Oxford Biomedica PLC Primary analysis results from JULIET trial (9275Y)
11 December 2017 - 6:08PM
UK Regulatory
TIDMOXB
RNS Number : 9275Y
Oxford Biomedica PLC
11 December 2017
Oxford BioMedica notes the primary analysis results from the
pivotal JULIET trial demonstrating that Kymriah(TM)
(tisagenlecleucel) sustained complete responses at six months in
adults with r/r DLBCL, a difficult-to-treat cancer
Oxford, UK - 11 December 2017: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE:OXB), a leading gene and cell
therapy group, today notes an announcement by Novartis on the
updated results from the JULIET clinical trial demonstrating
sustained responses with Kymriah(TM) (tisagenlecleucel) suspension
for intravenous infusion, formerly CTL019, in adult patients with
relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Kymriah is a novel immunocellular therapy and a one-time treatment
that uses a patient's own T cells to fight cancer.
The data from this pivotal trial, led by researchers from the
University of Pennsylvania (Penn), show an overall response rate
(ORR) of 53% (95% confidence interval [CI], 42% - 64%;
p<0.0001), with 40% achieving a complete response (CR) and 14%
achieving a partial response (PR) among 81 infused patients with
three or more months of follow-up or earlier discontinuation. At
six months from infusion, the ORR was 37% with a CR rate of 30%.
The median duration of response was not reached.
Results from this study of Kymriah, the first-ever FDA-approved
chimeric antigen receptor T cell (CAR-T) therapy, were included in
the US and EU regulatory filings for Kymriah in r/r DLBCL and will
be presented in an oral presentation at the 59th American Society
of Hematology (ASH) annual meeting (Abstract #577; Monday, December
11, 7:00 AM EST)(1) .
Results of a cost-effectiveness analysis of Kymriah for the
treatment of r/r B-cell ALL in the US will be presented in an oral
presentation at the meeting (Abstract #609; Monday, December 11,
7:30 AM EST). The analysis showed that, based on the current US
list price of $475,000, Kymriah is cost-effective compared to
standard of care(2) .
In addition, results of another analysis to determine the
potential societal value of Kymriah to patients with r/r ALL in the
United Kingdom were presented in a poster presentation at the
meeting (Abstract #1330; Saturday, December 9, 5:30 PM EST).
Results show that therapies such as Kymriah have the potential to
provide benefit to patients and society, particularly through gains
in survival, contributing to productivity(3) .
In April 2017, the US Food and Drug Administration (FDA) granted
Breakthrough Therapy designation to CTL019 based on data from the
JULIET study. In October 2017, Novartis submitted an application to
the FDA for CTL019 for the treatment of adult patients with r/r
DLBCL who are ineligible for or relapse after ASCT. Novartis is
also seeking approval from the European Medicines Agency (EMA) for
CTL019 in pediatric and young adult patients with r/r B-cell ALL
and adult patients with r/r DLBCL who are ineligible for or relapse
after ASCT. Additional filings beyond the US and EU are anticipated
in 2018.
Oxford BioMedica is the sole manufacturer of the lentiviral
vector that encodes CTL019. The Group signed an agreement with
Novartis in July 2017 for the commercial and clinical supply of
lentiviral vectors used to generate CTL019 and other undisclosed
CAR-T products, for which Oxford BioMedica could potentially
receive in excess of $100m from Novartis over the next three years.
As announced in October 2014, Oxford BioMedica will also receive
undisclosed royalties on potential future sales of Novartis CAR-T
products.
- Ends -
For further information, please
contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Stuart Paynter, Chief Financial
Officer
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Philippa 3709 5700
Gardner
Notes for editors
About Kymriah
In August 2017, Kymriah became the first available chimeric
antigen receptor T cell (CAR-T) therapy when it received FDA
approval for children and young adults with B-cell acute
lymphoblastic leukaemia (ALL) that is refractory or has relapsed at
least twice. Kymriah is a novel immunocellular therapy and a
one-time treatment that uses a patient's own T cells to fight
cancer. Kymriah uses the 4-1BB costimulatory domain in its chimeric
antigen receptor to enhance cellular expansion and persistence.
About Oxford BioMedica
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy
group focused on developing life changing treatments for serious
diseases. Oxford BioMedica and its subsidiaries (the "Group") have
built a sector leading lentiviral vector delivery platform
(LentiVector(R) ), which the Group leverages to develop in vivo and
ex vivo products both in-house and with partners. The Group has
created a valuable proprietary portfolio of gene and cell therapy
product candidates in the areas of oncology, ophthalmology and CNS
disorders. The Group has also entered into a number of
partnerships, including with Novartis, Sanofi, GSK, Orchard
Therapeutics and Immune Design, through which it has long-term
economic interests in other potential gene and cell therapy
products. Oxford BioMedica is based across several locations in
Oxfordshire, UK and employs more than 280 people. Further
information is available at www.oxfordbiomedica.co.uk.
References
1. Schuster S., et al. Primary Analysis of Juliet: A Global,
Pivotal, Phase 2 Trial of CTL019 in Adult Patients with Relapsed or
Refractory Diffuse Large B-Cell Lymphoma. 59(th) American Society
of Hematology Annual Meeting and Exposition. Abstract #577.
2. Hao Y., et al. Cost-Effectiveness Analysis of CTL019 for the
Treatment of Pediatric and Young Adult Patients with Relapsed or
Refractory B-Cell Acute Lymphoblastic Leukemia in the United
States. 59(th) American Society of Hematology Annual Meeting and
Exposition. Abstract #609.
3. Snider J., et al. The Economic Value of CTL019 Therapy for
Pediatric Patients with Relapsed and Refractory Acute Lymphoblastic
Leukemia in the United Kingdom. 59(th) American Society of
Hematology Annual Meeting and Exposition. Abstract #1330.
This information is provided by RNS
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