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A Reflection on a Decade-Long Clinical Trial by Wafik S. El-Deiry
Apr 2, 2024, 18:47

A Reflection on a Decade-Long Clinical Trial by Wafik S. El-Deiry

Wafik S. El-Deiry,

“This trial-in-progress was presented at the 2023 American Society of Clinical Oncology (ASCO) meeting. The trial will however be closing in the near future due to poor accrual.

Hopefully someone in the future will investigate the therapeutic efficacy of combined CDK4/6 inhibitors plus HSP90 inhibitors. Both drug classes are approved somewhere in the world and the combination has not been tested and so this was a first-in-human study.

Our research over a number of years has shown that synergy between the drugs is a class effect for both of the drug classes across tumor types including Rb-deficient cancers. Here is a publication from my lab that reported preclinical observations in 2021 “Anti-cancer efficacy including Rb-deficient tumors and VHL-independent HIF1α proteasomal destabilization by dual targeting of CDK1 or CDK4/6 and HSP90”. This paper was a culmination of 7 years of work that built upon 8 years of prior research in the lab.

This is a good case study and the team that stuck with it working on the clinical protocol for nearly 10 years will always know of how original basic research to clinical translation can be challenging. In this case, a general original scientific cancer therapeutic concept that is published, patented, IRB-approved but not supported by federal funds (such as the National Cancer Institute (NCI) clinical oncology study section, NCI Division of Cancer Treatment and Diagnosis Cancer Therapy Evaluation Program CTEP) or industry will not be tested as planned. It is sad for translational science and ultimately for patients.

(Taiho Oncology provided a limited supply of pimitespib and for that I am grateful) and Tim Whitten. I am grateful to the breast cancer patient advocates. who were interested in the concept at the 2023 ASCO meeting, and to the institutional support from Tour De Rhody and Legorreta Cancer Center that was allocated in support of the phase 1b trial. Extremely grateful to the scientists, clinicians and staff who worked hard for years to bring the trial to activation in 2023. Also grateful to prior support by the NCI of the basic science that 10 -15 years ago supported the basic science discoveries that prompted the translational efforts.

Here is additional information on the soon to close to enrollment NCT05655598 “TAS-116 Plus Palbociclib in Breast and Rb-null Cancer”.”

Source: Wafik S. El-Deiry/LinkedIn