Vitrakvi (Larotrectinib) Demonstrates 71% ORR and Sustained Quality of Life Improvements in Updated Clinical Data for TRK Fusion Cancer

Bayer Recently Announces Latest Clinical Data for Precision Oncology Drug Vitrakvi (larotrectinib): In an expanded dataset of 116 adult patients with TRK fusion cancers (including those with brain metastases), Vitrakvi continued to demonstrate high response rates and durable responses, along with a favorable safety profile, as follow-up data matured. An independent analysis using clinical questionnaires showed clinically meaningful improvements in quality of life (QoL) among both adult and pediatric patients, including infants under 2 years of age.

Vitrakvi is an oral TRK inhibitor specifically indicated for the treatment of pediatric and adult patients with advanced or metastatic solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. Currently, Vitrakvi has been approved in multiple countries and regions worldwide, including the United States, Brazil, Canada, and European Union member states, with applications in other regions either underway or planned.

The two analyses presented herein are derived from a pooled dataset of three clinical trials (NCT02122913, NCT02576431, NCT02637687) evaluating Vitrakvi in adult and pediatric patients with TRK fusion cancers.

Updated data as of July 15, 2019, showed that among 116 adult patients with TRK fusion cancer across 17 tumor types, the overall response rate (ORR) was 71% (95% CI: 62–79), and the complete response rate (CR) was 10%. Among patients with brain metastases (n=14), the ORR was 71% (95% CI: 42–92), with 10 patients achieving partial response (PR). At a median follow-up of 17.4 months, the median duration of treatment was 35.2 months (95% CI: 21.6–not estimable [NE]). At a median follow-up of 14.6 months, the median progression-free survival was 25.8 months (95% CI: 15.2–NE), and 87% of patients had an overall survival (OS) of ≥12 months.

The safety profile was consistent with the overall safety previously reported in the patient population. Most reported adverse events (AEs) were Grade 1 or 2. One patient (1%) discontinued treatment due to Vitrakvi-related adverse events. No treatment-related Grade 3 or 4 adverse events occurred in >3% of patients, and no treatment-related deaths were reported.

In another analysis, quality-of-life data were collected from the Vitrakvi trials using the EORTC QLQ-C30 (for adults) and PedsQL (for children) questionnaires, and descriptive and longitudinal analyses were performed. Compared with values reported in the literature for the general US population, the proportions of patients treated for more than 2 years with quality-of-life scores that were normal or above normal versus below normal were also calculated. The majority of adults and the majority of children and infants with TRK fusion cancers treated with Vitrakvi experienced rapid, clinically meaningful, and sustained improvements in quality of life. During Vitrakvi treatment, the quality-of-life scores for most patients aged ≥2 years remained within or improved to the normal range.

TRK Fusion CancersTRK fusion cancers are generally rare, can affect both children and adults, and occur with varying frequencies across different tumor types. TRK fusion cancers arise when an NTRK gene fuses with another unrelated gene, resulting in an altered TRK protein. This altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of intracellular signaling cascades. These TRK fusion proteins act as oncogenic drivers, promoting tumor growth and spread regardless of the tumor’s tissue of origin.

Vitrakvi is a first-in-class oral TRK inhibitor. Its active pharmaceutical ingredient, larotrectinib, is a potent, orally administered, selective tropomyosin receptor kinase (TRK) inhibitor designed to directly target TRKs (including TRKA, TRKB, and TRKC), thereby shutting down the signaling pathways that drive the growth of TRK fusion-positive tumors. TRK fusion-driven tumors can arise in various parts of the body, and conventional treatment modalities (such as surgery, chemotherapy, and radiation therapy) often fail to yield satisfactory therapeutic outcomes.

Vitrakvi is a histology-independent therapy specifically developed for the treatment of tumors harboring NTRK gene fusions, regardless of the tumor’s primary site in the body. In pediatric and adult patients with TRK fusion-positive cancers, Vitrakvi demonstrates robust efficacy, including in primary central nervous system (CNS) tumors and brain metastases, offering high response rates and durable responses irrespective of patient age or tumor histology.

In late November 2018, Vitrakvi received the world’s first approval in the United States, becoming the first oral TRK inhibitor ever approved. This drug is a “tumor-agnostic, broad-spectrum” targeted anticancer agent, independent of tumor type. Currently, Vitrakvi has been approved in many countries and regions worldwide, including the United States and the European Union.

Original Source: Efficacy of Vitrakvi® (larotrectinib) Further Established with Continued High Response Rates and Durable Responses in Updated Analyses in Adult Patients, and Quality of Life Data in Adult and Pediatric Patients with TRK Fusion Cancer

Original Title: Tumor-Agnostic! Bayer’s “Broad-Spectrum” Targeted Anti-Cancer Drug Vitrakvi for TRK Fusion Cancers: Overall Response Rate as High as 71%, Improving Quality of Life!

Source: Bioon. For more information, please download the Bioon APP (http://www.bioon.com/m/)