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Impressive Continuous Complete Response after Mogamulizumab in a Heavily Pretreated Sezary Syndrome Patient.

ABSTRACT: Background:Sézary syndrome (SS) is a rare lymphoproliferative neoplasm, almost incurable outside the setting of allogeneic transplantable patients. The prognosis for relapsed/refractory patients remains poor, as the available drugs confer short-lasting remission. In this setting, the anti-chemokine receptor type 4 (CCR4) monoclonal antibody mogamulizumab demonstrated efficacy in an international, open-label, randomized controlled phase 3 trial (MAVORIC) versus vorinostat. Case description:A heavily pretreated 57-year-old SS woman (stage IVA) was randomized in the mogamulizumab arm of MAVORIC at our Institution. She quickly achieved a response, but after 30 cycles, she was discontinued from therapy due to cutaneous toxicity. Nevertheless, she is still in complete response (CR). Conclusions:mogamulizumab is an anti-CCR4 monoclonal antibody that can induce long-lasting response also in very heavily pretreated patients not responding to any previous treatment. The extraordinary characteristic of our patient is that she is still in CR after 2.5 years since treatment discontinuation.

SUBMITTER: Lolli G

PROVIDER: S-EPMC7340218 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Impressive Continuous Complete Response after Mogamulizumab in a Heavily Pretreated Sézary Syndrome Patient.

Lolli Ginevra G Casadei Beatrice B Argnani Lisa L Nanni Laura L Cavo Michele M Zinzani Pier Luigi PL

Mediterranean journal of hematology and infectious diseases 20200701 1

<h4>Background</h4>Sézary syndrome (SS) is a rare lymphoproliferative neoplasm, almost incurable outside the setting of allogeneic transplantable patients. The prognosis for relapsed/refractory patients remains poor, as the available drugs confer short-lasting remission. In this setting, the anti-chemokine receptor type 4 (CCR4) monoclonal antibody mogamulizumab demonstrated efficacy in an international, open-label, randomized controlled phase 3 trial (MAVORIC) versus vorinostat.<h4>Case descrip ...[more]

PMID: 32670518

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Project description:Background: The prognosis of patients with advanced gastric cancer remains overall poor despite some recent innovations and the development of new therapeutic approaches. Current European guidelines do not recommend any specific treatment for patients with advanced gastric cancer refractory to two or more previous chemotherapy regimens, making this setting "orphan." Immunotherapy is quickly evolving also for this malignancy even if with controversial results and the correct patient selection is still debated, especially for Western patients. The phase III ONO-4538-12 "ATTRACTION-2" represents the current landmark trial for the development of immunotherapy for pretreated Asian patients and led to the approval of Nivolumab in some Asian countries, while only previous phase trials are available for Caucasians. Complete radiological response is anecdotic and has never been described both in the pivotal trial both in the others with Western patients enrolled. Case presentation: We report two cases of heavily pretreated Western elderly patients with metastatic gastric cancer who experienced durable complete radiological response to Nivolumab "off label" (more than 20 months to date) in a clinical practice context. Molecular analysis of potential predictive factors has been performed (PD-L1, EBV, MSI, and TMB) on primary tumor sample. Conclusions: Despite the lack of evidence for Western patients and the controversial outcome with the use of checkpoint inhibitors in previous settings, immunotherapy may dramatically change the prognosis and the natural history of pretreated Western metastatic gastric cancer, in a correctly selected population. Microsatellite instability and tumor mutational burden may be reliable predictive factors also for Caucasians. There is an urgent need for a change in clinical practice also for this "orphan" patients and more efforts are needed in order to clarify the role of predictive factors for a correct patient selection and better chances of survival for this awful malignancy.

Project description:Patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) following autologous stem cell transplant (ASCT) remain a management challenge with few reliably effective treatments. Lenalidomide, an immunomodulatory drug approved for patients with myelodysplastic syndrome with del(5q), multiple myeloma, and mantle cell lymphoma, has demonstrated some activity in patients with R/R cHL, though the toxicity of traditional doses and schedules has been a barrier to consistent use. Low dose continuous (LDC) schedules have emerged as promising, with a more favorable safety profile. We report herein that LDC schedules are associated with a far more tolerable toxicity profile, and exhibit at least equivalent efficacy in this patient population. We report that patients diagnosed with R/R cHL who previously underwent, or were not candidates for, ASCT and/or clinical trials, were administered daily LDC lenalidomide (20 mg orally with dose reduction for toxicity). Among the 19 patients included in this analysis, 11% of patients achieved a partial response (PR), with no documented complete responses (CR). A total of 12 (63%) patients maintained stable disease (SD), with 7 patients (37%) remaining in SD for more than 6 months. The clinical benefit rate (comprised of CR, PR, and SD for greater than 6 months) was 47% (7 out of 19 patients). The median progression-free survival and overall survival of all patients were 9.4 months (range, 4.6-14.4 months) and 90 months (range, 63.6-166.8 months), respectively. In general, the treatment was well tolerated, with grade 3 or 4 adverse events consisting of neutropenia (n = 4), and one case each of thrombocytopenia, fatigue, rash, creatinine elevation, aspartate transaminase/alanine transaminase elevation, and treatment related secondary malignancy. In a heavily treated R/R cHL patient population, daily LDC lenalidomide was associated with a high disease control rate with a favorable toxicity profile.

Dataset Information

Impressive Continuous Complete Response after Mogamulizumab in a Heavily Pretreated Sezary Syndrome Patient.

Publications

Impressive Continuous Complete Response after Mogamulizumab in a Heavily Pretreated Sézary Syndrome Patient.

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