Λίστα αντικειμένων
With a limited follow-up, the German experience (203 pts) with SOC
CAR-T cells in LBCL is in keeping with the approval trials in terms of
safety, whereas our efficacy data appear to be inferior to published
results.
ABSTRACT EBMT
AA2-2 STANDARD-OF-CARE CAR-T CELL THERAPY FOR LARGE B-CELL LYMPHOMA:
REAL WORLD DATA GERMANY
Background: In 2018 the European Medicines Agency (EMA) approved
axicabtagene ciloleucel and tisagenlecleucel for the treatment of
relapsed/refractory (r/r) large B-cell lymphoma (LBCL) in Europe. In
Germany, reimbursement of commercial CAR-T cell therapies is linked to
mandatory reporting of baseline and outcome data to the DRST, which is
the National partner organization of the EBMT. The purpose of this study
was to perform the first outcome analysis on CD19-targeted CAR-T cell
therapy used as standard of care (SOC) for r/r LBCL in Germany.
Methods: Eligible were all patients receiving above mentioned approved
CAR-T products for SOC treatment of r/r LBCL from December 2018 through
September 2020 and registered with the DRST. Baseline patient, disease,
and transplant data were collected from MED-A Cellular Therapy forms.
Centers were contacted to provide additional treatment and follow-up
information. Main outcomes analyzed were patient characteristics,
toxicities, hospitalization time, response, non-relapse mortality, and
survival endpoints.
Results: 203 patients consecutively received SOC CAR-T cells in 16
centers, 98 patients axicabtagene ciloleucel and 105 patients
tisagenlecleucel. Patients' median age was 60 (range, 19-83) years. 69
were female and 134 were male. 167 (82%) patients had diffuse large
B-cell lymphoma (DLBCL), 15 (7%) transformed follicular lymphoma, 9 (4%)
primary mediastinal B-cell lymphoma, and 7 (3%) other high grade B-cell
lymphoma, 3 follicular lymphoma, 1 Burkitt lymphoma and 1 primary CNS
DLBCL. Patients received a median of 3 (range, 2-8) prior lines of
therapy. 6 patients had previous allogeneic, 19 previous autologous
transplant. 74% (151/203) of patients were refractory to the last line
of treatment.
82% (161/203) patients needed bridging therapy between the time of
apheresis and start of lymphodepleting chemotherapy. Median hospital
stay for CAR-T cell therapy were 21 (range, 9-128) days. CRS of any
grade was reported in 137/203 (67%, 20/203 (10%) grade 3-4) and ICANS of
any grade in 55/203 (27%, 14/203 (7%) grade 3-4). 47/203 (23%) were
transferred to ICU during their inpatient treatment. 7 (3%) patients
died due to non-relapse mortality. 130 patients are alive and 73
patients died. Overall response was evaluable in 197 patients. Overall
response rate to CAR-T cell treatment was 60% with 57 CR (29%), and 61
PR (31%). SD as best response was seen in 27 (14%) and progressive
disease in 52 patients (26%). With a median follow-up for patients alive
of 183 (range, 30-648) days, 129 patients (64%) relapsed or progressed.
Kaplan-Maier estimated overall survival was 53% and disease-free
survival 20% at one year.
Conclusions: With a limited follow-up, the German experience with SOC
CAR-T cells in LBCL is in keeping with the approval trials in terms of
safety, whereas our efficacy data appear to be inferior to published
results.
Presenter: Prof.Spyridonidis
Participants: Dr Liga, Dr Tsokanas, Dr Lekka, Dr Bali
CAR-T cells in LBCL is in keeping with the approval trials in terms of
safety, whereas our efficacy data appear to be inferior to published
results.
ABSTRACT EBMT
AA2-2 STANDARD-OF-CARE CAR-T CELL THERAPY FOR LARGE B-CELL LYMPHOMA:
REAL WORLD DATA GERMANY
Background: In 2018 the European Medicines Agency (EMA) approved
axicabtagene ciloleucel and tisagenlecleucel for the treatment of
relapsed/refractory (r/r) large B-cell lymphoma (LBCL) in Europe. In
Germany, reimbursement of commercial CAR-T cell therapies is linked to
mandatory reporting of baseline and outcome data to the DRST, which is
the National partner organization of the EBMT. The purpose of this study
was to perform the first outcome analysis on CD19-targeted CAR-T cell
therapy used as standard of care (SOC) for r/r LBCL in Germany.
Methods: Eligible were all patients receiving above mentioned approved
CAR-T products for SOC treatment of r/r LBCL from December 2018 through
September 2020 and registered with the DRST. Baseline patient, disease,
and transplant data were collected from MED-A Cellular Therapy forms.
Centers were contacted to provide additional treatment and follow-up
information. Main outcomes analyzed were patient characteristics,
toxicities, hospitalization time, response, non-relapse mortality, and
survival endpoints.
Results: 203 patients consecutively received SOC CAR-T cells in 16
centers, 98 patients axicabtagene ciloleucel and 105 patients
tisagenlecleucel. Patients' median age was 60 (range, 19-83) years. 69
were female and 134 were male. 167 (82%) patients had diffuse large
B-cell lymphoma (DLBCL), 15 (7%) transformed follicular lymphoma, 9 (4%)
primary mediastinal B-cell lymphoma, and 7 (3%) other high grade B-cell
lymphoma, 3 follicular lymphoma, 1 Burkitt lymphoma and 1 primary CNS
DLBCL. Patients received a median of 3 (range, 2-8) prior lines of
therapy. 6 patients had previous allogeneic, 19 previous autologous
transplant. 74% (151/203) of patients were refractory to the last line
of treatment.
82% (161/203) patients needed bridging therapy between the time of
apheresis and start of lymphodepleting chemotherapy. Median hospital
stay for CAR-T cell therapy were 21 (range, 9-128) days. CRS of any
grade was reported in 137/203 (67%, 20/203 (10%) grade 3-4) and ICANS of
any grade in 55/203 (27%, 14/203 (7%) grade 3-4). 47/203 (23%) were
transferred to ICU during their inpatient treatment. 7 (3%) patients
died due to non-relapse mortality. 130 patients are alive and 73
patients died. Overall response was evaluable in 197 patients. Overall
response rate to CAR-T cell treatment was 60% with 57 CR (29%), and 61
PR (31%). SD as best response was seen in 27 (14%) and progressive
disease in 52 patients (26%). With a median follow-up for patients alive
of 183 (range, 30-648) days, 129 patients (64%) relapsed or progressed.
Kaplan-Maier estimated overall survival was 53% and disease-free
survival 20% at one year.
Conclusions: With a limited follow-up, the German experience with SOC
CAR-T cells in LBCL is in keeping with the approval trials in terms of
safety, whereas our efficacy data appear to be inferior to published
results.
Presenter: Prof.Spyridonidis
Participants: Dr Liga, Dr Tsokanas, Dr Lekka, Dr Bali