Treatment Of Relapsed Follicular Lymphoma Research Articles

Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial

BackgroundRelapsed or refractory follicular lymphoma (rrFL) is an incurable disease associated with shorter remissions and survival after each line of standard therapy. Many promising novel, chemotherapy-free therapies are in development, but few are licensed as their role in current treatment pathways is poorly defined.MethodsThe REFRACT trial is an investigator-initiated, UK National Cancer Research Institute, open-label, multi-centre, randomised phase II platform trial aimed at accelerating clinical development of novel therapies by addressing evidence gaps. The first of the three sequential novel therapy arms is epcoritamab plus lenalidomide, to be compared with investigator choice standard therapy (ICT). Patients aged 18 years or older with biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma and assessable disease by PET-CT are eligible. The primary outcome is complete metabolic response by PET-CT at 24 weeks using the Deauville 5-point scale and Lugano 2014 criteria. Secondary outcomes include overall metabolic response, progression-free survival, overall survival, duration of response, and quality of life assessed by EQ-5D-5 L and FACT-Lym. The trial employs an innovative Bayesian design with a target sample size of 284 patients: 95 in the ICT arm and 189 in the novel therapy arms.DiscussionWhilst there are many promising novel drugs in early clinical development for rrFL, understanding the relative efficacy and safety of these agents, and their place in modern treatment pathways, is limited by a lack of randomised trials and dearth of published outcomes for standard regimens to act as historic controls. Therefore, the aim of REFRACT is to provide an efficient platform to evaluate novel agents against standard therapies for rrFL. The adaptive Bayesian power prior methodology design will minimise patient numbers and accelerate trial delivery.Trial registrationClinicalTrials.gov: NCT05848765; 08-May-2023.EudraCT2022-000677-75; 10-Feb-2022.

Population Pharmacokinetics and Exposure-Response Analyses from Phase I-III Studies Support Copanlisib Dose Selection in Relapsed Indolent Non-Hodgkin Lymphoma

Introduction: Copanlisib is a novel PI3K inhibitor that is approved for single-agent treatment of relapsed follicular lymphoma in patients (pts) who have received ≥2 systemic therapies. In the pivotal Phase III CHRONOS-3 study, pts with relapsed iNHL were randomized to copanlisib at the approved maximum tolerated dosing regimen of 60 mg administered on days 1, 8, and 15 of a 28-day cycle in combination with standard rituximab (C+R) or placebo plus rituximab (P+R) and demonstrated superior progression-free survival (PFS) of C+R vs P+R (hazard ratio [HR]: 0.52; Matasar et al. Lancet Oncol 2021). In an updated 1-year follow-up analysis, the benefit of C+R was confirmed in the overall relapsed iNHL population (Zinzani et al. EHA 2022). No dedicated dose-finding studies have been undertaken to investigate copanlisib dose selection when used in combination with rituximab; however, initial safety assessments demonstrated acceptable tolerability. We investigated popPK and ER relationships for copanlisib efficacy and safety from a pooled analysis, with particular focus on the 1-year follow-up of CHRONOS-3 to confirm copanlisib dose selection. Methods: A copanlisib comprehensive popPK model was developed from 712 pts across 9 copanlisib clinical Phase I-III studies. Demographic, laboratory, and co-medication covariates were investigated for their influence on copanlisib between-patient PK variability. Individual static and time-varying exposure estimates for pts enrolled in CHRONOS-3 were derived to investigate relationships to efficacy (PFS) and key treatment-emergent safety events using Cox proportional hazards (CPH) and multivariate logistic regression analyses after accounting for predefined potentially prognostic demographic, laboratory, and/or disease-related baseline covariates. Results: Copanlisib PK was best described by a 3-compartment PK model with first-order elimination following intravenous infusion. Copanlisib PK was dose proportional and time independent, with no accumulation with the approved dosing regimen. Statistically selected covariates influencing copanlisib PK included rifampin (strong CYP3A inducer) and itraconazole (strong CYP3A inhibitor) co-administration and mild or worse hepatic impairment, confirming the results of dedicated clinical pharmacology studies. Additional covariates influencing copanlisib PK included female sex, residence in Japan, and a CHRONOS-3 study effect, with the majority of covariates or subpopulations defined by sex, age, body weight, renal function, and geographic region showing exposure variations not exceeding traditional bioequivalence ranges (80-125%). In CHRONOS-3, CPH analyses demonstrated a statistically significant, positive ER relationship for PFS for all 3 time-varying copanlisib exposure estimates (average concentration [Cavg] over 2 weeks [Cavg2wk]: p=0.002; 4 weeks [Cavg4wk]: p=0.004; and 8 weeks [Cavg8wk]: p=0.002), along with a near-significant relationship for area under the curve from 0 to 168 hours (AUC(0-168)nd) [p=0.023] (Figure 1). Therefore, greater copanlisib exposure was associated with prolonged PFS, while lower copanlisib doses may result in reduced efficacy in relapsed iNHL. CPH and/or logistic regression analyses demonstrated no significant ER relationship for investigated safety events (serious adverse events [AEs], grade ≥3 treatment-emergent AEs, hyperglycemia, hypertension, diarrhea, nausea, fatigue, lung infections, and neutropenia of any grade). Thus, lower starting doses of copanlisib are not anticipated to improve safety and tolerability. ER analyses support the overall positive benefit/risk assessment of copanlisib reported from the clinical efficacy and results of CHRONOS-3 in iNHL. Conclusion: PopPK and ER analyses substantiate administration of a dosing regimen of copanlisib 60 mg on days 1, 8, and 15 of a 28-day cycle in the relapsed iNHL population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Modern approaches to the treatment of relapsed follicular lymphoma

Follicular lymphoma is a tumor of mature B-lymphocytes, characterized by a predominantly indolent course. Despite advances in first-line therapy, disease relapses still occur, and with an increase in the follow-up period, the risk of transformation into diffuse large B-cell lymphoma also increases. The choice of a further anticancer therapy is based on the results of a comprehensive examination and repeated biopsy. In addition, previous remission duration, previous treatment, clinical manifestation of relapse, the patient's somatic condition and comorbidity are taken into account. A clinical observation of a 57-year-old patient with relapsed follicular lymphoma, who received various chemotherapy regimens in combination with rituximab in the 1st and subsequent lines, is presented. After repeated biopsy and exclusion of transformation into diffuse large B-cell lymphoma, the patient received lenalidomide therapy in combination with obinutuzumab. A partial antitumor response after 4 cycles with decrease in tumor volume by more than 80 % by the end of induction was achieved. The absence of severe adverse events, together with a pronounced antitumor effect, significantly improved the patient's quality of life.

Long-Term Efficacy and Safety of Copanlisib in Multiply Relapsed or Refractory Patients with Marginal Zone Lymphoma

Long-Term Efficacy and Safety of Copanlisib in Multiply Relapsed or Refractory Patients with Marginal Zone Lymphoma

Long-Term Follow-up of Idelalisib Monotherapy in Patients with Double-Refractory Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma/ Waldenstrom's Macroglobulinemia

Long-Term Follow-up of Idelalisib Monotherapy in Patients with Double-Refractory Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma/ Waldenstrom's Macroglobulinemia

Abstract 3080: Activity of pan-FGFR inhibitor rogaratinib and PI3K inhibitor copanlisib in preclinical urothelial bladder cancer models

Abstract Rogaratinib is a potent small molecule pan-FGFR inhibitor that leads to downregulation of MAPK and PI3K signaling (1). In a recent Phase I study rogaratinib demonstrated higher ORR in locally advanced or metastatic urothelial bladder cancer (UBC) with FGFR mRNA overexpression in patients with PIK3CA and RASwildtype than in those harboring PIK3CA or RAS mutations (2). In UBC, about 25% of tumors contain mutated PIK3CA of which 75% represent hot spot mutations E545K or E542K (3). Copanlisib is a potent pan class I PI3K inhibitor with predominant activity against the α and δ isoforms being approved for treatment of relapsed follicular lymphoma (4). We evaluated the activity of rogaratinib in cellular and in vivo efficacy studies in bladder cancer models in monotherapy and in combination with copanlisib. Cell proliferation and viability in response to rogaratinib, copanlisib or the combination of both was studied in rogaratinib-sensitive UBC cell lines like RT112 as well as in a recombinant RT112-PIK3CAE545K cell line. Rogaratinib potently inhibited cell proliferation with IC50 values in the double nM range. Copanlisib’s potency varied between 20 and 900 nM. In combination, rogaratinib and copanlisib increased cell death and were synergistic as shown by their proliferation combination indices for the absolute IC50 and IC80. Expression of the PIK3CAE545K hot spot mutant in RT112 cells decreased the anti-proliferative efficacy of rogaratinib but did not change the sensitivity to copanlisib. In vivo, rogaratinib led to tumor regression in the FGFR1-expressing JMSU1 xenograft and strongly inhibited tumor growth in the FGFR3-driven RT112 model. Copanlisib did not show significant inhibition of tumor growth in monotherapy in either model. In the JMSU1 model the combination was not superior to rogaratinib alone at maximal tolerated doses. In the RT112 as well as in the RT112-PIK3CAE545K model, the combination significantly improved anti-tumor activity. In a PDX model with FGFR3 overexpression and a PIK3CAH1047R hot spot mutation rogaratinib did not inhibit tumor growth significantly while copanlisib displayed significant anti-tumor effects. The combination of both drugs reduced tumor growth compared to either monotherapy group. In conclusion, in UBC tumor models overexpressing FGFR with differing sensitivities to rogaratinib, its anti-tumor activity could be further enhanced when combined with copanlisib and suggests that PIK3CA mutations may play a role in reduced sensitivity of UBC to FGFR inhibition. These promising results warrant further development of rogaratinib in monotherapy and in combination. Clinical trials with rogaratinib are currently recruiting (NCT03517956, NCT03410693, NCT03473756).

Copanlisib: An Intravenous Phosphatidylinositol 3-Kinase (PI3K) Inhibitor for the Treatment of Relapsed Follicular Lymphoma.

Objective: To review the mechanism of action, clinical efficacy, safety, dosage, administration, and role of copanlisib in the treatment of relapsed follicular lymphoma (FL). Data Sources: Sources of information were identified through searches of PubMed (August 2014 to January 2019) using the key terms copanlisib, Aliqopa, PI3K inhibitor, and BAY 80-6946. Unpublished abstract information was obtained from the American Society of Clinical Oncology. Study Selection and Data Extraction: Review articles and studies in the English language evaluating the pharmacology, efficacy, and safety of copanlisib were included. Data Synthesis: Copanlisib is the first intravenous phosphatidylinositol 3-kinase (PI3K) inhibitor approved for the treatment of relapsed FL in patients who have received at least 2 prior systemic therapies. The safety and efficacy of copanlisib has been studied in the multicenter, single-arm, phase II CHRONOS-1 study. The results reported for FL patients were an objective response rate of 59%, a complete response of 14%, median duration of response of 22.6 months, and median progression-free survival of 11.2 months. The most common adverse events reported were hyperglycemia and hypertension, which were infusion related and transient. Relevance to Patient Care and Clinical Practice: Copanlisib is unique in that it is a pan-class I PI3K inhibitor with preferential inhibitory activity against the PI3K-α and PI3K-δ isoforms. It has a more favorable safety profile than the other agents in its class with no late-onset toxicities. Conclusions: Copanlisib provides an alternative option for patients with relapsed FL. It is safe and effective and has an acceptable toxicity profile.

Idelalisib for Treatment of Follicular Lymphoma and Chronic Lymphocytic Leukemia in Clinical Trials Versus the Real World: Treatment Duration and Survival Are Associated with Pretreatment Modified Charlson Score

Background: Idelalisib (IDEL) is a phosphatidylinositol-3 kinase (PI3K) inhibitor approved as a single agent for treatment of relapsed follicular lymphoma (FL) and in combination with rituximab for treatment of relapsed chronic lymphocytic lymphoma (CLL). The clinical trials supporting IDEL approval excluded patients with many comorbidities. We sought to investigate whether higher comorbidity burden among real world (RW) patients receiving IDEL might lead to differences in treatment duration, overall survival, or infection rates compared to clinical trial (CT) subjects.Methods: CT data from the sponsor and RW data from Medicare were obtained for patients aged ≥65 years receiving: 1) IDEL monotherapy for FL or 2) IDEL with rituximab (IDEL+R) for CLL. A pretreatment modified Charlson Score (mCS; Quan H, 2011) was calculated using medical records for CT subjects and diagnostic reimbursement codes for RW beneficiaries. Treatment duration for IDEL was calculated from treatment start until the last patient contact for CT subjects and until the final day supply for RW beneficiaries. Overall survival was obtained from intention to treat data for CT subjects and through linkage to Social Security for RW beneficiaries. Serious infections were coded as Grade ≥3, as a serious adverse event, or required intravenous antibiotics for CT subjects. For RW beneficiaries, serious infections were obtained through manual abstraction of hospital discharge diagnoses or coded with intravenous antibiotics in emergent care. Fatal infections were defined as serious infections within 30 days prior to death. Results are reported descriptively and using Cox Proportional Hazards Models, adjusted by age, gender, mCS, and US location. Statistical modeling was intended to describe the generalizability of CT results to unselected RW population.Results: A total of 26 CT subjects aged ≥65 years receiving IDEL monotherapy for FL from Study 101-09 were compared to 305 RW beneficiaries aged ≥65 years receiving IDEL for FL. A total of 89 CT subjects aged ≥65 years receiving IDEL+R for CLL in Study 312-116/117 were compared to 294 RW beneficiaries aged ≥65 years receiving IDEL+R for CLL. Key clinical comparisons are presented in the table below.Age and mCS•RW beneficiaries receiving IDEL for FL had more patients ≥75 years (54% vs 35%) and with a mCS >3 (52% vs 12%) than CT subjects.•RW beneficiaries receiving IDEL+R for CLL had more patients ≥75 years old (52% vs 36%) and with a mCS >3 (52% vs 24%) than CT subjects.Idelalisib Persistency•CT subjects had a longer median idelalisib treatment duration and a lower treatment discontinuation rate by day 180 compared to RW beneficiaries. Differences were more pronounced for CLL.•A nonlinear, convex relationship was observed between mCS and treatment discontinuation among RW beneficiaries, indicating a higher mCS predicts more (than linearly expected) reduction in treatment duration. Few CT subjects had a mCS >3.Overall Survival•Mortality was numerically worse for RW beneficiaries with FL (HR 1.39 95%CI: 0.69-2.78) or CLL (HR 1.40 95%CI: 0.93, 2.11) compared to CT subjects.•Among RW beneficiaries, each 1-point increase in mCS predicted a 10% (95%CI: 1.06, 1.14) increase in overall mortality for FL and CLL. Among CT subjects with CLL, mortality was worse for subjects with mCS >3 than for subjects with mCS ≤3 (HR 2.25, 95%CI: 1.13-4.49). Analysis of mCS among FL subjects had insufficient sample size.Serious Infections•Serious infections occurred more frequently by day 180 in RW beneficiaries than CT subjects for FL (32.1% vs 19.2%) but not for CLL (34.0% vs 38.2%).•RW beneficiaries had higher rates of fatal infections for both FL (27.6/100PY vs 18.6/100PY) and CLL (18.4/100PY vs 9.8/100PY) compared to CT subjects.Conclusions: The RW beneficiaries were older and had higher comorbidity burden compared to subjects ≥65 years included in CTs. RW beneficiaries had a shorter treatment duration, higher mortality rates, and higher fatal infection rates than CT subjects. Higher comorbidity, as measured through a pretreatment mCS, was associated with worse study outcomes. CT inclusion and exclusion criteria should allow enrollment of patients who are representative of the intended treatment population to maximize generalizability of CT results.Acknowledgment: Clinical trial data provided by Gilead Sciences, Inc. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Effects of rifampin on the pharmacokinetics of copanlisib, a novel pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor in cancer patients.

e14559Background: Copanlisib, an iv pan-PI3K inhibitor recently approved for treatment of relapsed follicular lymphoma, is metabolized by CYP3A4 ( > 90%) in vitro. Here, we report effects of rifamp...

Idelalisib- a PI3Kδ targeting agent for B-cell malignancies.

Idelalisib, the first in-class phosphotidlyinositol 3-kinase delta (PI3Kδ) inhibitor, was approved by the US Food and Drug Administration in July 2014. It simultaneously received breakthrough therapy designation in combination with rituximab for the treatment of relapsed chronic lymphocytic leukemia (CLL) as well as accelerated approval as monotherapy for the treatment of relapsed follicular lymphoma and relapsed small lymphocytic lymphoma. In a pivotal phase III study of 220 patients with relapsed CLL, the overall response rate of patients who received rituximab plus idelalisib was 81%. The median progression-free survival (PFS) was 5 months with rituximab plus placebo group, but was not reached in the idelalisib arm. At 24 weeks, the PFS in patients receiving idelalisib was 93%. In a phase II trial of 125 patients with relapsed or refractory indolent non-Hodgkin lymphoma who received idelalisib 150 mg twice daily, the response rate was 57%. Complete response was seen in 6% of patients. The median duration of response was 12.5 months, and median PFS was 11 months. Idelalisib is a promising new therapy for relapsed indolent B-cell malignancies.

A Single Center Phase II Trial Of 90yttrium-Ibritumomab-Tiuxetan Produces High Response Rates As First-Line Therapy For Early Stage B Cell Indolent Lymphoma, Including Bulky Disease

Background90YIT is approved for the treatment of relapsed follicular lymphoma or as consolidation therapy after first line chemotherapy. Its role as therapy for the front line treatment of early stage B cell indolent lymphoma is under investigation. Patient and MethodsThirty-one patients with B cell lymphoma: grade 1 or 2 follicular lymphoma [FL], or marginal zone lymphoma (MZL) with stages I or II were enrolled for treatment with Zevalin (90yttrium-ibritumomab-tiuxetan [90YIT]). Patients received 90YIT according to standard procedure. Primary end points were overall response rates and progression-free survival. Initial evaluation included CT scans, PET-CT, CBC and bone marrow biopsies. Assessment of response was made at 4 months, and monitored every 3, 6 and 12 months during year 1, 2 and 3 of follow up, respectively. CBC was analyzed every 2 weeks until recovery of counts. Median and range for quantitative, absolute and relative frequencies for categorical variables were calculated. PFS was estimated by using Kaplan-Meier method. ResultsTwenty-one patients had FL and 10 had MZL. The median age was 57 years (range 28-87) with 6/31 (19%) having bulky lymphoma (greater than 5 cm diameter). The overall response rate was 100% with CR 87% and Cru 13% with a median follow up of 56 months for the censored observations. The median progression free survival time has not been reached. 10 patients relapsed; 8/20 (40%) with FL and 2/11 (18%) with MZL. The rate of relapses was 33% in bulky and 32% in nonbulky lymphoma. Adverse events were primarily hematologic; the incidence of grade 3 and 4 neutropenia, thrombocytopenia, and anemia were 45% and 16%, 19% and 16% and 0% and 3%, respectively. Non-hematologic toxicity never exceeded grade 2 according to CTCAE v3.0. Conclusion90YIT is well-tolerated and has achieved high response rates in patients with early stage B cell indolent lymphoma. Bulky disease did not adversely affect tumor responses. Disclosures:Pro:Spectrum: Honoraria.

The outcome of reduced intensity allogeneic stem cell transplantation and autologous stem cell transplantation when performed as a first transplant strategy in relapsed follicular lymphoma: an analysis from the Lymphoma Working Party of the EBMT

Both auto-SCT and reduced intensity allo-SCT (RIST) are employed in the treatment of relapsed follicular lymphoma (FL). We have analysed the outcome of these two transplant procedures when used as a first transplant in this setting. We conducted a retrospective comparison of 726 patients who underwent an auto-SCT and 149 who underwent a RIST as a first transplant procedure for relapsed FL as reported to the Lymphoma Working Party of the European Bone Marrow Transplant. The non-relapse mortality (NRM) was significantly worse for patients undergoing a RIST (relative risk (RR) 4.0, P<0.001). The 1-year NRM was 15% for those undergoing a RIST compared with 3% for those undergoing an auto-SCT. Disease relapse or progression were significantly worse for those receiving an auto-SCT (RR 3.1, P<0.001). Patients undergoing a RIST had a 5-year relapse rate of 20% compared with 47% for those undergoing an auto-SCT. The PFS at 5 years was 57% for patients receiving a RIST compared with 48% for those receiving an auto-SCT. There was no significant difference in OS between the two groups. RIST is associated with a higher NRM and lower relapse rate in patients with relapsed FL.

Monoclonal Antibodies in the Treatment of Non-Hodgkin???s Lymphoma

Antibody-based therapeutic approaches have had a significant impact in the treatment of non-Hodgkin's lymphoma (NHL). Rituximab's development as an anti-CD20 antibody heralded a new era in treatment approaches for NHL. While rituximab was first shown to be effective in the treatment of relapsed follicular lymphoma, it is now standard monotherapy for front-line treatment of follicular lymphoma, and is also used in conjunction with chemotherapy for other indolent, intermediate and aggressive B-cell lymphomas. The development of rituximab has led to intense interest in this type of therapeutic approach and to development and approval of the radioimmunoconjugates of rituximab, (90)Y-ibritumomab tiuxetan and (131)I-tositumomab, which have added to the repertoire of treatments for relapsed follicular lymphoma and increased interest in developing other conjugated antibodies. Since rituximab is a chimeric antibody, there is a need to develop fully humanised antibodies, such as IMMU-106 (hA20), in order to minimise infusion reactions and eliminate the development of human antibodies against the drug. Further clinical evaluation of antibodies has been based largely on our knowledge of antigen expression on the surface of lymphoma cells and has led to the development of antibodies against CD22 (unconjugated epratuzumab and calicheamicin conjugated CMC-544 [inotuzumab ozogamicin]), CD80 (galiximab), CD52 (alemtuzumab), CD2 (MEDI-507 [siplizumab]), CD30 (SGN-30 and MDX-060 [iratumumab]), and CD40 (SGN-40). Furthermore, the VEGF (vascular endothelial growth factor) inhibitor bevacizumab, which was first approved for the treatment of colon cancer is currently under investigation in NHL, and agonists rather than antibodies to TRAIL (tumour necrosis factor-related apoptosis-inducing ligand) [rApo2L/TRAIL, HGS-ETR1{mapatumumab}, HGS-ETR2] are currently being investigated as treatments for both advanced solid tumours and NHL. Knowledge of the ability of cancer cells to become resistant to a targeted therapy by activating an alternative pathway to evade apoptosis has driven studies that combine antibodies such as epratuzumab plus rituximab (ER) or ER plus chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) [ER-CHOP], inotuzumab ozogamicin plus rituximab, alemtuzumab plus CHOP (CHOP-C), bevacizumab plus rituximab, and now the combination of rApo2L/TRAIL plus rituximab. As a result of the expansion of research in this area, several treatment-specific adverse effects have been noted, including infusion-related reactions for rituximab, myelosuppression secondary to (90)Y-ibritumomab tiuxetan and (131)I-tositumomab, and immunosuppression leading to infectious complications for alemtuzumab. Also, soluble forms of the antigens (sCD30) are now being investigated as potential mechanisms of resistance to antibody treatments by binding the antibody before the drug can bind to the lymphoma cell. In addition, it has also become apparent that these antibodies often have a dose-dependent half-life (rituximab) or long half-lives of up to 2-3 weeks (epratuzumab and galiximab) with a consequent delay to a response, thus influencing how long we should wait for a response before declaring an antibody to be ineffective. Antibody-based therapeutic approaches have already had a profound impact on the treatment of NHL, and it is almost certain that, as their clinical development progresses, we will continue to refine the optimum methods of incorporating these drugs in NHL treatment in order to offer our patients the best clinical benefits.

Radioinmunoterapia en los linfomas no Hodgkin: desarrollo histórico y estado actual

Radioimmunotherapy treatment for lymphoma is a novel targeted therapeutic approach. Several years of development of radioimmunotherapeutic compounds came to fruition in February of 2002 when 90Y-ibritumomab tiuxetan (Zevalin (™), Y2B8) was approved in the USA and later in Europe, for the treatment of relapsed or refractory, low grade or transformed B-cell lymphoma in the USA. 90Y-ibritumomab tiuxetan utilizes a monoclonal anti-CD20 antibody to deliver β-emitting yittrium-90 to the malignant B-cells. Clinical trials have demonstrated its efficacy, with observed clinical responses in the 80% range. This product has become available in Europe, with simplified administration, for the treatment of relapsed follicular lymphoma. A similar anti-CD20 radiotherapeutic compound, 131I-tositumomab, was subsequently approved in the USA. Promising studies exploring expanded applications of radioimmunotherapy as consolidation, as part of transplant, or in other histologic types have been recently completed or are under way. Radioimmunotherapy has been shown to be an effective and clinically relevant complementary therapeutic approach for patients with lymphoma, bringing the Nuclear Medicine into lymphoma therapeutics.

Response to tositumamab and 131 I-tositumomab in follicular lymphoma based on the Follicular Lymphoma International Prognostic Index (FLIPI)

6629 Background: Bexxar (tositumamab and 131 I-tositumomab) demonstrated efficacy in treatment of relapsed follicular lymphoma. Prior analyses showed that predictive factors of durable response hav...