Rozlytrek Shows Potential for Non-Small Cell Lung Cancer

Rozlytrek (entrectinib) demonstrated a high level of clinical benefit with no new safety signals found for patients with locally advanced or metastatic ROS proto-oncogene (ROS1) fusion-positive non-small cell lung cancer, according to an analysis published in the Journal of Clinical Oncology.

“Before the approval of (Rozlytrek), there was an unmet need for (central nervous system)-active treatment for patients with locally advanced or metastatic ROS1 fusion-positive non-small cell lung cancer,” the study authors wrote. “As well as confirming the overall efficacy of (Rozyltrek), our results provide strong evidence that (Rozyltrek) can treat existing (central nervous system) metastases and may have a potential (central nervous system)-protective effect in patients without (central nervous system) involvement at baseline. These data will help physicians to make more informed treatment decisions for their patients.”

With a median follow-up of 15.8 months, 161 patients received at least 600 mg of Rozlytrek fora median treatment duration of 10.7 months. In addition, 34.8% of patients had central nervous system metastases at the beginning of the study, of whom 46.4% of them has completed brain radiotherapy.

Researchers assessed objective response rate, defined as “the proportion of responders with a confirmed complete responds or partial response,” which was 67.1%. Responses to the treatment were durable, with a 12-month response rate of 63% and a median duration of response of 15.7 months

Progression free survival, defined as the length of time during and after treatment without disease progression, was 55% at 12 months with a median of 15.7 months. The overall survival rate at 12 months was 81%.

The authors report that up to 40% of patients with ROS1 fusion-positive metastatic non-small-cell lung cancer have central nervous system metastases, meaning the cancer has spread to their nervous systems. Authors wrote it is important that targeted agents demonstrate activity in the central nervous system.

In 24 patients with central nervous system metastases, intracranial objective response rate was 79.2%, with a median intracranial progression-free survival of 12 months and the median intercranial duration of response was 12.9 months.

Any grade of side effects was reported in 196 patients (93.3%). Nearly all side effects were mild or moderate, with the most common being impaired taste (42.9%), dizziness (34.3%) and constipation (31.4%). The most common severe side effects were weight gain (8.1%), increase in alanine aminotransferase levels potentially indicating liver disease(3.3%) and diarrhea (2.9%). Seven patients experienced life-threatening side effects such as excessive uric acid in the blood, high levels of triglycerides in the blood, brain inflammation, potential heart attack, disorders of the anal canal and rectum, and inflammation of the heart.

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