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Efficacy (median follow-up: 17.6 months)

An update of the primary dataset set of 55 patients at 17.6 months’ follow-up has also been reported, together with results from an additional 67 patients in a supplementary dataset at 7.4 months’ follow-up [1]. Results from an integrated dataset of both study populations are also reported.

Table 5: Efficacy of Larotrectinib Across Three Trialsa at 17.6 Months Follow-up [1]

Efficacy endpoint

Value (investigator assessment)

Primary efficacy dataset
(n = 55)

Supplementary dataset
(n = 54)b

Integrated
dataset
(n = 109)b

Overall response rate

80% (95% CI 67-90%)

81% (95% CI 69-91%)

81% (95% CI 72-88%)

Partial response rate

62%

65%

63%

Complete response rate

18%

17%

17%

aLOXO-TRK-14001, SCOUT and NAVIGATE trials; bevaluable patients included 9 unconfirmed partial responses and did not include 13 patients continuing on study and awaiting initial response assessment.
CI, confidence interval.

Kaplan-Meier landmark analyses of the supplementary dataset were highly concordant with the primary dataset with 93% of responses ongoing at 6 months and 81% of responses ongoing at 12 months from start of response [1]. In the integrated dataset, 84% of responding patients remained on treatment or had undergone surgery with curative intent [1]. Activity was also reported in a patient with non-small cell lung cancer with liver and brain metastases, demonstrating activity in CNS disease.

In the primary dataset, median progression-free survival was 28.3 months (95% CI 9.9 months – not estimable) [2]. Of note, it was reported that this estimate was not statistically stable due to a low number of progression events [2].

References

  1. Lassen UN, Albert CM, Kummar S et al. 409OLarotrectinib efficacy and safety in TRK fusion cancer: An expanded clinical dataset showing consistency in an age and tumor agnostic approach. Annals of Oncology 2018; 29: mdy279.397-mdy279.397.
  2. Loxo Oncology I. Loxo Oncology announces larotrectinib clinical update in patients with TRK fusion cancers at the European Society for Medical Oncology 2018 Congress. 2018.

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