ALBERT

Description: Introduction: Lymphomas are an important complication of HIV infection where they occur with high frequency and are a significant cause of morbidity and mortality.The most prevalent lymphoma subtype in HIV positive population is the diffuse large B cell lymphoma (DLCBL). Antiretroviral therapy (ART) and intensive chemotherapy have been introduced to these patients aiming to increase their response to treatment. Recently, dose adjusted-EPOCH (DA-EPOCH) was associated with better outcome when compared with CHOP. Since these publications, many centers in the world started treating HIV DLBCL patients with EPOCH. In Brazil, Rituximab is not allowed for the treatment of HIV lymphomas (any subtype) in the public health system, so HIV DLBCL patients usually are treated with CHOP or DA-EPOCH. Objective:To compare the progression free survival and overall survival in HIV DLBCL patients treated with CHOP and DA-EPOCH at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, a university public hospital from the southern part of Brazil. Material and Methods:A retrospective cohort of all HIV positive patients and DLBCL, treated from 2007 to 2017 at HCPA. The medical records were reviewed to collect clinical data, reports on pathology, immunohistochemistry, computed tomography (TC) and/or FDG-PET scan from diagnosis and after treatment. Overall survival and progression free survival was determined by the Kaplan-Meier method, and statistical significance was determined by a log-rank test. The study was approved by the institutional review board and complied with the Declaration of Helsinki. All patients gave written informed consent. Results:Forty-three HIV positive patients with untreated DLBCL were enrolled. The median age was 44 years, and 93% had a intermediate or high age-adjusted international prognostic index (aa-IPI). Specific adverse prognostic features included elevated LDH in 84%, B symptoms in 82%, Ann Arbor stage III or IV in 70% and extra-nodal disease in 81%. Central nervous system involvement was found in 9% of patients before treatment. Patients had a median CD4 cell count of 113 cells/mm3 with 21% having a CD4 cell count less than 50 cells/mm3 and 16% of patients were ART naive. Until 2014, CHOP was the chosen treatment for 34 patients. After 2014, DA-EPOCH was the prefered chemotherapy for HIV DLBCL patients and 9 patients were treated with this protocol. The progression free survival at 24 months was 69% in the CHOP group and 83% in DA-EPOCH (p=0.68). Overall survival at same period was 34.5% for CHOP vs 37% for EPOCH (p=0.74). CHOP and DA-EPOCH treatment groups presented similar features regarding the lymphoma and HIV infection, except for higher LDH level and aa-IPI score in the CHOP arm (p=0.02 and p=0.03, respectively). Discussion:The acquired immunodeficiency syndrome-related to DLBCL in this subgroup of patients was associated with a very high-risk prognostic score group. Moreover, 21% of them presented a low count of CD4 cells (less than 50 cells/mm3) at diagnosis. The overall survival was lower than expected for both groups and DA-EPOCH was not associated with better outcome when compared to CHOP. This unexpected finding could be explained in part by the small sample of patients treated with DA-EPOCH, the population prognostic features and the unavailability of rituximab in the treatment of these patients. The follow up study will provide more informations about the impact of DA-EPOCH in our HIV patients. The access to rituximab in HIV DLBCL treatment should be an important point of discussion with public health care providers in Brazil. Disclosures No relevant conflicts of interest to declare.

Description: Introduction: Myelofibrosis (MF) is a rare and progressive myeloproliferative neoplasm (MPN), with increased risk of death due to disease complications and progression. The only curative therapy, bone marrow transplantation, is rarely feasible due to patients' age and comorbidities. Genetic study for prognostication and JAK inhibitors drugs are not available for all patients. Thus, patients with MF, especially those with poor prognosis (int-2 and high-risk IPSS), present decreased quality of life and survival. In Brazil, there is a lack of information regarding the epidemiology and management of the disease. Aims and methods: An expert panel was conducted in June 2019 with seven hematologists from different centers to identify limitations to MF care in Brazil and address pertinent recommendations. The experts received the questions in advance, conducted a literature review, and then discussed results and proposals for MF management in Brazil. Results: Diagnosis of MF, including hematologic, morphologic, and molecular findings, is challenging. In Brazil, patients are often diagnosed in advanced phases of MF what may suggest a late referral for specialized centers. The specialists concluded that awareness about the clinical findings of MF requires attention. An effort also needs to be made regarding morphological diagnosis according to the WHO revised criteria for MPN differential diagnosis. Although the mutational profile is essential for diagnosis and risk stratification, in Brazil, most of the centers have no access to driver mutations tests. The risk stratification relies on clinical scores such as IPSS or DIPSS, which leads to a lower identification of patients with a higher risk of disease that should be considered for transplantation. Regarding the quality of life, there is a sense of low perception about symptomatic severity of patients and physicians. Symptomatic scores, not yet available in Portuguese, are not applied routinely: patients have difficulties in understanding the questions without supervision. Finally, even though the Brazilian public healthcare system is based on the principles of universal coverage, the integrality of care and equity, most patients have limited access to drugs that improve symptoms and survival, like the JAK1/2 inhibitor ruxolitinib. Availability of medications is greater in the private system. However, there is a mandatory list of drugs approved by the insurance companies and updated every two years. Thus, new drugs are not readily available even in this setting. Of note, the majority of the Brazilian population is covered by the public system, while the private system covers 24% of the entire population. Therefore, disparities in health care between public and private systems can affect MF assistance. Based on these findings, the expert panel made the following suggestions: 1) A Brazilian registry, with a representative coverage of the national territory, to better understand the MF patient journey. 2) In order to improve diagnosis, investment in hematopathologist training and molecular testing for JAK2, CALR, and MLP mutations should be encouraged. 3) New prognostic classifications, such as MIPSS70+ version 2.0, that combine genetic and clinical variables, reinforce the need for adopting molecular tests as routine risk assessment. 4) Urgent need to develop a specific instrument to assess the impact of symptoms on the quality of life. Therefore, translation and validation of MPN-SAF TSS have been recently accomplished and will be used by MF reference centers when published. 5) Lack of equity in access to treatment options between public and private system was a consensus among experts. Measures that could address this issue include the establishment of MPN reference centers according to geographic distribution and centralization of the drugs purchasing system. A recently elaborated guideline endorsed by the Brazilian Society of Hematology is being used to circumvent the lack of a national protocol. In conclusion, the identification of limiting factors for MF management leads us to propose recommendations for the Brazilian healthcare system in an attempt to improve patient care. Urgent actions should be taken to improve the unmet needs for these patients, especially in the public system where diagnostic, prognostic, and therapeutic approaches deserve special attention. Disclosures Solza: Novartis: Honoraria. Apa:Novartis: Honoraria. Magalhaes:Novartis: Honoraria. Delamain:Novartis: Honoraria. Tavares:Novartis: Honoraria. Figueiredo-Pontes:Novartis: Honoraria.

Description: Background: Acalabrutinib is a highly selective, covalent irreversible Bruton tyrosine kinase inhibitor with minimal activity against other kinases. Acalabrutinib has demonstrated durable responses as a single agent or combined with O in treatment-naïve (TN) CLL. Here, interim results are presented for the multicenter, open-label Phase 3 ELEVATE-TN study (NCT02475681), which evaluated the efficacy and safety of acalabrutinib + O vs acalabrutinib alone vs O + Clb in pts with TN CLL. Methods: Eligible pts had TN CLL requiring treatment per iwCLL criteria and were aged ≥65 y or 6, creatinine clearance

Description: Background: Indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL), is typically responsive to initial chemoimmunotherapy, but relapse is expected. Single-agent rituximab is FDA approved and frequently administered for patients with relapsed/refractory (R/R) low-grade or follicular CD20-positive B-cell NHL. Lenalidomide is an immunomodulatory agent with preclinical and clinical antilymphoma activity alone and in combination with rituximab. We compared the efficacy and safety of lenalidomide plus rituximab (R2) to rituximab (plus placebo) in patients with R/R iNHL. Methods: AUGMENT (NCT01938001) is a multicenter, double-blind, randomized phase III study of R2 vs rituximab/placebo (control) in patients with FL grade 1-3a or MZL who were previously treated with ≥ 1 prior systemic therapy with documented relapsed or refractory disease but not refractory to rituximab (refractory was defined as 〈 partial response to rituximab or rituximab-chemotherapy OR disease progression 〈 6 months after last rituximab dose). Patients were stratified by prior rituximab treatment (yes vs no), time since last antilymphoma therapy (≤ 2 vs 〉 2 years), and histology (FL vs MZL), and then randomized 1:1 to R2 or control for up to 1 year. R2 patients received oral lenalidomide 20 mg/day (d), d1-21/28 for 12 cycles plus rituximab IV 375 mg/m2 weekly in cycle 1 and d1 of cycles 2-5. Control patients received rituximab and placebo on the same schedule. Dose modifications were pre-specified in the protocol to manage toxicities. The primary endpoint was progression-free survival (PFS) per 2007 IWG criteria without PET as assessed by Independent Review Committee (IRC; central review). Secondary endpoints included overall response rate (ORR), complete response (CR), duration of response (DOR), time-to-next antilymphoma treatment (TTNLT), overall survival (OS), and safety. Results: A total of 358 patients were randomized (n = 178 R2; n = 180 control), median age was 63 years (range, 26 - 88), 34% FLIPI score ≥ 3, and histologies of 82% FL/18% MZL. Median number of prior systemic treatments was 1 (range, 1 - 12); 84% received prior rituximab and 51% had prior antilymphoma therapy within 2 years of enrollment. At median follow-up of 28.3 months, the study met its primary endpoint of PFS with HR = 0.46 (95% CI, 0.34 - 0.62; P 〈 0.0001) (Figure 1). Median PFS was 39.4 months for R2 vs 14.1 months for control. IRC-assessed ORR for R2 was 78% vs 53% for control (P 〈 0.0001). CR was 34% for R2 vs 18% for control (P = 0.001). Median DOR was 36.6 and 21.7 months for R2 and control arms, respectively. TTNLT was improved for R2 vs control with HR = 0.54 (95% CI, 0.38 - 0.78; P = 0.0007). OS data were not mature with 16 deaths reported in the R2 arm vs 26 deaths in control (HR = 0.61 [95% CI, 0.33 - 1.13]). Selected all-grade treatment-emergent adverse events (TEAEs) of interest more common in the R2 vs control arm (≥ 10% difference) were infections (63% vs 49%), cutaneous reactions (32% vs 12%), constipation (26% vs 14%), thrombocytopenia (15% vs 4%), and tumor flare reaction (11% vs 1%). Grade 3/4 TEAEs were reported in 69% R2 and 32% control patients. More frequent grade 3/4 TEAEs in the R2 vs control arm were primarily attributable to increased neutropenia (50% vs 13%) and leukopenia (7% vs 2%). Grade 5 TEAEs were reported in 2 patients in each arm. TEAEs leading to discontinuation of lenalidomide occurred in 9% of patients vs 5% for rituximab + placebo. Neutropenia was the only TEAE leading to discontinuation of lenalidomide in 〉 1 patient (n = 5). Seventy-one percent of R2 patients completed all 12 cycles of planned treatment vs 61% of control. Disease progression was the leading reason for discontinuation of lenalidomide/placebo (n = 21 R2, n = 54 control). Conclusions: R2 demonstrated superior efficacy over rituximab monotherapy (plus placebo) as measured by the primary endpoint of progression-free survival as well as secondary endpoints of ORR, CR, DOR, and TTNLT in patients with R/R FL grade 1-3a and MZL. At this early analysis, fewer deaths have been observed in the R2 arm. Despite additional hematologic toxicity, greater efficacy of the R2 regimen (and fewer early progressions) allowed more patients to complete the planned therapy and delayed the need for subsequent treatment. R2 represents an important new treatment option in patients with previously treated FL/MZL, with meaningful advantages over single-agent rituximab. Disclosures Leonard: Celgene: Consultancy; Karyopharm: Consultancy; ADC Therapeutics: Consultancy; MEI Pharma: Consultancy; Juno: Consultancy; Bayer: Consultancy; AstraZeneca: Consultancy; Sutro: Consultancy; Biotest: Consultancy; United Therapeutics: Consultancy; Pfizer: Consultancy; Novartis: Consultancy; Genentech/Roche: Consultancy; Gilead: Consultancy; BMS: Consultancy. Trněný:F. Hoffman-La Roche Ltd: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory board, Research Funding; Incyte: Membership on an entity's Board of Directors or advisory committees, Other: Advisory board; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory board; Abbvie: Honoraria, Research Funding; Gilead: Honoraria; Janssen: Membership on an entity's Board of Directors or advisory committees, Other: Advisory board; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory board; Morphosys: Membership on an entity's Board of Directors or advisory committees, Other: Advisory board; Sandoz: Honoraria. Izutsu:Otsuka: Honoraria; Bristol- Myers Squibb: Honoraria; Nihon Medi-Physics: Honoraria; Novartis: Honoraria; Mundhi: Honoraria; HUYA Bioscience International: Research Funding; Kyowa Hakko Kirin: Honoraria; Takeda: Honoraria, Research Funding; Abbvie: Honoraria, Research Funding; Amgen: Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Gilead Sciences: Honoraria; Eisai: Honoraria, Research Funding; Chugai: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding; Astellas: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Zenyaku: Research Funding; Celltrion: Research Funding; MSD: Honoraria; Ono: Honoraria, Research Funding; Symbio: Research Funding; Celgene: Consultancy, Research Funding; Solasia: Research Funding; Sanofi: Research Funding; Meiji Seika: Honoraria; Shionogi: Honoraria; Asahi Kasei: Honoraria. Fowler:Janssen: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding. Zhu:Beijing Cancer Hospital (Peking University Cancer Hospital): Employment. Scheliga:INCA - Instituto Nacional Do Cancer, Brazil: Employment. Pinto:Servier: Consultancy; BMS: Honoraria, Research Funding; MSD: Honoraria; Roche: Honoraria; Takeda: Honoraria; Celgene: Honoraria; Gilead: Honoraria. Scheinberg:Novartis: Consultancy, Speakers Bureau; Janssen: Honoraria, Research Funding; Pfizer: Speakers Bureau. Flinn:Trillium: Research Funding; Takeda: Research Funding; Calithera: Research Funding; Incyte: Research Funding; Verastem: Research Funding; ArQule: Research Funding; Janssen: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Research Funding; Forty Seven: Research Funding; Agios: Research Funding; BeiGene: Research Funding; Kite: Research Funding; Portola: Research Funding; Verastem: Consultancy, Research Funding; Celgene: Research Funding; Pfizer: Research Funding; Forma: Research Funding; Merck: Research Funding; Novartis: Research Funding; Constellation: Research Funding; Curis: Research Funding; Infinity: Research Funding; TG Therapeutics: Research Funding; Genentech: Research Funding; Gilead: Research Funding. Moreira:Instituto Português de Oncologia do Porto FG, EPE, Porto, Portugal: Employment. Liu:Celgene: Employment, Equity Ownership. Kalambakas:Celgene: Employment, Equity Ownership. Fustier:Celgene: Employment, Equity Ownership. Wu:Celgene: Employment, Equity Ownership. Gribben:Cancer Research UK: Research Funding; Unum: Equity Ownership; Novartis: Honoraria; Abbvie: Honoraria; Wellcome Trust: Research Funding; Acerta Pharma: Honoraria, Research Funding; Kite: Honoraria; NIH: Research Funding; Roche: Honoraria; Janssen: Honoraria, Research Funding; Medical Research Council: Research Funding; Celgene: Consultancy, Honoraria, Research Funding; TG Therapeutics: Honoraria; Pharmacyclics: Honoraria.

Description: Quantitative RT-PCR (RQ-PCR) is an essential test for BCR-ABL transcripts monitoring in patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI), to guide therapy and for monitoring after a discontinuation attempt in patients with deep molecular response. RT-PCR (RQ-PCR) is currently not reimbursed by the public health system in Brazil. Aims: To assess the proportion of CML patients treated with first-line imatinib eligible for discontinuation, and to calculate the financial impact resulting from IM discontinuation. Methods: Between January 2010 and December 2011, 151 consecutive cases of chronic phase myeloid leukemia treated with Glivec first-line therapy were evaluated. Between June and December 2013 there was a switch in treatment from Glivec to generic IM. Cases that exhibited stable MR4.5 for 2 years with first-line IM were selected for the study. Cases which switched treatment to second-generation inhibitors and patients older than 75 years of age were excluded from the study. The methodology used was a pharmacoeconomic cost-utility analysis. Glivec monthly cost has been estimated at U$ 3,257.54 and the generic IM U$ 365.48, while the unitary value for the PCR test was U$ 117.49. In order to calculate the period of IM consumption, the median age of the patients and the life expectancy data released in 2015 by the Brazilian Institute of Geography and Statistics (IBGE) of 75 years was considered. In the first analysis, the life expectancy for the sample group, and the total cost of treatment (cost of Glivec, generic IM and four annual RQ-PCR tests for each patient) were calculated. The second analysis consisted of a hypothetical calculation of costs under the scenario where the study group is therapy-free (estimating that the survival rate under discontinued therapy was similar to data available in the literature, with discontinuation success of 50% in this group) with molecular monitoring by PCR monthly in the first year, bimestrial in the second year and every three months from the third year on. Results: One hundred fifty-one cases were analyzed, with a median age at diagnosis of 45. From those, 56 (37%) patients achieved stable MR4.5 with a median time to achieve MR4.5 of 71 months. The median duration of follow-up was 8 (0-10) years. In the last follow-up, 108 patients were still in treatment, 10% (11/108) with Glivec, 90% (97/108) on generic IM. Patients excluded from the analysis: 4 cases aged more than 75 years; 13 that switched therapy to another TKI and one during the bone marrow transplant period. Finally, 38/56 (25%) patients who obtained MR4.5 with IM were eligible for analysis. Analysis 1: Total treatment cost for the 38 eligible cases, if the individuals sustained continuous use of IM, considering the life expectancy of 75 years. The calculations resulted in an average of 29 years of treatment, with an estimated cost of U$ 9,363,866.00. Analysis 2: The cost after discontinuation of generic IM, estimating that 50% of patients would resume the treatment. Nineteen cases were analyzed. The costs related to the monthly PCR exam in year 1, bimestrial exam in year 2 and trimester in year 3, until the patient reaches 75 years of age, have been calculated, with a total cost of U$ 7,823.515. Conclusions: The economy resulting from the discontinuation of treatment (US$1.540.340,00) by 19 patients could support 219 patients tests over 29 years, or 12.110 tests each year. This data is relevant, providing that RQ-PCR is essential for the appropriate management of CML and to allow safe discontinuation of the therapy in eligible patients. Such results may help to change the current health policies concerning RQ-PCR tests reimbursement for CML management and future attempting of TFR in Brazil. Disclosures Centrone: Novartis: Honoraria; Janssen: Honoraria. Magalhaes:Novartis: Honoraria. Pagnano:Pint Pharma: Consultancy; Abbvie: Consultancy; Sandoz: Consultancy.

Description: Introduction: Asciminib, unlike all approved TKIs that bind to the ATP site of the BCR-ABL1 oncoprotein, is a first-in-class STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor with a new mechanism of action. BOS, an ATP-competitive TKI, has shown clinical efficacy in pts who received ≥2 TKIs and in newly diagnosed CML, in prospective clinical trials. We asked if asciminib could provide superior efficacy to BOS beyond 2nd line, based on the clinical activity of asciminib monotherapy in heavily pretreated pts with CML in a phase 1 study. Methods: Adults with CML-CP previously treated with ≥2 TKIs were randomized 2:1 to asciminib 40 mg twice daily (BID) or BOS 500 mg once daily (QD). Randomization was stratified by major cytogenetic response (MCyR; Ph+ metaphases ≤35%) status at baseline. Pts intolerant of their most recent TKI were eligible if they had BCR-ABL1IS 〉0.1% at screening (19 pts with BCR-ABL1IS 10% or Ph+ 〉65% after 6 months of therapy (asciminib 10.8%, BOS 25.0%). Among the 24 pts who discontinued BOS due to lack of efficacy, 22 switched to asciminib. At baseline, ≥1 BCR-ABL1 mutation was present in 12.7% pts on asciminib (most common: F359C/V) and 17.1% on BOS (most common: M244V, F317L). Median duration of follow-up was 14.9 months from randomization to cutoff. Median duration of exposure was 43.4 wks (range, 0.1-129.9) for asciminib and 29.2 wks (range, 1.0-117.0) for BOS; median relative dose intensity was 99.7% (87-100) and 95.4% (74-100). MMR rate at 24 wks was 25.5% with asciminib and 13.2% with BOS, meeting the primary objective. The between-arm common treatment difference for MMR at 24 wks, after adjustment for MCyR status at baseline, was 12.2% (95% CI, 2.19-22.3: 2-sided P=.029). Among those pts who achieved MMR, median time to MMR was 12.7 wks and 14.3 wks with asciminib and BOS, respectively. At 24 wks, more pts on asciminib (17 [10.8%] and 14 [8.9%]) than on BOS (4 [5.3%] and 1 [1.3%]) achieved deep molecular response (MR4 and MR4.5, respectively). CCyR rate at 24 wks was 40.8% with asciminib vs 24.2% with BOS. Preplanned subgroup analysis showed that the MMR rate at 24 wks was superior with asciminib than BOS across most major demographic and prognostic subgroups, including in pts who received ≥3 prior TKIs, in those who discontinued the prior TKI due to treatment failure, and regardless of baseline cytogenetic response (Figure). Grade ≥3 adverse events (AEs) occurred in 50.6% and 60.5% of pts receiving asciminib and BOS, respectively. The proportion of pts who discontinued treatment due to AEs was lower with asciminib (5.8%) than BOS (21.1%). Grade ≥3 AEs and AEs requiring dose interruption and/or adjustments were reported less frequently with asciminib than BOS (Table 2). Most frequent grade ≥3 AEs (occurring in 〉10% of pts in any treatment arm) with asciminib vs BOS were thrombocytopenia (17.3%; 6.6%), neutropenia (14.7%; 11.8%), diarrhea (0%, 10.5%), and increased alanine aminotransferase (0.6%, 14.5%). On-treatment deaths occurred in 2 pts (1.3%) on asciminib (ischemic stroke and arterial embolism, 1 pt each) and 1 pt (1.3%) on BOS (septic shock). Conclusions: In this first controlled study comparing treatments for resistant/intolerant (R/I) pts with CML, asciminib, a first-in-class STAMP inhibitor, demonstrated statistically significant and clinically meaningful superiority in efficacy compared with BOS (primary objective), deeper MR rates, and a favorable safety profile. These results support the use of asciminib as a new treatment option in CML, particularly in R/I pts who received ≥2 prior TKIs. Disclosures Hochhaus: Novartis: Research Funding; Incyte: Research Funding; Pfizer: Research Funding; Bristol Myers Squibb: Research Funding. Boquimpani:Novartis: Speakers Bureau. Rea:BMS: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees. Minami:Pfizer Japan Inc.: Honoraria; Takeda: Honoraria; Bristol-Myers Squibb Company: Honoraria; Novartis Pharma KK: Honoraria. Lomaia:Bristol Myers Squibb: Speakers Bureau; Pfizer: Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Voloshin:Novartis: Honoraria, Speakers Bureau. Turkina:Pfizer: Honoraria; Novartis Pharma: Honoraria; BMS: Honoraria. Kim:Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; ILYANG: Consultancy, Honoraria, Research Funding; Takeda: Research Funding; Sun Pharma.: Research Funding. Apperley:Bristol Myers Squibb: Honoraria, Speakers Bureau; Incyte: Honoraria, Research Funding, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Pfizer: Honoraria, Research Funding, Speakers Bureau. Cortes:Pfizer: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; BioPath Holdings: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Telios: Research Funding; Astellas: Research Funding; Amphivena Therapeutics: Research Funding; Arog: Research Funding; BiolineRx: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Bristol-Myers Squibb: Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Jazz Pharmaceuticals: Consultancy, Research Funding; Immunogen: Research Funding; Merus: Research Funding; Sun Pharma: Research Funding. Abdo:Novartis: Honoraria; Takeda: Honoraria. Kim:Paladin: Consultancy, Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Research Funding. le Coutre:Pfizer: Honoraria; Incyte: Honoraria; Novartis: Honoraria. Saussele:Novartis: Honoraria, Research Funding; Incyte: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Pfizer: Honoraria. Hughes:BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Chee:Novartis: Other: Travel support for attendance at investigator meeting. García Gutiérrez:Novartis Pharma AG: Consultancy, Honoraria, Other: travel/accommodations/expenses, Research Funding; Pfizer: Honoraria, Other: travel/accommodations/expenses, Research Funding; Incyte: Consultancy, Honoraria, Other: travel/accommodations/expenses, Research Funding. Sasaki:Pfizer Japan: Consultancy; Otsuka: Honoraria; Novartis: Consultancy, Research Funding; Daiichi Sankyo: Consultancy. Aimone:Novartis: Current Employment. Allepuz:Novartis: Current Employment. Quenet:Novartis: Current Employment. Bédoucha:Novartis: Current Employment. Mauro:Bristol-Myers Squibb: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Novartis: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Takeda: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Pfizer: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Sun Pharma/SPARC: Research Funding.

Description: Introduction: The open-label, international, randomized, phase 3 KEYNOTE-204 (NCT02684292) study showed that in pts with R/R cHL, the PD-1 inhibitor pembro was superior to BV and demonstrated statistically significant, clinically meaningful improvement in PFS, with safety consistent with previous reports. This post hoc exploratory analysis of KEYNOTE-204 evaluated pembro vs BV by number of prior lines of therapy. Methods: Eligible pts were aged ≥18 y, had measurable disease and ECOG PS 0 or 1, and were post−autologous stem cell transplant (auto-SCT) or ineligible for auto-SCT. Pts who were BV-naive or BV-exposed were also eligible. Pts were randomized 1:1 to pembro 200 mg IV Q3W or BV 1.8 mg/kg IV Q3W. Randomization was stratified by status after 1L therapy (primary refractory vs relapsed

Description: Introduction: Chronic lymphocytic leukemia (CLL) typically occurs in elderly patients and has a highly variable clinical course. It is important to understand the aspects that affect the outcomes of CLL in a real-world setting. Besides biological factors, other socioeconomic and health system factors may influence the clinical course of CLL. Hence, data from the Brazilian Registry of CLL was analyzed to compare clinical and treatment-related characteristics in patients with CLL treated in public or in private institutions in Brazil. Objective: To describe the outcomes of a series of CLL patients followed in public or in private hospitals in Brazil. Methods: The Brazilian Registry of CLL was started in 2004 as a prospective non-interventional data collection tool. Inclusion criteria for enrollment followed the IWCLL guidelines. For this analysis, we included all patients with minimum available data for analysis of patient and disease characteristics and survival. Results/discussion: From January 2004 to July 2020, 2927 patients from 37 centers met eligibility criteria for this analysis: 2324 (79%) were followed at public hospitals and 603 (21%) at private hospitals. The majority were male (57%), with median age of 65 years (ranging from 23 to 106). Binet stage was A in 1618 (58%) patients, B in 628 (23%) and C in 525 (19%). FISH for del(17p) was performed in only 479 patients (16%), while FISH for the most common aberrations [del(13q), +12, del(11q), and del(17p)] was performed in only 445 patients (15%). IGVH mutational status was performed in only 211 patients (7%), and karyotype in only 140 patients (5%). Comparing public and private hospitals, we observed that patients in public hospital are slightly older (median age 66 years vs. 64 years for private hospitals, P=0.04), had more advanced diseases at diagnosis (frequency of Binet B or C was 44% in public vs. 32% in private hospital, P