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ROS1-positive non-small cell lung cancer accounts for approximately 2% of new NSCLC cases
The US Food and Drug Administration (FDA) has approved Nuvation Bio’s Ibtrozi (taletrectinib) to treat adults with a rare and aggressive form of lung cancer.
The oral tyrosine kinase inhibitor (TKI) has been authorised for use in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
ROS1-positive NSCLC accounts for approximately 2% of new NSCLC cases and more frequently occurs in people who have never smoked. The brain is the most common site of disease progression, with around half of previously treated patients developing central nervous system (CNS) metastases.
The FDA’s decision on Ibtrozi, a ROS1 inhibitor, was supported by positive results from the phase 2 TRUST-I and TRUST-II studies of over 300 patients with ROS1-positive NSCLC.
Ibtrozi was associated with a confirmed overall response rate (cORR) of 90% and 85% in TKI-naïve patients in TRUST-I and TRUST-II, respectively. Consistent results were seen among patients who were previously treated with a ROS1 TKI, with a cORR of 52% in TRUST-I and 62% in TRUST-II.
Nuvation’s drug also demonstrated durable response rates and was generally well-tolerated. Due to the single-arm nature of the studies, median progression-free survival is not provided in the label, the company outlined.
David Hung, founder, president and chief executive officer of Nuvation Bio, said the approval “marks a major milestone in the evolution of targeted therapy for advanced ROS1-positive NSCLC”.
He continued: “We believe one of the greatest threats to ROS1-positive lung cancer patients is disease progression, especially in the first-line setting… With its clinically proven efficacy and safety profile, we believe Ibtrozi has the potential to become a new standard for what targeted therapies can achieve in this type of lung cancer.”
Janet Freeman-Daily, co-founder and president of global patient group the ROS1ders, also welcomed the approval, describing it as a “meaningful step forward for the advanced ROS1-positive lung cancer community”.
“For people living with advanced ROS1-positive lung cancer, who tend to be diagnosed at a younger age, having another treatment option can make a real difference for them and their loved ones,” Freeman-Daily said.
