Roche is planning to file its investigational cancer drug entrectinib following positive results from early and mid-stage trials with patients with ROS1-positive non-small cell lung cancer (NSCLC).
An integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials showed that entrectinib shrank tumours in 77.4% of people with the disease carrying the ROS-1 mutation.
Entrectinib also induced a durable response of more than two years and was also shown to shrink tumours in more than half (55%) of people with cancer in the central nervous system (CNS).
ROS-1 gene fusions are present in 1%-2% of people with NSCLC, while around 30%-40% with ROS1-positive NSCLC have brain metastases at time of diagnosis.
Roche said it would submit the data to global regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The drug giant is also currently exploring the drug’s potential in NTRK fusion-positive tumours across several different cancer types.