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® (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 60th 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 oedema2. 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
care3.
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.
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®), 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. 60th 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. 60th American Society of Hematology Annual
Meeting and Exposition. Abstract #: 11525.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181201005023/en/
Oxford BioMedica plc:John Dawson, Chief Executive
OfficerStuart Paynter, Chief Financial OfficerSarah MacLeod, Head
of CommunicationsTel: +44 (0)1865 783 000media@oxb.com
Consilium Strategic CommunicationsMary-Jane
Elliott/Matthew Neal/Laura ThorntonTel: +44 (0)20 3709 5700
Oxford Biomedica (LSE:OXB)
Historical Stock Chart
From Apr 2024 to May 2024
Oxford Biomedica (LSE:OXB)
Historical Stock Chart
From May 2023 to May 2024