OUTCOME OF HIGH-GRADE LYMPHOMA PATIENTS TREATED WITH CD19 CAR-T – UPDATED REAL-WORLD EXPERIENCE IN THE UK
Author(s): ,
Andrea Kuhnl
Affiliations:
Haematology,King's College Hospital,London,United Kingdom
,
Claire Roddie
Affiliations:
UCLH,London,United Kingdom
,
Eleni Tholouli
Affiliations:
Manchester Royal Infirmary,Manchester,United Kingdom
,
Tobias Menne
Affiliations:
Freeman Hospital,Newcastle,United Kingdom
,
Kim Linton
Affiliations:
The Christie Manchester,Manchester,United Kingdom
,
Sanne Lugthart
Affiliations:
Bristol University Hospital,Bristol,United Kingdom
,
Sridhar Changanti
Affiliations:
Queen Elizabeth Hospital,Birmingham,United Kingdom
,
Amy Kirkwood
Affiliations:
UCL CTC,London,United Kingdom
,
Robin Sanderson
Affiliations:
Haematology,King's College Hospital,London,United Kingdom
,
Maeve O'Reilley
Affiliations:
UCLH,London,United Kingdom
,
Jane Norman
Affiliations:
Manchester Royal Infirmary,Manchester,United Kingdom
,
Wendy Osborne
Affiliations:
Freeman Hospital,Newcastle,United Kingdom
,
Amit Patel
Affiliations:
The Christie Manchester,Manchester,United Kingdom
,
Nikesh Chavda
Affiliations:
Bristol University Hospital,Bristol,United Kingdom
,
Ram Malladi
Affiliations:
Queen Elizabeth Hospital,Birmingham,United Kingdom
,
Ceri Jones
Affiliations:
Cardiff University Hospital,Cardiff,United Kingdom
,
Piers Patten
Affiliations:
King's College Hospital,London,United Kingdom
,
Lorna Neill
Affiliations:
UCLH,London,United Kingdom
,
Nuria Martinez-Cibrian
Affiliations:
Manchester Royal Infirmary,Manchester,United Kingdom
,
Katherine Smith
Affiliations:
Fremann Hospital,Newcastle,United Kingdom
,
John Radford
Affiliations:
The Christie Manchester,Manchester,United Kingdom
,
Stephen Robinson
Affiliations:
Bristol University Hospital,Bristol,United Kingdom
,
Sunil Iyengar
Affiliations:
Royal Marsden Hospital,London,United Kingdom
,
Anne-Louise Latif
Affiliations:
Queen Elizabeth University Hospital,Glasgow,United Kingdom
,
Cathy Burton
Affiliations:
St James's Hospital ,Leeds,United Kingdom
,
Ben Uttenthal
Affiliations:
Addenbrooke's Hospital,Cambridge,United Kingdom
,
Orla Stewart
Affiliations:
King's College Hospital,London,United Kingdom
,
Maria Marzolini
Affiliations:
UCLH,London,United Kingdom
,
William Townsend
Affiliations:
UCLH,London,United Kingdom
,
Kirit Ardeshna
Affiliations:
UCLH,London,United Kingdom
,
Arzhang Ardavan
Affiliations:
NCRI consumer forum,London,United Kingdom
,
Kate Robinson
Affiliations:
NCRI consumer forum,London,United Kingdom
,
Tony Pagliuca
Affiliations:
King's College Hospital,London,United Kingdom
,
Kristian Bowles
Affiliations:
Norfolk and Norwich University Hospital,Norwich,United Kingdom
,
Graham Collins
Affiliations:
Oxford University Hospital,Oxford,United Kingdom
,
Rod Johnson
Affiliations:
St James's Hospital ,Leeds,United Kingdom
Andrew McMillan
Affiliations:
Nottingham University Hospital,Nottingham,United Kingdom
EHA Library. Kuhnl A. 06/12/20; 295063; S243
Andrea Kuhnl
Andrea Kuhnl
Contributions
Abstract

Abstract: S243

Type: Oral Presentation

Presentation during EHA25: All oral abstract presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Session title: Aggressive Lymphomas: Cellular and bispecific antibody therapies

Background
After EMA approval of CD19 CAR-T for relapsed/refractory (r/r) high-grade lymphoma in 2018, several European countries have started delivering this treatment in standard practice. However, selection criteria and referral pathways are not well defined and significantly vary between countries and centres, resulting in inequity of treatment access and difficulties to adequately use and monitor health economic resources. 

England was the first European country to implement a national service for CD19 CAR-T using objective and transparent eligibility criteria, and other countries have started following a similar structure. Cases are reviewed and approved by a National CAR-T Clinical Panel (NCCP) and outcome data are prospectively collected. Since December 2018, treatment has been delivered at 7 commissioned CAR-T centres in England, more recently expanded to further centres in England, Scotland and Wales. We have previously presented results from the first 6 months of the CAR-T national program (Kuhnl, ASH annual meeting 2019).

Aims
 To provide an updated analysis of 250 lymphoma patients enrolled over 12 months.

Methods
Consecutive patients with r/r high-grade lymphoma submitted to the NCCP between December 2018 and December 2019 were analysed. Eligibility was assessed at the centre’s CAR-T multidisciplinary team meeting and confirmed by the NCCP independent panel. The choice of CAR-T product (axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisagen)) was at the discretion of the treating centre.  

Results
272 cases have been submitted to the NCCP for treatment with CD19 CAR-T and 250 have been approved. 174 patients were selected for axi-cel and 76 for tisagen. 232 patients completed leukapheresis, 18 procedures were cancelled.

163 of 232 patients received CAR-T cells, 27 patients are awaiting infusion at the time of abstract submission.

In the intention to treat population, patients’ median age was 58 years (range 18-75). 174 (70%) patients had de novo diffuse large B-cell lymphoma, 13 (5%) primary mediastinal B-cell lymphoma, and 63 (25%) transformed lymphoma (49 follicular lymphoma background, 14 non-follicular indolent histology). 79% of cases were advanced stage, 31% had bulky disease and 66% extranodal involvement. 97/250 (39%) of patients had received 3 or more prior lines of treatment, 33 patients had previous autologous transplant, 5 previous allograft. 77% of patients had stable or progressive disease as best response to the last line of treatment.

Details on bridging therapy, toxicities and outcomes will be provided at the meeting, with an expected number of 170 patients evaluable for the 3 months response assessment.

Conclusion
The UK national CAR-T service provides an excellent structure for broad, efficient and fair access to licenced CD19 CAR-T products and can serve as a model for implementing cost-intense complex therapies on a national basis. This prospective, unselected real-world population of CAR-T eligible and –treated patients offers valuable insights into the clinical benefit and health economic implications of CD19 CAR-T in daily practice.

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): DLBCL, Relapsed lymphoma

Abstract: S243

Type: Oral Presentation

Presentation during EHA25: All oral abstract presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Session title: Aggressive Lymphomas: Cellular and bispecific antibody therapies

Background
After EMA approval of CD19 CAR-T for relapsed/refractory (r/r) high-grade lymphoma in 2018, several European countries have started delivering this treatment in standard practice. However, selection criteria and referral pathways are not well defined and significantly vary between countries and centres, resulting in inequity of treatment access and difficulties to adequately use and monitor health economic resources. 

England was the first European country to implement a national service for CD19 CAR-T using objective and transparent eligibility criteria, and other countries have started following a similar structure. Cases are reviewed and approved by a National CAR-T Clinical Panel (NCCP) and outcome data are prospectively collected. Since December 2018, treatment has been delivered at 7 commissioned CAR-T centres in England, more recently expanded to further centres in England, Scotland and Wales. We have previously presented results from the first 6 months of the CAR-T national program (Kuhnl, ASH annual meeting 2019).

Aims
 To provide an updated analysis of 250 lymphoma patients enrolled over 12 months.

Methods
Consecutive patients with r/r high-grade lymphoma submitted to the NCCP between December 2018 and December 2019 were analysed. Eligibility was assessed at the centre’s CAR-T multidisciplinary team meeting and confirmed by the NCCP independent panel. The choice of CAR-T product (axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisagen)) was at the discretion of the treating centre.  

Results
272 cases have been submitted to the NCCP for treatment with CD19 CAR-T and 250 have been approved. 174 patients were selected for axi-cel and 76 for tisagen. 232 patients completed leukapheresis, 18 procedures were cancelled.

163 of 232 patients received CAR-T cells, 27 patients are awaiting infusion at the time of abstract submission.

In the intention to treat population, patients’ median age was 58 years (range 18-75). 174 (70%) patients had de novo diffuse large B-cell lymphoma, 13 (5%) primary mediastinal B-cell lymphoma, and 63 (25%) transformed lymphoma (49 follicular lymphoma background, 14 non-follicular indolent histology). 79% of cases were advanced stage, 31% had bulky disease and 66% extranodal involvement. 97/250 (39%) of patients had received 3 or more prior lines of treatment, 33 patients had previous autologous transplant, 5 previous allograft. 77% of patients had stable or progressive disease as best response to the last line of treatment.

Details on bridging therapy, toxicities and outcomes will be provided at the meeting, with an expected number of 170 patients evaluable for the 3 months response assessment.

Conclusion
The UK national CAR-T service provides an excellent structure for broad, efficient and fair access to licenced CD19 CAR-T products and can serve as a model for implementing cost-intense complex therapies on a national basis. This prospective, unselected real-world population of CAR-T eligible and –treated patients offers valuable insights into the clinical benefit and health economic implications of CD19 CAR-T in daily practice.

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): DLBCL, Relapsed lymphoma

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