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 As a patient being treated with Merck & Co's immunotherapy drug
Keytruda, O’Flynn is one of the lucky ones.
Data presented at the European Society for Medical Oncology (ESMO)
congress suggest her early treatment with immunotherapy, as part of
a clinical trial in Britain, will become standard for a growing
number of patients.
But there is a catch: it doesn't work for all.
Giving immunotherapy 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, which makes them more
receptive to immunotherapy.
From now on, oncologists in Copenhagen have been told, lung cancer
patients should be routinely tested for this biomarker.
However, only a quarter to a third of non-small cell lung cancer
patients have tumors with at least 50 percent of cells producing
PD-L1, leaving the majority unserved and around 70 percent of the
market still up for grabs.
The inability to treat everyone with monotherapy using one single
drug is a blow for Bristol, which tried to make treatment with its
Opdivo drug work across the board, only to fail comprehensively in a
major clinical trial.
But it has opened up the field to rivals like Merck, Roche and
AstraZeneca, which own what could be among the biggest-selling drugs
of all time, and all companies are now racing to find smart ways to
combine treatments.
Oncologists poring over immunotherapy trial results at Europe's
biggest cancer meeting have learnt one thing: finding optimal
treatments for different patient groups will take more research.
"I think the future of immunotherapy will be defined over the next
10 or 15 years," said lung cancer specialist Solange Peters from
Lausanne University Hospital, one of the organizers of the
Copenhagen meeting.
Despite immunotherapy successes and the prospect of a potential
market worth up to $40 billion in sales, veteran cancer experts urge
caution.
"In oncology, we see these kind of waves from cosmic pessimism to
over-optimism, so we have to be cautious," ESMO President Fortunato
Ciardiello said.
Investors, though, were quick to position themselves as shares in
Bristol fell 10 percent in early trade on Monday, while Merck hit
its highest level since 2001.
FIGHTING BACK
By taking the brakes off the immune system and allowing the body's
natural killer cells to home in on tumors, immunotherapy offers a
different approach to toxic chemotherapy treatment, which causes
collateral damage to healthy tissue.
It is not without side effects but it is a kinder option, which also
promises much longer-lasting efficacy.
Bristol, Merck and Roche have U.S. approval for immunotherapies,
while Bristol and Merck also sell their drugs in Europe. China,
however, has yet to license them.
Lung cancer, the world's biggest cancer killer with an annual death
toll of 1.6 million, will account for by far the largest portion of
future prescriptions, although immunotherapy is used additionally in
melanoma, Hodgkin lymphoma and cancers of the bladder, kidney, head
and neck.
With Merck set to sweep the board in lung cancer monotherapy,
doctors are looking to the next phase of the story and there is a
growing consensus that combination treatments are the future for
remaining patients with lower PD-L1 levels.
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"Clearly, the race is on," said Jean-Charles Soria, a professor of
medicine at France's Institut Gustave Roussy, of the looming battle
for dominance in the combination market.
In theory, researchers believe, it should be possible to get more
people to respond by adding other drugs to the mix in order to coax
the immune system to fight back against cancer cells.
Most attention so far has been on combining two immunotherapies,
although this raises questions over cost, with each medicine
typically priced at $100,000 to $150,000 a year.
The strategy creates an opportunity for AstraZeneca, which has
lagged rivals so far but hopes to jump ahead with a drug cocktail
that should report clinical results early next year. Bristol is
chasing the same idea, although its double-immunotherapy trial is
not expected to have results until 2018.
But the ESMO meeting has also raised the prospect of another
approach -- successfully combining immunotherapy and chemotherapy.
A lot of scientists have been sceptical of this idea in the past,
and there are still questions over whether patients will have a
long-lasting response, but positive data from a mid-stage study at
ESMO suggests the concept has real promise. Roche and Merck are both
enthusiastic.
Steering a path through all these permutations is going to be a
challenge and ESMO's Ciardiello says the cancer community must await
more clinical trial results over the next few years.
"I think we live in great times for rendering cancer a curable
disease but it will take time because the more we learn, the more we
understand that it is hugely complex," he told Reuters.
$30-40 BILLION SALES
While nobody yet knows what the "gold standard" treatment regimen is
going to be, it is already clear this new generation of drugs is
going to be big.
"Every time we come back to the immunotherapy market we are amazed
at just how large the opportunity is," said Leerink analyst Seamus
Fernandez, who sees combined annual sales of $30 billion to $40
billion for drugs like Keytruda and Opdivo, as well as rivals from
Roche, AstraZeneca and Pfizer.
How the market will ultimately divide between companies is still
unclear but Merck certainly emerges from the past weekend in
Copenhagen as the main winner.
That underscores a shift in expectations that has been evident since
August, when Bristol first revealed its monotherapy trial had
failed.
British patient O'Flynn, whose tumors shrunk dramatically, is just
glad she has a chance to try something new.
"My brother had cancer and he had chemotherapy, which was very
gruelling. But I haven't experienced any real side effects, apart
from a bit of tiredness."
(Reporting by Ben Hirschler, editing by Peter Millership)
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