- Multiple Myeloma Research and Treatments
- Protein Degradation and Inhibitors
- Lymphoma Diagnosis and Treatment
- Cancer Treatment and Pharmacology
- Chronic Lymphocytic Leukemia Research
- Peptidase Inhibition and Analysis
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Cancer therapeutics and mechanisms
- Viral-associated cancers and disorders
- Immune Cell Function and Interaction
- Histone Deacetylase Inhibitors Research
- Advanced Breast Cancer Therapies
- PI3K/AKT/mTOR signaling in cancer
- HER2/EGFR in Cancer Research
- Cancer Mechanisms and Therapy
- Lung Cancer Research Studies
- Acute Lymphoblastic Leukemia research
- T-cell and Retrovirus Studies
- Acute Myeloid Leukemia Research
- HIV/AIDS drug development and treatment
- Cholinesterase and Neurodegenerative Diseases
- Cancer-related Molecular Pathways
- CAR-T cell therapy research
- Monoclonal and Polyclonal Antibodies Research
- Glycosylation and Glycoproteins Research
Boehringer Ingelheim (Germany)
2021-2023
Bristol-Myers Squibb (Switzerland)
2014-2020
Abstract In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone (PVd) demonstrated superior efficacy vs bortezomib (Vd) in patients with relapsed or refractory multiple myeloma previously treated lenalidomide, including those to lenalidomide. This analysis evaluated outcomes at first relapse ( N = 226) by lenalidomide-refractory status, prior exposure, stem cell transplant (SCT). Second-line PVd significantly improved PFS Vd (17.8 9.5 months; P 0.0276)...
Abstract Background Xentuzumab is a humanised monoclonal antibody that binds to IGF-1 and IGF-2, neutralising their proliferative activity restoring inhibition of AKT by everolimus. This study evaluated the addition xentuzumab everolimus exemestane in patients with advanced breast cancer non-visceral disease. Methods double-blind, randomised, Phase II was undertaken female hormone-receptor (HR)-positive/human epidermal growth factor 2 (HER2)-negative disease who had received prior endocrine...
Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs important ensure continue therapy long enough receive the best clinical benefit. Data from MM-002, MM-003, MM-010 trials were pooled further characterize safety profile of pomalidomide plus low-dose dexamethasone AE management.This analysis included 1088 who received ≥ 2 prior therapies, including lenalidomide bortezomib, progressed ≤ 60 days last...
In the randomized phase-3 OPTIMISMM study, addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement progression-free survival (PFS) lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide patients. Here, we report health-related quality life (HRQoL) results from this trial. Patients received PVd Vd 21-day cycles until disease progression discontinuation. HRQoL was assessed using EORTC...
Summary In the mantle cell lymphoma ( MCL )‐002 study, lenalidomide demonstrated significantly improved median progression‐free survival PFS ) compared with investigator's choice IC in patients relapsed/refractory . Here we present long‐term follow‐up data and results of preplanned subgroup exploratory analyses from ‐002 to evaluate potential impact demographic factors, baseline clinical characteristics prior therapies on ‐002, were randomized 2:1 receive (25 mg/day orally days 1–21; 28‐day...
8547 Background: Lenalidomide, an immunomodulator with antineoplastic and antiproliferative effects, showed clinically significant improved activity over investigator choice (IC) in relapsed/refractory (R/R) MCL. This preplanned MCL-002 analysis evaluated efficacy across patient subgroups receiving lenalidomide vs IC. Methods: Patients received (25 mg/day PO on days 1-21/28 days) or single-agent IC therapy (chlorambucil, cytarabine, fludarabine, gemcitabine, rituximab). The primary endpoint...
Abstract In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib and dexamethasone (PVd) significantly improved progression‐free survival (PFS) overall response rate (ORR) vs (Vd) in patients with relapsed or refractory multiple myeloma. All were previously treated lenalidomide (70% to lenalidomide) had received one three prior regimens. Here we report first efficacy safety analysis of PVd Vd Japanese Seventeen enrolled trial Japan. With a median follow‐up 14.8 months, PFS was 17.6 months...
e20562 Background: Upfront LEN until disease progression is a standard treatment (Tx) in multiple myeloma (MM). Data are limited on optimal Tx after first-line LEN, especially LEN-refractory patients (pts), growing population. In OPTIMISMM (phase 3, NCT01734928), PVd significantly improved median PFS at first relapse relapsed refractory MM (RRMM) pts, of whom 100% were pretreated and 57% (median, 20.7 vs 11.6 mos; HR = 0.54 [95% CI, 0.36-0.82]; P .0027) Vd (Richardson, 2019). Pd has shown...
Background: The immunomodulatory agent pomalidomide (POM) in combination with dexamethasone (DEX) is approved Japan for the treatment (Tx) of relapsed refractory multiple myeloma. Results from multicenter phase 3 OPTIMISMM trial (NCT01734928) demonstrated a significantly improved progression‐free survival (PFS; median 11.2 vs 7.1 mos, HR, 0.61, P < .0001) pomalidomide, bortezomib, and low‐dose (PVd) bortezomib (Vd) intent‐to‐treat population 100% LEN pretreated patients (pts; 70%...
Background: IBER is a novel cereblon E3 ligase modulator (CELMoD) with enhanced tumoricidal and immunostimulatory activities. Preclinically, overcomes immunomodulatory drug (IMiD) resistance has synergy daratumumab (DARA), bortezomib (BORT), dexamethasone (DEX). Aims: This phase 1b/2a multicenter, open‐label, dose‐escalation study (NCT02773030) was conducted to evaluate the maximum tolerated dose (MTD), recommended 2 (RP2D), safety preliminary efficacy of in combination DEX, patients...
1057 Background: Cyclin-dependent kinase (CDK) 4 & 6 inhibitors plus endocrine therapy (ET) are standard of care for advanced HR+ BC. Combining xentuzumab, an insulin-like growth factor (IGF) ligand-neutralizing antibody, with ET and everolimus, suggested progression-free survival (PFS) benefit in pts BC non-visceral disease. Activation the IGF pathway leads to increase cyclin D1, providing a rationale combining CDK4 inhibition. This prospective, open-label study is investigating...
Background: Multiple myeloma (MM) is associated with significant immunodeficiency involving T, B, NK and NKT cells. Moreover, impact of immunomodulatory agents, such as lenalidomide pomalidomide (Pom), has been demonstrated in pre‐clinical studies, however their vivo on immune function remains unclear. Aims: The large MM007 study relapsed/refractory MM (N = 540) randomizing patients to receive Pom (PVd) versus placebo (Vd) combination bortezomib dexamethasone provided us a unique opportunity...