The cause of TRK fusion tumors is the fusion of one NTRK gene with another unrelated gene, resulting in abnormal TRK proteins. These TRK fusion proteins can promote the spread and growth of tumors. Recently, a summary of data on the expansion of the targeted drug larotinib Vitrak Vi showed that compared with the previous treatment regimen, most TRK-fused tumor patients using larotinib Vitrak Vi achieved meaningful clinical benefits.
Summary of patient data for 21 cancer types：
Continuous remission for more than 4 years, 77% have lived for 3 years
This is a meta-analysis of long-term follow-up data from three clinical trials. As of July 20, 2020, the research team compiled information on 218 patients with TRK fusion tumors, with a median age of 38.0 years, who received larotrectinib (Vitrakvi) treatment, of whom 206 were evaluable for efficacy. A total of 21 different tumor types were involved, the most common being soft tissue sarcoma (46%), thyroid cancer (13%), salivary gland cancer (11%), lung cancer (9%), and colorectal cancer (5%). 45% of the participants had previously received two or more lines of systemic therapy, and 27% had not.
Results showed that 75% of patients achieved an objective response (tumor volume reduction to a predefined value and maintenance for the minimum required duration), including 45 patients (22%) with complete response and 109 patients (53%) with partial response; 33 patients (16%) had stable disease and 13 patients (6%) experienced disease progression. 19 patients had brain metastases at baseline, and 15 were evaluable for treatment; the objective response rate for patients with brain metastases was 73%. The median duration of response (the time from the first assessment of complete or partial response to the first assessment of disease progression or death from any cause) was 49.3 months. The median progression-free survival (the time from onset to tumor progression or death) was 35.4 months. At 36 months, the overall survival rate was as high as 77%. Median survival data have not yet been reached and are still being accumulated.
Advanced lung cancer：
The median total survival is more than 3 years
The latest data obtained in adult patients with TRK fusion tumors who have received severe pretreatment (median of 3 times) (as of July 20, 2020) show that Larotinib Vitracvi has a high degree of antitumor activity, can cause a rapid and long-lasting response, and prolong the survival period., and has good long-term safety characteristics. Among the 15 evaluable lung cancer patients, according to the researchers' evaluation, the confirmed ORR was 73% (95% CI 45-92), and among the evaluable patients with baseline CNS metastasis (n=8), the ORR was 63% (95%CI 25-91).
Among all evaluable patients (n=15), the 12-month rates of DoR and PFS were 81% and 65%, respectively. At a median follow-up of 16.2 months, the median OS was 40.7 months (95% CI 17.2–NE). Sixteen patients reported TRAEs, including two grade 3 events. No patients discontinued larotrectinib (Vitrakvi) due to TRAEs. These data were investigator-assessed from enrolled patients in two clinical trials (NCT02576431 and NCT02122913).
Primary central nervous system tumors：
85% have lived for 12 months
Results showed that 75% of patients achieved an objective response (tumor volume reduction to a predefined value and maintenance for the minimum required duration), including 45 patients (22%) with complete response and 109 patients (53%) with partial response; 33 patients (16%) had stable disease and 13 patients (6%) experienced disease progression. 19 patients had brain metastases at baseline, and 15 were evaluable for treatment; the objective response rate for patients with brain metastases was 73%. The median duration of response (the time from the first assessment of complete or partial response to the first assessment of disease progression or death from any cause) was 49.3 months. The median progression-free survival (the time from onset to tumor progression or death) was 35.4 months. At 36 months, the overall survival rate was as high as 77%. Median survival data have not yet been reached and are still being accumulated.
Larotinib Vitra Kvi Drug Introduction
Drug name: Larotrectinib
Product name: Vitrak Vi
Chinese name: Larotinib
Manufacturer: Bayer, Loxo Oncology
Consultant: United Cancer Centre of Hong Kong
Results showed that 75% of patients achieved an objective response (tumor volume reduction to a predefined value and maintenance for the minimum required duration), including 45 patients (22%) with complete response and 109 patients (53%) with partial response; 33 patients (16%) had stable disease and 13 patients (6%) experienced disease progression. 19 patients had brain metastases at baseline, and 15 were evaluable for treatment; the objective response rate for patients with brain metastases was 73%. The median duration of response (the time from the first assessment of complete or partial response to the first assessment of disease progression or death from any cause) was 49.3 months. The median progression-free survival (the time from onset to tumor progression or death) was 35.4 months. At 36 months, the overall survival rate was as high as 77%. Median survival data have not yet been reached and are still being accumulated.
Reminder: Larotinib Vitracvi is the first oral TRK inhibitor approved for the market. This drug is a “unlimited cancer type, broad-spectrum” targeted anti-cancer drug regardless of the tumor type.
