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 Novartis is testing CTL019, its investigational chimeric antigen
receptor T cell therapy, or CART, on 15 adult patients with the
most-common non-Hodgkins lymphoma, called diffuse large B-cell
lymphoma (DLBCL), and 11 follicular lymphoma patients.
The ongoing Phase II study is on patients with advanced disease, who
have not responded to standard treatment.
According to findings, overall response rates, or those who saw some
reduction in cancer, at three months were 47 percent in DLBCL
patients, and 73 percent in follicular lymphoma, Novartis said on
Sunday at the American Society of Hematology conference in Orlando.
Earlier findings, from just half the patient count, were similar,
said Usman Azam, Novartis' global head of cell & gene therapies.
Novartis said the findings keep CTL019 on track for 2017 regulatory
submission with the U.S. Food and Drug Administration as it seeks to
find new ways of fighting DLBCL, which has an estimated 25,000 new
U.S. cases and 10,000 deaths each year.
"We remain consistent again with the data set," Azam said. "It's an
attractive population, it's a population that continues to have a
huge unmet need, it's a cornerstone of our investments."
Four patients developed an inflammatory, often flu-like response
common when cancer cells are killed; two developed neurologic
toxicity, Novartis said.
CART therapies rely on extracting immune system T cells from a
patient. Then, their DNA is re-engineered to help them spot and kill
cancer cells. Finally, they are re-infused into the same patient.
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The eventual aim is a one-time treatment; if it works, signs of the
cancer are eliminated and treatment can end.
With CTL019, also being studied by Novartis on children with
advanced leukemia, the Basel-based drug giant has joined smaller
rivals including Juno Therapeutics and Kite Pharma seeking to launch
new, more-effective -- and likely very expensive -- treatments for
blood cancers.
Analysts expect CART therapies to command prices up to $450,000 when
they hit the market by 2017. Novartis acknowledged costs will be
high, but declined to give dimensions.
"With any disruptive innovation that comes, initially, cost of goods
is very challenging," Azam said. "As time goes on, and more patients
are treated, we will simplify that cost base."
(Reporting by John Miller, editing by David Evans)
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