Bayer presents New Analyses for Vitrakvi®

Bayer announced findings from new analyses and data for Vitrakvi® (larotrectinib), which is approved for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In the analysis of children with TRK fusion cancer, there was an ORR of 94% as per investigator assessment using RECIST 1.1, with median DOR not reached at the time of data cut-off of July 30, 2018. In the analysis of adult patients with TRK fusion cancer, a response rate of 68% as per independent assessment and 76% as per investigator assessment was seen using RECIST 1.1, and with median follow up of 17.5 and 17. months, respectively, the median DOR had not been reached at time of data cut-off (July 30, 2018). New data on patients with primary central nervous system (CNS) tumors of various histologies or brain metastases will be presented as part of an oral presentation. An analysis on quality of life (QoL) with Vitrakvi treatment was also conducted in both children and adults with TRK fusion cancer. Adverse events seen with the new data for adults and children were mostly grade 1-2.

"These data further confirm the efficacy and safety of larotrectinib in patients with TRK fusion cancer, regardless of tumor type and age, including those who present with brain metastases or primary CNS tumors," said Douglas S. Hawkins, M.D., hematology/oncology division chief at Seattle Children's Hospital and professor of pediatrics at the University of Washington School of Medicine. "It underscores the urgency for widespread genomic testing to identify patients."

"These latest data add to the body of evidence for larotrectinib in patients with TRK fusion cancer," said Scott Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer's Pharmaceutical Division. "With our commitment to developing treatments like larotrectinib as well as the investigational TRK inhibitor BAY 2731954, we are demonstrating our commitment to researching and advancing the future of cancer care, while providing true value for patients and physicians."

Data from pediatric patients from the expanded dataset show an ORR of 94% (n=32/34) with Vitrakvi as per investigator assessment using RECIST 1.1, including 12 complete responses (CR), 18 confirmed partial responses (PR) and 2 PR pending confirmation.1 At the time of data cut-off (July 30, 2018), the median DOR had not been reached (range 1.6+ to 26.7+ months).

Data in adult patients from the expanded dataset show an ORR of 68% as per independent assessment (n=44/65), including a 17% CR and 51% PR, and 76% by investigator assessment (n=56/74) with a 9% CR, 57% confirmed PR, and 9% PR pending confirmation. At the time of data cut-off (July 30, 2018), the median DOR had not been reached.

An analysis across clinical trials of TRK fusion cancer patients with evaluable brain metastases (n=5) shows an ORR of 60% per investigator assessment using RECIST 1.1. Additional data will be provided in an oral presentation at ASCO on June 3, 2019.

Vitrakvi® is indicated for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Research suggests that the NTRK gene can become abnormally fused to other genes, producing a TRK fusion protein that can act as an oncogenic driver, promoting cell growth and survival in tumor cell lines.