Safety and Efficacy of Tenalisib Given in Combination with Romidepsin in Patients with Relapsed/Refractory T-Cell Lymphoma: Final Results from a Phase I/II Open Label Multi-Center Study

Background: Tenalisib (RP6530), a highly selective PI3K δ/γ and SIK3 inhibitor has shown promising activity as a single agent in T Cell lymphoma (TCL) and a differentiated safety profile (Huen A et al., Cancers,2020). In vitro studies in TCL cell lines showed synergistic activity when tenalisib was combined with romidepsin. A Phase I/II study of tenalisib in combination with romidepsin was designed to assess safety, pharmacokinetics, and efficacy in patients with relapsed/refractory (R/R) TCL peripheral (PTCL) and cutaneous T cell lymphoma (CTCL) (NCT03770000). Methods: This was a multi-center, open label study. We performed a Phase I, 3+3 dose escalation study to determine the MTD/recommended Phase II dose (RP2D), and a dose expansion study in both the subtypes separately (PTCL and CTCL). Patients received tenalisib at doses ranging from 400-800 mg BID (fasting), orally in combination with romidepsin at doses ranging from 12-14 mg/m 2, intravenously, given on Days 1,8 and 15 of a 28-day cycle. Results: Thirty-three patients (16 PTCL and 17 CTCL) who received more than 1 prior therapy were enrolled in the study; 9 in dose escalation and 24 in dose expansion. Of the 33 patients, 64% were refractory to their last therapy. The median number of prior therapies was 3. Most patients (67%) had stage III/IV disease at time of enrolment. No dose limiting toxicity (DLT) was reported during dose escalation; tenalisib 800 mg BID with romidepsin 14 mg/m 2 (given on Days 1, 8, and 15) was chosen as the RP2D. The most frequent treatment emergent adverse events (TEAEs) were nausea (All: 73% and ≥G3:0%), thrombocytopenia (All:57% and ≥G3:21%), fatigue (All: 54% and ≥G3:6%), AST elevation (All:33% and ≥G3:6%) ALT elevation (All:27% and ≥G3:18%), neutropenia (All: 27% and ≥G3:15%), vomiting (All:27% and ≥G3:0%), decreased appetite (All: 27% and ≥G3:0%). There were no unexpected TEAEs. Among CTCL patients, five related TEAEs led to drug discontinuation were sepsis, ALT elevation, GGT elevation, rash, and dysgeusia. None of the PTCL patients discontinued the study drug due to related TEAEs. Incidences of TEAEs leading to drug interruption (72%) and dose reduction (45%) of any the drugs in the combination were similar in PTCL and CTCL groups. Based on C max and AUC, dose proportional exposure of tenalisib was observed from doses 400-800 mg BID. Co-administration of romidepsin with tenalisib did not significantly alter the PK of either agent. Of the 33 patients enrolled, 27 (12 PTCL and 15 CTCL) who received at least 1 dose of study drug and provided at least 1 post-baseline efficacy assessment were considered evaluable for efficacy as per protocol. The overall response rate (ORR) was of 63%; 7 (26%) patients achieved CR and 10 (37%) patients had PR (Table 1). The median duration of response (DoR) was 5.03 months (range: 2.16 months-Not Reached). In twelve evaluable PTCL patients, the ORR was 75% with 6 CR (50%) and 3 PR (25%). Among 15 evaluable CTCL patients, 8 responded with an ORR of 53.3%, 1 CR (6.7%) and 7 PR (46.7%). The median DoR was 5.03 (range: 2.16 months-Not Reached) for PTCL and 3.8 months (1.9-18.86) for CTCL. Three of the six (50%) PTCL patients with CR were bridged to transplant. Six patients who benefitted with the treatment and completed the protocol were enrolled in an open-label compassionate medication study after Cycle 7 and are being followed up. Conclusions: The combination of tenalisib and romidepsin demonstrates a favorable safety profile and promising anti-tumor activity in patients with R/R TCL. Based on these encouraging results, further development of this combination in PTCL patients in being planned. Figure 1 Figure 1. Disclosures Huen: Rhizen: Research Funding; Elorac: Research Funding; Kyowa Kirin: Research Funding; Tillium: Research Funding; Innate: Research Funding; Galderma: Research Funding; Miragen: Research Funding. Ai: Kymria, Kite, ADC Therapeutics, BeiGene: Consultancy. Feldman: Alexion, AstraZeneca Rare Disease: Honoraria, Other: Study investigator. Alderuccio: ADC Therapeutics: Consultancy, Research Funding; Oncinfo / OncLive: Honoraria; Puma Biotechnology: Other: Family member; Inovio Pharmaceuticals: Other: Family member; Agios Pharmaceuticals: Other: Family member; Forma Therapeutics: Other: Family member. Kuzel: Cardinal Health: Membership on an entity's Board of Directors or advisory committees; Exelixis: Membership on an entity's Board of Directors or advisory committees; Genomic Health: Membership on an entity's Board of Directors or advisory committees; Sanofi-Genzyme Genomic Health Tempus laboratories Bristol Meyers Squibb: Honoraria; Abbvie: Other; Curio Science: Membership on an entity's Board of Directors or advisory committees; AmerisourceBergen Corp: Membership on an entity's Board of Directors or advisory committees; CVS: Membership on an entity's Board of Directors or advisory committees; Tempus Laboratories: Membership on an entity's Board of Directors or advisory committees; Bristol Meyers Squibb: Membership on an entity's Board of Directors or advisory committees; Merck: Other: Data Monitoring Committee Membership; Amgen: Other: Data Monitoring Committee Membership; SeaGen: Other: Data Monitoring Committee Membership; Medpace: Other: Data Monitoring Committee Membership.

Four-Fold Increased Mortality from Sars-Cov-2 Infection in Patients with Hematologic Versus Non-Hematologic Malignancies Treated at the Largest Tertiary COVID-19 Center in Chicago/Rush University Medical Center (March 1, 2020-December 31,2020)

N.K.Y., P.C., & P.R.Y. contributed equally to this study Introduction: Many studies have concluded that active cancer patients infected with SARS-CoV-2 have a more complicated infection course and worse outcomes compared to the general patient population hospitalized with COVID-19. However, little evidence exists whether having a history of cancer plays a significant role in these observations. Patients with hematologic malignancy (HM) might have worse prognosis among all cancer patients but the reason remains unclear. Our objective is to evaluate outcomes and severity of COVID-19 in patients with Hematological Malignancy (HM) versus Solid-tumors (ST) in different clinical settings and also compare these outcomes within the group of patients with hematological malignancies. Methods: This retrospective study examines risk factors and outcomes of COVID-19 in patients with a history of cancer and laboratory-confirmed COVID-19 diagnosis between March 1 st, 2020, and December 31 st, 2020, at Rush University Medical Center, one of the largest COVID-19 tertiary care hospitals in Chicago. Baseline characteristics, malignancy type and types of cancer treatment within the last 30 days were recorded. Measures of COVID-19 severity included hospital admission versus outpatient care, use of oxygen, intensive care unit (ICU) admission, and mechanical ventilation. The primary outcome was death. Statistical analysis was conducted using optimal discriminant analysis, a non-parametric exact machine-learning algorithm which identifies the relationship between independent and dependent variables that maximizes model predictive accuracy adjusted to remove the effect of chance. Analysis was performed separately for each attribute using the entire sample ("training" analysis), then one-sample jackknife analysis was conducted to estimate cross-generalizability of findings using the model to classify an independent random sample. Results: 378 total patients with a history of cancer tested positive for COVID-19 within the time frame of the study. Of these, 294 (78%) patients had ST malignancy and 84 (22%) patients had HM. Characteristics and outcomes are summarized in Table 1. ST patients were marginally older than HM patients (p<0.025). A significantly greater proportion of HM patients were male (p<0.0023). HM and ST patients did not differ with respect to percentage receiving active cancer treatment (p<0.81). Compared to ST patients, more HM patients had received corticosteroids in the 30 days prior to COVID-19 diagnosis (p<0.017), had higher rates of hospitalization (p<0.0013) and ICU requirement (p<0.0001) with a significantly longer length of ICU stay (p<0.0036). Compared to ST patients, HM patients also required oxygen (p<0.002) and mechanical ventilation (p<0.0005) more often and had a 3.88-fold statistically higher death rate (OR 3.88 [95% CI 1.62-9.29] p<0.003). Patients with HM are categorized by disease subtype and summarized in Table 2. The case fatality rate from COVID-19 was 33.3% for patients with myeloproliferative neoplasms/myelodysplastic syndromes (MPN/MDS), 21.4% for patients with chronic lymphocytic leukemia (CLL), 13.6% for patients with non-Hodgkin lymphoma, 10.5% for patients with plasma cell neoplasms, and 4.5% for patients with acute leukemia. When looking at outcomes, CLL had the highest percentage of patients requiring hospital admission, oxygen, and ICU admission, and MPN/MDS had the highest percentage of patients requiring mechanical ventilation. Conclusions: Patients with hematologic malignancies had more severe COVID-19 illness and hospitalization rates and a 3.88-fold higher rate of death than patients with solid tumors. The comparable proportion of patients on anti-cancer therapy despite differences in survival suggests that being on anti-cancer therapy is less important than the underlying diagnosis of HM versus ST as a determinant of poor outcomes. Clinicians should closely monitor and initiate early COVID-19 treatments for all patients with HM and COVID-19. Because HM are highly heterogenous group of cancers, it is important to look at subtypes in greater detail. Numerous patient-level, disease-specific, and therapy-related factors may impact outcomes of COVID-19 among patients with HM, and we are currently analyzing additional data to better understand the factors which make this disease group more susceptible to severe infection. Figure 1 Figure 1. Disclosures Kuzel: Sanofi-Genzyme Genomic Health Tempus laboratories Bristol Meyers Squibb: Honoraria; Genomic Health: Membership on an entity's Board of Directors or advisory committees; Exelixis: Membership on an entity's Board of Directors or advisory committees; Cardinal Health: Membership on an entity's Board of Directors or advisory committees; Abbvie: Other; Curio Science: Membership on an entity's Board of Directors or advisory committees; AmerisourceBergen Corp: Membership on an entity's Board of Directors or advisory committees; CVS: Membership on an entity's Board of Directors or advisory committees; Tempus Laboratories: Membership on an entity's Board of Directors or advisory committees; Bristol Meyers Squibb: Membership on an entity's Board of Directors or advisory committees; Merck: Other: Data Monitoring Committee Membership; Amgen: Other: Data Monitoring Committee Membership; SeaGen: Other: Data Monitoring Committee Membership; Medpace: Other: Data Monitoring Committee Membership.

Fixed Duration Combination Therapy with Ibrutinib (ibr) and Venetoclax (ven) Leads to Deep Responses in Relapsed/Refractory (rel/ref) Chronic Lymphocytic Leukemia (CLL): Results of a Phase 2 Study

Introduction: Ibr and ven are 1 st generation BTK and BCL2 inhibitors respectively that are approved for use in patients with CLL. They are both oral agents that have been shown to work synergistically together with no unexpected toxicities beyond what is already known about each of them. Their combination is very effective in the frontline treatment of CLL including fixed duration therapy for 15 cycles which produces high complete remissions (CR) and undetectable minimal residual disease (uMRD) rates as well as high progression free survival (PFS) and overall survival (OS) independent of high-risk features [Allen JH, et al. EHA virtual annual meeting 2021; Jain N, et al N Engl J Med 2019]. There is also data to support the use of this combination in the rel/ref setting [Hillmen P, et al. J Clin Oncol 2019] and here we present results of a phase 2 trial of fixed duration therapy with ibr+ven in rel/ref CLL (NCT03045328). Methods: Patients with rel/ref CLL with indications for treatment were enrolled at Stanford Cancer Institute and City of Hope National Medical Center. Treatment was initiated with ibr monotherapy (420mg daily) for 8 weeks after which ven ramp up was introduced. Ven was escalated to full dose (400mg daily) over 5 weeks and the combination of ibr+ven was then continued for a total of 2 years. Treatment was stopped in all patients at week 118 and all patients were evaluated 30 days later to complete study follow up. The primary endpoint was the assessment of CR rate at week 62. Secondary endpoints included overall response rate (ORR), duration of response (DOR), PFS, OS, evaluation of adverse events (AEs), as well as rate of uMRD in the bone marrow at week 62 and week 117 of treatment by flow cytometry (10 -4 sensitivity [uMRD4]) and Clonoseq sequencing (10 -6 sensitivity [uMRD6]). Results: A total of 22 patients were enrolled. Median age of the patients was 68 (range 39-82 years). Median prior treatment regimens were 1 (range 1-3). Eleven patients received prior FCR as 1 st line therapy, 9 received BR, 1 received FR, and 1 had received rituximab alone. None had prior BTK inhibitor or ven. Baseline characteristics are shown in Table 1. Twenty-one patients initiated ven. One patient withdrew consent prior to the start of ven. Eighteen patients completed full trial treatment. Three patients discontinued treatment for these reasons: Hodgkin's transformation, kidney failure, need for a coronary stent. Five patients interrupted dosing due to toxicity and five patients had dose reductions. Three patients reduced ibrutinib, 2 due to rash and 1 due to recurrent atrial fibrillation, and 5 patients reduced ven due to fatigue, neutropenia (2), or diarrhea (2). CR rate (intention to treat [n=22]) at week 62 was 55% while the ORR was 91%. PFS and OS were 95% and 100% at 2 years. After 1 year of combination therapy, 13 of 20 (65%) evaluable patients had achieved bone marrow uMRD4 (5 positive and 2 not done) and 4 of 20 (20%) achieved bone marrow uMRD6. After 2 years, 2 additional patients achieved bone marrow uMRD4 (15 of 20 [75%]). Bone marrow flow and Clonoseq MRD data were available in 13 patients at the end of study. Eight were undetectable by flow and Clonoseq (uMRD6), 3 by flow only (uMRD4), and 2 were positive with both (MRD+). Seven patients experienced 11 serious AEs attributed to treatment: 3 with sepsis, 3 pneumonia, 2 atrial fibrillation, and 1 each diarrhea, dehydration, and pulmonary embolism. AEs ≥ Grade 3 are shown in Table 2. There were no TLS events. Conclusions: Ibr+ven combination for a fixed duration of 2 years after initial ibrutinib lead in is a well-tolerated, effective, oral, targeted therapy regimen for patients with rel/ref CLL. Most patients achieve an uMRD4 response in the bone marrow. The effect of poor risk features of disease and dose interruptions on depth of response will be reported. Figure 1 Figure 1. Disclosures Siddiqi: Janssen: Speakers Bureau; Oncternal: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pharmacyclics LLC, an AbbVie Company: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Kite Pharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; BeiGene: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Juno Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics: Research Funding. Coutre: Acerta: Other: Data Safety Monitoring Committee, Research Funding; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Beigene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Data Safety Monitoring Committee, Research Funding; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

MEKANISME GOOD CORPORATE GOVERNANCE DAN DEWAN PENGAWAS SYARIAH PADA KINERJA KEUANGAN PERBANKAN SYARIAH INDONESIA

This study aims to discuss and analyze about how the mechanism internal of good corporate governance such as: Effect of audit committe effectiveness on the performance of sharia banking, Effect of risk monitoring committee effectiveness on sharia banking performance, Effect of remuneration and nomination committee effectiveness on sharia banking performance, and also sharia supervisorsboard effectiveness on sharia banking performance in Indonesian between 2014-2018. The data used in this study are secondary data by measuring the number of meetings taken from each variable. The method used in sample selection is purposive sampling. The number of samples in this study were 12 banks taken from the annual report with 60 samples. The hypothesis test used in this study is the statistical t test. The data analysis technique used in this study is multiple linear analysis using statistical products and service solutions (SPSS) version 20.0. The results of the study showed that the effectiveness of audit committee, risk monitoring committee, nomination and remuneration committee, and sharia supervisory board had a positive effect on the financial performance of sharia banking

Peran Monitoring Terhadap Peningkatan Kinerja Keuangan di Industri Perbankan Indonesia

The purpose of this study was to examine the role of company monitoring on the financial performance of Regional Development Banks (BPD) in Indonesia. The monitoring role is proxied by the characteristics of the Board of Commissioners, the Audit Committee and the Risk Monitoring Committee. Financial performance is measured by Return on Assets (ROA). By purposive sampling, secondary data was selected from 66 annual reports of Regional Development Banks (BPD) for 2017-2019 in Indonesia. The average level of financial performance is at 4.11%. This figure shows that the company's assets to generate profits for shareholders amounted to 4.11%. The regression results show that there is a positive influence on the proportion of independent commissioners on financial performance at Regional Development Banks and there is a positive influence on the size of the risk monitoring committee on financial performance at Regional Development Banks. Other Results The size of the board of commissioners, the size of the audit committee and the number of audit committee meetings have a negative effect. While the control variable, namely company size, has a positive effect in predicting financial performance.

Courts, COVID-19, and the Indigenous People

The present study aims to analyze how the government and the Brazilian Supreme Court are dealing specifically with the situation of indigenous people in the global pandemic scenario of COVID-19. The Brazilian indigenous people, a group vulnerable and marginalized, face specific and even greater problems in the fight against coronavirus for several historic reasons, such as the existence of trespassers in their lands, logistics for the treatment of the disease in remote locations, and misleadings and failures, commissive and omissive, in public policies, potentialized for the socio-epidemiological characteristics of the group. This study will turn to the analysis of the constitutional remedy filed by Articulation of Indigenous People of Brazil (ADPF 709) and the Brazilian Supreme Court structural injunction relief with the objective that the government take specific measures to protect the indigenous people in the global pandemic scenario. The Court ruled to establishing sanitary barriers, determining a situation room and a mixed monitoring committee, among another measures.

Efficacy of Top down audits and Community Monitoring

In this paper we survey the recent literature on top down audits and community monitoring. Whilein the case of top down audits the efficacy of audits depends on the type of punishment- electoral punishmentvs legal punishment, the literature finds that electoral punishment is less effective than legalpunishment. Moreover, electoral punishment depends on whether voters are aware of audit reports.The type of service being audited - the opportunity for corruption and the clarity of rules and regulationseffect the success of audits. However, even when top down audits succeed in cutting down corruption,they may not always lead to better outcomes. Social audits are effective when collective actionproblems are less salient e.g. when groups are homogeneous, when the design is such that communityparticipants feel empowered e.g. through elections to the monitoring committee, information is notuseful by itself unless accompanied by tools to influence outcomes, and finally there is not a clear mapbetween finding corruption and improving ultimate outcomes. We suggest that a fertile area for futureresearch is the design of optimal audit schemes that take account of the opportunities for corruptionand the motivations of both the providers and the auditors.

Development and Evaluation of Internet-based Geographic and Environment Biodiversity Information System in Nueva Ecija

This study delved on the development and evaluation of an Internet-based geographic, environment, and biodiversity information system in the province of Nueva Ecija, Philippines. The purpose of this study was to help facilitate various environment and biodiversity management processes, which includes a tool for facts-based decision-making, operation, monitoring, and evaluating ecosystems. The researcher implemented a research and development design wherein the developed system underwent design and development, testing, and evaluation for its significance. This research design used the SCRUM Agile Methodology as a guide in developing and improving the capability of the system. The system was developed based on the requirements of the users and pilot tested to determine its usability. The end users consisted of ten (10) Provincial Environment and Natural Resources Office (PENRO) employees and Biologist/Biodiversity Monitoring Committee members, and twenty (20) people from the community. They agreed that the developed system was usable, functional, reliable, and user-friendly. Moreover, three (3) Information Technology (IT) experts agreed that the system uses an appropriate database design, user interface. The IT experts also approved that the developed system was functional, maintainable, and secured.

Impact of Cryopreservation of Donor Grafts on Outcomes of Allogeneic Hematopoietic Cell Transplant (HCT)

Introduction: Cryopreservation of peripheral blood stem cell (PBSC) or bone marrow (BM) grafts is rarely performed, thus information about the effect of cryopreservation on graft characteristics and HCT outcomes is limited. Given the global pandemic leading to changing practices for donor graft collection and increasing utilization of cryopreservation, we evaluated the outcomes of HCT recipients who received either fresh or cryopreserved allogeneic BM or PBSC grafts. The primary endpoint was engraftment. Secondary endpoints were incidence of acute graft-vs.-host disease (aGVHD), relapse, transplant related mortality (TRM), disease free survival (DFS), and overall survival (OS). Methods: We included 7397 patients transplanted between 2013 and 2018. 1883 cryopreserved graft recipients were divided into three cohorts based on graft source and donor type: matched related (MRD) PBSC (n=1,051), matched unrelated (MUD) PBSC (n=678), and matched related or unrelated bone marrow donors (n=154). All patients received conventional calcineurin-based GVHD prophylaxis strategies. Patients who received cryopreserved grafts were matched with 5514 patients who received fresh adjusting for graft type (BM vs. PB), donor source (MRD vs. 8/8 MUD), Disease Risk Index (DRI, low risk vs. intermediate risk vs. high risk), recipient age (within 5-years) and propensity score (within 1 standard deviation from pooled sample). The propensity score was based on age, Karnofsky score, diagnosis, disease risk index, HCT-comorbidity index, and conditioning intensity. The level of statistical significance for the main analyses was p<0.01 due to multiple comparisons. The reason for cryopreservation was available on a subset of URD product recipients. Results: Baseline characteristics for all cohorts are shown in Table 1. CD34+ doses reflect enumeration at infusion. In univariate analyses, rates of graft failure and neutrophil recovery at day 28 were similar for cryopreserved and fresh grafts for BM or related PBSC recipients but differed in cryopreserved vs. fresh MUD PBSC (5% vs 2%, p<0.001 and 87 vs 94%, p<0.001, respectively). Rates of platelet recovery within 28 days were similar in marrow cohorts, but lower with cryopreserved related (92% vs 96%, p<0.001) and MUD PBSC (87 vs 94%, p<0.001) grafts. In matched pair multivariable analyses, there were no significant differences in any outcomes with cryopreserved vs fresh BM grafts, irrespective of donor type. With related donor PBSC, cryopreservation was associated with decreased platelet recovery (HR=0.73, CI=0.68-0.78, p<0.001) and an increased risk of both grade II-IV (HR=1.27, CI=1.09-1.48, p=0.002) and grade III-IV (HR=1.48, CI=1.19-1.84, p<0.001) aGVHD, but had no impact on other outcomes. In contrast, with MUD PBSC grafts, cryopreservation was associated with delayed engraftment of neutrophils (HR=0.77, CI=0.71-0.84, p<0.001) and platelets (HR=0.61, CI=0.56-0.66, p<0.001), an increased risk of TRM (HR=1.4, CI=1.18-1.66, p<0.001) and relapse (HR=1.32, CI=1.11-1.58, p=0.002), and decreased DFS (HR=1.36, CI=1.20-1.55, p<0.001) and OS (HR=1.38, CI=1.22-1.58, p<0.001) but did not affect the incidence of aGVHD. In a subset analysis of 299 URD recipients, the most common reason for cryopreservation was delays due to patient-related events, eg., additional chemotherapy, infection. These recipients had decreased OS compared to products cryopreserved for non-patient reasons (HR=0.65, CI=0.44-0.96, p=0.029). Conclusions: The retrospective nature of this analysis, and the fact that cryopreservation is likely to have been performed in recipients with a different (higher) risk profile compared to those receiving fresh products limits our ability to draw firm confusions. Despite these limitations, we conclude that cryopreservation in some patient populations may have a negative impact on engraftment and transplant outcomes. The decision to cryopreserve donor grafts, particularly PBSC grafts, should be carefully considered and highlights the need for further investigation of the effect of cryopreservation of allogeneic grafts where patient factors can be controlled for. Disclosures Farhadfar: CSL Behring: Research Funding; Incyte pharmaceutical: Other: Member of GVHD advisory forum. Frey:Kite Pharma: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Syntax: Consultancy, Honoraria. Devine:Magenta Therapeutics: Consultancy. Shaw:Orca Bio: Consultancy. Wingard:Shire: Other: Personal Fees - serve on data monitoring committee for clinical trial; Ansun: Other: Personal Fees - serve on data monitoring committee for clinical trial; Merck: Other: Personal Fees - serve on data monitoring committee for clinical trial; Cidara: Other: Personal Fees - serve on data monitoring committee for clinical trial; ReViral: Other: Personal Fees - serve on data monitoring committee for clinical trial.