On December 11, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported updated data from its completed pilot study1 of NY‑ESO SPEAR T-cell therapy in multiple myeloma patients in the setting of autologous stem cell transplant (ASCT) presented by the main investigator at the annual ASH (Free ASH Whitepaper) meeting (Press release, Adaptimmune, DEC 11, 2017, View Source;p=RssLanding&cat=news&id=2322198 [SID1234522540]).

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"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, University of Pennsylvania Abramson Cancer Center, presented an update on all twenty-five multiple myeloma patients treated in Adaptimmune’s pilot study in the setting of ASCT. The data cut-off for this oral presentation was August 16, 2017.

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