Updated analysis for larotrectinib confirms high response rate and durable responses over three years in children and adults with TRK fusion cancer.- Bayer HealthCare

Updated clinical data for larotrectinib in adult and pediatric patients with TRK fusion cancer showed a high response rate with an overall response rate (ORR) of 79% (95% CI: 72�85) with 16% complete responses (n=24) and 63% partial responses (n=97). These results, which are based on 153 evaluable patients at a data cut-off of February 19, 2019, makes it the largest dataset and longest follow-up data of any TRK inhibitor.

Among the patients with confirmed responses (n=108), those responses continued to be durable with a median duration of response of nearly three years (35.2 months; 95% CI: 22.8�NE). For the integrated dataset (n=159), median progression free survival was 28.3 months (95% CI: 22.1�NE) and median overall survival was 44.4 months (95% CI; 36.5�NE), with 88% (95% CI: 83�94) of patients being still alive at one year after the start of therapy. The data were presented in a poster discussion at the 44th European Society for Medical Oncology (ESMO) Congress 2019 taking place in Barcelona, Spain (EU) from September 27 � October 1, 2019.

In a subanalysis from the integrated dataset (n=12), larotrectinib showed a high ORR of 75% in solid tumors with brain metastases. Larotrectinib activity was previously reported in primary CNS tumors (ASCO 2019, Drilon et al.) CNS tumors are aggressive and larotrectinib has achieved disease control in this patient population over an extended period of time.

The safety data presented at the ESMO 2019 Congress encompassed the entire larotrectinib safety database in cancer patients (n=260), continuing to show a favorable safety profile even as the patient population increases. The majority of adverse events (AE) reported were grade 1 or 2. No treatment-related grade 3 or 4 AEs occurred in more than three percent of patients, and no treatment-related deaths were reported.

On September 19, 2019, the European Commission granted marketing authorization in the European Union (EU) for Vitrakvi (larotrectinib) for adult and pediatric patients with solid tumors that display an NTRK gene fusion, making it the first tumor-agnostic approval in the EU. Larotrectinib is already approved in the U.S., Canada and Brazil under the brand name Vitrakvi, with additional filings in other regions underway or planned.