Atara, Pierre Fabre’s EBV T-Cell Therapy Recommended For Approval In Europe

Europe’s drug regulator has issued a positive opinion recommending Atara Biotherapeutics and Pierre Fabre’s Ebvallo (tabelecleucel) for marketing approval in Europe. 

The positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) paves the way for Ebvallo as a monotherapy for patients aged two and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed at least one prior therapy. For solid organ transplant patients, prior therapy could include chemotherapy or rituximab. 

Related Article: EMA Signals Positive Opinion for Regeneron’s Cervical Cancer Monotherapy

Potential Treatment For EBV+ PTLD

EBV is an extremely common human virus that infects around 95% of the world’s population. Once infected, the virus usually lies dormant in the human body for life. Reactivation may occur under certain circumstances, such as after post-transplant immunosuppression. PTLD can occur in 20% of hematopoietic stem cell (HSC) and solid organ transplant (SOT) patients, and 60-80% of cases could be traced to EBV infection or reactivation.

Ebvallo is a T-cell immunotherapy that eliminates EBV-infected cells by targeting EBV-associated antigens. The positive CHMP opinion was based on results from the pivotal Phase 3 Allele study which showed a 50% Objective Response Rate (ORR) to Ebvallo. At least 11 of the 19 responders had a duration of response of over six months, while the one-year survival rate was 89.2% in responders compared with 32.4% in non-responders.

If approved, Ebvallo will be the first allogeneic — off-the-shelf — T-cell therapy with the potential to treat EBV+ PTLD, an ultra-rare and aggressive cancer with no approved therapies, said Pascal Touchon, President and CEO of Atara. 

Atara expects an EC approval by the end of 2022. A nod will clear commercialization partner Pierre Fabre to market and distribute Ebvallo in Europe. The two companies last year agreed to collaborate over Ebvallo in a deal worth $365 million plus royalties. 

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Joy Lin

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