09 May VITRAKVI® (larotrectinib): Outcomes by Prior Treatment & Performance Status in TRK Fusion Cancer Patients
Posted at 11:01h
in AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies
MedicalResearch.com Interview with:
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Dr. Hong[/caption]
David S Hong, M.D
MD Anderson
Department of Investigational Cancer Therapeutics
Division of Cancer Medicine
University of Texas
MedicalResearch.com: What is the background for this study?
Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets.
In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%.
In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status.
ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc).





Dr. Jeffrey Smith[/caption]
Jeffrey R. Smith, MD PhD
Department of Medicine, Division of Genetic Medicine
Vanderbilt-Ingram Cancer Center, and Vanderbilt Genetics Institute
Vanderbilt University Medical Center
Medical Research Service
Tennessee Valley Healthcare System, Veterans Administration
Nashville, TN
MedicalResearch.com: What is the background for this study?
Response: Roughly 20% of men with prostate cancer have a family history of the disease, and 5% meet criteria for hereditary prostate cancer. Although prostate cancer has the greatest heritability of all common cancers (twice that of breast cancer), extensive heterogeneity of its inherited causes has presented a considerable obstacle for traditional pedigree-based genetic investigative approaches. Inherited causes across, as well as within families are diverse.
This study introduced a new familial case-control study design that uses extent of family history as a proxy for genetic burden. It compared a large number of men with prostate cancer, each from a separate family with a strong history of the disease, to screened men with no personal or family history. The study comprehensively deconstructs how the 8q24 chromosomal region impacts risk of hereditary prostate cancer, introducing several new analytical approaches. The locus had been known to alter risk of prostate, breast, colon, ovarian, and numerous additional cancers.