At the annual conference of the American Society of Clinical Oncology (ASCO), starting tomorrow in Chicago, drug giant Merck will be presenting no less than 100 abstracts detailing its efforts to develop new cancer drugs. The company’s oncology franchise head, Gary Gilliland—who left a 20-year faculty position at Harvard to join New Brunswick, NJ-based Merck in 2009—is excited about every one of them. This is, after all, why he left academia to work in the drug industry. “We have an increasingly sophisticated understanding of the genetics of cancer, but we need to effectively apply that so we can improve patient outcomes,” Gilliland says. “From my perspective, the best place to do that is at a company like Merck.”
At ASCO, Merck (NYSE: MRK) will spotlight several examples of the company’s evolving approach to cancer drug development. Under Gilliland’s tutelage, Merck has increased its focus on what he calls “biomarker-driven patient stratification”—the effort to identify the people who are most likely to respond to particular drugs based on the molecular characteristics of their tumors. The company has also doubled down on its efforts to form innovative partnerships in oncology research, and to make the entire development process more efficient, so the drugs with the highest likelihood of success will get to the market quickly.
Gilliland points to a couple of key drugs that will be presented at ASCO as examples of the early fruits of Merck’s oncology strategy. The first is MK-3475, which was designed to mobilize the patient’s own immune system to kill tumor cells. The molecule is part of an emerging class of drugs called programmed death-1 (PD-1) inhibitors. In some tumors, a particular type of PD-1 is over expressed, resulting in a breakdown of vital immune regulators called T-cells. In early human trials, Merck’s PD-1 inhibitor appears to re-activate T-cells without causing the high level of side effects seen in other drugs in the class.
Merck is currently assessing whether the positive results seen in the trials are enough to speed MK-3475 into late-stage trials. “When you have striking efficacy signals, it’s tempting to move forward at a more rapid pace,” Gilliland says. “Sometimes you don’t need as many patients to demonstrate the value.” He says his team is now determining how best to move the compound forward into the pivotal trials that will be required for FDA approval.
At ASCO, Merck will also present early-stage results trials of MK-2206, a drug that inhibits a cancer-causing enzyme called AKT. In some of the studies, Merck teamed up with AstraZeneca (NYSE: AZN) to test MK-2206 in combination with an AstraZeneca molecule that inhibits a different enzyme involved in cancer. “We anticipated that as a single agent, [MK-2206] was not likely to have dramatic therapeutic activity,” Gilliland says. “The reason for that is if you turn one pathway off, cancer cells are very clever and they simply turn on another one with enzymes that enhance their proliferation.”
Gilliland says Merck and AstraZeneca were the first two pharmaceutical companies to form a partnership designed to test a combination of drugs that have not yet been approved … Next Page »