Clinical Trial Data Show Efficacy of Investigational Lung Cancer Drug

An investigational treatment for ROS1-positive non-small cell lung cancer (NSCLC), entrectinib, was effective in patients with the disease, according to an integrated analysis of clinical trial data.

The analysis was based on data from 53 individuals with ROS1-activating gene fusions from the phase 2 STARKTR-2, phase 1 STARTRK-1, and phase 1 ALKA trials. According to a Genentech press release, ROS1 gene fusions have been identified in 1% to 2% of patients with NSCLC, and approximately 30% to 40% of those with ROS1-positive NSCLC have brain metastases at the time of diagnosis.

In the trials, entrectinib demonstrated tumor shrinkage in 77.4% of patients with locally advanced or metastatic ROS1-positive NSCLC and 55% of patients with cancer in the central nervous system. According to the data, the treatment also showed a durable response rate of more than 2 years.

Additionally, the safety profile of entrectinib was consistent with the findings from previous analyses and no new safety signals were identified. The most commonly reported adverse effects were those affecting the nervous system, as well as constipation, altered sense of taste, and fatigue.

“These results showed the potential of precision medicines to deliver tailored and effective treatment options for people with non-small cell lung cancer, including those whose tumors have spread to the central nervous system,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release.

According to Dr Horning, Genentech is also investigating entrectinib in NTR fusion-positive tumors across several different cancer types and is looking forward to presenting those results in the near future.

Entrectinib, a selective tyrosine kinase inhibitor, is designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer, according to the release. The drug is also being evaluated across a range of solid tumor types, including NSCLC, pancreatic cancer, sarcomas, thyroid cancer, salivary cancer, gastrointestinal stromal tumors, and cancers of unknown primary.

Based on the integrated analysis of these studies, Genentech plans to submit these data to global regulatory authorities, including the FDA, according to the release.

Reference

Genentech’s Investigational Medicine Entrectinib Showed a Durable Response of More Than Two Years in People With a Specific Type of Lung Cancer [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14745/2018-09-24/genentechs-investigational-medicine-entr. Accessed September 27, 2018.