Anavex Life Sciences Corp (AVXL)

[indialong]

Here are two example approvals using biomarker-positive subgroup analyses:

"For example, cetuximab was approved for metastatic colorectal cancer based on a phase III RCT that enrolled all patients and retrospectively assessed tumor biopsies for KRAS mutations 28, 29. Treatment was effective for patients with KRAS wild-type tumors (progression-free survival HR?=?0.57; 95% CI, 0.36–0.91) but not for those with KRAS-mutated tumors (HR?=?1.83; 95% CI, 1.10–3.06, p(interaction)?=?0.001)."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537292/

"An example of a non-significant treatment-by-biomarker interaction in the pivotal RCT is lapatinib, for treating metastatic breast cancer that overexpresses the human epidermal growth factor receptor 2 (HER2), combined with letrozole. Data supporting this indication were derived from a double-blind RCT. Among 1286 randomized patients, 219 (17%) were HER2-positive and benefited from lapatinib (disease progression HR?=?0.71; 95% CI, 0.53–0.96), with no benefit demonstrated for HER2-negative tumors (HR?=?0.90; 95% CI, 0.77–1.05)"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537292/