New data for larotrectinib to treat children with TRK fusion cancer

Bayer has announced findings from new analyses for larotrectinib, showing an overall response rate (ORR) of 94% in children with TRK fusion cancer , with median duration of response (DOR) not reached at the time of data cut-off (July 30, 2018). In adult patients, a high response rate of 76% was seen, with the median DOR not reached at the time of data cut-off (July 30, 2018; median follow-up of 17.2 months per investigator assessment). New data on patients with primary central nervous system (CNS) tumors of various histologies or brain metastases confirm the activity of larotrectinib in these patients. In an analysis on quality of life, clinically meaningful improvements were seen with larotrectinib treatment in both children and adults with TRK fusion cancer. Safety data were consistent with previous publications, with the majority of adverse events (AEs) being grade 1 or 2. The full data from these analyses will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2019, taking place in Chicago, Illinois (U.S.) from May 31 – June 4, 2019.

In an analysis of the adult subset from the expanded dataset, larotrectinib demonstrated an ORR of 76% by investigator assessment (INV) (n=74) across 14 tumor types with a 9% CR rate, and an ORR of 68% (n=65) by independent review committee (IRC), including a 17% CR rate. At the time of data cut-off (July 30, 2018), the median duration of response had not been reached. (Poster Presentation 3122, Session: Developmental Therapeutics and Tumor Biology (Nonimmuno); Saturday, June 1, 8:00AM – 11:00AM (CDT), Room: Hall A)

. An analysis across clinical trials of patients with brain metastases (n=6) shows a partial response (PR) for 60% of patients (n=3), stable disease (SD) of 20% (n=1), with one patient not evaluable. In the 9 patients with primary CNS tumors, disease control was achieved in all evaluable patients. Additional data will be provided in an oral presentation at ASCO on June 3, 2019. (Oral Presentation 2006, Session: Central Nervous System Tumors.

In a new evaluation on patient-reported outcomes, children and adults (n=37) reported meaningful early improvement in quality of life following treatment with larotrectinib. Improvements versus baseline were observed quickly (within three to five cycles) and were sustained in the majority of patients. (Poster Presentation 6602, Session: Health Services Research, Clinical Informatics, and Quality of Care; Saturday, June 1, 1:15PM – 4:15PM (CDT), Room: Hall A).