NUVB News & Events

Nuvation Bio announced that the U.S. FDA has accepted a supplemental New Drug Application with updated data for IBTROZI in both TKI-naive and TKI-pretreated advanced ROS1-positive non-small cell lung cancer with a target action date of January 4, 2027.

Reports Q1 revenue $83.23M, consensus $62.34M. "We are pleased with IBTROZI's ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC. The newly updated long-term follow-up data from our pivotal studies presented at AACR demonstrated an unprecedented durability for IBTROZI of now more than four years in TKI-naive patients, further supporting healthcare providers and their patients' confidence in selecting IBTROZI. With our partners, we are well on our way to bringing this important medicine to patients in need around the world," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also thrilled to have secured exclusive global development and commercialization rights to safusidenib. We look forward to advancing the pivotal Phase 3 SIGMA study for patients with high-risk IDH1-mutant glioma, where targeted treatment options are incredibly limited. Additionally, we are well on track to provide updates on our drug-drug conjugate platform later this year as we further our mission to tackle some of the toughest challenges in cancer treatment."

Nuvation Bio announced results from a pooled analysis of long-term follow-up data from the pivotal TRUST-I and TRUST-II trials for IBTROZI, or taletrectinib, in patients with advanced ROS1-positive, or ROS1+, non-small cell lung cancer, or NSCLC. The updated efficacy and safety results for both TKI-naive and TKI-pretreated patients were presented at the American Association for Cancer Research, or AACR, Annual Meeting 2026 in oral and poster presentations. The long-term pooled results in TKI-naive patients demonstrated a confirmed objective response rate, or cORR, of 89.8%, a median duration of response, or mDOR, of 49.7 months and a median progression-free survival, or mPFS, of 46.1 months. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology, demonstrating robust ORR, mDOR and mPFS in TKI-naive patients, with a median follow up of 51 months. The new pooled analysis presented at AACR demonstrated robust efficacy with IBTROZI for both TKI-naive and TKI-pretreated patients in TRUST-I and TRUST-II. For TKI-naive patients: the analysis showed a cORR of 89.8%, a median DOR of 49.7 months, a median PFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). Median OS was not yet reached. For TKI-pretreated patients: the analysis showed a cORR of 55.8%, a median DOR of 16.6 months, a median PFS of 9.7 months and an intracranial response rate of 65.6% in patients with brain metastases. Median OS was 29.8 months. Notably, 98% of TKI-pretreated patients enrolled following progressive disease on entrectinib or crizotinib. The remaining two patients were enrolled following intolerance to a prior TKI. A pooled safety analysis demonstrated a favorable and manageable safety profile for IBTROZI, consistent with its prescribing information. Adverse events of clinical interest (diarrhea, nausea, vomiting and dizziness) were generally low-grade and resolved quickly. Treatment discontinuations due to treatment-emergent AEs were low, 8.5%. No new safety signals were identified with the longer follow-up. In another poster session at AACR, new preclinical data showed that taletrectinib inhibited the migration of lung cancer cells, suggesting the ability of taletrectinib to reduce the invasive capacity of lung cancer cells based on its tropomyosin receptor kinase B (TRKB) inhibition profile. In mechanistic studies, taletrectinib reduced the expression of key markers associated with the epithelial to mesenchymal transition pathway. The data also suggested that TRKB-sparing agents may not reduce the migration of TRKB expressing lung cancer cells and may lack the potential CNS-protective effects of TRKB inhibition.

Nuvation Bio announced the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma. Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care. In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all IDH1-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control.