The Oncology Institute Enrolls Nation’s First Two Patients in a Phase 3 Open-Label, Randomized ...

CERRITOS, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- The Oncology Institute, Inc. (NASDAQ: TOI), today announces the enrollment of two of its patients as the first and second patients dosed in the United States in a phase 3 open-label, randomized study of Pirtobrutinib (LOXO-305) versus Ibrutinib in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314). Pirtobrutinib (LOXO-305) is currently in clinical trial phase, whereas Ibrutinib has been available in the market since 2013. If approved, Pirtobrutinib (LOXO-305) aims to have better efficacy than other alternatives currently available. Benefits can include symptom reduction for patients. Eli Lilly and Company serves as the sponsor of this clinical trial.

Pirtobrutinib and Ibrutinib are both oral treatments that bind to the Bruton Tyrosine Kinase (BTK) protein to inhibit its activity. Ibrutinib, sold as Imbruvica, was first approved by the FDA in 2013.

Pirtobrutinib reversibly binds to BTK allowing for higher BTK inhibition and selectivity. This effect allows for the reduction of any off-target adverse effects. Other BTK inhibitors currently available in the market irreversibly bind to BTK. There is a growing concern about developing resistance to covalent BTK inhibitors, leading to treatment discontinuation in most patients. Researchers recognize Pirtobrutinib for its ability to treat recurrent or relapsing CLL.

Dr. Merrill Shum, TOI’s Pharmacy Director, Sub Investigator and Treating Physician for this study, enrolled the patient in Whittier, California. His extensive experience includes being a lead principal investigator and sub-investigator in over 300 clinical trials and aiding in the FDA approval of several drugs.