“Mature data from this study in multiple myeloma continues to show promising efficacy and acceptable safety,” said Rafael Amado, Adaptimmune’s Chief Medical Officer. “We have observed a high response rate, long response duration, and encouraging long‑term survival in this population of patients with poor prognosis, treatment refractory myeloma. In addition, NY-ESO SPEAR memory T-cells persist long-term and respond to antigen after more than three years post‑treatment. NY-ESO SPEAR T-cell therapy is currently being evaluated in a second study in multiple myeloma patients with or without KEYTRUDA®, all without stem cell transplant.”
Long-term follow up data from the pilot study of NY-ESO in multiple myeloma in the context of ASCT
During an oral presentation, Dr. Edward Stadtmauer,
Overall Conclusions
- NY-ESO SPEAR T-cell therapy in the setting of ASCT has promising efficacy and acceptable safety in multiple myeloma patients
- Durable responses and long-term survival demonstrated in this refractory population
- NY-ESO SPEAR T-cells persisted long term (>1000 days), but were are not exhausted
- The most common adverse events (summarized below) were generally not unexpected in this patient population
- Persisting cells produced multiple cytokines in response to antigen
- Persisting cells included highly differentiated effector subsets and a population of self-renewing stem cell memory cells
- A follow up study is ongoing in combination with KEYTRUDA®, which will transition to GSK
Efficacy Results
- Of the twenty-five patients treated in this study, 11 were alive at data cut-off
- Three patients remain disease-progression free at 3, 4.5, and 5 years post-treatment
- Five of 18 subjects tested were minimal residual disease negative at day 100
- The median duration of response was >12 months
- The median predicted overall survival is approximately three years
- Overall response rate (ORR) at 100 days and one year were 76% and 44%, respectively, using International Myeloma Working Group criteria
Safety Results
- There were no fatal adverse events (AEs), and cytokine release syndrome was not reported
- Autologous graft versus host disease (GvHD) was reported in six patients; all resolved with corticosteroids and supportive therapy
- Most common AEs (any grade AE occurring in >50% of patients) included diarrhea (100%), nausea (100%), anemia (96%), thrombocytopenia (92%), fatigue (88%), pyrexia (84%), rash (84%), hypokalemia (76%), febrile neutropenia (72%), vomiting (72%), neutropenia (68%), back pain (60%), leukopenia (60%), cough (56%), dyspnea (56%), hypocalcemia (56%), peripheral edema (56%), stomatitis (56%), and abdominal pain (52%).
Exploratory Endpoints
- TCR-transduced NY-ESO SPEAR T-cells persisted long term (>1000 days) with minimal expression of exhaustion markers, and persisting cells:
- Were functional, producing multiple cytokines in response to antigen in vitro
- Included highly differentiated effector subsets and a population of self-renewing stem cell memory cells
AboutAdaptimmune
Adaptimmune 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 is currently conducting clinical trials with SPEAR T-cells targeting MAGE-A4, -A10, and AFP across several solid tumor indications.
Forward-LookingStatements
This 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
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1 This study closed for enrollment in 2015. All ongoing NY-ESO studies will ultimately transition to GSK as part of its option exercise over Adaptimmune’s NY‑ESO SPEAR T-cell therapy program that was announced in
Adaptimmune Contacts:
Media Relations:
Sébastien Desprez – VP, Communications and Investor Relations
T: +44 1235 430 583
M: +44 7718 453 176
Sebastien.Desprez@adaptimmune.com
Investor Relations:
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com
Source: Adaptimmune Therapeutics plc