11 th Best of ASCO Lebanon

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2 11 th Best of ASCO Lebanon September 2-3, Phoenicia Hotel, Beirut - Lebanon Organized by LSMO Sponsored by ASCO Co- Joseph Makdessi, MD Nagi El Saghir, MD Planning Committee: Adnan Atallah, MD - Nizar Bitar, MD - Nagi El Saghir, MD - Oussama Jradi, MD Joseph Makdessi, MD - Arafat Tfayli, MD Invited Guest Ghassan Abou-Alpha, MD Sana Al-Sukhun, MD Ahmad Awada, MD Hamdy A. Azim, MD Showki Bazarbachi, MD Tony Choueiri, MD Nuhad Ibrahim, MD Mohamad Jaloudi, MD Fadlo R. Khuri, MD Eileen O Reilly, MD Mohamad Mohty, MD Memorial Sloan Kettering Cancer Center University of Jordan Institut Jules Bordet Cairo University King Faisal Specialist Hospital Dana Farber Cancer Institute MD Anderson Cancer Center Tawwam Hospital American University of Beirut Memorial Sloan Kettering Cancer Center Hopital Saint-Antoine, Paris, France

3 Friday 2 nd of September :00 Registration 09:00-11:00 Lung Cancer-Non-Small Cell Metastatic / Small Cell / Head Neck Developmental therapeutics Fadlo Khuri, MD - Arafat Tfayli, MD - Fadi Karak, MD Fady Geara, MD - Salim Shammas, MD - Francois Kamar, MD Hazem Assi, MD 09:00-09:40 Part 1: Systemic Agents - Lung Abstract 108: Efficacy and safety of crizotinib in patients (pts) with advanced MET exon 14-altered non-small cell lung cancer (NSCLC). Alexander E. Drilon, MD Presented by Fadlo Khuri, MD Abstract 9008: Primary analysis for alectinib versus crizotinib in ALK-inhibitor naïve ALK positive non-small cell lung cancer (ALK+ NSCLC) in randomized openlabel phase III trial (J-ALEX study). Hiroshi Nokihara, MD Presented by Fadlo Khuri, MD Abstract 9012: A phase II open-label single-arm study of vandetanib in patients with advanced RET-rearranged non-small cell lung cancer (NSCLC): LURET study. Takashi Seto, MD Presented by Hazem Assi, MD Abstract LBA8505: Safety and efficacy of single-agent rovalpituzumab tesirine (SC16LD6.5), a delta-like protein 3 (DLL3)-targeted antibody-drug conjugate (ADC) in recurrent or refractory small cell lung cancer (SCLC). Charles M. Rudin, MD Presented by Fadi Karak, MD

4 Friday 2 nd of September :40-10:00 Part 2: Head and Neck Abstract 6000: Induction docetaxel platinum 5-FU (TPF) followed by cetuximabradiotherapy (cetux-rt) versus concurrent chemo-radiotherapy (CT/RT) in patients with N2b/c-N3 non operated stage III-IV squamous cell cancer of the head and neck (SCCHN): Results of the GORTEC phase III randomized trial. Lionnel Geoffrois, MD Presented by Arafat Tfayli, MD Abstract 6007: Gemcitabine plus cisplatin (GP) versus 5-FU plus cisplatin (FP) as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC): A randomized, open-label, multicenter, phase III trial. Li Zhang, MD Presented by Arafat Tfayli, MD 10:00-10:10 Part 3: Brain Abstract LBA2: A phase III randomized controlled trial of short-course radiotherapy with or without concomitant and adjuvant temozolomide in elderly patients with glioblastoma (CCTG CE.6, EORTC , TROG 08.02, NCT ). James R. Perry, MD Presented by Francois Kamar, MD 10:10-10:50 Part 4: Immunotherapy Abstract 6009: Nivolumab versus therapy of investigator s choice (IC) for recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): CheckMate 141. Robert L. Ferris, MD Presented by Fadlo Khuri, MD 30-12:00 Coffee Break Abstract 6011: Preliminary results from KEYNOTE-055: pembrolizumab after platinum and cetuximab failure in head and neck squamous cell carcinoma (HNSCC). Joshua Bauml, MD Presented by Fadlo Khuri, MD Abstract 100: CheckMate 032: Nivolumab (N) alone or in combination with ipilimumab (I) for the treatment of recurrent small cell lung cancer (SCLC). Scott Joseph Antonia, MD Presented by Fadi Karak, MD

5 Friday 2 nd of September 2016 Abstract 3001: CheckMate 012: Safety and efficacy of first-line (1L) nivolumab (nivo; N) and ipilimumab (ipi; I) in advanced (adv) NSCLC. Matthew David Hellmann, MD Presented by Arafat Tfayli, MD 10:00-11:10 Part 5: Radiation Therapy Abstract 9004: Local Consolidative Therapy (LCT) to improve progression-free survival (PFS) in patients with oligometastatic non-small cell lung cancer (NSCLC) who receive induction systemic therapy (IST): Results of a multi-institutional phase II randomized study. Daniel Richard Gomez, MD Presented by Fadi Geara, MD Abstract 8500: Bayesian randomized trial comparing intensity modulated radiation therapy versus passively scattered proton therapy for locally advanced non-small cell lung cancer. Zhongxing X. Liao, MD Presented by Fadi Geara, MD Abstract 8504: CONVERT: An international randomised controlled trial of concurrent chemo-radiotherapy (cctrt) comparing twice-daily (BD) and once-daily (OD) radiotherapy (RT) schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status (PS) (NCT ). Corinne Faivre-Finn, MD Presented by Selim Chamas, MD 11:10-11:30 Coffee Break

6 Friday 2 nd of September :30-12:30 Gastrointestinal (Colorectal) Cancer Ghassan Abou-Alfa, MD - Ali Shamseddine, MD Shawki Bazarbachi, MD Abstract 3503: NCI9673: A Multi-Institutional ETCTN Phase 2 Study of Nivolumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal (SCCA). Van Karlyle Morris II, MD Presented by Ali Shamseddine, MD Abstract 3504: Impact of primary (1º) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mcrc): Analysis of CALGB/SWOG (Alliance). Alan P. Venook, MD Presented by Ghassan Abou-Alfa, MD Abstract 3507: CREST: Randomised phase III study of stenting as a bridge to surgery in obstructing colorectal cancer Results of the UK ColoRectal Endoscopic Stenting Trial (CREST). James Hill, MD Presented by Ali Shamseddine, MD Abstract 3511: The potential of circulating tumor DNA (ctdna) to reshape the design of clinical trials testing adjuvant therapy in patients with early stage cancers. Jeanne Tie, MD Presented by Ghassan Abou-Alfa, MD Abstract 3512: FOLFIRINOX combined to targeted therapy according RAS status for colorectal cancer patients with liver metastases initially non-resectable: A phase II randomized study - Prodige 14 Accord 21 (METHEP-2), a UNICANCER GI trial. Marc Ychou, MD Presented by Shawki Bazarbachi, MD 12:30-13:00 Educational Session: Genomic and Genetic Testing in Oncology Hamdy Abdel Azim, MD - Nagi El Saghir, MD 13:00-14:00 Lunch Break

7 Friday 2 nd of September :00-15:00 Gastrointestinal (Noncolorectal) Cancer Eileen O Reilly, MD - Ghassan Abou-Alfa, MD Abstract 4000: A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer: First results from the CRITICS study. Marcel Verheij, MD Presented by Eileen O Reilly, MD Abstract LBA4001: FAST: An international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without IMAB362, a firstin-class anti-cldn18.2 antibody, as first-line therapy in patients with advanced CLDN18.2+ gastric and gastroesophageal junction (GEJ) adenocarcinoma. Salah-Eddin Al-Batran, MD Presented by Eileen O Reilly, MD Abstract 4003: Phase III randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC)- CALGB (Alliance). Ghassan K. Abou-Alfa, MD Presented by Ghassan Abou-Alfa, MD Abstract 4005: NETTER-1 Phase III: Efficacy and Safety Results in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate. Jonathan R. Strosberg, MD Presented by Eileen O Reilly, MD Abstract LBA4006: ESPAC-4: A multicenter, international, open label randomized controlled phase III trial of adjuvant combination chemotherapy of gemcitabine (GEM) and capecitabine (CAP), versus monotherapy gemcitabine in patients with resected pancreatic ductal adenocarcinoma. John P. Neoptolemos, MD Presented by Eileen O Reilly, MD 11:30-12:00 Coffee Break

8 Friday 2 nd of September :00-15:45 Hematologic Malignancies Lymphoma & Chronic Lymphocytic Leukemia Hamdy Abdel Azim, MD - Ali Bazerbachi, MD Nizar Bitar, MD - Jean El Cheikh, MD - Jawad Makarem, MD Abstract 7501: A prospective, multicenter, randomized study of anti-ccr4 monoclonal antibody mogamulizumab (moga) vs investigator's choice (IC) in the treatment of patients (pts) with relapsed/refractory (R/R) adult t-cell leukemialymphoma (ATL). Adrienne Alise Phillips, MD Presented by Ali Bazerbachi, MD Abstract 7503: Two years rituximab maintenance vs. observation after first line treatment with bendamustine plus rituximab (B-R) in patients with mantle cell lymphoma: First results of a prospective, randomized, multicenter phase 2 study (a subgroup study of the StiL NHL MAINTAIN trial). Mathias J. Rummel, MD Presented by Jawad Makarem, MD Abstract 7504: Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab or no maintenance in patients with diffuse large B-cell lymphoma: Results from a HOVON-Nordic Lymphoma Group study. Pieternella J. Lugtenburg, MD Presented by Nizar Bitar, MD Abstract 7506: PILLAR-2: A randomized, double-blind, placebo-controlled, phase 3 study of adjuvant everolimus (EVE) in patients (pts) with poor-risk diffuse large B-cell lymphoma (DLBCL). Thomas E. Witzig, MD Presented by Hamdy Abdel Azim, MD Abstract 7508: A phase 2 trial of ABVD followed by brentuximab vedotin consolidation in limited stage non-bulky Hodgkin lymphoma. Steven I. Park, MD Presented by Jean El Cheikh, MD 15:45-16:00 Coffee Break

9 Friday 2 nd of September :00-16:30 Hematologic Malignancies - Leukemia, Myelodysplastic Syndromes, & Allotransplant Ziad Salem, MD - Nabil Chamseddine, MD Ahmad Ibrahim, MD Abstract 7000: Phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. Jeffrey E. Lancet, MD Presented by Ziad Salem, MD Abstract 7001: Treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline nilotinib: Results from the ENESTfreedom study. Andreas Hochhaus, MD Presented by Nabil Chamseddine, MD Abstract 7008: Crenolanib besylate, a type I pan-flt3 inhibitor, to demonstrate clinical activity in multiply relapsed FLT3-ITD and D835 AML. Jorge E. Cortes, MD Presented by Ahmad Ibrahim, MD Abstract 7009: Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients 65 years ineligible for standard induction therapy. Daniel Aaron Pollyea, MD Presented by Ahmad Ibrahim, MD 11:30-12:00 Coffee Break

10 Friday 2 nd of September :30-17:00 Hematologic Malignancies - Plasma Cell Dyscrasia Mohamad Mohty, MD Abstract 8000: Upfront autologous stem cell transplantation (ASCT) versus novel agent-based therapy for multiple myeloma (MM): A randomized phase 3 study of the European Myeloma Network (EMN02/HO95 MM Trial). Michele Cavo, MD Presented by Mohamad Mohty, MD Abstract 8001: Lenalidomide (LEN) maintenance (MNTC) after high-dose melphalan and autologous stem cell transplant (ASCT) in multiple myeloma (MM): A meta-analysis (MA) of overall survival (OS). Michel Attal, MD Presented by Mohamad Mohty, MD Abstract 8003: Genetic plasma cell signatures in high-risk smoldering myeloma versus multiple myeloma patients. Sham Mailankody, MD Presented by Mohamad Mohty, MD Abstract LBA4: Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study. Antonio Palumbo, MD Presented by Mohamad Mohty, MD 17:00-17:30 Opening Ceremony 20:00 Gala Dinner 15:45-16:00 Coffee Break 11:30-12:00 Coffee Break

11 Saturday 3 rd of September :00 Registration 09:00-09:45 Breast Cancer - Triple-Negative / Cytotoxic Chemotherapy / Local Therapy Nuhad Ibrahim, MD - Hamdy Abdel Azim, MD - Jaber Abbas, MD Abstract 1000: Interim joint analysis of the ABC (anthracyclines in early breast cancer) phase III trials (USOR , NSABP B-46I/USOR 07132, NSABP B-49 [NRG Oncology]) comparing docetaxel + cyclophosphamide (TC) v anthracycline/ taxane-based chemotherapy regimens (TaxAC) in women with high-risk, HER2- negative breast cancer. Atilla Soran, MD Presented by Nuhad Ibrahim, MD Abstract 1005: A randomized controlled trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer: Turkish Study (Protocol MF07-01). Ravi Vij, MD Presented by Hamdy Abdel Azim, MD Abstract 1007: Ten-year survival results of ACOSOG Z0011: A randomized trial of axillary node dissection in women with clinical T1-2 N0 M0 breast cancer who have a positive sentinel node (Alliance). Armando E. Giuliano, MD Presented by Jaber Abbas, MD

12 Saturday 3 rd of September :45-10:45 Breast Cancer - HER2/ER+ Sana Al-Sukhun, MD - Nuhad Ibrahim, MD - Nagi El-Saghir, MD Abstract LBA1: A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer. Paul E. Goss, MD Presented by Sana Al-Sukhun, MD Abstract 500: Pathologic complete response rates after neoadjuvant trastuzumab emtansine (T-DM1) + pertuzumab vs docetaxel + carboplatin + trastuzumab + pertuzumab treatment in patients with HER2-positive early breast cancer (KRISTINE). Sara A. Hurvitz, MD Presented by Nuhad Ibrahim, MD Abstract LBA503: Heritage: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O vs Herceptin. Hope S. Rugo, MD Presented by Nuhad Ibrahim, MD Abstract 507: PALOMA-2: Primary results from a phase 3 trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ER+/HER2 advanced breast cancer (ABC). Richard S. Finn, MD Presented by Nagi El-Saghir, MD Abstract 512: Efficacy of palbociclib plus fulvestrant (P+F) in patients (pts) with metastatic breast cancer (MBC) and ESR1 mutations (mus) in circulating tumor DNA (ctdna). Nicholas C. Turner, MD Presented by Nagi El-Saghir, MD 11:00-11:30 Coffee Break

13 Saturday 3 rd of September :30-12:00 Gynecologic Cancer Muhieddine Seoud, MD Abstract 5501: Overall survival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: An interim analysis. Jonathan A. Ledermann, MD Presented by Muhieddine Seoud, MD Abstract LBA5503: OV21/PETROC: A randomized Gynecologic Cancer Intergroup (GCIG) phase II study of intraperitoneal (IP) vs. intravenous (IV) chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer (EOC). Helen Mackay, MD Presented by Muhieddine Seoud, MD Abstract 5507: Performance characteristics and stage distribution of invasive epithelial ovarian/tubal/peritoneal cancers in UKCTOCS. Usha Menon, MD Presented by Muhieddine Seoud, MD

14 Saturday 3 rd of September :00-13:00 Melanoma / Skin Cancers Ahmad Awada, MD - Hazem Assi, MD Abstract 9502: Genomic analysis and 3-y efficacy and safety update of COMBI-d: A phase 3 study of dabrafenib (D) + trametinib (T) vs D monotherapy in patients (pts) with unresectable or metastatic BRAF V600E/K-mutant cutaneous melanoma. Keith T. Flaherty, MD Presented by Ahmad Awada, MD Abstract 9503: 3-year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Caroline Robert, MD Presented by Ahmad Awada, MD Abstract 9504: Pembrolizumab versus ipilimumab for advanced melanoma: Final overall survival analysis of KEYNOTE-006. Jacob Schachter, MD Presented by Hazem Assi, MD Abstract 9505: Updated results from a phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067). Jedd D. Wolchok, MD Presented by Ahmad Awada, MD Abstract 9506: Pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma: Results of the KEYNOTE-029 expansion cohort. Georgina V. Long, MD Presented by Ahmad Awada, MD 13:00-14:00 Lunch Break

15 Saturday 3 rd of September :00-14:30 Educational session: What s Next in Cancer Immunotherapy Speaker: Ahmad Awada, MD 14:30-14:45 Patient and Survivor Care Mohamad Jaloudi, MD Abstract 10019: Placebo-controlled phase III study comparing dexamethasone on day1 to on day1-3 with NK1 receptor antagonist and palonosetoron in high emetogenic chemotherapy. Kunihiro Matsuzaki, MD Presented by Mohamad Jaloudi, MD 14:45-15:45 Genitourinary (Prostate) Cancer Tony Choueiri, MD - Joseph Kattan, MD - Elie Nasr, MD Abstract 5001: A randomized phase III trial between adjuvant docetaxel and surveillance after radical prostatectomy for high risk prostate cancer: Results of SPCG12. Goran Ahlgren, MD Presented by Joseph Kattan, MD Abstract 5004: Quality of life (QOL) analysis from CHAARTED: Chemohormonal androgen ablation randomized trial in prostate cancer (E3805). Linda J. Patrick-Miller, MD Presented by Tony Choueiri, MD Abstract 5006: Cabazitaxel vs docetaxel in chemotherapy-naïve (CN) patients with metastatic castration-resistant prostate cancer (mcrpc): A 3-arm phase III study (FIRSTANA). Oliver Sartor, MD Presented by Tony Choueiri, MD

16 Saturday 3 rd of September 2016 Abstract 5008: Phase III non-inferiority study of cabazitaxel (C) 20 mg/m2 (C20) versus 25 mg/m2 (C25) in patients (pts) with metastatic castration-resistant prostate cancer (mcrpc) previously treated with docetaxel (D). Johann de Bono, MD Presented by Tony Choueiri, MD Abstract 5003: A randomized trial of a shorter radiation fractionation schedule for the treatment of localized prostate cancer. Charles N. Catton, MD Presented by Elie Nasr, MD 15:45-16:30 Genitourinary (Nonprostate) Cancer Tony Choueiri, MD Abstract 4503: Limited versus extended pelvic lymphadenectomy in bladder cancer patients undergoing radical cystectomy: survival results from a prospective, randomized trial (LEA AUO AB 25/02). Juergen E. Gschwend, MD Presented by Tony Choueiri, MD Abstract 4506: Overall survival (OS) in METEOR, a randomized phase 3 trial of cabozantinib (Cabo) versus everolimus (Eve) in patients (pts) with advanced renal cell carcinoma (RCC). Toni K. Choueiri, MD Presented by Tony Choueiri, MD Abstract LBA4500: Atezolizumab (atezo) as first-line (1L) therapy in cisplatinineligible locally advanced/metastatic urothelial carcinoma (muc): Primary analysis of IMvigor210 cohort 1. Arjun Vasant Balar, MD Presented by Tony Choueiri, MD 16:30 Adjourn 3:00-14:00 Lunch Break

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