TIDMOXB
RNS Number : 1447J
Oxford Biomedica PLC
03 December 2018
Oxford BioMedica notes the longer-term analyses from pivotal
Kymriah(R) trials, which showed durable responses are maintained in
patients with advanced blood cancers
Oxford, UK - 03 December 2018: 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
longer-term analyses of both the ELIANA and JULIET pivotal trials
in children and young adult patients with relapsed or refractory
(r/r) acute lymphoblastic leukaemia (ALL) and adult patients with
r/r diffuse large B-cell lymphoma (DLBCL), respectively. Kymriah(R)
(tisagenlecleucel) continued to demonstrate strong efficacy with
durable responses and maintained a consistent and
well-characterised safety profile. These data are being presented
at the 60(th) American Society of Hematology (ASH) annual meeting.
Additionally, today, the New England Journal of Medicine published
online the 14-month results from JULIET, the study led by the
Abramson Cancer Center at the University of Pennsylvania [1].
In the 24-month follow-up analysis of the ELIANA study in
children and young adults with r/r B-cell ALL, Kymriah demonstrated
deep and durable responses without subsequent therapy in a
significant portion of patients in this population. Among 79
evaluable patients, who were followed for at least three months or
discontinued earlier, 82% (95% confidence interval [CI], 72% - 90%)
achieved complete response (CR) or CR with incomplete blood count
recovery (CRi) within three months of infusion; and among these
responding patients, 98% had negative minimal residual disease
(MRD). The relapse-free survival rate was 62% at 24 months; and the
median duration of remission (mDOR) and median overall survival
(mOS) remained unreached, signifying responses are deep and
sustained, and further reinforcing the potential for Kymriah to be
a definitive therapy for many patients. The probability of OS was
76% (95% CI, 65% - 85%) at 12 months and 66% (95% CI, 58% - 79%) at
24 months. The safety profile observed in this updated analysis was
consistent with previously reported results, with no emergence of
new safety signals. Grade 3/4 cytokine release syndrome (CRS) - as
defined by the rigorous Penn Grading Scale - occurred in 49% of
patients. Within eight weeks of infusion, 13% of patients
experienced grade 3 neurological events, with no grade 4 events or
cerebral oedema[2]. These updated data will be presented in an oral
session at the ASH annual meeting (Abstract # 895; Monday, December
3, 4:30PM PST).
Results from the 19-month analysis from the JULIET study of
Kymriah in adult patients with r/r DLBCL (n=99) indicated prolonged
durability of response in patients who had previously been through
multiple rounds of chemotherapy and unsuccessful stem cell
transplants (Abstract # 1684). The overall response rate (ORR)
after a median of 19 months of follow-up was 54% (95% CI, 43% -
64%; CR, 40%; partial response [PR], 13%) among patients who were
followed for at least 3 months or discontinued earlier. The mDOR
was not reached at the time of analysis indicating most responders
were still experiencing a response at the time of analysis; and the
relapse-free probability, which was 66% (95% CI, 51%-78%) at 6
months, remained consistent at 64% (95% CI, 48%-76%) between
12-month and 18-month analyses. Further, 54% (15/28) of patients
who had achieved a PR converted to CR. Median OS for all infused
patients was 11.1 months (95% CI, 6.6 months-NE) and not reached
(95% CI, 21 months-NE) for patients in CR. The OS probability was
48% (95% CI, 38%-57%) at 12 months and 43% (95%CI, 33%-53%) at 18
months (max follow-up, 29 months). Analyses of ORR, DOR and OS data
showed consistent results across all patient subgroups, regardless
of relapsed/refractory status, age and high-risk cytogenetics.
The safety profile observed in the 19-month follow-up from
JULIET continued to be consistent with previous reports and no
deaths occurred due to causes other than disease progression in
this longer-term follow up analysis. Within eight weeks of infusion
with Kymriah, Grade 3/4 CRS, as defined by the Penn Grading Scale,
was reported in 23% of patients. CRS management was conducted per
the Penn CRS management algorithm, which is specific to Kymriah.
Tocilizumab and steroids were used in 16% and 11% of patients,
respectively, to treat CRS. Eleven percent of patients had Grade
3/4 neurologic adverse events, which were managed with supportive
care[3].
Oxford BioMedica is the sole manufacturer of the lentiviral
vector used in Kymriah. The Group signed an agreement with Novartis
in July 2017 for the commercial and clinical supply of lentiviral
vectors used to generate Kymriah and other undisclosed CAR-T
products. This collaboration has reached important milestones in
2018 with the US FDA approval of Kymriah to treat adult patients
with r/r DLBCL, and the approval of Kymriah in these two distinct
indications in the European Union, Canada and Switzerland. These
important achievements follow the initial US launch of Kymriah in
paediatric and young adult patients with r/r B-cell ALL in 2017.
Oxford BioMedica 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.
- 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 media@oxb.com
Sarah MacLeod, Head of Communications
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Laura Thornton 3709 5700
Notes for editors
About the ELIANA Trial
ELIANA is the first paediatric global CAR-T cell therapy
registration trial, examining patients in 25 centres in 11
countries across the US, Canada, Australia, Japan and the EU,
including: Austria, Belgium, France, Germany, Italy, Norway and
Spain, demonstrating effective distribution of Kymriah across four
continents using a global supply chain. In 2012, Novartis and Penn
entered into a global collaboration to further research, develop
and commercialize CAR-T cell therapies, including Kymriah, for the
investigational treatment of cancers.
About the JULIET Trial
JULIET is the first multi-centre global registration study for
Kymriah in adult patients with r/r DLBCL. JULIET, led by
researchers at the University of Pennsylvania, is the largest and
only global registration study examining a CAR-T cell therapy in
DLBCL, enrolling patients from 27 sites in 10 countries across the
US, Canada, Australia, Japan and Europe, including Austria, France,
Germany, Italy, Norway and the Netherlands.
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, Bioverativ, Sanofi, Axovant,
Orchard Therapeutics, Boehringer Ingelheim/UK Cystic Fibrosis Gene
Therapy Consortium/Imperial Innovations and GC LabCell, 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 360 people.
Further information is available at www.oxb.com.
[1]Schuster S., et. al. Tisagenlecleucel in Adult
Relapsed/Refractory Diffuse Large B-Cell Lymphoma. New England
Journal of Medicine. December 2018.
[2]Grupp S., et al. Updated Analysis of the Efficacy and Safety
of Tisagenlecleucel in Pediatric and Young Adult Patients with
Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60(th)
American Society of Hematology Annual Meeting and Exposition.
Abstract #112599.
[3]Schuster S., et. al. Sustained Disease Control for Adult
Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma:
An Updated Analysis of Juliet, a Global Pivotal Phase 2 Trial of
Tisagenlecleucel, Acute Lymphoblastic Leukemia. 60(th) American
Society of Hematology Annual Meeting and Exposition. Abstract #:
11525.
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