Larotrectinib

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Efficacy (median follow-up: 9.9 months)

The first efficacy results reported for the LOXO-TRK-14001, SCOUT and NAVIGATE trials was a combined analysis of the first 55 consecutively enrolled and evaluable adult and paediatric patients with cancers with NTRK gene fusion, which was performed at a median follow-up of 9.9 months [1]:

Table 4: Efficacy of Larotrectinib Across Three Trialsa at 9.9 Months Follow-up [1]

Efficacy endpoint Value (independent radiology review) Value (investigator assessment)
Overall response rate 75% (95% CI 61–85%) 80% (95% CI 67%–90%)
Partial response rate 62% 64%
Complete response rate 13% 16%
Median time to response 1.8 months

aLOXO-TRK-14001, SCOUT and NAVIGATE trials.
CI, confidence interval.

Seventeen unique cancer types harbouring NTRK gene fusions were included, and responses were observed regardless of fusion type (NTRK1, NTRK2 or NTRK3 gene fusions), tumour type, or patient age [1, 5].

Figure 7: Change in Tumour Size Following Larotrectinib Treatment Across Three Trialsa at 9.9 Months Follow Up[M1]  b [1]

Figure 7: Change in Tumour Size Following Larotrectinib Treatment

aLOXO-TRK-14001, SCOUT and NAVIGATE trials; bInvestigator assessment.
With permission from Drilon et al. 2018 [1].

In addition, two paediatric patients with locally-advanced disease had substantial tumour shrinkage that allowed curative limb-sparing surgery, indicating potential utility of TRK inhibition as neoadjuvant therapy in patients with cancers with NTRK gene fusion [1].

Reference

  1. Drilon A, Laetsch TW, Kummar S et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med 2018; 378: 731-739.

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Last update: 24 June 2019