CTIM-32. IMMUNE CHECKPOINT INHIBITOR NIVOLUMAB IN PEOPLE WITH RECURRENT SELECT RARE CNS CANCERS: RESULTS OF INTERIM ANALYSIS IN A HEAVILY PRETREATED COHORT

INTRODUCTION Standard and experimental therapies for patients with rare CNS tumors are scarce. Nivolumab (PD-1 inhibitor) is approved for several non-CNS cancers. This ongoing Phase II trial (NCT03173950) will determine the efficacy of nivolumab in adults with recurrence/progression of one of 11 selected rare primary CNS tumors. Efficacy is measured by Disease Control Rate (DCR; confirmed CR/PR or durable SD for ≥ 6 months) in 2 cohorts: heavily and non-heavily pretreated patients (heavily pretreated: ≥ 3 prior therapies; non-heavily pretreated: ≤ 2). We report efficacy and safety results of a preplanned interim analysis in the heavily pretreated cohort. METHODS Eligibility includes recurrence/progression of an eligible tumor; age ≥ 18 years; tumor tissue available for histopathology, molecular and immune profiling; KPS ≥ 70; and no steroids at study entry. A total of 150 evaluable patients will be enrolled (75 to each cohort). Prior therapies include radiation and/or standard or investigational drugs. Nivolumab treatment is 240 mg IV every 2 weeks (4 doses); then 480 mg every 4 weeks (14 additional doses). Interim analysis was planned when sample size reached 32 in each cohort. RESULTS As of March 10, 2021, DCR exceeded the minimum required for interim analysis in the heavily pretreated cohort. Among 30 patients, 4 achieved SD > 6 months (medulloblastoma, anaplastic ependymoma, myxopapillary ependymoma, metastatic atypical meningioma). Safety profile (related AEs): grade 3 = 7; grade 4 = 1. Most frequent grade 3-5 AEs regardless of attribution: tumor progression (6); anemia, hydrocephalus, lymphopenia (3 each); cerebral edema, headache (2 each). CONCLUSION DCR exceeded the “go” boundary (i.e., > 2) in the heavily pretreated cohort. Nivolumab showed safety profile consistent with other studies. This cohort will continue to stage 2 and complete total accrual of 75 patients. The trial is currently being expanded to 10 additional sites across the BTTC/NCI-CONNECT consortium.

PENDETEKSIAN KECURANGAN LAPORAN KEUANGAN DENGAN BENISH M-SCORE PADA PERUSAHAAN YANG TERDAFTAR DI BURSA EFEK INDONESIA

<p>Beneish M-Score adalah suatu teknik analisis laporan keuangan dapat dit-erapkan untuk mendeteksi kecurangan laporan keuangan berupa manipulasi laba earning overstatement. Pernyataan ini telah dijawab oleh Messod D. Beneish, seorang profesor di Indiana University yang melakukan penelitian atas perbedaan kuantitaif antara perusahaan yang teridentifikasi telah melakukan manipulasi laba dan perusahaan yang teridentifikasi tidak melakukan manipulasi laba.</p><p>Objek penelitian ini adalah perusahaan sektor Penghasil bahan baku dan manufaktur yang terdaftar di BEI tahun 2019. Terdapat 178 perusahaan yang menjadi sampel pada penelitian ini. Teknik penentuan sampel menggunakan non probability-purposive judgement sampling. Metode pengumpulan data menggunakan metode dokumentasi. Metode analisis data dengan deskriptif kuantitatif menggunakan rasio yang dikemukakan oleh Messod D.Beneish. Terdapat 5 variabel pengukuran yaitu Days’ Sales In Receivables Index (DSRI), Gross Margin Index (GMI), Asset Quality Index (AQI), Sales Growth Index (SGI), dan Total Accrual To Total Assets Index (TATA).</p><p>Hasil dari penelitian ini adalah: 1) terdapat 2 perusahaan yang tergoLong manipulator yang ditunjukkan dengan masuk kategori manipulator pada 3 kategori dari 5 kategori yang diukur; 2)sedangkan lainnya termasuk dalam kategori Non manipulator dan Grey company.</p><p align="left"> </p><p align="left"> </p><p align="left">Kata kunci: Beneish M-Score, Laporan keuangan</p>

Analisis Financial Statement Fraud Menggunakan Beneish M-Score Model Pada Perusahaan Pertambangan Yang Terdaftar Di Bursa Efek Indonesia

Penelitian ini bertujuan menguji dan menganalisis penggunaan model Beneish M-Score untuk mendeteksi financial statement fraud. Data yang digunakan adalah data sekunder berupa laporan keuangan perusahaan pertambangan terbuka di Indonesia. Metode penelitian yang digunakan adalah metode kuantitatif dengan analisis diskriminan. Metode analisis diskriminan digunakan untuk menganalisa hubungan antara model Beneish M-Score dengan financial statement fraud dengan cara melihat faktor atau variabel mana yang secara nyata dapat mempengaruhi variabel dependen. Pengaplikasian analisis diskriminan dilakukan untuk menguji variabel independen manakah yang secara akurat dapat membedakan sampel laporan keuangan yang diduga telah dimanipulasi dan laporan keuangan yang diduga tidak dimanipulasi. Hasil penelitian menunjukkan bahwa variabel yang mampu membedakan sampel laporan keuangan yang diduga telah dimanipulasi dan diduga tidak dimanipulasi adalah variabel Days Sales Receivable Index (DSRI), Gross Margin Index (GMI), Sales Growth Index (SGI), dan Total Accrual to Total Asset (TATA) sementara variabel Asset Quality Index (AQI), Depreciation Index (DEPI), Sales and General Administration Expenses Index (SGAI), Leverage Index (LVGI) terbukti tidak mampu membedakan laporan keuangan yang diduga telah dimanipulasi dan diduga tidak dimanipulasi.

Non-Executive Chairman, Audit Quality and Earnings Management

The purpose of this paper is twofold, first, it examines the association of non-executive chairman and the quality of financial earnings and second, it examines the role of audit quality and non-executive chairman in earnings quality. This paper uses the modified jones model and the performance adjusted modified Jones model considering two cash flow methods of total accrual and perform regression analysis on the energy sector firms from the year 2010-2012. The study result does not find any significant association of earnings management and non-executive director and audit quality in the Australian context. This finding raises concerns regarding the effectiveness of such a corporate governance mechanism to maximize monitoring over the operation of the firm.

Analisis Faktor Risiko Yang Mempengaruhi Financial Statement Fraud : Prespektif Diamond Fraud Theory

Meningkatnya berbagai kasus skandal akuntansi di dunia menyebabkan berbagai pihak berspekulasi bahwa manajemen telah melakukan kecurangan pada laporan keuangan. Penilaian faktor risiko kecurangan banyak yang mengadopsi beberapa standar pengauditan mengenai pendeteksian kecurangan (yakni SAS No.82, ISA 240, dan SAS No.99), dan merujuk pada teori Fraud Triangle. Wolfe dan Hermanson (2004), meningkatkan pendeteksian kecurangan fraud triangle dengan mempertimbangkan elemen keempat, yaitu kemampuan (capability) dan dikenal sebagai Fraud Diamond. Penelitian ini bertujuan untuk menguji pengaruh Fraud Diamond terhadap financial statement fraud. Sampel penelitian ini adalah 29 perusahaan di subsektor perbankan yang terdaftar di Bursa Efek Indonesia periode 2014-2018 dengan menggunakan 128 laporan tahunan. Metode analisis data yang digunakan adalah metode analisis regresi linear berganda. Variabel independen dalam penelitian ini terdiri financial stability, external pressure, personal financial need, financial target, nature of industry, ineffective monitoring, opinion auditor, change in auditor, total accrual, dan change in director. Sedangkan variabel dependen dalam penelitian ini adalah Financial Statement Fraud yang diproksikan dengan nilai discretionary accrual dari Modified Jones Model. Hasil penelitian menunjukkan bahwa variabel personal financial need dan total accrual yang berpengaruh positif dan signifikan terhadap financial statemanet fraud. Adapun variabel financial stability, external pressure, financial target, nature of industry, ineffective monitoring, opinion auditor, change in auditor, dan change in director tidak dapat digunakan untuk mendeteksi kecurangan laporan keuangan.

PENDETEKSIAN PENIPUAN LAPORAN KEUANGAN DENGAN KINERJA KEUANGAN SEBAGAI VARIABLE MODERATING DENGAN MENGGUNAKAN FRAUD TRIANGLE PADA PERUSAHAAN MANUFAKTUR DI BURSA EFEK INDONESIA 2016 - 2018

<p>Penulisan ini bertujuan untuk membuktikan secara empiris pengaruh unsur fraud triangle (<em>pressure, opportunity dan rationalization</em>) dalam penipuan laporan keuangan yakni praktik <em>real earning management</em> pada perusahaan manufaktur di bursa efek indonesia tahun 2016-2018. Penelitian ini bersifat kuantitatif dengan menggunakan data sekunder. Populasi dari penelitian ini adalah 162 perusahaan manufaktur di bursa efek indonesia. Pemilihan sampel dengan menggunakan purposive sampling yang terbatas pada individu spesifik dengan kriteria tertentu untuk memenuhi kebutuhan penelitian (Sekaran dan Bougie, 2013). Hasil penelitian ini menunjukan bahwa kepemilikan saham orang dalam <em>(personal financial need) dan Total Accrual to Asset (rationalization) </em> pada perusahaan memiliki banyak kesempatan memanipulasi laporan keuangan. Sedangkan perubahan saldo piutang (<em>nature of industry)</em> tidak memiliki pengaruh terhadap kecurangan laporan keuangan pada praktik <em>real earning management</em>.</p>

A phase II, multicenter, single-arm trial of CV301 plus atezolizumab (Atezo) in locally advanced (unresectable) or metastatic urothelial cancer (UC).

TPS494 Background: Anti-PD1/PD-L1 can achieve durable responses in advanced UC but most patients (pts) do not respond. Combination strategies with agents that “prime” the immune system may improve outcomes. CV301 comprises two recombinant poxviruses, Modified Vaccinia Ankara (MVA) and Fowlpox (FPV), encoding the human transgenes for CEA, MUC-1, and a Triad of Co-stimulatory Molecules (TRICOM: ICAM-1, LFA-3, and B7-1). MVA-CV301 is used for priming doses and FPV-CV301 is used for booster doses to achieve a heterologous prime boost regimen. In preclinical studies, BN-platform vaccine plus PD1/PD-L1 inhibitors exhibited synergistic anti-tumor efficacy, T-cell infiltration, and PD-L1 upregulation in tumors. CEA and MUC-1 are expressed, in 41-90% and 55-91% of any stage UC, respectively, and in ~100% of metastatic UC. An ongoing Phase Ib trial of CV301 plus anti-PD-1 agent has demonstrated a similar safety profile to anti-PD-1 monotherapy with only mild vaccine-related adverse events (AEs). Methods: This is a Phase 2, single-arm, multi-institutional trial designed to study CV301 plus atezo as 1st-line treatment in pts with advanced UC ineligible for cisplatin-based chemotherapy regardless of PD-L1 (Cohort 1) and as salvage treatment in pts with UC progressing after platinum-based chemotherapy (Cohort 2). MVA-CV301 is given subcutaneously (SC) on Days 1 and 22 and FPV-CV301 SC every 21 days for 4 doses, then every 6 weeks until 6 months, then every 12 weeks until 2 years. Atezo 1200mg is given every 21 days. Primary endpoint is objective response rate (ORR; RECIST 1.1). Secondary endpoints: immune response, OS, PFS, response duration, AEs. Tumor and serial blood samples will be collected for biomarker analyses; 1-sided α is 0.025/cohort in this design. With a 2-stage design, success criteria are based on historic ORR (H0) and alternative ORR (H1) with ≥70% power. For Cohort 1, assuming H0 = 0.23, H1 = 0.43, then Cohort 1 sample size N1= 14, responders required at stage 1 to continue R1≥3, total accrual goal N = 33, total responders to reject H0, R≥13. For Cohort 2, assuming H0 = 0.15, H1 = 0.33, then N1= 13, R1≥2, N = 35, R≥10. Accrual has begun; completion is expected within 1 year. Clinical trial information: NCT03628716.

Does Accounting Conservatism Mitigate the Operating Cash Flows Downside Risk?

The aim of this study is to investigate whether the two types of accounting conservatism (conditional and unconditional) mitigate the risk of falling operating cash flows in the presence of cash holdings of Jordanian companies for the period from (2005–2014) for a sample of (160) companies listed in Amman Stock Exchange (ASE). By using the principle components analysis method in the SPSS system to generate a composite measure for the measurement of the conditional conservatism (CC_CM) consisting of three measures: negative accruals (CC_NACC), current accruals to total accruals (CC_CACC), and accounting conservatism to the good news (CC_ACGN). As well as to generate another composite measure for the measurement of the unconditional conservatism (UC_CM) consisting of three measures: total accrual (UC_TACC), book to market (UC_BTM) ratio, and skewness (UC_Skew). In order to measure the downside risk of operating cash flows, we used the root lower partial moment of operating cash flow (RLPM_OCF). We find that two types of accounting conservatism are significantly positively effect on cash holdings. In addition, we conclude that there is a significantly negatively indirect effect for accounting conservatism on downside risk of operating cash flows in Jordanian companies that have cash holdings. It means that the increasing of the accounting conservatism leads to the increasing of cash holdings, which leads to mitigate the operating cash flows downside risk.

Business Ethics in Providing Financial Statements: The Testing of Fraud Pentagon Theory on the Manufacturing Sector in Indonesia

The article studies the causes and consequences of manipulating the financial statements of companies, identifies the most influential drivers of fraudulent reporting actions by employees and business owners. This research aimed to examine the effect of fraud indicators in fraud pentagon theory against the detection of fraudulent financial reporting on manufacturing companies. Independent variables in this research were variable pressure proxy by financial stability, external pressure, and financial target, opportunity proxy by nature of the industry, rationalization proxy by total accrual, capability proxy by the change of directors, and arrogance proxy by ownership by management. The dependent variable was the fraudulent financial reporting proxy by fraud score. The sample of this research used 57 manufacturing companies listed on the Indonesia Stock Exchange Effect in 2013-2015. It is found that the result of the determination coefficient test shows an adjusted R2 value of 0.068, it means that the ability of the independent variable in explaining the variants of the dependent variable is still limited, which is 6.8%. The ANOVA test, which shows the possibility of using the regression model to predict the Fraudulent Financial Report, serves as the methodological tool of the study. It is determined that pressure with proxies of financial stability (current), external pressure (Lev), and financial target (ROA), opportunity with the nature of industry (receivable) proxy, and arrogance with managerial ownership (OM) proxy do not affect fraudulent financial reporting. The result of this research showed that rationalization variables proxy by the total accrual ratio and capability proxy by the change of directors had an influence on the fraudulent financial reporting. While the pressure variable proxy by financial stability measured with the current ratio, external pressure measured with leverage ratio, financial target measured with ROA, opportunity variable proxy by nature of industry variable measured with the change in inventory ratio, and arrogance proxy by ownership by management had no influence on financial statement fraud. The results obtained can be useful both for the management of the company and for regulatory authorities in terms of understanding the growth indicators of the financial statement fraud frequency and tools to minimize their impact. Keywords: fraud, fraud pentagon, fraudulent financial reporting, financial statement fraud, leverage ratio, managerial ownership and manufacturing sector.