Bayer’s tumour agnostic therapy Vitrakvi has demonstrated sustained, long-term efficacy and safety in a number of tropomyosin receptor kinase (TRK) fusion-positive cancers, including lung and thyroid tumours.

Vitrakvi is approved in the US for the treatment of adults and paediatric patients with solid tumours that have NTRK gene fusion, whose cancer is metastatic or where surgery is likely to result in severe morbidity.

In a new integrated dataset of 175 adult and paediatric patients with non-primary central nervous system (CNS) TRK fusion-positive cancer, Vitrakvi demonstrated an overall response rate (ORR) of 78%, with 19% complete responses and 59% partial responses.

The ORR in 14 patients with CNS metastases was 71%, with all of these being partial responses. Although the median duration of response was not available at 13.5 months follow-up, the 12 month duration of response rate stood at 81%.

After a median follow-up of 13.8 months, the median progression-free survival was 36.8 months, with median overall survival (OS) having not been reach after 15.3 months of follow-up. The 12-month estimated median OS rate was 90% while 24-month estimated OS rate was 83%.

In a subgroup analysis of 14 adults with heavily pre-treated, metastatic lung cancer with NTRK gene fusion, the demonstrated ORR was 71%, with 7% complete response and 64% partial responses, as well as 21% with stable diseases.

In a seperate subset of 28 adults and children with locally advanced or metastatic TRK fusion thyroid cancer, the ORR was 75%, with 7% complete responses and 68% partial responses.

“Designed specifically to treat TRK fusion cancer, Vitrakvi is a meaningful advancement in the treatment of both adult and paediatric patients with TRK fusion cancer and represents a true paradigm shift in cancer care – where treatment is based on the oncogenic driver and not the tumour location,” said Scott Fields, senior vice president and head of Oncology Development at Bayer's Pharmaceutical Division.

“These data affirm Vitrakvi’s robust clinical profile with the largest dataset and longest follow-up of any TRK inhibitor and reinforce our longstanding commitment to developing innovative treatments for patients,” he added.