Publications by authors named "S V Ambarkhane"
Background: ATOR-1017 (evunzekibart) is a human agonistic immunoglobulin G4 antibody targeting the costimulatory receptor 4-1BB (CD137). ATOR-1017 activates T cells and natural killer cells in the tumor environment, leading to immune-mediated tumor cell death.
Methods: In this first-in-human, multicenter, phase I study, ATOR-1017 was administered intravenously every 21 days as a monotherapy to patients with advanced, unresectable solid tumors having received multiple standard-of-care treatments.
Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study.
Lancet Oncol
July 2024
Article Synopsis
- Current treatments for metastatic pancreatic ductal adenocarcinoma yield very low survival rates, prompting research into new therapies like mitazalimab combined with a modified chemotherapy regimen called mFOLFIRINOX.
- The OPTIMIZE-1 study enrolled 70 patients across 14 hospitals in Belgium, France, and Spain to evaluate the safety and effectiveness of this combination therapy, focusing on determining the optimal dose of mitazalimab as well as measuring tumor response.
- The trial successfully determined 900 μg/kg of mitazalimab as the recommended dose for the next phase and gathered data on the initial outcomes for the patients treated within the study timeframe from September 2021 to March 2023.
CD40-targeting therapies can enhance the dendritic cell priming of tumor-specific T cells and repolarize intratumoral macrophages to alleviate the tumoral immunosuppressive environment and remodel the extracellular matrix. Mitazalimab is a potent agonistic CD40 monoclonal IgG1 antibody currently under clinical development. This study used RNA sequencing of blood samples from a subset of patients from a Phase I trial with mitazalimab (NCT02829099) to assess peripheral pharmacodynamic activity.
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- 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.
Introduction: Tafasitamab plus lenalidomide (TAFA + LEN) received accelerated US Food and Drug Administration approval and conditional European Medicines Agency approval for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for autologous stem cell transplant. This study investigates the relative efficacy of TAFA + LEN versus comparator treatments.
Methods: Matching-adjusted indirect comparisons (MAICs) of TAFA + LEN were performed using data from L-MIND, and comparator studies assessing rituximab-based combination therapies, including polatuzumab vedotin + bendamustine + rituximab (POLA + BR) bendamustine + rituximab (BR), and gemcitabine + oxaliplatin + rituximab (R-GEMOX) to provide relative efficacy estimates for overall survival (OS), progression-free survival (PFS), duration of response (DOR), objective response rate (ORR), and complete response rate (CRR).