Paclitaxel in Advanced or Recurrent Endometrial Cancer), the study seeks to address the urgent need for effective therapies in endometrial cancer, particularly given its high mutation rate in the PI3K pathway.
As the trial progresses, it aims to build on previous Phase 1b results where there was an 80% objective response rate observed in patients suffering from endometrioid endometrial cancer, leading to a promising 11 months of progression-free survival. The innovative use of dual inhibitors targeting distinct nodes of the PI3K/AKT/mTOR pathway marks a fresh approach in treating endometrial cancer, a disease that has remained largely unaddressed with existing pharmacological options. With the PI3K pathway being the most commonly mutated pathway in cancer and primarily implicated in tumor metabolism, this collaborative trial responds directly to the pressing challenge of unmet medical needs in the gynecological oncology landscape.
Endometrial cancer is notably the most prevalent gynecological malignancy in the United States, with expectations that nearly 66,000 women will be diagnosed in 2022 alone. Despite the alarming statistics, pharmaceutical advancements have struggled to deliver effective therapies for patients with advanced or recurrent disease. The investigational agents being studied, serabelisib and sapanisertib, are both part of a new wave of metabolism-targeting strategies that aim to harness the potential of personalized medicine and enhance treatment efficacy.
Faeth Therapeutics’ innovative platform integrates artificial intelligence to fuel discovery and development of its cancer treatment programs. This novel academic-industry partnership with The GOG Foundation promotes excellence in clinical research specifically tailored to gynecologic cancers. The GOG Foundation’s wealth of experience over five decades makes them a fitting ally, ready to navigate the complexities inherent in a clinical trial of such scope and significance.
As highlighted by Anand Parikh, J.D., Chief Executive Officer of Faeth Therapeutics, the utilization of PIKTOR signifies a transformative approach toward addressing endometrial cancer and may extend its applicability to other solid tumors. The trial seeks to contribute valuable insights into cancer metabolism, initiating a new horizon where combination therapy can enhance outcome-based treatment landscapes. The integration of metabolic targeting represents a paradigm shift in oncology, aligning with contemporary advancements in precision medicine.
Dr. David Starks, Principal Investigator and an Associate Professor at the Avera Cancer Institute, emphasizes the potential impact of this unique trial. There is optimistic anticipation that the outcomes will confirm preliminary data and alter the treatment pathways for patients confronting endometrial cancer. This hope is echoed within the scientific community, recognizing that breakthrough methodologies, such as targeting cancer metabolism, may unveil promising therapeutic avenues.
Notably, endometrial cancer represents a significant health threat, leading to substantial mortality rates among women. With the five-year survival rate for women diagnosed with metastatic and recurrent forms lingering at approximately 20%, the urgency for improved treatment options is undeniably critical. The collaboration aims to respond to this challenge head-on, empowering patients with innovative therapeutic strategies that cater to their specific needs.
While the challenges posed by clinical oncology trials persist, the collaborative efforts between Faeth Therapeutics and The GOG Foundation forge a vital path forward, ensuring robust trial execution. This has significant implications for how cancer treatments could evolve in the coming years, not only for endometrial cancer patients but also potentially influencing broader oncological practices.
The trial embodies hope and innovation, blending theoretical insights with tangible advancements in clinical research. As it unfolds, the stakes are high, reflecting the dire need for groundbreaking therapies that can feasibly alter survival statistics and allow patients to regain autonomy over their health. This partnership is a proactive response to the sobering realities faced by those impacted by endometrial cancer and offers hope for a brighter future in cancer therapeutics.
As researchers herald this collaborative endeavor, the implications extend far beyond academic interest; they resonate within the communities affected by these devastating diseases. The promise of improved outcomes, safety, and quality of life rests on the successful implementation of this trial, which stands as a testament to the relentless pursuit of advancements in cancer care.
With the backdrop of evolving therapies and the commitment of dedicated partners like Faeth Therapeutics and The GOG Foundation, the endeavor encapsulates a crucial moment in the fight against endometrial cancer. As results emerge, the potential to redefine treatment protocols is not merely a dream but an attainable objective, setting the stage for revolutionary changes in the landscape of gynecologic oncology.
This partnership also reflects a broader movement within the scientific community to embrace collaborative frameworks in addressing health crises, showcasing the integral role of research institutions and biotechnology firms in developing and delivering impactful solutions. The epoch of personalized medicine is increasingly within reach, and studies like the PIKTOR trial will undoubtedly help shape future directions in oncological research.
Subject of Research: People
Article Title: FAETH THERAPEUTICS AND THE GOG FOUNDATION, INC. LAUNCH FIRST PHASE 2 COMBINATION TRIAL FOR SAPANISERTIB-SERABELISIB IN PATIENTS WITH ENDOMETRIAL CANCER
News Publication Date: March 12, 2025
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Image Credits: Faeth Therapeutics | The GOG Foundation, Inc.
Keywords: Clinical trials, Uterine cancer, Cancer patients, Gynecology, PI3K inhibitors, Cancer research, Clinical research.
Tags: advanced endometrial cancerchemotherapy paclitaxeldual inhibitors in cancer therapyEndometrial Cancer TreatmentFaeth TherapeuticsGOG Foundationobjective response ratePhase 2 clinical trialPI3K pathway mutationsPIKTOR trialprogression-free survival in cancer patientssapanisertib serabelisib combination
