With ASCO looming at the end of this month, previews of the world's most anticipated new cancer drugs are getting under way. And today Bloomberg's Robert Langreth leads off with a collection of experimental immunotherapies that have grabbed the industry's attention with their blockbuster potential.
Which experimental drugs make Langreth's list? There's Bristol-Myers' ($BMY) nivolumab, a PD-1 drug that is being put at center stage of the next-gen field. Now in 6 late-stage studies, the treatment (BMS-936558 acquired in the Medarex buyout) spurred tumor shrinkage in three of 5 cancer groups studied, including 18% of 72 lung cancer patients, close to a third of 98 melanoma patients and 27% of 33 patients with kidney cancer. Merck ($MRK), meanwhile, has the melanoma drug lambrolizumab, which grabbed the FDA's new breakthrough designation after impressive Ib data came through for skin cancer. Now Merck believes it may be able to win an approval with the right mid-stage data, a bid that would considerably enhance its position after frustrating investors with a weak late-stage pipeline.
Then there's the PD-L1 drug from Roche ($RHHBY), which could be better than nivolumab. Early data from a small study showed that investigators could use the maximum dose safely, making this a strong candidate in mid-stage studies. PD-1 and PD-L1 both come into play in preventing a T cell attack on tumor cells. These new drugs are designed to sustain the assault.
Significantly, a series of new drug approvals over the past two years has left investors and the industry looking further down the pipeline for new oncology stars. But with the FDA vowing to provide a shortcut on new drugs, cancer patients as well as investors may not have the usual long wait before some of these drugs are available. And that could spur a major shift in the development timelines being provided by many drug developers.
If the new generation of immune therapies lives up to its promise, "this is going to be a paradigm shift for treating cancer," Merck senior vice president Gary Gilliland told Langreth. "We are pretty good at shrinking tumors, but not good at getting rid of them. Immune therapy is a way to begin to approach that."
"A couple of years ago the big story was that immunotherapy can work," added Jedd Wolchok, director of immunotherapy at the Ludwig Center at Memorial Sloan-Kettering Cancer Center. "Now immunotherapy has entered the mainstream."
- here's the story from Bloomberg