The Oncology Institute Enrolls Nation’s First Two Patients in a Phase 3 Open-Label, Randomized Clinical Trial of Pirtobrutinib

Rhea-AI Summary

The Oncology Institute, Inc. (NASDAQ: TOI) has announced the successful enrollment of two patients in a Phase 3 clinical trial (BRUIN-CLL-314) comparing Pirtobrutinib (LOXO-305) to Ibrutinib for treating Chronic Lymphocytic Leukemia. Pirtobrutinib targets the Bruton Tyrosine Kinase with a reversible binding mechanism, potentially providing better efficacy and fewer side effects than Ibrutinib, which has been on the market since 2013. The trial is sponsored by Eli Lilly and aims to enhance treatment options for patients with recurring CLL.

Positive

• Enrollment of two patients in a pivotal Phase 3 trial for Pirtobrutinib.
• Pirtobrutinib may offer better efficacy and a lower risk of resistance in CLL patients.
• The Oncology Institute is conducting over 170 clinical trials, improving patient access to cutting-edge therapies.

Negative

• None.

Value-based Oncology Leader Improving Access to Cutting-Edge Therapies

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.

Dr. John Khoury, one of TOI’s Medical Directors, Sub Investigator and Treating Physician for this study, enrolled the patient in Glendale, California. He is the recipient of the 40 under 40 in Cancer Award and Freeman Wilner Foundation Compassionate care award. He has served as a Principal Investigator for multiple trials and has presented his research at many national conferences.

Dr. Richy Agajanian, TOI's Principal Investigator, leads this clinical trial. A dedicated and highly decorated physician, his past work includes cancer research that has contributed to developing new FDA-approved medications. Dr. Agajanian is also the Founder of The Oncology Institute.

“We at TOI are extremely proud of our role in this important clinical trial,” says Dr. Yale Podnos, Chief Medical Officer of The Oncology Institute. “New, effective treatments can’t be made available to the public without this important research. We look forward to working with the scientific community to continue to be at the forefront of cutting-edge oncology research.”

TOI increases access to clinical trials by bringing this cutting-edge service into its 50+ community-based clinics. Currently TOI is conducting over 170 trials.

About The Oncology Institute, Inc.

Founded in 2007, TOI is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.7 million patients including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With 90+ employed clinicians and more than 700 teammates in over 50 clinic locations and growing, TOI is changing oncology for the better. For more information visit www.theoncologyinstitute.com.

Media Contact
Julie Korinke
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(562) 735-3226 x 88806

Juan Lezama
juanlezama@theoncologyinstitute.com
(562) 374-8434

Investor Relations
Solebury Trout
Maria Lycouris
investors@theoncologyinstitute.com

FAQ

What is the purpose of the clinical trial BRUIN-CLL-314 involving TOI?

The BRUIN-CLL-314 trial aims to compare the effectiveness of Pirtobrutinib against Ibrutinib in treating Chronic Lymphocytic Leukemia.

What are the expected benefits of Pirtobrutinib over Ibrutinib?

Pirtobrutinib may provide better efficacy and reduced off-target effects due to its reversible binding to the BTK protein.

Who sponsors the clinical trial for Pirtobrutinib?

Eli Lilly and Company sponsors the clinical trial for Pirtobrutinib.

How many clinical trials is The Oncology Institute currently conducting?

The Oncology Institute is currently conducting over 170 clinical trials.

When was Ibrutinib first approved and what is its market status?

Ibrutinib was first approved by the FDA in 2013 and has been available in the market since then.