Core Insights - Nuvation Bio has enrolled the first patient in a global, randomized study (G203) to evaluate safusidenib for maintenance treatment of high-grade IDH1-mutant glioma, a condition with no currently FDA-approved targeted therapies [1][2][3] Study Details - The G203 study will assess the efficacy and safety of safusidenib versus placebo in approximately 300 patients with newly diagnosed IDH1-mutant astrocytoma, either grade 3 with high-risk features or grade 4, following standard treatment [2] - Patients will be randomized 1:1 to receive either 250 mg of safusidenib or placebo twice daily, with the primary endpoint being progression-free survival (PFS) [2] - The study has received alignment from the FDA, indicating that PFS could support full approval for safusidenib in this setting [2] Clinical Background - IDH1-mutant gliomas are the most common type of brain cancer in adults, with nearly 2,400 new diagnoses annually in the U.S. [4] - Patients with IDH1 mutations generally have longer survival times compared to those with wild-type IDH1, but prognosis worsens for high-grade tumors [4] Drug Profile - Safusidenib is described as a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1, which has shown promising activity in a Phase 1 study [5] - The drug was well-tolerated and demonstrated anti-tumor activity along with high blood-brain barrier penetration [5] Company Overview - Nuvation Bio is focused on developing therapies that address significant unmet needs in cancer treatment, with a diverse pipeline that includes safusidenib and other innovative therapies [6][7] - The company was founded in 2018 by David Hung, M.D., and has offices in major cities including New York, San Francisco, Boston, and Shanghai [7]

Core Insights - Nuvation Bio Inc. has initiated the enrollment of the first patient in the TRUST-IV Phase 3 study, which aims to evaluate the efficacy and safety of IBTROZI™ (taletrectinib) compared to placebo for the adjuvant treatment of resected ROS1-positive early-stage non-small cell lung cancer (NSCLC) [1] Company Summary - Nuvation Bio Inc. is a global oncology company focused on addressing significant challenges in cancer treatment [1] - The company is conducting a Phase 3 study to assess a next-generation ROS1 inhibitor, IBTROZI™, in patients with ROS1-positive NSCLC [1]

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]