Repotrectinib Shows Promising Activity in ROS1+ NSCLC

Excerpt:

“Repotrectinib (TPX-0005) demonstrated a clinically meaningful and durable benefit across multiple doses in patients with ROS1 fusion–positive non–small cell lung cancer (NSCLC).

“Overall response rates (ORRs) were 80% for tyrosine kinase inhibitor (TKI)-naïve patients (95% CI, 44-97) and 18% for TKI-refractory patients (95% CI, 4-44), including 33% for those who received a dose of 160 mg once daily, according to findings from the ongoing phase I/II TRIDENT-1 study. Interim analysis results were presented at the 19th World Conference on Lung Cancer (WCLC).”

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FDA Expands Use of Xalkori to Treat Rare Form of Advanced Non-Small Cell Lung Cancer

“The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC.

“Lung cancer is the leading cause of cancer-related deaths in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute.  ROS-1 gene alterations, thought to lead to abnormal cells, have been identified in various cancers, including NSCLC. ROS-1 gene alterations are present in approximately 1 percent of patients with NSCLC. The overall patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLC with anaplastic lymphoma kinase (ALK) gene alterations, for which crizotinib use was previously approved. Xalkori was approved to treat certain patients with late-stage NSCLC that expresses an abnormal ALK gene in 2011.”