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e20049 Background: Rituximab (RTX) is an effective therapy for some patients with CD20 positive (CD20+), B-cell malignancies. Infusion-related reactions (IRRs) are the most common adverse event (AE) associated with infusion of RTX. The objective of this analysis was to assess if IRRs were correlated with infusion rates of the first dose of the RTX biosimilar PF-05280586 (RTX-PF) or reference RTX sourced from the EU (RTX-EU). Methods: This analysis incorporates data from a randomized, double-blind comparative trial of 394 patients (RTX-PF, n = 196; RTX-EU, n = 198) with low tumor burden follicular lymphoma. RTX was administered at a dose of 375 mg/m2 on days 1, 8, 15 and 22 (one cycle), with a follow-up period through 52 weeks. Logistic regression analysis was performed with infusion rate and treatment or maximum serum concentration (Cmax) as independent variables. Treatment or Cmax was excluded from the model if not significant. Descriptive statistics of baseline CD20+ B-cell level, baseline anti-drug antibody (ADA) status and baseline tumor burden (Ann Arbor stage and bone marrow biopsy lymphoma results) were summarized by occurrence of IRR (yes/no). Results: The median RTX infusion duration on day 1 was 3.50 h for each of the two treatments. There was a significant positive correlation between infusion rate and all-grade IRR AEs occurring within 24 h after infusion (p < 0.0001). The estimated probability of developing an IRR was 0.16 and 0.29 at infusion rates of 189 mg/h and 227 mg/h, respectively. The estimated odds ratio with an increase in rate of 100 mg/h was 7.7. Treatment (RTX-PF or RTX-EU) was not a significant covariate and was excluded from the model. There was a non-significant trend between Cmax of RTX and developing an IRR; the estimated probability of developing an IRR was 0.26 at the median Cmax (196.5 μg/mL) of RTX. Patients who developed IRRs had a higher median baseline CD20+ B-cell level. The trough plasma concentration (Ctrough), collected before the second dose, and baseline tumor burden did not correlate with increased IRR incidence. Baseline ADA status did not predict IRR outcome. Conclusions: The results of this analysis suggest that higher infusion rates of RTX, administered as RTX-PF or RTX-EU, are positively correlated with IRR after the first dose. Clinical trial information: NCT02213263 .

e21663Background: Medication-related osteonecrosis of the jaw (MRONJ) is defined as exposed jawbone or bone that can be probed through a fistula, persisting for 8 or more weeks. MRONJ occurs in the...

TPS2606Background: Certain tumor types show dramatic responses to targeted treatments based on demonstration of the corresponding molecular abnormality. The NCI-MATCH study hypothesizes that patients (pts) across a range of histologies whose tumors share molecular abnormalities that have been shown to respond to a targeted treatment may respond to that same treatment, and that responsiveness or resistance may be predictable by concurrent molecular abnormalities. Methods: Pts with refractory solid tumors or lymphomas have molecular profiling on a proximate biopsy, using a validated, locked next generation sequencing (NGS) assay (143 genes; single nucleotide variants, copy number variants and fusions) and selected other molecular assays. The trial will have > 20 phase II targeted treatments (arms). Drugs are provided by various pharmaceutical companies and could be FDA approved or investigational single agents or combinations. The arms are placed under a “master protocol”, allowing new arms to be added to r...