Clinical Experience of Tabelecleucel in Patients with EBV+ Primary (PID) or Acquired Immunodeficiency (AID) Associated Lymphoproliferative Disease

Nikiforow, S

Oral and Poster Abstracts
905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster I

Biological, Adult, Diseases, Therapies, Adverse Events, immunotherapy, Lymphoid Malignancies, Study Population, Clinically relevant

S Nikiforow, MD, PhD¹, Robert Baiocchi, MD, PhD², S Nasta, MD³, W-K Weng, MD, PhD⁴, D Loeb⁵^*, K M Mahadeo, MD⁶, J Whangbo, MD, PhD¹, P Phuong⁷^*, W Navarro, MD⁷, L Gamelin⁷^*, Y Sun, PhD⁸^*, N Guzman-Becerra⁸^* and S Prockop, MD⁹

¹Dana-Farber Cancer Institute, Boston, MA
²OSU James Cancer Hospital, Columbus, OH
³University of Pennsylvania, Philadelphia, PA
⁴Division of Blood and Marrow Transplantation, Dept. of Medicine, Stanford Univ. School of Med., Stanford, CA
⁵Children’s Hospital at Montefiore, Bronx, NY
⁶MD Anderson Cancer Center, Houston, TX
⁷Atara Biotherapeutics, South San Francisco, CA
⁸Atara Biotherapeutics, Thousand Oaks, CA
⁹Memorial Sloan Kettering Cancer Center, New York, NY

Background: Patients (pts) with PID or AID are at higher risk of developing Epstein-Barr virus-driven lymphoproliferative disease (EBV⁺ LPD). Although there are no approved therapies, initial treatment (tx) of EBV⁺ PID or AID LPDs includes chemo +/- rituximab; however, effective options after tx failure are limited. Tabelecleucel (tab-cel), an investigational off-the-shelf, allogeneic EBV-specific T-cell immunotherapy, has previously shown clinical activity in pts with EBV⁺ post-transplant lymphoproliferative disease (Prockop S et al. JCI 2020; EHA 2018). Here, we report data in pts with EBV⁺ PID and AID LPDs treated with tab-cel, after failure of initial therapies, in an expanded access program (NCT02822495).

Methods: Pts received tab-cel at 1.6–2.0 x 10⁶ cells/kg/dose on days 1, 8 and 15, with investigator-assessed response per Lugano criteria on Day 28 of each 5-week cycle. Pts who do not respond (progressive disease [PD] or stable disease [SD]) can switch to tab-cel with a different human leukocyte antigen (HLA) restriction (restriction switch). Pts continued tx until unacceptable toxicity, maximal response (two consecutive complete responses [CR] or three partial responses [PR]), or up to four different HLA restrictions. All tx-emergent serious adverse events (TESAEs) were collected.

Results: Pt characteristics, treatment exposure, responses and safety data are reported in Table 1. Objective response rates (ORR) were 37.5% in the PID (3/8) and 33.3% in the AID (3/9) LPD cohorts. There were five pts with tx-related TESAEs in the PID (n=3) and AID LPD (n=2) cohorts. No fatal events were reported as tx-related.

Conclusions: Tab-cel was well tolerated and showed evidence of clinical activity in pts with EBV⁺ AID and PID LPDs. Based on these results, further clinical investigation of tab-cel in EBV⁺ PID and AID LPDs is planned within an upcoming study (ATA129-EBV-205).

Previously presented at ESMO 2020, FPN 1527, Nikiforow S et al. Reused with permission.

Disclosures: Nikiforow: Kite: Consultancy, Other: Travel, accommodation, expenses; Gilead: Consultancy, Other: Travel, accommodation, expenses; Novartis: Consultancy, Other: Travel, accommodation, expenses; Nkarta Therapeutics: Consultancy, Other: Travel, accommodation, expenses. Baiocchi: viracta: Consultancy, Membership on an entity's Board of Directors or advisory committees; Prelude Therapeutics: Consultancy, Research Funding. Nasta: Merck: Consultancy; Debiopharm: Research Funding; Rafael: Research Funding; Millenium/Takeda: Research Funding; Genentech/Roche: Research Funding; Pharmacyclics: Research Funding. Mahadeo: Atara: Research Funding. Whangbo: Orchard Therapeutics: Consultancy, Other: Travel, accommodation, expenses. Phuong: Atara Biotherapeutics: Current Employment, Current equity holder in publicly-traded company. Navarro: Atara Biotherapeutics: Current Employment, Current equity holder in publicly-traded company. Gamelin: Atara Biotherapeutics: Current Employment, Current equity holder in publicly-traded company. Sun: Atara Biotherapeutics: Current Employment, Current equity holder in publicly-traded company. Guzman-Becerra: Atara Biotherapeutics: Current Employment, Current equity holder in publicly-traded company. Prockop: Mesoblast: Consultancy, Research Funding; Memorial Sloan Kettering: Patents & Royalties: IP related to the development of third party viral specific T cells with all of my interests assigned to MSK; Atara Biotherapeutics: Research Funding; Jasper Pharmaceuticals: Research Funding.

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1658 Clinical Experience of Tabelecleucel in Patients with EBV+ Primary (PID) or Acquired Immunodeficiency (AID) Associated Lymphoproliferative Disease