03 Jun Larotrectinib (VITRAKVI® ): Efficacy and Safety in Pediatric TRK Fusion Cancer Patients
MedicalResearch.com Interview with:
Dr. Hawkins
Douglas S. Hawkins, M.D.
Hematology/Oncology Division Chief and Professor
Pediatrics at Seattle Children’s Hospital
University of Washington School of Medicine
MedicalResearch.com: What is the background for this study?
Response: TRK fusion cancer is caused by a rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
Larotrectinib is a central nervous system (CNS) active, oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have a rare genomic alteration called an NTRK gene fusion. Larotrectinib was approved at the end of 2018 in the U.S. under the brand name VITRAKVI®, with European and worldwide regulatory submissions underway.
At ASCO 2019, we will be presenting results from a new analysis specifically looking at the efficacy and safety of larotrectinib in pediatric patients (n=34) included in the expanded dataset from both adults and children across 24 tumor types, which was presented first at the European Society for Medical Oncology (ESMO) 2019 Annual Meeting.
MedicalResearch.com: What are the main findings?
Response: In children with TRK fusion cancer, the analysis found an overall response rate (ORR) of 94 percent, with 12 patients achieving complete responses, 18 patients achieving partial responses (PR), and two patients with PRs pending confirmation. At the time of data cut-off of July 30, 2018, the median duration of response had not been reached (range 1.6+ to 26.7+ months), with 84 percent of patients on treatment for greater than one year. The analysis further found that safety data were consistent with previous publications, with the majority of adverse events being grade 1 or 2.
MedicalResearch.com: What should readers take away from your report?
Response: The data presented from this analysis reinforce the efficacy of larotrectinib in children with TRK fusion cancer. The high and durable response rates further confirm the consistent efficacy and safety of larotrectinib in patients with TRK fusion cancer regardless of tumor type and age.
Larotrectinib represents a meaningful advancement in the fight against cancer, as it treats the oncogenic driver that causes tumor spread and growth, rather than where the tumor originates in the body.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The efficacy observed in the new analysis with the use of larotrectinib warrants broader adoption of high-quality testing for cancer patients to detect NTRK gene fusions along with other potential targets. Testing for TRK fusion cancer as part of comprehensive tumor profiling will allow researchers to transform the epidemiological profile by identifying patients that are most likely to benefit from larotrectinib.
Disclosures: Dr. Hawkins received reimbursement for travel to attending Medical Advisory Board Meetings for Bayer and Loxo Oncology. He has been a speaker at a Bayer Product Theater discussing larotrectinib. He has not received honoraria or other compensation as a Medical Advisory Board member or as a speaker. Seattle Children’s Hospital received research funding from Bayer and Loxo Oncology to cover the cost of the conduct of clinical trials conducted at the institution, for which Dr. Hawkins was an investigator.
Citation: ASCO 2019 Abstract #10010: Larotrectinib efficacy and safety in pediatric TRK fusion cancer patients.
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Last Updated on June 3, 2019 by Marie Benz MD FAAD