2019 ASCO Annual Meeting!
Session: Head and Neck Cancer
Type: Poster Session
Time: Saturday June 1, 1:15 PM to 4:15 PM
Location: Hall A
Tabelecleucel in combination with pembrolizumab (Pembro) in platinum-pretreated, recurrent/metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma (EBV+NPC).
Head and Neck Cancer
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #79b)
J Clin Oncol 37, 2019 (suppl; abstr TPS6092)
Author(s): Lillian L. Siu, Joshua Bauml, Douglas Adkins, A. Dimitrios Colevas, Cesar Augusto Perez, Jennifer Hsing Choe, Yang Zhang, Wen Shi, Willis H. Navarro, Missak Haigentz, Guilherme Rabinowits, David G. Pfister; Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Phialdelphia, PA; Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO; Stanford Cancer Institute, Stanford, CA; Sylvester Comprehensive Cancer Center, Miami, FL; Duke University, Chapel Hill, NC; Atara Biotherapeutics, South San Francisco, CA; Atlantic Health System, Morristown Medical Center, Morristown, NJ; Head and Neck and Cutaneous Medical Oncology, Miami Cancer Institute, Miami, FL; Memorial Sloan Kettering Cancer Center, New York, NY
Background: Approximately 25% of patients (pts) with NPC develop RM disease, which has a poor prognosis (median overall survival [mOS]: 12–16 mo), despite standard treatments with radiation and/or chemotherapy. NPC is an EBV-associated cancer in which programmed cell death ligand 1 (PD-L1) expression is upregulated upon EBV activation. Pembro showed antitumor activity in a phase 1b study of pts with RM-NPC (objective response rate [ORR]: 26%; mOS: 16.5 mo) (Hsu, J Clin Oncol 2017;35:4050-56). Targeting RM EBV+ NPC with tab-cel immunotherapy (off-the-shelf, allogeneic EBV-specific T cells) in pts has also shown promise, with 2-yr OS rates of 84% (Prockop, ASCO 2016;34:3012). The favorable safety profile of tab-cel offers the opportunity for combination immunotherapy with pembro for increased efficacy. Methods: This multicenter, open-label, single-arm phase 1b/2 study evaluates safety and efficacy of tab-cel in combination with pembro. Study participants are ≥12 yrs of age with incurable, locally recurrent or metastatic EBV+ NPC previously treated with platinum-containing therapy. Pts are checkpoint-inhibitor naïve (phase 1b/2) or refractory to anti-PD-1 or anti-PD-L1 therapy (phase 1b). Tab-cel is selected from a bank based on matching ≥2 HLA alleles, including ≥1 restricting HLA allele, between pts and donors. Tab-cel will be administered intravenously (IV) on days 1, 8, and 15 of a 21-day cycle. Initial tab-cel dose is 2x106 cells/kg and the de-escalated tab-cel dose (if needed) is 1x106 cells/kg. Pembro is administered at 200 mg IV Q3W in adults and 2 mg/kg IV Q3W in pts aged 12 to 17 yrs. Primary outcomes of phase 1b are to characterize dose-limiting toxicities, identify the maximum tolerated dose (MTD) or in the absence of MTD, the recommended phase 2 dose, and assess safety. Primary outcomes for phase 2 are ORR and safety. Secondary endpoints include progression-free survival, OS, and duration of response. Enrollment is ongoing for 12-24 participants in the phase 1b portion of the study with a 6+6 design. Phase 2 is expected to enroll 36 pts. Clinical trial information: NCT03769467