NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZIâ"¢ (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC). "While surgi. ...

Core Insights - Onco360 has been selected as a pharmacy partner by Nuvation Bio Inc. for IBTROZI™ (taletrectinib), a kinase inhibitor for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) [1] - The approval of IBTROZI is based on Phase 2 TRUST-I and TRUST-II studies involving over 300 patients [1][2] - IBTROZI is a next-generation ROS1 inhibitor therapy that is CNS-active and oral, targeting a rare and aggressive form of lung cancer that accounts for approximately 2% of new NSCLC cases in the U.S. [1] Company Overview - Onco360 is the largest independent Oncology Pharmacy in the U.S., founded in 2003 to meet the specialized needs of oncologists, patients, and healthcare facilities [14] - The company is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation [14] Product Information - IBTROZI is indicated for adult patients with ROS1-positive NSCLC, which has a median diagnosis age of around 50 years and is more common in non-smokers [1] - The drug has shown a significant potential in treating patients with advanced or metastatic ROS1-positive NSCLC, with approximately 3,000 new diagnoses annually in the U.S. [1] Safety and Efficacy - Hepatotoxicity is a notable risk, with 88% of patients experiencing increased AST levels and 85% experiencing increased ALT levels [2][3] - The median time to first onset of AST or ALT elevation is 15 days, with fatal liver events occurring in 0.6% of patients [2] - Interstitial Lung Disease (ILD) or pneumonitis occurred in 2.3% of patients, with a median onset time of 3.8 months [3][4] - The most frequently reported adverse reactions (≥20%) include diarrhea (64%), nausea (47%), and vomiting (43%) [12] Drug Interactions and Administration - IBTROZI should be administered on an empty stomach and should avoid concomitant use with strong and moderate CYP3A inhibitors [6][15] - The drug can cause significant QTc interval prolongation, which may increase the risk of serious cardiac events [5][6] Conclusion - The partnership between Onco360 and Nuvation Bio for IBTROZI represents a significant advancement in the treatment options available for patients with ROS1-positive NSCLC, addressing a critical need in oncology [1][14]