Adaptimmune Announces an Oral Presentation on Data from NY-ESO Study in Synovial Sarcoma and Four Trials in Progress Posters ...
June 05 2017 - 9:50AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced an oral presentation on
updated data from its NY-ESO study in synovial sarcoma, as well as
four trials in progress posters. The data were presented at the
2017 ASCO annual meeting in Chicago, Illinois.
The Company will host a live teleconference and webcast slide
presentation on June 6th from 8:00–9:00 AM EDT (1:00–2:00 PM BST)
to discuss the updated synovial sarcoma clinical data. Call in
details and the webcast link are provided below.
“We have seen responses across all of our ongoing cohorts in our
NY-ESO study in synovial sarcoma, including in patients who express
lower levels of NY‑ESO, and in those receiving conditioning with
modified doses of fludarabine / cyclophosphamide,” said Rafael
Amado, Adaptimmune’s Chief Medical Officer. “A lower response rate
was observed in the absence of fludarabine conditioning and that
cohort is now closed. For patients from Cohort 1, an updated
survival analysis shows a promising median predicted overall
survival of 120 weeks or approximately 28 months. The data continue
to suggest that NY-ESO is well-tolerated. We have seen no events of
seizure, cerebral edema, or encephalopathy; most events of cytokine
release syndrome are grades 1-2 and all resolved with supportive
care.”
He continued: “We are in a period of significant operational
momentum with ongoing trials in our three wholly-owned assets,
MAGE‑A4, MAGE-A10 and AFP, as well as additional studies through
our collaboration with GSK with NY-ESO in myxoid / round cell
liposarcoma, ovarian, and non-small cell lung cancer – study
designs and screening progress for some of these trials were also
presented at ASCO.”
Data Update from the Ongoing NY-ESO Synovial Sarcoma
StudyDuring an oral presentation on June 5th entitled,
“Open label, non-randomized, multi-cohort pilot study of
genetically engineered NY-ESO-1 specific NY-ESO-1c259t in HLA-A2+
patients with synovial sarcoma (NCT01343043),” Dr. Sandra P.
D’Angelo of the Memorial Sloan Kettering Cancer Center presented an
update on all cohorts from Adaptimmune’s ongoing study.
- NY-ESO continues to be generally well-tolerated and initial
anti-tumor activity has been observed in all ongoing cohorts
including low expressors of NY‑ESO (Cohort 2)
- Of the twelve patients treated in Cohort 1 (non-modified
fludarabine / cyclophosphamide [“Flu/Cy”] lymphodepletion regimen),
five remain alive with a median predicted overall survival of 120
weeks (~28 months) (data cutoff March 30, 2017)
- Confirmed responses have been observed in all cohorts as
follows:— Cohort 1 (High Flu/Cy, High NY-ESO): 6/12 (50%) patients
with a median progression free survival (PFS) of 15 weeks (range:8,
38); 6/10 (60%) response rate in patients who received a target
dose of at least one billion cells— Cohort 2 (High Flu/Cy, Low
NY-ESO): 2/5 (40%); ongoing— Cohort 3: (High cyclophosphamide,
no fludarabine, High NY-ESO): 1/5 (20%); cohort closed— Cohort
4 (Modified Flu/Cy, High NY-ESO): 3/6 (50%); (ongoing)
- Peak and long-term expansion of NY-ESO SPEAR T-cells appears to
correlate with clinical efficacy
- Fludarabine appears to be an important component of the
lymphodepletion regimen
- All reported events of cytokine release syndrome resolved with
supportive care, and the majority of events were Grade 1 or 2
- There were no reported events of seizure, cerebral edema, or
encephalopathy
Overview of Study Designs from the Trials in Progress
PostersThe four trials in progress posters summarized the
study designs for Adaptimmune’s ongoing NY‑ESO trials in
myxoid/round cell liposarcoma (MRCLS), ovarian cancer, and
non-small cell lung cancer (NSCLC); the Company’s ongoing MAGE-A10
trial in NSCLC, and its MAGE-A10 triple tumor study in patients
with head and neck, melanoma, or urothelial “bladder” tumors.
- NY-ESO in MRCLS
(NCT02992743):— Open-label, non-randomized pilot
study evaluating the safety, tolerability, and antitumor activity
of NY-ESO SPEAR T-cells in patients with MRCLS— Initially, 10
subjects are planned to be enrolled, with potential to enroll an
additional 5 subjects. Subjects who do not receive the minimum
cell dose or who do not receive the T‑cell infusion may be
replaced.— Subjects must be: ≥ 18 yrs old; HLA-A*02:01,
*02:05, or *02:06 positive; have advanced (metastatic or
inoperable) MRCLS expressing NY-ESO-1 at 2+/3+ intensity in ≥30% of
tumor cells by IHC; measurable disease; prior systemic
anthracycline therapy; have ECOG status 0 or 1; and adequate organ
function. — Lymphodepletion regimen: fludarabine (30mg/m2/day)
and cyclophosphamide (600 mg/m2/day) for 3 days; same as
Cohort 4 in Synovial Sarcoma study— Target dose of 1 – 8 × 109
transduced SPEAR T-cells— Efficacy assessed by overall
response rate, time to response, duration of response,
progression-free survival, and overall survival at weeks 4, 8, and
12, month 6, and then every 3 months until confirmation of disease
progression— This study is open and actively enrolling; as of
May 18, 2017, 3 subjects have been enrolled
- NY-ESO in Ovarian Cancer
(NCT01567891):— Single-arm, open-label clinical trial
evaluating the safety, tolerability, and antitumor activity of
NY-ESO SPEAR T-cells in patients with ovarian cancer— Subjects
must be ≥ 18 years old; HLA-A*02:01, *02:05, or *02:06 positive;
have recurrent epithelial ovarian, primary peritoneal or fallopian
tube carcinoma with refractory or platinum-resistant disease
expressing NY-ESO-1 at ≥1+ intensity in ≥10% of tumor cells by IHC;
have measurable disease; have ECOG status 0 or 1; and have adequate
organ function.— The study evaluates two lymphodepleting
regimens: cyclophosphamide alone (enrollment completed; n=7) and
cyclophosphamide plus fludarabine (up to 10 subjects to be
treated)— The first 6 subjects were lymphodepleted prior to
T-cell infusion with various regimens of cyclophosphamide alone.
None of these subjects achieved a response per RECIST v1.1
(ASCO 2016).— The lymphodepletion regimen has been
amended to include both fludarabine and cyclophosphamide
(fludarabine [30mg/m2/day] and cyclophosphamide
[600 mg/m2/day] for 3 days; same as Cohort 4 in Synovial
Sarcoma study)— Target dose of 1 – 6 × 109 transduced SPEAR
T-cells— Efficacy assessed by response rate, duration of
response, progression-free survival, and overall survival at weeks
4, 8, and 12, month 6, and then every 3 months until confirmation
of disease progression— Enrollment is ongoing
- NY-ESO (NCT02588612) and MAGE-A10 (NCT02592577) in
NSCLC:— Open-label studies of NY-ESO or MAGE A-10
SPEAR T-cells in patients with NSCLC— Subjects are screened
under a separate protocol (Screening Protocol: NCT02636855) to
identify those who have the relevant HLA-A*02 alleles and NY-ESO-1
or MAGE-A10 tumor expression.— Subjects must have Stage IIIb
or IV NSCLC, have failed at least one platinum-containing regimen
(may have received CPIs), have measurable disease, ECOG 0-1,
adequate organ function, and be without brain metastases, history
of severe autoimmune disease or current uncontrolled
illness— The NY-ESO trial is a 10 subject study with a target
dose of 1-6 x 109 transduced cells— The MAGE-A10 trial is a
first-in-human study utilizing a modified 3+3 design in up to
28 patients with escalating doses of 0.1, 1.0 and 1-6 x 109
transduced T-cells to evaluate safety, including dose limiting
toxicities (DLTs). The DLT observation period will be during the
first 30 days following SPEAR T-cell infusion for each patient
in all groups.— For the NY-ESO study, the lymphodepletion
regimen is: fludarabine (30mg/m2/day) and cyclophosphamide
(600 mg/m2/day) for 3 days; same as Cohort 4 in Synovial
Sarcoma study— For the MAGE-A10 study, the lymphodepletion
regimen for the first group is cyclophosphamide alone :
cyclophosphamide (1800 mg/m2/day) for 2 days; subsequent groups
will receive fludarabine (30mg/m2/day) and cyclophosphamide
(600 mg/m2/day) for 3 days; same as Cohort 4 in Synovial
Sarcoma study— For both studies, efficacy assessed by response
rate, duration of response, progression-free survival, and overall
survival at weeks 4, 8, and 12, month 6, and then every 3 months
(for 2 years) and then every 6 months until confirmation of disease
progression— These studies are currently active and enrolling;
as of May 18, 2017, 3 subjects have been enrolled in the NY-ESO-1
study and 2 subjects have been enrolled in the MAGE-A10 study
- MAGE-A10 Triple Tumor
(NCT02989064):— Open-label first-in-human study
utilizing a modified 3+3 design in up to 10 patients receiving
the target dose with escalating doses of 0.1, 1.0 and 1-6 x 109
transduced T-cells to evaluate safety, including DLTs. The DLT
observation period will be during the first 30 days following
SPEAR T-cell infusion for each patient in all
groups.— Subjects are screened under a separate protocol
(Screening Protocol: NCT02636855).— Subjects must be HLA*02:01
and/or *02:06 positive and have inoperable or metastatic (advanced)
urothelial “bladder” cancer, melanoma, or squamous cell head and
neck tumors with MAGE-A10 expression at ≥1+ intensity in ≥10% of
tumor cells by IHC; and, have received standard of care therapies
and have progressive disease.— Lymphodepletion regimen:
fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day)
for 3 days; same as Cohort 4 in Synovial Sarcoma
study— Efficacy assessed by overall response rate, best
overall response, time to response, duration of response, duration
of stable disease, progression-free survival, and overall survival
at weeks 6, 12, 18, and 24 weeks, and then every 3 months until
confirmation of disease progression— This study is currently
active and enrolling; as of May 18, 2017, 4 subjects have been
enrolled
Conference Call and Webcast Link for Slide
PresentationThe Company will host a live teleconference
and slide presentation to discuss the updated synovial sarcoma data
at 8:00 a.m. EDT (1:00 p.m. BST) tomorrow, June 6, 2017. The live
webcast of the conference call will be available via the Investors
section of Adaptimmune’s website at
http://adaptimmune.equisolvewebcast.com/data-update An
archive will be available after the call at the same address. To
participate in the live webinar, if preferred, please dial
(866)-405-1247 (U.S. and Canada) or + 201-689-8045
(International).
About AdaptimmuneAdaptimmune is a
clinical-stage biopharmaceutical company focused on the development
of novel cancer immunotherapy products. The Company’s unique SPEAR
(Specific Peptide Enhanced Affinity Receptor) T-cell platform
enables the engineering of T-cells to target and destroy cancer,
including solid tumors. Adaptimmune has a number of proprietary
clinical programs, and is also developing its NY-ESO SPEAR T-cell
program under a strategic collaboration and licensing agreement
with GlaxoSmithKline. The Company is located in Philadelphia, USA
and Oxfordshire, U.K. For more information, please visit
http://www.adaptimmune.com
Forward-Looking StatementsThis release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 (PSLRA). These
forward-looking statements involve certain risks and uncertainties.
Such risks and uncertainties could cause our actual results to
differ materially from those indicated by such forward-looking
statements, and include, without limitation: the success, cost and
timing of our product development activities and clinical trials
and our ability to successfully advance our TCR therapeutic
candidates through the regulatory and commercialization processes.
For a further description of the risks and uncertainties that could
cause our actual results to differ materially from those expressed
in these forward-looking statements, as well as risks relating to
our business in general, we refer you to our Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC)
on May 10, 2017, and our other SEC filings. The forward-looking
statements contained in this press release speak only as of the
date the statements were made and we do not undertake any
obligation to update such forward-looking statements to reflect
subsequent events or circumstances.
Adaptimmune Contacts
Investor Relations
Juli P. Miller, Ph.D.
T: (215) 825-9310
E: juli.miller@adaptimmune.com
Media Relations
Margaret Henry
T: +44 (0)1235 430036
Cell: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
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