AVEO Pharmaceuticals Initiates Phase 1b/2a Clinical Trial of AV-951 for Treatment of Advanced Non-Small Cell Lung Cancer

Strategic Insights -

AVEO Pharmaceuticals has announced the initiation of a Phase 1b/2a clinical trial of AV-951 as monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC). This trial builds on the company's broad development program for AV-951, a novel triple VEGF receptor inhibitor being studied in multiple single agent and combination clinical trials across various cancer types, including renal cell carcinoma, breast cancer, colorectal cancer, and now, lung cancer. The Phase 1b portion of the trial will evaluate the safety, tolerability, and maximum tolerated dose (MTD) of continuous, escalating daily doses of oral AV-951 over four weeks in approximately 21 patients with recurrent or progressive NSCLC, or who are non-responsive to standard therapy.

Key Takeaways:

  • AV-951 is a novel, highly potent, and selective inhibitor of VEGF receptors 1, 2, and 3, exhibiting picomolar inhibitory activity against all three receptors.
  • The Phase 1b/2a clinical trial will evaluate the safety, tolerability, and maximum tolerated dose of AV-951 in 21 patients with recurrent or progressive NSCLC.
  • The Phase 2a portion of the trial will evaluate the overall response rate to daily dosing with AV-951 in 21-41 patients with recurrent, progressive, or non-responsive NSCLC and no prior exposure to anti-angiogenic therapy.
  • AVEO will study global and targeted gene expression patterns in all patients to evaluate biomarkers for response and patient selection.
  • The company has a robust development program for AV-951, with ongoing combination trials in RCC, breast cancer, and colorectal cancer.
  • AVEO believes that AV-951 may enable optimal inhibition of the VEGF pathway, while avoiding many side effects associated with off-target binding.

Statistics:

  • The Phase 1b portion of the trial will enroll approximately 21 patients with recurrent or progressive NSCLC.
  • The Phase 2a portion of the trial will enroll 21-41 patients with recurrent, progressive, or non-responsive NSCLC and no prior exposure to anti-angiogenic therapy.
  • AVEO has a balanced pipeline of novel cancer therapies focused on well-validated targets (VEGFR, EGFR) and promising novel targets (HGF, FGFR).
  • The company's lead product, AV-951, is in a Phase 2 clinical trial in more than 270 patients with metastatic renal cell cancer.

Sources:

  • AVEO Pharmaceuticals, Inc.
  • Angiogenesis Weekly
  • NewsRx.com