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Clinical Development Programme

BAY 2731954 (LOXO-195) is being studied in a single phase 1/2 clinical trial [1, 2]. This is a real-time, safety- and pharmacokinetic-guided study in patients with advanced cancers with NTRK gene fusion whose tumours have progressed on a prior TRK inhibitor [3].  As of December 2019, 31 cancer patients with NTRK gene fusion (7 paediatric, 24 adults) with 11 cancer types had been treated [4]. In the phase 1 part of the study in which doses of 32 mg once-a-day to 150 mg twice-a-day were evaluated, adverse events included dizziness/ataxia (65% of patients), nausea/vomiting (50%) of patients, anaemia (30%), myalgia, abdominal pain, fatigue and lymphopenia (all in 20% of patients each). Overall responses occurred in 10/29 patients (34%). Dose selection is ongoing. 

Table 14: Summary of Ongoing Clinical Trials for BAY 2731954 (LOXO-195)

Registry number



EudraCT 2017-004246-20


Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers

These data are current as of 6 June 2019 ( clinicaltrials.gov)


  1. Lassen UN, Albert CM, Kummar S et al. Larotrectinib 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, https://doi.org/210.1093/annonc/mdy1279.1397.
  2. Sartore-Bianchi A, Ardini E, Bosotti R et al. Sensitivity to Entrectinib Associated With a Novel LMNA-NTRK1 Gene Fusion in Metastatic Colorectal Cancer. J Natl Cancer Inst 2016; 108.
  3. Drilon A, Nagasubramanian R, Blake JF et al. A Next-Generation TRK Kinase Inhibitor Overcomes Acquired Resistance to Prior TRK Kinase Inhibition in Patients with TRK Fusion-Positive Solid Tumors. Cancer Discov 2017; 7: 963-972.
  4. Hyman D, Kummar S, Farago A et al. Phase I and expanded access experience of LOXO-195 (BAY 2731954), a selective next-generation TRK inhibitor (TRKi). Presented at: AACR Annual Meeting: March 29 to April 3, 2019; Atlanta, GA. Abstract CT127. 2019.

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