Immuno-oncology has become a significant opportunity for oncology drug discovery and development. The ability to harness each person's unique immune system in a meaningful way to dampen the deadly effects of tumor cells has created the explosion of precision medicine. Integrate your flow cytometry, efficacy models, imaging, biomarker and companion diagnostics to quickly advance to the next milestone—because patients can't wait.
It is essential to meaningfully assess the immune effector cells involved in the development of a particular tumor model and those involved in mediating the anti-tumor response of individual therapeutics. For many of our models, we have growth curves available, and we continue to build our database with treatment response to agents of interest like anti-CTLA-4, anti-PDL-1 and anti-PD-1 antibodies.
In addition to testing immune-modulating agents themselves or testing other agents in combination with immune-modulators, it is important to consider the impact of radiation therapy, which is being integrated into and increasingly investigated in combination with these immuno-oncology protocols. Data showing abscopal effects of radiotherapy and immune modulators, along with direct combination anti-tumor effects, has provided proof-of-concept and is attracting further investigation of this highly utilized, clinically relevant modality in the preclinical setting.
Making gains in precision medicine requires the use of novel methods to quickly test and target the right therapy to the right individual. At Labcorp, we have proven experience in immuno-oncology studies, including over 100 protocols in the past five years, performed in 58 countries at more than 2,860 sites with over 19,750 patients.
Our commitment to immuno-oncology is also evident through our support of more than 70% of all FDA-approved companion diagnostic products. As part of a recent pivotal Phase III registration trial, our central laboratory was the sole provider of testing for PD-L1 expression, which led to a new FDA-approved diagnostic test for OPDIVO® (nivolumab). In addition, our best-in-class companion diagnostic capabilities supported the approval of TagrissoTM (osimertinib) and its EGFR mutation test along with the immunotherapy Keytruda® (pembrolizumab) and its PD-L1 companion diagnostic.