Vitrakvi Is Approved In The UK For The Treatment Of NTRK Fusion Solid Tumors

- Mar 13, 2020-

German pharmaceutical giant Bayer (Bayer) precision oncology drug Vitrakvi (larotrectinib) has recently received good news in the UK. The National Institute of Health and Clinical Optimization (NICE) has issued guidance to approve Vitrakvi for use in the National Health Service (NHS) of the United Kingdom, for solid tumors that contain a neurotrophic receptor tyrosine kinase (NTRK) gene fusion in tumors Child and adult patients, specifically: patients with positive NTRK gene fusion, locally advanced, metastatic or surgical resection may cause serious complications, and there is no satisfactory alternative treatment option. It is worth mentioning that Vitrakvi is the first "unlimited cancer species (unrelated to histology)" drug provided by the UK through the Cancer Drug Fund (CDF) for NHS patients.

Vitrakvi is a pioneer oral TRK inhibitor, which is a histology-independent treatment method, specially developed for the treatment of tumors carrying NTRK gene fusion, regardless of where the tumor originated in the body. TRK fusion-driven tumors can occur in various parts of the body, usually in rare tumor types, and conventional treatment options (such as surgery, chemotherapy, radiotherapy, etc.) may not be satisfactory. Vitrakvi has strong efficacy in children and adults with TRK fusion tumors, including primary central nervous system (CNS) tumors and brain metastases, which can provide high remission rates and lasting remissions.

At the end of November 2018, Vitrakvi received the world's first batch in the United States, becoming the first oral TRK inhibitor approved in history and the first "unlimited cancer species, broad-spectrum" anti-cancer drug unrelated to tumor type, opened A new era of "tumor agnostic" treatment. At present, Vitrakvi has been approved in many countries and regions around the world, including the European Union.

NICE ’s decision in the UK was based on aggregated data from a total of 102 patients from the Phase I study of adult patients, the Phase II NAVIGATE study of adult and pediatric patients, and the Phase I / II SCOUT study of pediatric patients, of which 93 patients were from the main analysis group and 9 others Patients with primary central nervous system (CNS) tumors. The results showed that Vitrakvi treatment showed a high remission rate, lasting and rapid remission. The specific data are: The main analysis set shows that the total response rate (ORR) is 72% (95% CI: 62,81), of which the complete response rate (CR) is 16% and the partial response rate (PR) is 55%. In another additional analysis, including patients with primary CNS, ORR was 67% (95% CI: 57,76), with CR of 15% and PR of 51%.

At the time of the main analysis, the median time to first response for patients receiving Viktarvy was 1.81 months. At the time of analysis, the median duration of remission had not been reached (range: 1.6+ to 38.7+ months), and 75% of patients had duration of remission ≥12 months. Of the patients who received treatment, 88% (95% CI: 81,95) were still alive one year after the start of treatment. At the time of analysis, the median progression-free survival (PFS) has not been reached. The safety of 125 patients with NTRK gene fusion was evaluated. Most adverse events (AEs) were grade 1 or grade 2. Only 3% of patients had to stop treatment permanently due to AEs that occurred during treatment. Nineteen (15%) patients reported a dose reduction, of which 10 (8%) were due to adverse events. Most adverse events that resulted in a dose reduction occurred during the first three months of treatment.

Viktarvy treatment of TRK fusion-driven adults and children with cancer has clinically significant improvements in patient quality of life (QoL). In two global multicenter clinical trials, 60% of adult patients reported an improvement in the EORTC QLQ-C30 global health score. For pediatric patients, 76% of patients reported an improvement in the total score of PedsQL.

Amanda Cunnington, Bayer UK ’s director of medicines for patients, said: “Bayer welcomes NICE ’s recommendation for Viktarvy because it will give clinicians in the UK the first opportunity to provide adult and pediatric patients with TRK fusion-driven cancer to target their disease Driver-specific treatments. Bayer is proud to collaborate with NICE and the UK National Service System (NHS) throughout the evaluation of this pioneering therapy to bring a new potentially beneficial oral population to cancer patients driven by TRK fusion Treatment options. "

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NTRK gene fusion is an abnormal genetic change that exists in a wide range of tumors, leading to uncontrolled TRK signaling and tumor growth. More and more evidence shows that the gene NTRKs encoding TRKs protein may be abnormally fused with other genes, generating signals that can cause cancer to grow in multiple parts of the body. TRK fusion cancer is generally rare, affecting no more than a few thousand patients in Europe each year. TRK fusion can affect children and adults and occurs at different frequencies in different tumor types.

The active pharmaceutical ingredient of Vitrakvi is larotrectinib, which is a potent, oral, selective tropomyosin receptor kinase (TRKs) inhibitor designed to directly target TRK (including TRKB, TRKB, and TRKC), resulting in shutdown TRK fuses the signal pathway of tumor growth. TRK fusion cancer is generally rare and affects no more than a few thousand patients in Europe each year. The disease can affect children and adults and occurs at different frequencies in different tumors. In clinical studies, Vitrakvi was investigated and treated 29 solid tumors with different histologies. The results show that Vitrakvi has significant and durable anti-tumor activity against TRK fusion tumors, including primary CNS tumors and brain metastases, regardless of patient age and tumor histology.

source:NICE approves oral drug VITRAKVI (larotrectinib), the first histology-independent treatment to be made available in England, for children and adults with TRK fusion driven cancer