Recent FDA Approvals and Clinical Trial Updates in Oncology Highlighted on OncLive On Air
核心洞察
Durvalumab gains FDA approval for perioperative treatment of resectable NSCLC (搜索), showing improved event-free survival in the AEGEAN trial.
Vorasidenib receives FDA approval for IDH1 (搜索)/2-mutated grade 2 astrocytoma (搜索) and oligodendroglioma (搜索), demonstrating significant progression-free survival benefits.
Denileukin diftitox-cxdl is approved by the FDA for relapsed/refractory CTCL (搜索), offering a new treatment option for patients after prior systemic therapies.
Recent episodes of OncLive On Air have spotlighted significant FDA approvals and clinical trial data impacting the treatment landscape for various cancers. Discussions with leading oncologists provided insights into the clinical implications of these advancements.
Durvalumab Approval for Resectable NSCLC
The FDA approved durvalumab in combination with platinum-containing chemotherapy for neoadjuvant treatment, followed by durvalumab monotherapy as adjuvant therapy, in resectable non-small cell lung cancer (NSCLC (搜索)) patients without EGFR (搜索) or ALK (搜索) alterations. This decision was based on the phase 3 AEGEAN trial. Sandip P. Patel, MD, emphasized the importance of bringing immune checkpoint blockade to earlier-stage disease, potentially increasing cure rates. The AEGEAN trial demonstrated a median event-free survival that was not reached (95% CI, 31.9 months-not estimable) in the durvalumab arm versus 25.9 months (95% CI, 18.9-NE) in the placebo arm (stratified HR, 0.68; 95% CI, 0.53-0.88; P = .0039).
Tepotinib Efficacy in MET+ NSCLC
Updated data from the phase 2 VISION trial, with an 18-month follow-up, highlighted the efficacy of tepotinib in NSCLC (搜索) patients with MET exon 14 skipping mutations. Martin Dietrich, MD, stressed the importance of upfront liquid and tissue biopsies to identify these tumors and match patients with the appropriate targeted therapy.
Vorasidenib Approval for IDH1/2-Mutated Gliomas
Vorasidenib received FDA approval for adult and pediatric patients (12 years and older) with IDH1 (搜索) or IDH2 (搜索)-mutated grade 2 astrocytoma (搜索) or oligodendroglioma (搜索) who have undergone prior surgery. The approval was based on the phase 3 INDIGO trial. Jennie W. Taylor, MD, MPH, noted that vorasidenib is the first effective drug approved in decades for IDH-mutant brain tumors. The INDIGO trial showed a median progression-free survival of 27.7 months (95% CI, 17.0-NE) with vorasidenib versus 11.1 months (95% CI, 11.0-13.7) with placebo (HR, 0.39; 95% CI, 0.27-0.56; P < .001).
Myelofibrosis Management with JAK Inhibitors
Aaron T. Gerds, MD, MS, and James K. McCloskey, MD, discussed factors influencing the choice of JAK inhibitors for myelofibrosis (搜索) patients. Gerds noted the importance of addressing spleen-related and cytokine-related symptoms, while McCloskey emphasized considering transplant for patients with disease progression or JAK inhibitor failure.
Denileukin Diftitox-cxdl for Relapsed/Refractory CTCL
The FDA approved denileukin diftitox-cxdl for relapsed/refractory cutaneous T-cell lymphoma (CTCL (搜索)) after one or more prior systemic therapies. Francine Foss, MD, highlighted the unmet need in CTCL and the value of a new treatment with a specific mechanism of action. The phase 3 Study 302 demonstrated an objective response rate of 36.2% (95% CI, 25.0%-48.7%) with the agent, including a complete response rate of 8.7%.
Other Highlights
Additional discussions covered the role of phase 1 trials for oncology fellows, NCCN guideline updates for hepatobiliary and colorectal cancers, liquid biopsy in NSCLC (搜索) biomarker testing, and quality of life outcomes with trifluridine-tipiracil plus bevacizumab in metastatic CRC (搜索).