As we entered the 21st century, an article published in The AAPS Journal talked about the promise of personalized healthcare (PHC) and how “therapy with the right drug at the right dose in the right patient,” would be the future of treatment. At MedImmune, our goal has always been to work toward understanding the biology of disease at the patient level.
Now 15 years later, we are still learning about why some patients respond to a treatment while others do not. We aim to achieve scientific leadership with a PHC approach across all therapeutic areas. We’ve taken the lead in developing oncology medicines from this standpoint, and are expanding such research into cardiovascular/metabolic diseases (CVMD) and asthma.
PHC requires a deep understanding of disease biology and expertise in the development of companion diagnostics. The pharmaceutical industry is taking a variety of approaches to carrying out relevant research. In addition, payers are assessing the value of personalized medicine; and regulators are working to determine the effectiveness of therapies that have a companion diagnostic for patient selection. Given the current situation, it is not surprising that there has been a lot of talk about PHC, but few new medicines that target select patient populations have actually become available.
MedImmune is committed to moving PHC from potential to reality. In fact, almost all of our oncology development programs currently have a diagnostic component and about 80 percent of our overall drug development work is following this approach.
Companions and combinations
We have further increased our efforts to identify and develop companion diagnostics which help us to identify what patients would benefit most from a drug. We know that companion diagnostics are important to the ultimate safety and success of a treatment, and we’ve entered into collaborations that help us to create these pairings.
Among these alliances is our recent acquisition of Definiens, a company that pioneered a unique imaging and data analysis technology that unlocks information from cancer tissue samples by measuring the identity, locations and, most importantly, the relationships between the many and varied components of the complex tumor microenvironment. This will strengthen our focus on the discovery of novel predictive biomarkers in immuno-oncology, advancing our most promising combination therapies and potentially shortening clinical timelines and increasing response rates.
Combining novel therapies with a diagnostic approach are at the heart of our strategy for redefining cancer treatment. We’re seeing the transformational potential of this approach right now, including the work we’re doing with our PD-L1 molecule MEDI4736. This molecule has demonstrated durable clinical activity and acceptable safety across multiple tumor types and in different combinations. As part of our research, we are developing a PD-L1 companion diagnostic test in collaboration with Ventana Medical Systems. The test has shown robust and reproducible results as a biomarker for predicting response to MEDI4736. For example, using a scoring algorithm, we’ve been able to accurately identify clinical trial samples as PD-L1 positive or PD-L1 negative in 97 percent of non-small-cell lung carcinoma (NSCLC) and 92 percent of squamous cell carcinoma of the head and neck (SCCHN) samples. In MEDI4736 monotherapy trials, both NSCLC and SCCHN PD-L1 positive patients identified by the scoring algorithm had a higher response to MEDI4736 than PD-L1 negative patients.
Exploring all critical areas
Looking ahead, the PHC landscape unfolds with vast possibilities. Our understanding is evolving swiftly as we begin to unlock its benefits for a greater number of patients. But, we’ve only scratched the surface. Our comprehensive, combination-focused development program is poised to rapidly deepen our scientific understanding, helping us to explore all of the critical areas of immuno-oncology. Through the development of companion diagnostics, we also can more fully understand the clinical value of investigational molecules such as MEDI4736, both as monotherapy and in combination.
Ultimately, this leads back to patients. By focusing on the right drug at the right dose in the right patient, our goal is to help transform their lives through PHC and ensure that innovative treatments are precisely matched to those who will benefit the most.