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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.   The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.   Read the full article

Prof. Fizazi Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy MedicalResearch.com: What is the background for this study? How does darolutamide differ from other medications for prostate cancer? Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC). In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects. While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension. Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important.   Darolutamide Response: Darolutamide has the potential to be the first novel androgen receptor (AR) antagonist to delay metastases and extend survival, while allowing patients with nmCRPC to continue their day-to-day life without adding any burden. The phase III ARAMIS trial results showed a significant improvement of 40.4 months of metastasis-free survival (MFS) with darolutamide plus androgen deprivation therapy (ADT), an improvement of 22 months versus ADT in combination with placebo. These results are highly clinically relevant. In addition to this significant improvement in MFS and a positive trend in overall survival (OS), ARAMIS trial results also showed a marked improvement in time to pain progression with darolutamide plus ADT, a patient-reported secondary endpoint compared to placebo plus ADT. Darolutamide plus ADT did not increase the rate of discontinuation due to adverse events (AEs) compared to placebo plus ADT and did not increase the rate of AEs typically seen with ADT and/or currently available AR antagonist therapies, including seizures, falls, fractures, rash, cognitive disorder, mental impairment and hypertension. The distinct clinical structure of darolutamide allows for lower blood-brain barrier penetration compared to currently available AR antagonists as demonstrated in preclinical studies. A lower blood-brain barrier penetration may explain the overall low incidence of CNS-related adverse events seen in the ARAMIS Phase III study. In addition, drug-drug interaction studies have demonstrated that darolutamide can be administered with certain types of medications that are typical in this patient population, such as simvastatin, warfarin and digoxin, whereas the prescribing information for currently available AR antagonist therapies recommends concomitant use with these medications should be avoided.  MedicalResearch.com: What are the main findings? Response: Results from the pivotal Phase III ARAMIS trial in men with nmCRPC showed a statistically significant improvement in metastasis-free survival (MFS) with darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P Read the full article

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