Bayer has released the latest clinical data for the treatment of TRK fusion cancer with the targeted drug Vitrakvi
Last Update: 2021-03-03
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Bayer recently released the latest clinical data from the precision oncology drug Vitrakvi, which continues to show high remission rates and duration of remission while maintaining good safety in an extended data set of 116 adult TRK fusion cancer patients, including those with brain metastasis. An independent analysis showed that the quality of life (QoL) of adult and child patients, including infants under 2 years of age, improved clinically using clinical questionnaires.
Vitrakvi is an oral TRK inhibitor specifically designed to treat children and adults with late-stage or metastasis solid tumors that have neurotrophic tyrosine-like kinase (NTRK) gene fusion in tumors. Currently, Vitrakvi has been approved in many countries and regions around the world, including the United States, Brazil, Canada, the European Union countries, and applications in other regions are under way or planned.
The two analyses published were based on a summary of 3 clinical trials (NCT02122913, NCT02576431, NCT02637687) in Vitrakvi's treatment of adult and pediatric patients with TRK fusion cancer.
As of July 15, 2019, updated data show that the total remission rate (ORR) of 116 adult TRK fusion cancer patients in 17 tumor types was 71% (95% CI:62-79) and the full remission rate (CR) was 10%. For patients with brain metastasis (n-14), the ORR was 71% (95% CI:42-92), of which 10 patients had partial remission (PR). At 17.4 months of medium follow-up, the medium duration of treatment was 35.2 months (95% CI: 21.6-unestimated. At 14.6 months of medium follow-up, the medium non-progression lifetime was 25.8 months (95% CI:15.2-NE), and 87% of patients had a total survival period (OS) ≥12 months.
The safety profile is consistent with the previously reported overall safety patient population. Most adverse events (AEs) reported are level 1 or 2. One patient (1%) stopped taking the drug due to adverse events related to Vitrakvi. No treatment> level 3 or 4 adverse events occurred in 3% of patients, nor were treatment-related deaths reported.
In another analysis, quality-of-life data was collected from the Vitrakvi trial and descriptive and longitudinal analysis was performed using the EORTC QLQ-C30 (adult) and PedsQL (children) questionnaires. Compared with the values in the U.S. general population literature, the proportion of patients with quality of life scores of more than 2 years was calculated to be normal or higher than normal and lower than normal. The quality of life of most adults and most children and infants treated with TRK fusion cancer in Vitrakvi is rapid, clinically significant and continuously improving. During Vitrakvi treatment, most patients ≥ 2-year-olds maintained or entered the normal range of quality of life scores.
TRK fusion cancer is generally rare and can affect children and adults and occurs at different frequencies in different tumor types. TRK fusion cancer occurs when one NTRK gene fuses with another unrelated gene to produce a modified TRK protein. The altered protein, or TRK fusion protein, becomes composively active or overextended, triggering the activation of the intercellular signal cascading. These TRK fusion proteins act as drivers of cancer genes and promote the spread and growth of tumors wherever they originate.
Vitrakvi is a pioneering oral TRK inhibitor, and its active drug ingredient, larotrectinib, is a powerful, oral, selective primary myoglobulin-invasive kinase (TRKs) inhibitor designed to directly target TRK (including TRKB, TRKB, and TRKC) by closing the signaling path pathrapies that cause TRK to fuse tumor growth. TRK fusion-driven tumors can occur in various parts of the body, and conventional treatment options (e.g. surgery, chemotherapy, radiotherapy, etc.) often do not achieve satisfactory results.
Vitrakvi is a histology-independent treatment specifically developed to treat tumors that carry the NTRK gene fusion, regardless of where the tumor originated in the body. Vitrakvi has strong results in children and adults with TRK fusion tumors, including for primary central nervous system (CNS) tumors and brain metastasis tumors, providing high rates of remission and long-lasting remission, regardless of patient age and tumor histology.
At the end of November 2018, Vitrakvi became the first oral TRK inhibitor ever approved in the United States, an "unlimited, broad-spectrum" targeted anti-cancer drug unrelated to tumor type. At present, Vitrakvi has been approved in many countries and regions around the world, including the United States and the European Union. (
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