* Keytruda cuts risk of death 40 pct in big lung cancer
* Drug also improves outcomes when given with chemotherapy
* Immunotherapy changing standard of care in cancer
(Adds further comment from researchers)
By Ben Hirschler
COPENHAGEN, Oct 9 Merck & Co scored a
double hit on Sunday with new clinical data showing its Keytruda
immunotherapy offered big benefits in previously untreated lung
cancer patients, either when given on its own or with
As a monotherapy, Keytruda halved the risk of disease
progression and cut overall deaths by 40 percent compared to
chemotherapy alone in pre-selected patients whose tumours had
been tested using a biomarker.
And when given with two older chemotherapy drugs in
non-selected patients, it was almost twice as likely to shrink
tumours as chemotherapy alone.
Another similar drug from Roche also demonstrated
broad efficacy as a so-called second-line option in patients who
had received prior treatment.
"Remember this day. It's a new day for lung cancer
treatment," Stefan Zimmermann of Lausanne's University Hospital
told reporters at the European Society for Medical Oncology
(ESMO) congress as the results were presented.
An editorial in the New England Journal of Medicine, where
the Merck monotherapy results were published, said Keytruda
could become "a new standard of care".
The various findings suggest that treating lung cancer - the
biggest cancer killer globally - with powerful new immune
system-boosting medicines is going to involve more permutations
than some experts originally expected.
Rival drugmaker Bristol-Myers Squibb had tried a
catch-all approach with its Opdivo drug but it failed to help
previously untreated patients when given on its own in a trial
that included people with low levels of a protein called PD-L1.
Keytruda, as a sole agent, was targeted only at patients
with high PD-L1, making them more receptive to immunotherapy.
Lead researcher Martin Reck of Germany's Lung Clinic
Grosshansdorf predicted that testing for the PD-L1 biomarker
would now become standard "from today".
U.S. regulators are expected to decide whether to approve
Keytruda for first-line non-small cell lung cancer, the most
common type, by Dec. 24.
Merck had already said in June that Keytruda worked in the
trial but the scale of the benefit was only disclosed at ESMO.
The second trial, mixing Keytruda with chemotherapy, was
much smaller but was notable because it was the first time that
a combination of immunotherapy and chemotherapy has been shown
to work in a randomised Phase II study.
Many experts have been sceptical about this approach and
investors' expectations, up until now, have been quite low.
In the event, researchers reported that Merck's combination
cut the risk of disease progression or death by 47 percent
compared to chemotherapy alone after 10.6 months, while 55
percent of patients saw their tumours shrink versus 29 percent.
Patients in this trial were not selected by PD-L1 expression
but the study did find that those with higher PD-L1 had a higher
Roger Perlmutter, Merck's head of research, said both trials
suggested Keytruda could offer a broad array of patients
meaningful improvement over standard platinum-based
chemotherapy, which is now more than two decades old.
Drugs like Keytruda and Opdivo work by taking the brakes off
the immune system and allowing the body's natural killer cells
to home in on tumours.
They are expected to sell tens of billions of dollars in the
years ahead, with lung cancer the largest market.
Up until now, Bristol has dominated the field but investors
have started to shift their bets, with forecasts for Opdivo
declining while those for Keytruda have risen.
The current consensus forecast among analysts is for
Keytruda sales to reach $8 billion in 2021, with Opdivo selling
$10.5 billion, according to Thomson Reuters data.
Results of Bristol's failed Opdivo trial, which included
patients with tumours testing only 5 percent or higher for PD-L1
against the 50 percent cut-off used by Merck, were also
presented at ESMO.
These showed progression-free survival was 4.2 months with
Opdivo and 5.9 months with chemotherapy, although the difference
was not statistically significant. Overall survival was 14.4
months with Opdivo versus 13.2 months.
The failure of Opdivo to work for "all comers" in lung
cancer was first announced in August, without any details. It
was a major setback for Bristol, wiping out around a quarter of
the company's market value, and it has caused investors to
rethink prospects for immunotherapy treatments.
Many now believe that combination therapy is the way ahead,
with Bristol and AstraZeneca working primarily on using
two immunotherapies together, while Roche and Merck look
at adding chemotherapy.
(Reporting by Ben Hirschler; Editing by Stephen Powell and