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Express The world's first off-the-shelf T-cell therapy is expected to come out! Lymphoma therapy is recommended for marketing in the European Union

 Last Update: 2022-10-20
 Source: Internet
 Author: User

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▎WuXi AppTec content team editor

Atara Biotherapeutics and Pierre Fabre today announced that their off-the-shelf T-cell immunotherapy Ebvallo (tabelecleucel) has been approved by the European Union Committee for Human Medicines (CHMP) for the treatment of post-transplant lymphoproliferative diseases (EBV+PTLD)
associated with Epstein-Barr virus (EBV).
Patients include adults and children over 2 years of age who have received at least one prior treatment
.
The European Commission is expected to complete its review
of Ebvallo by the end of this year.
According to the press release, if approved, Ebvallo would be the world's first approved allogeneic T cell therapy!

EBV+PTLD, a type of lymphoma, is a rare, acute, potentially fatal blood cancer that can occur
after solid organ transplantation (SOT) or allogeneic hematopoietic cell transplantation (HCT).
The median overall survival of patients with post-HCT EBV+PTLD who failed first-line therapy was 16-56 days, while the 1-year and 2-year survival rates for high-risk EBV+PTLD patients after SOT were 36% and 0%,
respectively.

▲Principles of EBV-targeted off-the-shelf T cell therapy (Image source: Reference [2]) Ebvallo is an off-the-shelf allogeneic T cell immunotherapy that targets EBV-infected cells in a human leukocyte antigen (HLA)
-defined manner.

In addition to post-transplant EBV+PTLD patients who have failed rituximab treatment, the therapy is also planned for the treatment of other EBV-related blood cancers and solid tumors
, including nasopharyngeal carcinoma.
In February 2015, the U.
S.
FDA granted Ebvallo Breakthrough Therapy Designation (BTD)
for the treatment of EBV+PTLD after HCT.
The therapy is also granted EU Orphan Drug Designation and Priority Drug Qualification (PRIME).

▲Results of Ebvallo clinical phase 3 trial (Image source: Reference [2]).

Ebvallo's marketing application is based on positive data from a Phase 3 clinical trial, which was published late last year showing that as of May 2021, the mean objective response rate (ORR) observed in 38 evaluable patients (24 post-SOT and 14 post-HCT) was 50% (19/38, 95% CI: 33.
4, 66.
6), including complete response (CR;n=5, SOT; n=5, HCT) and partial remission (PR; n=7，SOT； n=2，HCT）
。 Of the 19 patients who achieved remission, 11 had a duration of response (DOR) of more than 6 months, and the median duration of response had not yet been reached
.
The safety aspect is consistent with previously published data, with no new signals or issues
reported.
No adverse effects
such as graft-versus-host disease (GvHD), organ rejection, infusion reactions, or cytokine release syndrome associated with Ebvallo occurred.

Results of the Phase 3 clinical trial of Ebvallo (Image source: Reference [2])
"Today's CHMP recommendation is for the potential 'firs' of Atara This is an important step for T-In-Class' products, which target extremely rare and aggressive cancers
for which there is currently no approved treatment.
This recommendation is also a further validation of our unique allogeneic EBV-T cell platform," said Dr.
Pascal Touchon, President and CEO of Atara, "If approved, Ebvallo will be the first allogeneic T cell therapy to be approved and has the potential to change the way
patients with relapsed or refractory EBV+PTLD are treated.
" These patients face a median survival of only a few weeks or months and a very poor prognosis
.
"

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