has won the race to get the first immunotherapy drug that blocks
the PD-1 pathway on the U.S. market. Today, the FDA approved
pembrolizumab, which will go by the brand name Keytruda, for
patients with advanced or unresectable melanoma who are no
longer responding to other drugs.
It's good news for sure, but the development of PD-1 drugs is
like the Tour de France with multiple stages. Merck might be
wearing the yellow jersey right now, but it's far from winning it
all. Shares of the company hardly budged on the news,
highlighting the relative insignificance of this approval (and
the fact that it was widely expected).
The PD-1 pathway allows the immune system to recognize cells as
human and tells the immune system not to attack them.
Many tumor cells have enough mutations in them that the immune
system would recognize them as foreign, but they still have the
PD-1 pathway that shuts down the attack. PD-1 drugs block the
pathway, allowing the immune system to do its job.
PD-1 isn't tumor-specific, so Merck is testing Keytruda in a
wide variety of cancers. Beyond melanoma, there are clinical
trials in everything from lung cancer to kidney cancer and even
some blood cancers like multiple myeloma. In many cases, it can
be used in combination with current targeted cancer drugs. For
example, Merck is working with
to test the combination of Keytruda with GlaxoSmithKline's
Votrient in kidney cancer.
In the grand scheme of things, advancing into those other
cancers and getting approved as a first-line therapy for melanoma
is more important than the current approval for melanoma patients
using it as a last resort.
Of course, being on the market (for any indication) would
allow the drug to be used by doctors off-label to treat other
types of cancer, which is probably the main reason Merck pushed
to get Keytruda approved.
Merck isn't the only company going after the PD-1 pathway.
's Opdivo is already on the market in Japan. The company plans to
submit an application to market Opdivo in the U.S. this quarter,
theoretically putting it eight to nine months behind Keytruda,
but Merck got its approval almost two months early, so the delay
could be shorter.
For lung cancer, Bristol-Myers might actually be first to
approval. The company is working on a rolling submission with the
FDA, with plans to complete the submission by the end of the
also have drugs that target the PD-1 pathway, but they're further
behind and not an immediate threat (at the moment).
A long race
We can't declare a winner because we're still waiting on the
phase 3 data for lung cancer and later for other indications. How
long the drugs are able to extend survival will ultimately
determine the winner. Of course, there are so many opportunities
here, there are likely to be niches for each of the drugs to fit
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Merck & Co., Inc. Wins First Stage of the
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