{
    "abstract": "Diffuse large B-cell lymphoma comprises nearly 30% of non-Hodgkin lymphoma cases and patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for stem-cell transplantation have few treatment options and poor prognoses. We aimed to determine whether the novel combination of polatuzumab vedotin in combination with rituximab and lenalidomide (Pola+R+Len) would provide a tolerable treatment option with enhanced antitumour response in patients with relapsed or refractory diffuse large B-cell lymphoma.\nThis completed phase 1b/2, open-label, multicentre, single-arm study (GO29834) evaluated the safety and efficacy of Pola+R+Len in patients with relapsed or refractory diffuse large B-cell lymphoma at 19 sites in three countries (USA, Spain, and UK). Patients (\u226518 years old) were eligible for inclusion if they had histologically documented CD20-positive relapsed or refractory diffuse large B-cell lymphoma and Eastern Cooperative Oncology Group performance status of 2 or lower, had received at least one previous line of chemoimmunotherapy, including an anti-CD20 agent, and were ineligible for stem-cell transplantation. The dose-escalation phase (1b) used escalating doses of lenalidomide to find the recommended phase 2 dose. Patients received six 28-day cycles of induction treatment with intravenous rituximab 375 mg/m\nBetween July 11, 2017 and Feb 3, 2020, 57 patients were enrolled (median age 71 years [IQR 60-75]; 38 [67%] were male and 19 (33%) were female; 47 [82%] were not Hispanic or Latino; and the median previous lines of therapy was 2 [IQR 1-3]). 18 participants were included in phase 1b and 39 were included in phase 2. Phase 1b confirmed a 20 mg recommended phase 2 dose for lenalidomide. After a median follow-up of 11\u00b78 months (IQR 4\u00b77-25\u00b78), the complete response rate, as assessed by the Independent Review Committee, was 31% (90% CI 20-43). The most common grade 3-4 adverse events were neutropenia (35 [61%] of 57) and thrombocytopenia (eight [14%] of 57). Serious adverse events were reported in 23 (40%) of 57 patients and one patient died due to a treatment-related adverse event (neutropenic sepsis).\nAlthough the combination of Pola+R+Len did not meet the prespecified activity threshold, some patients derived clinical benefit and the regimen had a tolerable safety profile in patients with relapsed or refractory diffuse large B-cell lymphoma.\nGenentech/F Hoffmann-La Roche.",
    "authors": [
        {
            "affiliation": "Hospital Vall D'Hebron, Barcelona, Spain.",
            "firstname": "Pau",
            "initials": "P",
            "lastname": "Abrisqueta"
        },
        {
            "affiliation": "Insitut Catal\u00e0 d'Oncologia, Hospital Duran I Reynals and IDIBELL, Universitat de Barcelona, Barcelona, Spain.",
            "firstname": "Eva",
            "initials": "E",
            "lastname": "Gonz\u00e1lez-Barca"
        },
        {
            "affiliation": "Hospital Universitario Donostia, San Sebasti\u00e1n, Spain.",
            "firstname": "Carlos",
            "initials": "C",
            "lastname": "Panizo"
        },
        {
            "affiliation": "Complejo Hospitalario de Navarra, Pamplona, Spain.",
            "firstname": "Jos\u00e9 Mar\u00eda Argui\u00f1ano",
            "initials": "JMA",
            "lastname": "P\u00e9rez"
        },
        {
            "affiliation": "Department of Haematology, University Hospitals of Leicester NHS Trust, Leicester, UK.",
            "firstname": "Fiona",
            "initials": "F",
            "lastname": "Miall"
        },
        {
            "affiliation": "Hospital General Universitario Gregorio Mara\u00f1\u00f3n and Instituto de Investigaci\u00f3n Sanitaria Gregorio Mara\u00f1\u00f3n, Madrid, Spain.",
            "firstname": "Mariana",
            "initials": "M",
            "lastname": "Bastos-Oreiro"
        },
        {
            "affiliation": "Department of Haematology, Hospital Cl\u00ednic de Barcelona, Barcelona, Spain.",
            "firstname": "Ana",
            "initials": "A",
            "lastname": "Triguero"
        },
        {
            "affiliation": "Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Kent, UK.",
            "firstname": "Lalita",
            "initials": "L",
            "lastname": "Banerjee"
        },
        {
            "affiliation": "Centre for Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK.",
            "firstname": "Andrew",
            "initials": "A",
            "lastname": "McMillan"
        },
        {
            "affiliation": "Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.",
            "firstname": "Erlene",
            "initials": "E",
            "lastname": "Seymour"
        },
        {
            "affiliation": "Genentech, San Francisco, CA, USA.",
            "firstname": "Jamie",
            "initials": "J",
            "lastname": "Hirata"
        },
        {
            "affiliation": "Genentech, San Francisco, CA, USA.",
            "firstname": "Jayson",
            "initials": "J",
            "lastname": "de Guzman"
        },
        {
            "affiliation": "Syneos Health, Raleigh, NC, USA.",
            "firstname": "Sunil",
            "initials": "S",
            "lastname": "Sharma"
        },
        {
            "affiliation": "Genentech, San Francisco, CA, USA.",
            "firstname": "Hyun Yong",
            "initials": "HY",
            "lastname": "Jin"
        },
        {
            "affiliation": "Genentech, San Francisco, CA, USA.",
            "firstname": "Lisa",
            "initials": "L",
            "lastname": "Musick"
        },
        {
            "affiliation": "Perlmutter Cancer Center at NYU Langone Health, New York, NY, USA. Electronic address: catherine.diefenbach@nyulangone.org.",
            "firstname": "Catherine",
            "initials": "C",
            "lastname": "Diefenbach"
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2024 Elsevier Ltd. All rights reserved.",
    "doi": "10.1016/S2352-3026(23)00345-9",
    "journal": "The Lancet. Haematology",
    "keywords": [],
    "methods": null,
    "publication_date": "2024-01-09",
    "pubmed_id": "38190832",
    "results": null,
    "title": "Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study.",
    "xml": "<Element 'PubmedArticle' at 0x7885025758f0>"
}