On November 9, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, released updated data from the ongoing pilot study of NY‑ESO SPEAR T-cells in synovial sarcoma, as well as an overview of study design for the ongoing NY-ESO SPEAR T-cell trial in myxoid/ round cell liposarcoma (MRCLS) at the annual CTOS meeting at the Grand Wailea Resort in Hawaii (Press release, Adaptimmune, NOV 9, 2017, View Source;p=RssLanding&cat=news&id=2315812 [SID1234521851]).
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"The data from our ongoing pilot study in synovial sarcoma remain encouraging," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "GSK exercised its option over our NY-ESO program and, as a result, these studies, including the pivotal registration trial in synovial sarcoma, will transition to GSK. The synovial sarcoma data, as well as results from other ongoing studies in the NY-ESO program, continue to inform development plans with our wholly owned pipeline of products. We believe the efficacy we have seen in synovial sarcoma is indicative of the potential of our SPEAR T-cell platform."
Data update from the ongoing pilot study of NY-ESO SPEAR T-cells in synovial sarcoma1
During an oral presentation, Dr. Sandra P. D’Angelo of the Memorial Sloan Kettering Cancer Center presented an update on all cohorts from Adaptimmune’s ongoing pilot study of NY-ESO SPEAR T-cells in synovial sarcoma. The data cut-off for this oral presentation was September 5, 2017 and results are summarized below.
NY-ESO SPEAR T-cells continue to be generally well-tolerated with initial efficacy observed in all cohorts including low expressors of NY‑ESO (Cohort 2)
Of the twelve patients treated in Cohort 1 (non-modified fludarabine (Flu) / cyclophosphamide (Cy) lymphodepletion regimen), five remain alive with a median predicted overall survival of 120 weeks (~28 months)
Confirmed responses have been observed across all cohorts as follows:
Cohort 1 (follow-up only; High Flu/Cy, High NY-ESO): 6 /12 (50%) patients (unchanged from ASCO (Free ASCO Whitepaper) 2017)2
Cohort 2 (ongoing; High Flu/Cy, Low NY-ESO): 3/10 (33%) patients (ASCO 2017: 2/5 [40%])
Cohort 3 (follow-up only): 1/5 (20%) patients (unchanged from ASCO (Free ASCO Whitepaper) 2017)
Cohort 4 (ongoing): 4/11 (36%) patients (ASCO 2017: 3/6 [50%]). Overall survival is not mature in this cohort; progression free survival is 23 weeks.
Peak and long-term expansion of NY-ESO SPEAR T-cells appears to correlate with clinical efficacy
All reported events of cytokine release syndrome resolved with supportive care, the majority of events were Grade 1 or 2, and there were no events of seizure, cerebral edema or encephalopathy
1 Oral presentation entitled: "Open label, non-randomized, multi-cohort pilot study of genetically engineered NY-ESO-1 SPEAR T-cells in HLA-A2+ patients with synovial sarcoma (NCT01343043)"
2 Data cut-off for ASCO (Free ASCO Whitepaper) 2017 was March 30, 2017
Overview of Study Design from the Trial in Progress Poster for NY-ESO SPEAR T-cells in MRCLS
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 patients are planned to be enrolled, with potential to enroll an additional 5 patients
Patients who do not receive minimum cell dose or who do not receive T‑cell infusion may be replaced
Patients must be: ≥ 18 years 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: Flu (30mg/m2/day) and Cy (600 mg/m2/day) for 3 days
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
The study is open and enrolling
Ten patients have already been identified and enrolled