Publications by authors named "Georg Hess"

Article Synopsis
  • Patients with mantle cell lymphoma (MCL) who relapse are split into two groups: early and late progression, based on how long it's been since their diagnosis.
  • This study looked at treatment outcomes for 385 late-POD patients treated with two kinds of therapies: Bruton tyrosine kinase inhibitors (BTKi) and chemoimmunotherapy (CIT).
  • Findings showed that BTKi treatment led to longer survival without disease progression compared to CIT, suggesting it might be the better choice for these patients.
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Background: Adding ibrutinib to standard immunochemotherapy might improve outcomes and challenge autologous stem-cell transplantation (ASCT) in younger (aged 65 years or younger) mantle cell lymphoma patients. This trial aimed to investigate whether the addition of ibrutinib results in a superior clinical outcome compared with the pre-trial immunochemotherapy standard with ASCT or an ibrutinib-containing treatment without ASCT. We also investigated whether standard treatment with ASCT is superior to a treatment adding ibrutinib but without ASCT.

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Background: Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody approved in Europe and the United States for relapsed/refractory (R/R) follicular lymphoma (FL) after ≥ 2 prior therapies.

Materials And Methods: We present interim safety data from the mosunetuzumab GO29781 (NCT02500407) phase I/II dose-escalation study in R/R non-Hodgkin lymphoma (NHL), focusing on FL.

Results: Overall, 218 patients with R/R NHL, including 90 with R/R FL, received a median of eight 21-day cycles of intravenous mosunetuzumab with step-up dosing in Cycle (C) 1 (C1 Day [D] 1, 1 mg; C1D8, 2 mg; C1D15/C2D1, 60 mg; C3D1 and onwards, 30 mg).

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Article Synopsis
  • - The SCHOLAR-2 study showed that patients with relapsed/refractory mantle cell lymphoma (MCL) had poor overall survival using standard care after failing a Bruton tyrosine kinase inhibitor.
  • - In the ZUMA-2 trial, the CAR T-cell therapy brexucabtagene autoleucel (brexu-cel) showed high and lasting response rates in similar patients with prior BTKi treatment.
  • - Comparing overall survival rates, brexu-cel significantly outperformed standard care across multiple statistical methods, indicating better survival outcomes for patients with R/R MCL after BTKi failure.
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Background: The Bruton's tyrosine kinase inhibitor ibrutinib and the proteasome inhibitor bortezomib have single-agent activity, non-overlapping toxicities, and regulatory approval in mantle cell lymphoma (MCL). In vitro, their combination provides synergistic cytotoxicity. In this investigator-initiated phase 1/2 trial, we established the recommended phase 2 dose of ibrutinib in combination with bortezomib, and assessed its efficacy in patients with relapsed or refractory MCL.

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The phase 3 SELENE study evaluated ibrutinib + chemoimmunotherapy (CIT; bendamustine and rituximab [BR]; or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL). Adult patients who had received ≥1 prior line of CIT were randomized 1:1 to oral ibrutinib (560 mg) or placebo daily, plus 6 cycles of BR/R-CHOP. The primary end point was investigator-assessed progression-free survival (PFS).

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CD19-directed CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel) has substantially improved treatment outcomes for patients with relapsed/refractory mantle cell lymphoma (r/r MCL). Prolonged cytopenias and infections represent common and clinically relevant side effects. In this multicenter observational study, we describe cytopenias and infections in 103 r/r MCL patients receiving brexu-cel.

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RE-MIND2 (NCT04697160) compared patient outcomes from the L-MIND (NCT02399085) trial of tafasitamab+lenalidomide with those of patients treated with other therapies for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are autologous stem cell transplant ineligible. We present outcomes data for three pre-specified treatments not assessed in the primary analysis. Data were retrospectively collected from sites in North America, Europe, and the Asia Pacific region.

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Background: The prognosis for patients with relapsed and/or refractory (R/R) non-Hodgkin's lymphoma (NHL) or acute lymphoblastic leukaemia (ALL) remains poor, with existing treatments having significant side effects. Developed for the treatment of these cancers, AFM11 is a tetravalent, bispecific humanised recombinant antibody construct (TandAb®) designed to bind to human CD19 and CD3 and lead to the activation of T cells inducing apoptosis and killing of malignant B cells.

Methods: Two open-label, multicentre, dose-escalation phase 1 studies evaluated the safety, pharmacokinetics and activity of AFM11 in patients with R/R CD19-positive B cell NHL (AFM11-101) and in patients with CD19 + B-precursor Philadelphia-chromosome negative ALL (AFM11-102).

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Article Synopsis
  • * Data collected from 240 patients in Europe indicates a median overall survival of 14.6 months following the start of initial BTKi therapy, with varying outcomes based on subsequent treatments.
  • * Patients who received further therapy after BTKi failure had a median overall survival of 23.8 months, particularly with lenalidomide and bendamustine plus rituximab, providing a new benchmark for treatment effectiveness.
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Article Synopsis
  • The RE-MIND2 study compared patient outcomes of tafasitamab plus lenalidomide to other systemic therapies for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
  • Data from eligible patients aged 18 and older who had previously received multiple treatments were analyzed, and matching was done to ensure comparable groups for accurate results.
  • The findings indicated that patients receiving tafasitamab plus lenalidomide experienced significantly improved overall survival compared to those on pooled systemic therapies, bendamustine plus rituximab, and rituximab plus gemcitabine and oxaliplatin.
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Aims: The objective of this study is to estimate the cost-effectiveness of KTE-X19 versus standard of care (SoC) in the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) post-Bruton tyrosine kinase inhibitor (BTKi) treatment from a UK healthcare perspective.

Materials And Methods: A three-state partitioned survival model (pre-progression, post-progression and death) with a cycle length of one month was used to extrapolate progression-free and overall survival over a lifetime horizon. Population inputs along with KTE-X19 (brexucabtagene autoleucel) efficacy and safety data were derived from the single-arm trial ZUMA-2 (NCT02601313).

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219 HIV-negative adults ≤70 years with primary CNS lymphoma (PCNSL) were enrolled in the randomized IELSG32 trial. Enrolled patients were randomly assigned to receive methotrexate-cytarabine (arm A), or methotrexate-cytarabine-rituximab (B), or methotrexate-cytarabine-thiotepa-rituximab (MATRix; arm C). A second randomization allocated patients with responsive/stable disease to whole-brain irradiation (WBRT) or carmustine-thiotepa-conditioned autologous transplantation (ASCT).

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Purpose: Informed consent procedures in clinical trials often differ in length and complexity to those in clinical routine care. Little is known about the benefit of extensive procedures as intended in clinical trials compared to procedures in routine cancer treatment.

Methods: In two different clinical studies performed at a comprehensive cancer center, we compared patients' comprehension and satisfaction of current informed consent procedures in routine clinical care with the level of comprehension and satisfaction of patients treated within clinical trials.

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Data on outcome of patients with mantle cell lymphoma (MCL) and COVID-19 infection are limited. The European MCL (EMCL) registry is a centralized registry of the EMCL network, collecting real-world information about treatments and disease courses. During the COVID-19 pandemic, additional data on MCL patients with COVID-19 infection were collected, aiming to identify risk factors for mortality from COVID-19.

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The prognosis of patients with relapsed diffuse large B-cell lymphoma (DLBCL) remains poor with current options. Here we prospectively evaluated the combination of pixantrone with obinutuzumab for up to six cycles for patients with relapsed or refractory DLBCL. Overall response rate (ORR) was the primary end-point.

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Radioimmunotherapy with 90-yttrium-ibritumomab tiuxetan (90Y-IT) as first-line treatment in patients with follicular lymphoma (FL) demonstrated promising results with a complete remission (CR) rate of 56% and a median progression-free survival (PFS) of 26 months, when initially analyzed after a median follow-up of 30.6 months. The aim of this long-term follow-up was to investigate whether clinical benefits were maintained and new safety signals appeared.

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Article Synopsis
  • The study looked at a treatment, ibrutinib, for patients with a type of cancer called follicular lymphoma, finding that about 21% of patients responded well to it.
  • Researchers analyzed the genes in the patients' cancer cells to see which ones might predict who would respond to the treatment.
  • They discovered some important genes related to the patients’ responses, finding that certain genetic changes might make it harder for patients to respond to ibrutinib.
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Background: Information about the long-term tolerability of tafasitamab is still limited.

Methods: 5 of 92 patients treated within a phase IIa study of single-agent tafasitamab in relapsed or refractory B NHL were followed for up to five years or longer for long-term tolerability.

Results: Treatment was very well tolerated in an outpatient setting with no hospitalizations needed and mild and tolerable adverse events that occurred mostly within the first two years of treatment.

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Article Synopsis
  • There’s a significant need for new treatments for relapsed diffuse large B-cell lymphoma, and the mTOR inhibitor temsirolimus showed potential when combined with a standard salvage regimen.
  • A study was conducted using the STORM regimen, which included rituximab and DHAP, with temsirolimus being added at a managed dose depending on patient reactions.
  • The results showed a 66% overall response rate and good tolerability, with 2-year progression-free survival at 53% and overall survival at 59%, indicating that this combination therapy could be a promising option for patients.
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The antibody-drug conjugate polatuzumab vedotin (pola) has recently been approved in combination with bendamustine and rituximab (pola-BR) for patients with refractory or relapsed (r/r) large B-cell lymphoma (LBCL). To investigate the efficacy of pola-BR in a real-world setting, we retrospectively analyzed 105 patients with LBCL who were treated in 26 German centers under the national compassionate use program. Fifty-four patients received pola as a salvage treatment and 51 patients were treated with pola with the intention to bridge to chimeric antigen receptor (CAR) T-cell therapy (n = 41) or allogeneic hematopoietic cell transplantation (n = 10).

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Background: Preservation of kidney function in newly diagnosed (ND) multiple myeloma (MM) helps to prevent excess toxicity. Patients (pts) from two prospective trials were analyzed, provided postinduction (PInd) restaging was performed. Pts received three cycles with bortezomib (btz), cyclophosphamide, and dexamethasone (dex; VCD) or btz, lenalidomide (len), and dex (VRd) or len, adriamycin, and dex (RAD).

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The prognosis of elderly patients diagnosed with diffuse large B cell lymphoma (DLBCL) is considered to be clearly inferior to that of younger patients. Besides tumor biology and comorbidities, treatment selection due to an assumed reduced tolerability may contribute to this difference. With increasingly more patients diagnosed at advanced age, current treatment selections need to be reviewed carefully.

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