On May 18, 2017 Novartis reported it will present data from across its oncology portfolio at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held June 2-6 in Chicago; the 14th International Conference on Malignant Lymphoma (ICML), being held June 14-17 in Lugano, Switzerland; and the 22nd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), being held June 22-25 in Madrid (Press release, Novartis, MAY 18, 2017, View Source [SID1234519243]). With more than 75 abstracts accepted, data will highlight research across 34 compounds in key disease areas, including breast and lung cancers, melanoma, leukemia and other blood disorders, and myeloproliferative neoplasms (MPNs).

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"Our presence at key medical congresses this year is marked by our innovation in targeted therapies and immuno-oncology in difficult to treat cancers," said Bruno Strigini, CEO, Novartis Oncology. "We are particularly excited to show the first data from the JULIET trial, which evaluates the use of CTL019 in relapsed/refractory diffuse large B-cell lymphoma. These results, along with the data that led to our filing for CTL019 in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia, demonstrate our commitment to research in this area."

Novartis data at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting will highlight the following:

Update on outcomes with Kisqali* (ribociclib) in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer:

Updated Results from MONALEESA-2, a Phase 3 Trial of First-Line Ribociclib + Letrozole in Hormone Receptor-Positive (HR+), HER2-Negative (HER2-), Advanced Breast Cancer (ABC) [Abstract #1038; Sunday, June 4, 8:00 AM CDT]
Health-Related Quality of Life (HRQoL) of Postmenopausal Women with Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer (ABC) Treated with Ribociclib + Letrozole: Results from MONALEESA-2 [Abstract #1020; Sunday, June 4, 8:00 AM CDT]

Data showing patient-reported quality of life outcomes for CTL019** (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL):

Patient-Reported Quality of Life (QOL) Following CTL019 in Pediatric and Young Adult Patients (pts) with Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) [Abstract #10523; Sunday, June 4, 8:00 AM CDT]
New data evaluating long-term outcomes with Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy in patients with BRAF V600-mutated unresectable or metastatic melanoma as well as data from patients with other tumor types:

Five-Year Overall Survival (OS) Update from a Phase II, Open-Label Trial of Dabrafenib (D) and Trametinib (T) in Patients (pts) with BRAF V600-Mutant Unresectable or Metastatic Melanoma (MM) [Abstract #9505; Sunday, June 4, 9:24 AM CDT]
COMBI-MB: A Phase II Study of Combination Dabrafenib (D) and Trametinib (T) in Patients with BRAF V600-Mutant (mut) Melanoma Brain Metastases (MBM) [Abstract #9506; Sunday, June 4, 10:00 AM CDT]
Updated Survival of Patients (pts) with Previously Treated BRAF V600E-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC) who Received Dabrafenib (D) or D + Trametinib (T) in the Phase II BRF113928 Study [Abstract #9075; Saturday, June 3, 8:00 AM CDT]
Efficacy of Dabrafenib (D) and Trametinib (T) in Patients (pts) with BRAF V600E-Mutated Anaplastic Thyroid Cancer (ATC) [Abstract #6023; Monday, June 5, 1:15 PM CDT]
New data on Zykadia (ceritinib) as well as the investigational compound EGF816 which highlight continued investigations in the treatment of mutation-driven lung cancer:

Ceritinib Plus Nivolumab (NIVO) in Patients (pts) with Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-Small Cell Lung Cancer (NSCLC) [Abstract #2502; Saturday, June 3, 1:39 PM CDT]
Genomic Profiling of Resistant Tumor Samples Following Progression on EGF816, a Third Generation, Mutant-Selective EGFR Tyrosine Kinase Inhibitor (TKI), in Advanced Non-Small Cell Lung Cancer (NSCLC) [Abstract #11506; Sunday, June 4, 9:48 AM CDT]
Adjuvant treatment of renal cell carcinoma (RCC) and safety and efficacy of combination therapy in treatment of advanced RCC:

Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients with Locally Advanced Renal Cell Carcinoma (RCC) (PROTECT) [Abstract #4507; Monday, June 5, 10:12 AM CDT]
A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib (PAZ) and Pembrolizumab (PEM) in Patients (pts) with Advanced Renal Cell Carcinoma (aRCC) [Abstract #4506; Monday, June 5, 9:36 AM CDT]
Additional data presented at ASCO (Free ASCO Whitepaper) include:

Phase III Study of Lapatinib (L) Plus Trastuzumab (T) and Aromatase Inhibitor (AI) vs T+AI vs L+AI in Postmenopausal Women (PMW) with HER2+, HR+ Metastatic Breast Cancer (MBC): ALTERNATIVE [Abstract #1004; Saturday, June 3, 2:27 PM CDT]
Everolimus (EVE) Plus Endocrine Therapy in Patients with Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer (BC): First and Second-Line Data from the BOLERO-4 Study [Abstract #1010; Sunday, June 4, 8:00 AM CDT]
Cognitive Technology Addressing Optimal Cancer Clinical Trial Matching and Protocol Feasibility in a Community Cancer Practice [Abstract #6501; Monday, June 5, 8:12 AM CDT]
Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will present data for Zarxio, the company’s filgrastim biosimilar:

Safety and Efficacy of Alternating Treatment with EP2006, a Filgrastim Biosimilar, and Reference Filgrastim for the Prevention of Severe Neutropenia, in Patients with Breast Cancer Receiving Myelosuppressive Chemotherapy [Abstract #10116; Saturday, June 3, 1:15 PM CDT]
Novartis data at the 14th Meeting of ICML will highlight data from the multi-center Phase II JULIET study evaluating the efficacy and safety of CTL019 in adult patients with r/r diffuse large B-cell lymphoma (DLBCL):

Global Pivotal Phase 2 Trial of the CD19-Targeted Therapy CTL019 in Adult Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) – An Interim Analysis [Abstract #007; Wednesday, June 14, 3:40 PM CEST]
Novartis data at the 2017 EHA (Free EHA Whitepaper) Annual Congress will highlight the following:

Data evaluating CTL019** outcomes in r/r pediatric and young adult patients with B-ALL:

Global Registration Trial of Efficacy and Safety of CTL019 in Pediatric and Young Adult Patients with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL): Update to the Interim Analysis [Abstract #S476; Saturday, June 24, 4:00 PM CEST]
Analysis of Safety Data from 2 Multicenter Trials of CTL019 in Pediatric and Young Adult Patients with Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL) [Abstract #P517; Saturday, June 24, 5:30 PM CEST]
CTL019 Clinical Pharmacology and Biopharmaceutics in Pediatric Patients (pts) with Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract #S477; Saturday, June 24, 4:15 PM CEST]
New analyses of ENESTfreedom and ENESTop evaluating Treatment-free Remission (TFR) at 96-week follow-up in patients meeting rigorous criteria for treatment discontinuation:

Durable Treatment-free Remission (TFR) After Stopping Second-line Nilotinib (NIL) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTop 96-Wk Update [Abstract #P257; Friday, June 23, 5:15 PM CEST]
Durable Treatment-free Remission (TFR) Following Frontline Nilotinib in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTfreedom 96-Wk Update [Abstract #P601; Saturday, June 24, 5:30 PM CEST]

Pooled survival analysis of two clinical trials evaluating Rydapt (midostaurin) in adult patients with advanced systemic mastocytosis:

Pooled Survival Analysis of Midostaurin Clinical Study Data (D2201 + A2213) in Patients with Advanced Systemic Mastocytosis (ADVSM) Compared with Historical Controls [Abstract #S788; Sunday, June 25, 9:00 AM CEST]
New data in myeloproliferative neoplasms, including a long-term analysis evaluating Jakavi (ruxolitinib)*** in patients with inadequately controlled polycythemia vera in a less advanced phase of the disease:

Ruxolitinib For The Treatment Of Inadequately Controlled Polycythemia Vera Without Splenomegaly: 80-Week Follow-Up From The RESPONSE-2 Trial [Abstract #S784; Sunday, June 25, 8:00 AM CEST]
Comparing The Safety And Efficacy Of Ruxolitinib (Rux) In Patients (Pts) With DIPSS Low/Intermediate-1-, Intermediate-2-, And High-Risk Myelofibrosis (MF) In JUMP, A Phase 3b, Expanded-Access Study [Abstract #E1333; Friday, June 23, 9:30 AM CEST]
Treatment and Management Of Patients With MPNs – Findings From the International MPN LANDMARK Survey [Abstract #P706; Saturday, June 24, 5:30 PM CEST]
Perception Of Symptom Burden and Treatment Goals Between Physicians and Patients With MPNs: An Analysis From the International MPN LANDMARK Survey [Abstract #E1320; Friday, June 23, 9:30 AM CEST]
Additional data presented at EHA (Free EHA Whitepaper) include:

Mediation by Patient-Reported Outcomes on the Association Between Film-Coated versus Dispersible Formulations of Deferasirox and Serum Ferritin Reduction: A Post-Hoc Analysis of the ECLIPSE Trial [Abstract #P286; Friday, June 23, 5:15 PM CEST]
Crizanlizumab, a P-selectin Inhibitor, Increases the Likelihood of Not Experiencing a Sickle Cell-Related Pain Crisis While on Treatment: Results from the Phase II SUSTAIN Study [Abstract #S454; Saturday, June 24, 12:15 PM CEST]

Throughout the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting, ICML meeting and EHA (Free EHA Whitepaper) Annual Meeting, Novartis Oncology will host dedicated content on the Novartis Oncology website (View Source) that will feature unique insights and perspectives on emerging areas of cancer care and research.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

For full prescribing information, including approved indications and important safety information about marketed products, please visit
View Source

EGF816, CTL019 and crizanlizumab (SEG101, formerly SelG1) are investigational compounds. Efficacy and safety have not been established. There is no guarantee these compounds will become commercially available.

On May 18, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported an abstract featuring long-term follow up data from the DYNAMO study evaluating duvelisib in patients with follicular lymphoma (FL) has been selected for oral presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 22-25, 2017 in Madrid, Spain (Press release, Verastem, MAY 18, 2017, View Source [SID1234519242]).

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In addition, an abstract describing Phase 2 data, also from the DYNAMO study, evaluating duvelisib in patients with small lymphocytic lymphoma (SLL) has been selected for an e-poster presentation at the meeting. DYNAMO is a Phase 2 clinical trial evaluating the safety and efficacy of duvelisib in patients with indolent non-Hodgkin lymphoma (iNHL) that are double refractory to both rituximab and chemotherapy.

"In the previously reported Phase 2 DYNAMO study results, duvelisib monotherapy demonstrated statistically significant clinical activity in iNHL patients, acheiving the primary endpoint with a 46% overall response rate, and was generally well tolerated with a manageable safety profile with appropriate risk mitigation," said Hagop Youssoufian, MSc, MD, Head of Hematology and Oncology Development at Verastem. "We look forward to presenting the long-term follow up data in June."

Details for the presentations at EHA (Free EHA Whitepaper) 2017 are:
Oral Presentation
Title: DYNAMO: A Phase 2 Study Demonstrating the Clinical Activity of Duvelisib in Patients with Double-Refractory Follicular Lymphoma
Presenter: Pier Luigi Zinzani, MD, PhD, University of Bologna Institute of Hematology
Abstract code: S777
Topic: Indolent Non-Hodgkin lymphoma – Clinical
Session title: Follicular lymphoma – Clinical
Location: Hall C
Date and time: Sunday, June 25, 2017, 8:45 – 9:00 CET
A copy of the oral presentation slides will be available here following the conclusion of the oral presentation.
E-Poster Presentation
Title: DYNAMO: The Clinical Activity of Duvelisib in Patients with Double-Refractory Small Lymphocytic Lymphoma in a Phase 2 Study
Abstract code: E1130
Topic: Indolent Non-Hodgkin lymphoma – Clinical
Location: e-poster screens
Date and time: Friday, June 23, 2017 from 9:30 CET to Saturday, June 24, 2017 at 19:00 CET

A copy of the e-poster presentation will be available here following the conclusion of the meeting.

About the Tumor Microenvironment
The tumor microenvironment encompasses multiple tumor and non-tumor cell populations and an extracellular matrix that support cancer cell survival. This includes immunosuppressive regulatory T-cells, myeloid-derived suppressor cells, tumor-associated macrophages, cancer-associated fibroblasts and extracellular matrix proteins that can hamper the entry and therapeutic benefit of cytotoxic T-cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s product candidates, including duvelisib and defactinib, also target the tumor microenvironment to potentially improve a patient’s response to therapy.

About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory CLL,4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory iNHL that achieved its primary endpoint of ORR upon top-line analysis of efficacy data.5 Duvelisib is also being evaluated for the treatment of hematologic malignancies through investigator-sponsored studies, including T-cell lymphoma.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On May 18, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 22nd European Hematology Association (EHA) (Free EHA Whitepaper) annual congress, to be held June 22 – 25, 2017 in Madrid, Spain (Press release, TG Therapeutics, MAY 18, 2017, View Source [SID1234519240]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the data presentations are outlined below.

Oral Presentation:

• Title: Chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib is well tolerated and highly active in patients with advanced CLL and NHL

Abstract Number: S772
Presentation Date & Time: Sunday, June 25, 2017 8:45 – 9:00 CEST
Session Title: Targeted therapies in relapsed chronic lymphocytic leukemia
Location: Hall A
Presenter: Loretta J. Nastoupil, MD, MD Anderson Cancer Center
Poster Presentation:

• Title: Combination of TGR-1202, Ublituximab, and bendamustine is safe and highly active in patients with advanced DLBCL and follicular lymphoma

Abstract Number: P563
Presentation Date & Time: Saturday, June 24, 2017 17:30 – 19:00 CEST
Session Title: Aggressive Non-Hodgkin Lymphoma- Relapsed/Refractory
Location: Poster Area Hall 7
Presenter: Matthew Lunning, DO, University of Nebraska Medical Center
The EHA (Free EHA Whitepaper) abstracts were made available today May 18, 2017 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

On May 18, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported that an abstract and poster have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 53rd annual meeting to be held in Chicago, Illinois, 2-6 June 2017 (Filing, 6-K, Prima Biomed, MAY 18, 2017, View Source [SID1234519239]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The poster presentation, entitled "Combination of paclitaxel and LAG-3Ig (IMP321), a novel MHC class II agonist, as a first-line chemoimmunotherapy in patients with metastatic breast carcinoma (MBC): Interim results from the run-in phase of a placebo controlled randomized phase II" will be presented by lead author, Dr Francois P. Duhoux from Université Catholique de Louvain, Cliniques universitaires Saint-Luc, Brussels, Belgium.

It will provide initial safety, immune-monitoring and activity results of the 15 patient safety run-in phase of Prima’s AIPAC clinical trial for patients with hormone receptor positive (HR+) MBC combining IMP321 with first-line weekly paclitaxel.

The poster presentation will take place from 8:00am to 11:30am on Sunday, 4 June in Hall A. The shorter abstract (number 1062), just containing safety data, is available on the meeting website at View Source
The full poster presentation will be available from Monday 5 June, with a link provided on the Prima BioMed website – www.primabiomed.com.au

About AIPAC (Active Immunotherapy PAClitaxel)
AIPAC is the acronym for Prima’s multicentre, Phase IIb, randomised, double-blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel. The primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint in this patient population. The study consists of two parts: a safety run-in phase (15 patients) and a randomized and controlled phase (226 patients). Details of the AIPC study are posted on www.clinicaltrials.gov (clinicaltrials.gov identifier NCT 02614833).

On May 18, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) reported that preclinical and clinical data on cerdulatinib in relapsed/refractory b-cell malignancies will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper), which is taking place from June 22-25 in Madrid, Spain (Press release, Portola Pharmaceuticals, MAY 18, 2017, View Source [SID1234519238]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Cerdulatinib is an investigational oral, dual SYK/JAK kinase inhibitor in development to treat patients with resistant or relapsed hematologic cancers. Cerdulatinib inhibits two key signaling pathways that promote cancer cell growth in certain hematologic malignancies.

Details regarding the presentations follow.

Oral Presentation Details:

Presentation Title: The Dual SYK/JAK Inhibitor Cerdulatinib Demonstrates Complete Inhibition of SYK and JAK and Rapid Tumor Responses in a Phase 2 Study in Patients with Relapsed/Refractory B Cell Malignancies
Presenter: Paul Hamlin, M.D., Memorial Sloan-Kettering Cancer Center
Abstract Number: EHA (Free EHA Whitepaper)22
Presentation Date and Time: June 25, 2017 from 9:00-9:15 a.m. UTC
Location: Hall A
Poster Presentation Details:

Presentation Title: IL-4 Increases Expression of Positive Regulators of BCR Signaling in CLL Which Can Be Overcome by Cerdulatinib
Presenter: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton
Abstract Number: P587
Presentation Date and Time: June 24, 2017 from 5:30 – 6:00 p.m. UTC
Location: Poster Hall (Hall 7)