{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T12:32:09Z","timestamp":1791894729646,"version":"4.3.4"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"20","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,7,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      Peripheral T-cell lymphomas (PTCLs) are rare, heterogeneous, aggressive lymphomas. Five-year overall survival (OS) remains approximately 30%-40%, and most patients will develop relapsed or refractory (R\/R) disease. Duvelisib is an oral dual inhibitor of phosphatidylinositol 3-kinase (PI3K)-\u03b4 and PI3K-\u03b3 isoforms. Here, we report on the final analysis of the phase II PRIMO trial (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT03372057\">NCT03372057<\/jats:ext-link>\n                      ; Secura Bio, Inc) evaluating duvelisib monotherapy in R\/R PTCL.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>PRIMO was conducted in two phases (dose optimization and dose expansion [PRIMO-EP]) at 45 centers globally. Eligible patients were age 18 years and older, had histologically confirmed diagnosis of PTCL, and had received \u22652 cycles of one standard regimen for PTCL. Based on dose optimization results, the selected regimen for PRIMO-EP was 75 mg twice a day for two cycles (to maximize disease control) followed by 25 mg twice a day (to reduce late toxicities), continued until progressive disease or unacceptable toxicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>PRIMO-EP (N = 123) outcomes included independent review committee\u2013assessed objective response rate (ORR): 48.0%, complete response rate (CRR): 33.3%, median progression-free survival (mPFS): 3.4 months, median OS (mOS): 12.4 months, and median duration of response (mDOR): 7.9 months. In the angioimmunoblastic T-cell lymphoma (AITL) subgroup, outcomes were ORR: 62.2%, CRR: 51.4%, mPFS: 8.3 months, mOS: 18.1 months, and mDOR: 11.3 months. Treatment-emergent adverse events (TEAEs; any grade) occurred in 120 patients (97.6%), and TEAEs grade \u22653 occurred in 91 patients (74.0%). TEAEs resulting in dose hold or dose reduction occurred in 44.7% and 9.8% of patients, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>The PRIMO study demonstrates significant activity and tolerability of duvelisib in patients with R\/R PTCL, most notably in the AITL subgroup. This provides strong rationale for further development in PTCL, and more specifically in the subgroup of nodal T-follicular helper cell lymphoma.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-03120","type":"journal-article","created":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T19:59:12Z","timestamp":1776887952000},"page":"1889-1898","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":4,"title":["Duvelisib Induces Deep Responses in Peripheral T-Cell Lymphoma: Final Results of the Phase II PRIMO Trial of Duvelisib in Relapsed\/Refractory Peripheral T-Cell Lymphoma"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct03372057","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5744-0670","authenticated-orcid":false,"given":"Neha","family":"Mehta-Shah","sequence":"first","affiliation":[{"name":"Washington University School of Medicine in St. Louis, Saint Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2112-2651","authenticated-orcid":false,"given":"Pier Luigi","family":"Zinzani","sequence":"additional","affiliation":[{"name":"IRCCS Azienda Ospedalierao-Universitaria di Bologna Istituto di Ematologia \u201cSer\u00e0gnoli\u201d, Bologna, Italy"},{"name":"Dipartimento di Scienze Mediche e Chirurgiche, Universit\u00e0 di Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3014-0023","authenticated-orcid":false,"given":"Eric D.","family":"Jacobsen","sequence":"additional","affiliation":[{"name":"Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmine","family":"Zain","sequence":"additional","affiliation":[{"name":"Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9175-0189","authenticated-orcid":false,"given":"Monica","family":"Mead","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, University of California, Los Angeles (UCLA), Los Angeles, CA"},{"name":"Clinical Research Solutions, ProPharma Group, Raleigh, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9993-5065","authenticated-orcid":false,"given":"Carla","family":"Casulo","sequence":"additional","affiliation":[{"name":"University of Rochester Medical Center - James P. Wilmot Cancer Institute, Rochester, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6789-5123","authenticated-orcid":false,"given":"Giuseppe","family":"Gritti","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Pinter-Brown","sequence":"additional","affiliation":[{"name":"University of California\u2014Irvine, Irvine, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9129-8057","authenticated-orcid":false,"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[{"name":"National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4178-2072","authenticated-orcid":false,"given":"David","family":"Sidransky","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5976-7121","authenticated-orcid":false,"given":"Ohad S.","family":"Bentur","sequence":"additional","affiliation":[{"name":"Secura Bio, Inc, Berkeley Heights, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Pro","sequence":"additional","affiliation":[{"name":"Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6322-9254","authenticated-orcid":false,"given":"Christopher P.","family":"Fox","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6229-3609","authenticated-orcid":false,"given":"Jonathan E.","family":"Brammer","sequence":"additional","affiliation":[{"name":"Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6399-2006","authenticated-orcid":false,"given":"Steven M.","family":"Horwitz","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_11_2_2","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14092332"},{"key":"e_1_3_11_3_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41379-021-00937-0"},{"key":"e_1_3_11_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2016.10.001"},{"key":"e_1_3_11_5_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.16.4558"},{"key":"e_1_3_11_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-022-01620-2"},{"key":"e_1_3_11_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11912-022-01310-3"},{"key":"e_1_3_11_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(24)00102-9"},{"key":"e_1_3_11_9_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.18.00899"},{"key":"e_1_3_11_10_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.43.7285"},{"key":"e_1_3_11_11_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.44.7524"},{"key":"e_1_3_11_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25463"},{"key":"e_1_3_11_13_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2017-05-780049"},{"key":"e_1_3_11_14_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.9024"},{"key":"e_1_3_11_15_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.59.2782"},{"key":"e_1_3_11_16_2","doi-asserted-by":"publisher","DOI":"10.1186\/1756-8722-7-11"},{"key":"e_1_3_11_17_2","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2021005899"},{"key":"e_1_3_11_18_2","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2017.1384815"},{"key":"e_1_3_11_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12943-017-0670-3"},{"key":"e_1_3_11_20_2","unstructured":"COPIKTRA [Package Insert]: Las Vegas NV Secura Bio Inc 2021. https:\/\/copiktrahcp.com\/pdf\/COPIKTRA-PI-USCPR2419001.pdf"},{"key":"e_1_3_11_21_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2017-08-802470"},{"key":"e_1_3_11_22_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.54.8800"},{"key":"e_1_3_11_23_2","unstructured":"Data on File. 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