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 U.S. regulators have agreed to a speedy review of Merck's
application to combine its immune system-boosting drug Keytruda with
chemotherapy as an initial therapy for advanced lung cancer, the
U.S. drugmaker said.
Shares in AstraZeneca, which is developing a dual-immunotherapy
approach, fell around 1 percent in early trade on Wednesday, while
Roche, which is looking to add chemotherapy like Merck, slipped 0.6
percent.
Merck said the U.S. Food and Drug Administration (FDA) would decide
by May 10 whether to approve its Keytruda combination treatment,
sending the company's stock more than 3 percent higher in
after-hours trading.
Bristol-Myers Squibb is also working on an immunotherapy-based
combination approach for lung cancer.
Immunotherapy is revolutionising some areas of cancer care but
giving it on its own only seems to work better than chemotherapy in
previously untreated lung cancer patients who have high levels of a
protein called PD-L1.
Since just a quarter to a third of non-small cell lung cancer (NSCLC)
patients have tumours with at least 50 percent of cells producing
PD-L1, around 70 percent of the market is still up for grabs for
successful combination products.
Analysts at Evercore ISI estimate the market for first-line lung
cancer for all patients could be as high as $14 billion.
Although Merck presented good results from a mid-stage Phase II
trial for its Keytruda-chemotherapy combination at conference in
Denmark in October, many analysts had thought it would need to wait
for data from a larger Phase III study before filing.
"This comes as an important surprise because if FDA approves the
application, Merck would suddenly be catapulted ahead of all other
(immunotherapy) competitors who are also pursuing competing
combination regimens of their own," said Bernstein analyst Tim
Anderson.
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Merck had not previously indicated that it was close to filing for
the combination therapy and analysts had been looking for this news
toward the end of 2017.
RISKS REMAIN
Jefferies analyst Jeffrey Holford agreed the early move was positive
for Merck but said an approval was "high risk", given several
weaknesses in the small Phase II study.
Merck's early move, if successful, could change the dynamics of the
marketplace, since it had been assumed that so-called CTLA4
combinations from AstraZeneca and Bristol-Myers would be approved
before chemotherapy ones.
AstraZeneca's closely watched Phase III study of its two drugs
durvalumab and tremelimumab is due to report results in the first
half of this year, while Bristol-Myers and Roche are also expected
to have data during 2017.
Merck's Keytruda alone is already approved as an initial, or
first-line, treatment for advanced lung cancer in patients whose
tumours have a high level of PD-L1 expression, the protein that the
drug targets to help the immune system fight cancer.
"While Merck is unlikely to durably penetrate this entire
population, especially with multiple competing regimens on the
horizon, an approval in May would give them a significant
first-mover advantage," said Evercore analyst John Scotti.
(Reporting by Bill Berkrot; Editing by James Dalgleish/Keith Weir)
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