* Keytruda cuts risk of death 40 pct in big lung cancer
* Drug also improves outcomes when given with chemotherapy
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.
In contrast to rival Bristol-Myers Squibb, whose
Opdivo drug failed to help such first-line patients, Keytruda
was targeted at people who express high levels of a protein
called PD-L1, which makes them more receptive to immunotherapy.
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 the
annual European Society for Medical Oncology (ESMO) congress.
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 biggest cancer killer
globally, viewed as the largest market.
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.
Results of Merck's two trials were published online in the
New England Journal of Medicine and the Lancet Oncology journal.
(Reporting by Ben Hirschler; Editing by Stephen Powell)