Two Complete Responses and Response Rate of 41% for People with Synovial Sarcoma Reported at ASCO in Adaptimmune’s Phase 2 ...
May 19 2021 - 5:00PM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell
therapy to treat cancer, will report initial data from its Phase 2
SPEARHEAD-1 trial, with afamitresgene autoleucel (afami-cel,
formerly ADP-A2M4), at the American Society of Clinical Oncology
(ASCO) congress. Full abstracts were released online today. Data
will be presented in an oral presentation by Dr. Sandra D’Angelo of
the Memorial Sloan Kettering Cancer Center (Abstract #11504) on
June 4th.
“Patients are seeing substantial benefit from afami-cel in
SPEARHEAD-1 across a broad range of cell doses and levels of
MAGE-A4 expression,” said Adrian Rawcliffe, Adaptimmune Chief
Executive Officer. “We have shown a high response rate and these
responses are still evolving in many patients with increasing
depths of response over time and encouraging durability. I am
confident that SPEARHEAD-1 will support our BLA submission next
year and offer a life-changing treatment for people with synovial
sarcoma.”
“Initial data from SPEARHEAD-1 indicate that afami-cel has the
potential to offer people with synovial sarcoma a promising new
treatment option where there is currently a great unmet medical
need,” said Dr. Sandra P. D’Angelo of the Memorial Sloan Kettering
Cancer Center. “As clinicians, we want to be able to provide a
treatment regimen that can help offer a better quality of
life.”
SPEARHEAD-1 data will be presented at the time of the oral
presentation scheduled for June 4th during the sarcoma session
taking place from 1:30 p.m. to 4:30 p.m. EDT.
Afami-cel is efficacious and well-tolerated in heavily
pre-treated patients based on initial data
- At the time of data cut-off (March 29, 2021), 37 patients had
received afami-cel (32 with synovial sarcoma, 5 with myxoid/ round
cell liposarcoma [MRCLS])
- Of the 37 patients who had received afami-cel, 4 patients were
pending first efficacy assessment, and 33 had at least one scan as
of data cut off (29 with synovial sarcoma, 4 with MRCLS)
- The overall response rate1 was 39.3% (13/33), 41.4% (12/29) for
synovial sarcoma; 25.0% (1/4) for MRCLS
- Of the 29 patients with synovial sarcoma with at least one
scan, 2 had complete responses (CRs), 10 had partial responses
(PRs), 13 had stable disease (SD), 4 had progressive disease
(PD)
- The disease control rate for people with synovial sarcoma was
86.2% (25/29) (defined as either response or stable disease)
- Of the 4 patients with MRCLS with at least one scan, 1 patient
had a partial response, 2 had stable disease, and 1 had progressive
disease
- Objective responses have been reported across a wide range of
cell doses and MAGE-A4 antigen expression levels
- Initial durability data is encouraging, and the median duration
of response has not been reached
- To date, the safety profile of afami-cel has been favorable,
with mainly low-grade cytokine release syndrome and
tolerable/reversible hematologic toxicities.
Overview of SPEARHEAD-1 trial designSPEARHEAD-1
is a Phase 2, open-label trial for people with advanced synovial
sarcoma or MRCLS to evaluate the efficacy, safety, and tolerability
of afami-cel. Afami-cel SPEAR T-cells target MAGE-A4+ tumors.
MAGE-A4 is highly expressed in synovial sarcoma and MRCLS in the
context of HLA-A*02. Compelling clinical responses in patients with
synovial sarcoma were previously reported with afami-cel in a Phase
1 trial (CTOS 2020).
Approximately 90 patients are planned to be treated: 45 in
Cohort 1 and 45 in Cohort 2. Enrollment in Cohort 1 is complete,
and Cohort 2 is currently recruiting. The primary efficacy analysis
will be for Cohort 1 only, which will be used to support the BLA
filing next year. No formal hypothesis testing is planned for
Cohort 2. Cohort 2 will strengthen the efficacy and safety database
and will aid in descriptive sub-group analyses.
Eligible patients were ≥ 16 and < 75 years, HLA*02
positive with MAGE-A4 expression in ≥ 30% of tumor cells that were
≥ 2+ by immunohistochemistry. Eligible patients received afami-cel
doses between 1–10 × 109 transduced T-cells after receiving
lymphodepleting chemotherapy.
The primary endpoint is overall response rate per RECIST v1.1 by
independent review. The primary endpoint will be evaluated using a
one-sided exact-based Clopper-Pearson 97.5% confidence interval
(CI). If the lower bound of the CI exceeds the response rate
reported with historical second line therapy(ies), the
trial will have met the pre-specified threshold for
demonstrating efficacy.
An independent Data Safety Monitoring Board reviews ongoing
safety and benefit:risk during the interventional phase of the
trial.
About AdaptimmuneAdaptimmune is a
clinical-stage biopharmaceutical company focused on the development
of novel cancer immunotherapy products for people with cancer. The
Company’s unique SPEAR (Specific Peptide Enhanced Affinity
Receptor) T-cell platform enables the engineering of T-cells to
target and destroy cancer across multiple solid tumors.
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 6, 2021 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:
Media Relations:
Sébastien Desprez — VP, Communications and Investor RelationsT:
+44 1235 430 583M: +44 7718 453
176Sebastien.Desprez@adaptimmune.com
Investor Relations:
Juli P. Miller, Ph.D. — Senior Director, Investor RelationsT: +1
215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com
1 Reponses were evaluated by RECIST v1.1 per Investigator
assessment
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