This week, MedImmune and AstraZeneca were pleased to be among a group of organizations that announced the Lung Cancer Master Protocol, or Lung-MAP, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Its primary goal: to match patients with promising new cancer treatments based on their unique tumor profiles.
This is truly a groundbreaking collaboration, which has the potential to change and accelerate the way new biomarker-defined therapies are tested and approved for lung cancer—and, we hope, eventually for many other diseases that include other types of cancer.
To deliver on this ambitious effort, it requires strong collaboration and we have this with a group of several public and private entities that includes the National Cancer Institute, South West Oncology Group (SWOG) Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, and five pharmaceutical companies that include AstraZeneca, MedImmune, Amgen, Genentech and Pfizer.
Much of the excitement for all of us involved in this effort centers on the use of a diagnostic platform for genomic profiling, and immune profiling that is conducted to match patients to one of several different investigational treatments. The trial will initially test five experimental drugs—four targeted therapies that include MEDI4736, our anti-PD-L1 immunotherapy molecule, and AZD4547, AstraZeneca’s FGFR inhibitor. We anticipate that between 500 and 1000 patients will be screened per year for more than 200 cancer-related genes for genomic alterations. The results of this test will be used to assign each patient to the trial arm that best matches his or her tumor’s genomic profile.
One of our key company priorities is to bring innovative new treatments to patients in need as quickly as possible, which is why we’re so thrilled to be part of this exciting new paradigm in oncology drug development.
Squamous cell carcinoma has a high mortality rate and represents about a quarter of all lung cancer diagnoses, but there are few treatment options other than chemotherapy. This approach to clinical testing should not only improve access to promising drugs but also ease the significant recruitment and infrastructure burdens on researchers involved in traditional clinical trials.
For example, a typical trial for a targeted therapy tests each potential patient for a single biomarker and enrolls only a portion—sometimes a very small portion—of those who are tested. Lung-MAP will simultaneously test patients for many biomarkers to assess eligibility for several different experimental treatments. Then, the patients who have been tested will be enrolled into one of Lung-MAP’s five trial arms based on their genomic profile. This saves the patient and the physician the trouble of doing multiple invasive testing to qualify for the right study.
It is the first Phase II/III program to incorporate a broad diagnostic platform, and it represents true innovation in study design and personalized healthcare. We’re matching the right patient with the right molecule based upon the profile of the tumor. This is an extremely tailored approach that we hope will have a meaningful impact on cancer therapy.
If you’d like to learn more about this important trial, you can visit www.Lung-MAP.org