Loxo Oncology (NASDAQ:LOXO) may face challenges to define its market for LOXO-101 (larotrectinib) and LOXO-195, as the prevalence of NTRK-fusion tumours is still difficult to assess, experts said. Genetic sequencing tests may not be as commonly used to readily select for this population, they added.
The tropomyosin receptor kinases (TRK) inhibitors are being studied in adult and paediatric patients with locally advanced or metastatic solid tumours with an NTRK gene fusion. Analysts expect larotrectinib and LOXO-195 to generate more than USD 2bn in global sales across lung, colorectal and papillary thyroid cancers.
Larotrectinib is awaiting a PDUFA decision on 26 November, while Phase I/II LOXO-195 is intended to address larotrectinib resistance with results due in 1H19.