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 Instead of testing one drug at a time, a novel lung
cancer study announced on Thursday will allow British researchers to
test up to 14 drugs from AstraZeneca and Pfizer at the same time
within one trial.
The aim is to quickly pinpoint medicines that can fight advanced
lung cancer by targeting specific rare genetic mutations — and it
upends the normal approach of putting a particular drug at the
centre of a study.
Harpal Kumar, chief executive of charity Cancer Research UK, which
is working on the 25-million-pound ($42-million) project with the
two drugmakers, said the new approach would "re-write the rule book
on how we do clinical trials".
"We are shifting the emphasis from designing a trial around a
specific drug to designing it around selecting from a range of drugs
for a specific patient," he told reporters.
The National Lung Matrix trial, which is expected to open in July or
August at centers across Britain, is part of a growing trend in
cancer research to remodel the way new drugs are tested to keep up
with the age of genomic medicine — fine-tuning treatments to the
genetic profile of patients.
The U.S. group Friends of Cancer Research said in November it was
backing a similar multi-drug, multi-arm clinical trial to evaluate
five experimental lung cancer drugs.
Because any single gene mutation behind a particular cancer can be
extremely rare, perhaps affecting as few as 1 or 2 percent of
patients, studying one drug at a time is extremely challenging.
The new trial offers a way around this by creating a protocol under
which scientists can test patients' tumor samples for multiple gene
faults and then assign them to an appropriate drug from among those
in the trial for testing.
NO RANDOMIZATION
Significantly, it does away with the idea of randomization, where
some patients are given a treatment and others get a "control"
substance for comparison — traditionally the gold standard in drug
testing.
Increasingly, researchers are questioning whether such randomization
makes sense in patients with incurable cancer if a certain treatment
is genetically bound to work much better in some people than others.
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Faster, smaller testing could shave years off the usual drug
approval process. That also points to lower costs, although firms
will be left with small markets from which to recoup investment. "It's premature to talk about pricing but it will make drug
development more cost-effective," said Menelas Pangalos,
AstraZeneca's head of innovative medicines.
Mace Rothenberg, senior vice president at Pfizer Oncology, said: "It
should be a more efficient process but it is for a more niche,
focused group of patients."
The new trial in non-small cell lung cancer will use up to 12
experimental drugs from AstraZeneca, including two compounds
designed to boost the immune system that will be given to patients
who do not show one of 21 sets of gene faults.
Pfizer, meanwhile, is supplying Xalkori, which is approved for
certain rare lung cancers and may also work in some even more
unusual types, as well as the experimental drug palbociclib, which
has shown promise in breast cancer.
Around 15 to 20 patients will be given each drug initially and
promising medicines could be fast-tracked into larger-scale testing.
Those that show no benefit will quickly be dropped.
Kumar said new medicines could be added to the existing trial as
science advances, and he hopes other drug companies will join the
program in due course.
A successful program in lung cancer could also lead to the concept
being rolled out into testing drugs for other tumor types, he said.
(Editing by Kate Kelland and Janet Lawrence)
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