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Background: Tisagenlecleucel, an anti-CD19 chimeric antigen receptor T cell therapy, has demonstrated efficacy in children and young adults with relapsed/refractory B cell acute lymphoblastic leukemia (B-ALL) in two multicenter phase 2 trials (ClinicalTrials.gov, NCT02435849 (ELIANA) and NCT02228096 (ENSIGN)), leading to commercialization of tisagenlecleucel for the treatment of patients up to age 25 years with B-ALL that is refractory or in second or greater relapse.
Methods: A pooled analysis of 137 patients from these trials (ELIANA: n=79; ENSIGN: n=58) was performed to provide a comprehensive safety profile for tisagenlecleucel.
Results: Grade 3/4 tisagenlecleucel-related adverse events (AEs) were reported in 77% of patients. Specific AEs of interest that occurred ≤8 weeks postinfusion included cytokine-release syndrome (CRS; 79% (grade 4: 22%)), infections (42%; grade 3/4: 19%), prolonged (not resolved by day 28) cytopenias (40%; grade 3/4: 34%), neurologic events (36%; grade 3: 10%; no grade 4 events), and tumor lysis syndrome (4%; all grade 3). Treatment for CRS included tocilizumab (40%) and corticosteroids (23%). The frequency of neurologic events increased with CRS severity (p<0.001). Median time to resolution of grade 3/4 cytopenias to grade ≤2 was 2.0 (95% CI 1.87 to 2.23) months for neutropenia, 2.4 (95% CI 1.97 to 3.68) months for lymphopenia, 2.0 (95% CI 1.87 to 2.27) months for leukopenia, 1.9 (95% CI 1.74 to 2.10) months for thrombocytopenia, and 1.0 (95% CI 0.95 to 1.87) month for anemia. All patients who achieved complete remission (CR)/CR with incomplete hematologic recovery experienced B cell aplasia; however, as nearly all responders also received immunoglobulin replacement, few grade 3/4 infections occurred >1 year postinfusion.
Conclusions: This pooled analysis provides a detailed safety profile for tisagenlecleucel during the course of clinical trials, and AE management guidance, with a longer follow-up duration compared with previous reports.
Iran is a huge but understudied Middle Eastern country with a rich but chronically understudied bee fauna, including for the highly-speciose bee genus Andrena. Examination of unidentified museum material combined with recent field collections and a critical review of the literature has revealed a total of 197 species of Andrena in the Iranian fauna, of which 65 are newly reported for the country, with an additional 16 species new for science. Andrena (Aciandrena) deminuta Wood sp. nov., Andrena (Euandrena) boustaniae Wood sp. nov., Andrena (Euandrena) oblata sp. nov., Andrena (Euandrena) sani sp. nov., Andrena (Micrandrena) elam Wood sp. nov., Andrena (Micrandrena) subviridula Wood sp. nov., Andrena (Notandrena) idigna Wood sp. nov., Andrena (Planiandrena) flagrans Wood sp. nov., Andrena (Planiandrena) sella Wood sp. nov., Andrena (Ulandrena) bulbosa Wood sp. nov., Andrena (incertae sedis) hosseiniiae Wood & Monfared sp. nov., and Andrena (incertae sedis) rostamiae sp. nov. are described from Iran, Andrena (Micrandrena) extenuata sp. nov. is described from Iran and Syria, Andrena (Micrandrena) tabula Wood sp. nov. and Andrena (Micrandrena) obsidiana Wood sp. nov. are described from Iran and Turkey, and Andrena (Planiandrena) huma sp. nov. is described from Iran, Syria, and the Golan Heights. Eight taxa are synonymised (valid name first): Andrena (Melandrena) assimilis Radoszkowski, 1876 = Andrena (Melandrena) gallica Schmiedeknecht, 1883 syn. nov.; Andrena (Notandrena) emesiana Pérez, 1911 stat. resurr. = Andrena (Notandrena) recurvirostra Warncke, 1975 syn. nov.; Andrena (Plastandrena) eversmanni Radoszkowski, 1867 = Andrena (Plastandrena) peshinica Nurse, 1904 syn. nov.; Andrena (incertae sedis) hieroglyphica Morawitz, 1876 = Andrena (Carandrena) cara Nurse, 1904 syn. nov. and Andrena (Carandrena) halictoides Nurse, 1904 syn. nov.; Andrena (Melandrena) induta Morawitz, 1894 = Andrena (Melandrena) patella Nurse, 1903 syn. nov.; Andrena (incertae sedis) minor Warncke, 1975 stat. nov. = Andrena (Carandrena) splendula Osytshnjuk, 1984 syn. nov.; Andrena (Notandrena) zostera Warncke, 1975 = Andrena (Carandrena) subsmaragdina Osytshnjuk, 1984 syn. nov. Overall, these results considerably improve our understanding of the Iranian Andrena fauna, and suggest that overall bee diversity in this country is substantially more than 1000 species.