Nuvation Bio's Taletrectinib Gains FDA Priority Review and Expanded Access Program for ROS1+ NSCLC
核心洞察
The FDA granted priority review to Nuvation Bio's NDA for taletrectinib, a next-generation ROS1 (搜索) inhibitor, for advanced ROS1+ non-small cell lung cancer (搜索), setting a PDUFA date of June 23, 2025.
Taletrectinib demonstrated promising efficacy and tolerability in the TRUST-I and TRUST-II trials, showing durable responses and prolonged progression-free survival in ROS1 (搜索)+ NSCLC (搜索) patients.
Nuvation Bio has initiated an Expanded Access Program (EAP) in the U.S. for taletrectinib, offering access to eligible patients with advanced ROS1 (搜索)+ NSCLC (搜索) outside of clinical trials.
Nuvation Bio's taletrectinib, a next-generation ROS1 (搜索) tyrosine kinase inhibitor (TKI), has received priority review from the U.S. Food and Drug Administration (FDA) for the treatment of advanced ROS1-positive non-small cell lung cancer (搜索) (NSCLC (搜索)). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025, for the decision. Furthermore, Nuvation Bio has initiated an Expanded Access Program (EAP) for taletrectinib in the U.S., offering access to the drug for eligible patients with locally advanced or metastatic ROS1+ NSCLC who have no satisfactory alternative treatment options.
The New Drug Application (NDA) is based on pooled results from the pivotal Phase 2 TRUST-I and TRUST-II studies. These studies evaluated taletrectinib in over 300 patients with advanced ROS1 (搜索)+ NSCLC (搜索) and demonstrated durable responses and prolonged progression-free survival. The data, presented at the European Society of Medical Oncology (ESMO) Congress in September 2024, highlight taletrectinib's potential as a best-in-class treatment option.
Clinical Trial Data and Efficacy
The pooled efficacy and safety data from the TRUST-I and TRUST-II studies included 337 patients with advanced ROS1 (搜索)+ NSCLC (搜索) who received 600mg of taletrectinib orally once daily in 21-day cycles. The primary endpoint was confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints included intracranial cORR, duration of response (DOR), progression-free survival (PFS), and safety.
In TKI-naive patients, the confirmed objective response rate (cORR) was 88.8% (95% CI, 82.8%-93.2%), 86.5% (95% CI, 71.2%-95.5%) in TKI-naive patients with brain metastases, and 87.5% (95% CI, 71.01%-96.49%) in TKI-naive patients who underwent prior chemotherapy. The intracranial cORR was 76.5% (95% CI, 50.1%-93.2%).
In the TKI-pretreated population, the cORR was 55.8% (95% CI, 46.1%-65.1%), was 56.4% (95% CI, 42.3%-69.7%) in TKI-pretreated patients with brain metastases, and 59.5% (95% CI, 43.3%-74.4%) in TKI-pretreated patients who underwent prior chemotherapy. For TKI-pretreated patients with G2032R mutations, cORR was 61.5% (95% CI, 31.6%-86.1%). The intracranial cORR was 65.6% (95% CI, 46.8%-81.4%)
Expanded Access Program Details
The EAP allows patients with serious or immediately life-threatening ROS1 (搜索)+ NSCLC (搜索) to access taletrectinib outside of the ongoing pivotal Phase 2 TRUST-II study, as authorized by the FDA. Janet Freeman-Daily, Co-Founder and President of The ROS1ders, emphasized the importance of EAPs for patients who may not benefit from approved therapies or are ineligible for clinical trials.
About ROS1+ NSCLC
Approximately 2% of NSCLC (搜索) patients have ROS1 (搜索)+ disease. Up to 35% of newly diagnosed metastatic ROS1+ NSCLC patients have brain metastases, increasing to 55% in those whose cancer has progressed after initial treatment. Despite advancements, there remains a need for more effective and tolerable treatments.
Nuvation Bio's Perspective
David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, stated, "This EAP reflects our unwavering dedication to patients with ROS1 (搜索)-positive NSCLC (搜索). We are committed to working with the ROS1-positive NSCLC community, and the healthcare providers who serve them, to ensure this EAP provides eligible patients in the U.S. with efficient access to taletrectinib outside of our clinical trials."