Purpose
Many drugs have cured cancer in mice, yet failed to show efficacy in clinical trials. With the understanding that every cancer is different and every patient is different, the future of cancer treatment relies on precision medicine. CDMF Bioconsulting services are founded on the experience with advanced biomarker research, including planning, collection, testing, and interpretation.
CDMF Bioconsulting provides deep insights into predictive biomarkers helping your company understanding which patient population responds to the drug, and mechanistic biomarkers verifying how your drug is operating at the cellular and molecular levels.
Keytruda: how a good biomarker strategy results in a 20 billion dollars per year revenue
Pembrolizumab is one of the most sold drugs in the world. But do you know that this drug owes its success to a wise biomarker strategy?!
In many indications, Pembrolizumab alone did not show superiority compared to standard of care in the total patient population tested. As an example, the Keynote 48 Phase III trial (Burtness et al, Lancet 2019) evaluated the efficacy of Pembrolizumab versus Cetuximab+chemotherapy (Standard of care) as first line treatment for patients with recurrent/metastatic Head and Neck cancers. As indicated in the figure below, there was no survival benefit for the Pembrolizumab alone group in the total population.
However, retrospective biomarker analyses from previous Phase II trials suggested that patients with tumors positive for PDL1 demonstrated a better response to Pembrolizumab. Therefore, several sub-population analyses were prospectively included by Merck in their Keynote 48 trial, which proved to be a very wise choice: in patients with PDL1 CPS ≥ 1, Pembrolizumab alone increases the overall survival compared to Cetuximab + chemotherapy. This is one example of how a good biomarker strategy could lead to drug approval.
