Every year, thousands of clinicians, researchers and others with an interest in cancer gather at the annual meeting of the American Society of Clinical Oncology (ASCO). We all see the devastating impact of cancer on a daily basis, but here we gather to share knowledge, learn from each other and to strengthen our collective pact to figure out how to one day cure this deadly disease.
At this year’s ASCO, we shared data results from our novel investigational immunotherapy portfolio. Immunotherapy is redefining the cancer treatment landscape, and we’re well poised to play a key role in this critical area. Earlier this morning, we presented information from studies we’ve been doing on MEDI4736—an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1).
Signals from PD-L1 help tumors avoid detection by the immune system, but MEDI4736 blocks those signals, thus countering a tumor’s immune-evading tactics and empowering the patient’s own immune system to attack the cancer.
We presented multiple sets of data from our Phase I study of MEDI4736 that demonstrate this, including dose-escalation and dose-expansion data, and an analysis of pharmacokinetic data. Here, I’ll talk about some of those highlights beginning with our dose-escalation data in which we observed a reduction of tumor burden at all dose levels as early as six weeks. Tumor types included non-small cell lung cancer (NSCLC), melanoma, colorectal cancer and renal cell cancer, and we did this study with patients who had advanced solid tumors.
In one expansion study, we narrowed in on patients with NSCLC and we found early activity occurring in both squamous and non-squamous NSCLC. In another expansion study, we gleaned more information on the clinical activity and tolerability profile of MEDI4736. What we saw here was early evidence of clinical activity in multiple tumor types, including SCCHN, pancreatic cancer, gastroesophageal cancer, uveal and cutaneous melanoma, triple negative breast cancer (TNBC) and hepatocellular cancer.
Additionally, an analysis of pharmacokinetic data reported no immunogenicity impacting pharmacokinetics or pharmacodynamics at the Phase II and III dose. It also demonstrated dose-dependent pharmacokinetics and soluble PD-L1 suppression in patients with solid tumors.
These outcomes prompted our decision to initiate the first Phase III study for MEDI4736. This is definitely something that excites us because it reinforces our expectations that this drug will potentially play an important role in cancer therapy, alone and in combination with other treatments. We’re looking forward to seeing more data on this molecule as part of the Phase III program, as well as the numerous ongoing combination trials that are underway.