Cancer immunotherapy has revolutionized how we view cancer treatment. When it works, the results are transformative. But right now, only a subset of people treated with immunotherapies respond. The ability to reliably identify both responders and non-responders to immunotherapy is one of the most important challenges facing the field of personalized oncology. And understanding who is most likely to benefit may save significant time and costs associated with drug development, and more importantly, help patients find potentially lifesaving treatments.
Fortunately, an important predictive genomic biomarker of response called tumor mutational burden (TMB) is poised to help us identify those people most likely to realize clinical benefit from immunotherapy approaches.
Independently, and in collaboration with others, Foundation Medicine has advanced the oncology community’s recognition of the powerful role of TMB across a wide range of cancers and is working with regulatory bodies and advocacy organizations to set appropriate standards for TMB measurement.
The potential of TMB is being seen today in real clinical settings. A recent retrospective analysis and the first study to evaluate the potential utility of TMB across diverse cancers, showed that 151 immunotherapy-treated patients across 21 different cancer types with high TMB had better outcomes compared to patients with low TMB.
This knowledge is driving new partnerships with industry, and importantly, with studying TMB prospectively as well as retrospectively. Today, new trials are being designed that focus on how people with different levels of TMB will respond to different immunotherapies before they enter clinical trials.
Toward this goal, we announced a collaboration with Bristol-Myers Squibb (BMS) last year to evaluate TMB in patients receiving dozens of their investigational or approved immunotherapy drugs, in 35 types of cancer. We believe partnerships like these could help the pharmaceutical industry design more targeted and effective clinical trials, and this is exactly what we’re working toward.
When BMS initially used the protein biomarker PD-L1 to evaluate the role of their anti-PD1 immunotherapy as a first-line treatment of advanced non-small cell lung cancer (NSCLC) patients, it failed to meet the primary endpoint of progression-free survival (PFS). But our retrospective analyses showed that TMB was a better predictor of response, so we worked with BMS to evaluate TMB prospectively in another trial.
The results of this trial were recently announced and showed that advanced NSCLC patients with high TMB treated with their immunotherapy combination as a front-line option had significantly longer PFS compared to those on chemotherapy ― regardless of their PD-L1 expression status.
This speaks not only to the value of TMB, but in our ability to work quickly with others in the oncology community to adapt trial design and identify ways to maximize benefits to patients.
And we believe that our innovative leadership in advancing TMB, including the work toward the first validated test for this important immunotherapy marker on our FDA-approved FoundationOne CDx platform, is one of the many reasons why BMS and others continue to partner with us to advance and improve patient care.