FDA Approves Ibtrozi For Adults With ROS1+ NSCLC

The FDA has approved Nuvation Bio Inc.’s Ibtrozi (taletrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults, according to a news release published yesterday. An investors call was held this morning.

ROS1+ NSCLC is a rare and aggressive form of lung cancer, accounting for approximately 2% of new NSCLC cases annually. It is more common in patients who do not smoke and caused by a mutation in the ROS1 gene, which leads to uncontrolled cancer growth in cells. The average age of diagnosis is 50 years old, whereas the median age for lung cancer is 70 years old. The survival rate of ROS1+ NSCLC is approximately 4 years, with brain metastases the leading cause of mortality.

“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,” Janet Freeman-Daily, co-founder and president of ROS1+ NSCLC advocacy group, The ROS1ders, said in the news release. “The approval of this new targeted therapy is a meaningful step forward for the advanced ROS1+ lung cancer community and offers hope for patients facing the added challenge of cancer spreading to the brain.”

Ibtrozi is a kinase inhibitor available in 200 mg oral capsules. The recommended daily dose of Ibtrozi is 600 mg taken on an empty stomach at the same time each day until disease progression or unacceptable toxicity occurs.

This approval is based on the results of the TRUST-I (NCT04395677) and TRUST-II (NCT04919811), which were two multicenter, single-arm, open-label clinical trials that determined the efficacy and safety of Ibtrozi.

Researchers gave 157 treatment-naïve and 113 patients pretreated with tyrosine kinase inhibitors ROS1+ NSCLC patients 600 mg of Ibtrozi. The overall response rate of treatment-naïve patients was 90% in TRUST-I and 85% in TRUST-II. Seventy-two percent and 63% of responders had a duration of response for at least 12 months, respectively.

Among previously treated patients, the overall response rate was 52% in TRUST-I and 62% in TRUST-2. Seventy-four percent and 83% of responders, respectively, had a duration of response for at least 6 months. Response rates were calculated using RECIST v1.1.

Adverse reactions occurred in at least 20% of patients, the most common being diarrhea (64%), nausea (47%) and vomiting (43%). Serious adverse reactions occurred in at least 2% of patients, including pneumonia (7%), pleural effusion (4.7%) and hepatotoxicity (2.4%). Reactions were fatal in 18 patients, the most common cause being pneumonia (2.4%).

Tumor growth was monitored via imaging every 6 weeks for the first 24 weeks, every 9 weeks for the following year and every 12 weeks thereafter.

Ibtrozi may be available at no cost per month for eligible patients with commercial insurance. The NuvationConnect^™ Patient Assistance Program is also available for uninsured patients.