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Vanderbilt Researchers Present New Data on Clinical Trials at ASCO 2021

Brian Rini, MD

Vanderbilt-Ingram Cancer Center researchers will present data on clinical trials involving targeted therapies, immunotherapies and drug combination synergies at the 2021 American Society of Clinical Oncology Annual Meeting, June 4-8. The meeting is a virtual event this year.

Brian Rini, MD, chief of Clinical Trials at Vanderbilt-Ingram and professor of Medicine, is the lead author of an abstract on 3.5-year survival data from the KEYNOTE-426 trial, which has already led to the decision by the U.S. Food and Drug Administration (FDA) in 2019 to approve the combination of the immunotherapy pembrolizumab and the targeted therapy axitinib as a first-line treatment for patients with advanced renal cell carcinoma. The phase 3 trial compares this combination therapy against sunitinib, a targeted therapy the FDA approved in 2006 for the kidney cancer. Longer-term data continue to show the combination therapy has superior efficacy over sunitinib for overall survival, progression-free survival and overall response rate.

Ingrid Mayer, MD, Ingram Professor of Cancer Research, professor of Medicine and co-leader of the Breast Cancer Research Program at VICC, is the lead author of an abstract on a phase 3 clinical trial for patients with residual triple-negative breast cancer. The ECOG-ACRIN EA1131 clinical trial compared treatment with platinum-based chemotherapy to capecitabine. The trial originated after pre-clinical models from VICC investigators which demonstrated the possibility that a platinum-based chemotherapy might work better for patients with basal subtype triple-negative breast cancer. However, the ECOG-ACRIN Data Safety and Monitoring Committee recommended in March 2021 that the trial be stopped at its interim analysis, after results failed to show superiority in the platinum-based arm of the trial, solidifying the use of standard of care capecitabine for this high-risk group of patients.

Mayer and Vandana Abramson, MD, professor of Medicine, are authors of an abstract about an ongoing triple combination clinical trial for patients with metastatic triple-negative breast cancer. The trial combines the HDAC-blocker romidepsin, the chemotherapy cisplatin and the immunotherapy nivolumab. Fifty-one patients have been enrolled in this clinical trial, which has shown encouraging efficacy.

Christine Lovly, MD, PhD, Ingram Professor of Cancer Research and associate professor of Medicine, is track leader for Non-Small Cell Lung Cancer (metastatic) at this year's meeting and also serves on the educational committee. She is chair of the education session "Lung Cancer in 2021: Testing, Targets and Treatment," during which she will speak about "Not All Variants Within a Given Target Are Created Equal: a Case-based Approach to Understanding When and How to Match a Target with Available Therapies Based on a Mechanistic Understanding of the Molecular Data." Lovly is also an invited discussant during the lung cancer oral session, where she will be giving a talk entitled "Biomarker Testing for Lung Cancer in 2021: Further Precision but Still Not Meeting the Mark for Equitable Distribution." In addition, Lovly is principal investigator of the ongoing registrational phase 2 Alpha-T phase 2 clinical trial, which will be presented at ASCO 2021. This study utilizes an innovative home-based remote design to explore the efficacy and safety of the targeted therapy alectinib in locally advanced or metastatic ALK-positive solid tumors.

Olalekan Oluwole, MBBS, MPH, associate professor of Medicine, is an author of an abstract related to a chimeric antigen receptor (CAR) T-cell therapy for relapsed or refractory B-cell acute lymphoblastic leukemia. It involves KTE-X19, which would be the first CAR T therapy approved for people 18 and older with acute lymphoblastic leukemia. Phase 2 results from the ZUMA-3 study are being presented after a median follow-up of 16.4 months.

Other Vanderbilt researcher are presenting research in abstracts and poster discussions as well as providing lectures during educational sessions.


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