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Verastem Oncology to Present Duvelisib Data at EHA 2018 Annual Meeting

On May 17, 2018 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the selection of four abstracts for oral and poster presentations at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 14-17, 2018 in Stockholm, Sweden (Press release, Verastem, MAY 17, 2018, View Source [SID1234526786]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. An oral presentation by Dr. Matthew Davids, Dana-Farber Cancer Institute, will highlight the latest data from a Phase Ib/II study of duvelisib in combination with FCR (dFCR) as a frontline treatment in younger patients with chronic lymphocytic leukemia (CLL). Three posters will highlight additional duvelisib data, including crossover extension results from the Phase 3 DUO study in patients with relapsed or refractory CLL/small lymphocytic lymphoma (CLL/SLL), and new biomarker analyses on the tumor microenvironment modulation from DUOTM and the Phase 2 DYNAMOTM study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and the dual PI3K-delta and PI3K-gamma activity of duvelisib in the CONTEMPOTM study in patients with untreated follicular lymphoma who are treated with duvelisib in combination with CD20 antibody immunotherapy.

"At EHA (Free EHA Whitepaper) 2018, Dr. Matthew Davids will deliver an oral presentation describing results from the ongoing Phase Ib/II study evaluating duvelisib in combination with FCR (chemo-immunotherapy) in younger CLL patients," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology. "To date, the combination regimen has shown to be effective as an initial therapy with an ORR of 97%, including 28% of evaluable patients achieving a complete response or complete response with incomplete blood count recovery, and 69% achieving a partial response. A high rate of 81% bone marrow MRD negativity was observed in patients with at least one evaluation. Collectively, the data being presented at EHA (Free EHA Whitepaper) this year continue to provide important insights to guide the future clinical development of duvelisib across a wide range of hematologic malignancies, both as a monotherapy and in combination with other agents."

Details for the EHA (Free EHA Whitepaper) 2018 presentation and posters are as follows:

Oral Presentation

Title: A Phase IB/II Study of duvelisib in combination with FCR (DFCR) for Frontline Therapy of Younger CLL Patients
Lead author: Dr. Matthew Davids, Dana-Farber Cancer Institute
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Combination treatment with targeted agents in CLL
Date and Time: Saturday, June 16, 12:15 – 12:30 CEST
Location: Victoria Hall
Final Abstract Code: S807
Poster Presentations

Title:The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in a Phase 3 Crossover Extension Study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF354

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma.
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF646

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study).
Lead author: Dr. David Weaver, Verastem Oncology
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF649

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes 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- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov

BioClin Therapeutics, Inc.Announces Poster Presentation of
B-701at the 2018 American Society of Clinical Oncology
(ASCO) Annual Meeting

On May 17, 2018 BioClin Therapeutics, Inc., a clinical stage drug development company reported that data will be presented from its ongoing Phase 1b/2 study of B-701, a first-in-class anti-fibroblast growth factor receptor 3 (FGFR3) monoclonal antibody, plus docetaxel for metastatic bladder cancer at a poster session at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting being held June 1-5, 2018 in Chicago, IL (Press release, BioClin Therapeutics, MAY 17, 2018, View Source [SID1234526785]).

The details of the poster presentation are as follows:

[Abstract 4534]
FIERCE-21: Phase 1b/2 study of Docetaxel + B-701, a Selective Inhibitor of FGFR3, in Relapsed or Refractory (R/R) Metastatic Urothelial Carcinoma (mUCC).

Joaquim Bellmunt, M.D., Ph.D., Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster Session Date/Time: Saturday, June 3, 2018, 8:00 – 11:30 a.m., CDT, Hall A

Tarveda Therapeutics to Present Data from Phase 1 Study of PEN-221 at the 2018 American Society for Clinical Oncology (ASCO) Annual Meeting

On May 17, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that it will present Phase 1 results from a Phase 1/2a study of PEN-221 in patients with neuroendocrine tumors or small cell lung cancer at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting occurring June 1-5, 2018 in Chicago IL (Press release, Tarveda Therapeutics, MAY 17, 2018, View Source [SID1234526784]).

The data presented will describe the safety, tolerability, pharmacokinetics, and preliminary efficacy of PEN-221, a miniature drug conjugate containing a peptide ligand that is highly selective in targeting the somatostatin receptor 2 (SSTR2) that is conjugated to the potent payload DM1. SSTR2 is a cell surface target that is overexpressed in a variety of solid tumor cancers. PEN-221 is currently being evaluated in a Phase 2a trial in patients with gastrointestinal midgut neuroendocrine tumors, pancreatic neuroendocrine tumors, or small cell lung cancer.

"We are very pleased to have completed the Phase 1 portion of our Phase 1/2a clinical trial for PEN-221 on schedule and to present the data from the Phase 1 trial evaluating PEN-221 at ASCO (Free ASCO Whitepaper)," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "We are encouraged by the data from studies of PEN-221 to date and look forward to advancing the Phase 2a portion of the study for PEN-221 as well as our Phase 1 trial for PEN-866."

Details of the poster presentation are as follows:

Title: First in human phase 1/2a study of PEN-221 somatostatin analog (SSA)-DM1 conjugate for patients (PTS) with advanced neuroendocrine tumor (NET) or small cell lung cancer (SCLC): Phase 1 results.
Abstract Number: 4097
Date: June 3, 2018
Time: 8:00 – 11:30 AM CT
Location: Hall A

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

Flatiron Health Announces Research to Be Presented at American Society of Clinical Oncology 2018 Annual Meeting

On May 17, 2018 Flatiron Health reported 11 abstracts accepted for presentation at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 1-5 in Chicago (Press release, Flatiron Health, MAY 17, 2018, View Source [SID1234526783]). The research, spanning multiple tumor types and areas of study, utilized Flatiron’s highly-curated, nationally-representative, real-world oncology datasets, the largest in the United States.

The research to be presented includes collaborations with the Abramson Cancer Center of the University of Pennsylvania, Fred Hutchinson Cancer Research Center, Genentech (a member of the Roche Group), Huntsman Cancer Institute at the University of Utah, the National Cancer Institute, Roche, the U.S. Food & Drug Administration, and Yale Cancer Center.

The presentation schedule and links to abstracts can be found below. To learn more about Flatiron Health, visit our booth #2049 during the conference or click here.

Oral Presentation

Application of a real-world endpoint to identify and characterize genetic profiles of patients (pts) with poor prognosis in advanced non-small-cell lung cancer (aNSCLC)

Presenting Author: Greg Riely (Memorial Sloan Kettering Cancer Center)
Date/Time: 6/5/2018, 10:00 – 10:12 AM
Abstract: #12006
Location: S406
Session: Tumor Biology

Poster Discussion Presentation

Cost-effectiveness of multi-gene panel sequencing (MGPS) for advanced non-small cell lung cancer (aNSCLC) patients

Presenting Author: Lotte Steuten (Fred Hutchinson Cancer Research Center)
Date/Time: 6/2/2018, 4:45 – 6:00 PM
Abstract: #6513
Poster: #339
Location: S102
Session: Health Services Research, Clinical Informatics, and Quality of Care

Poster Presentations (Location: Hall A)

Real-world (RW) characteristics, treatment (tx) patterns, and overall survival (OS) in US patients (pts) with metastatic breast cancer (mBC) and CNS metastases (CNS mets)

Presenting Author: Ashwini Shewade (Genentech, a member of the Roche Group)
Date/Time: 6/2/2018, 8:00 – 11:30 AM
Abstract: #1037
Poster: #118
Session: Breast Cancer—Metastatic

Diffusion of innovation in oncology: A case study of immuno-oncology (IO) adoption for advanced non-small lung cancer (aNSCLC) patients across practices in the US

Presenting Author: Carrie Bennette (Flatiron Health)
Date/Time: 6/2/2018, 1:15 – 4:45 PM
Abstract: #6537
Poster: #363
Session: Health Services Research, Clinical Informatics, and Quality of Care

Association of baseline body mass index (BMI) with overall survival (OS) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) treated with nivolumab (N) and pembrolizumab (P)

Presenting Author: Jizu Zhi (U.S. Food & Drug Administration)
Date/Time: 6/2/2018, 1:15 – 4:45 PM
Abstract: #6553
Poster: #379
Session: Health Services Research, Clinical Informatics, and Quality of Care

Development of a dashboard for end-of-life care at an academic hospital

Presenting Author: Kerin Adelson (Yale Cancer Center)
Date/Time: 6/2/2018, 1:15 PM – 4:45 PM
Abstract: #6590
Poster: #415
Session: Health Services Research, Clinical Informatics, and Quality of Care

Real-world data (RWD) on tumor response (rwTR) in advanced non-small cell lung cancer (aNSCLC) patients receiving cancer immunotherapy and targeted therapies

Presenting Author: Michael W Lu (Genentech, a member of the Roche Group)
Date/Time: 6/2/2018, 1:15 – 4:45 PM
Abstract: #6578
Poster: #403
Session: Health Services Research, Clinical Informatics, and Quality of Care

Comparative effectiveness of carboplatin-pemetrexed (carbo-pem) with vs without bevacizumab (bev) in patients with advanced non-squamous (sq) non-small cell lung cancer (NSCLC)

Presenting Author: Stephen Bagley (Abramson Cancer Center of the University of Pennsylvania)
Date/Time: 6/3/18, 8:00 – 11:30 AM
Abstract: #9073
Poster: #396
Session: Lung Cancer—Non-Small Cell Metastatic

Age-related real-world outcomes for patients (pts) with metastatic colorectal cancer (mCRC)

Presenting Author: Rebecca Miksad (Flatiron Health)
Date/Time: 6/3/2018, 8:00 – 11:30 AM
Abstract: #3613
Poster: #106
Session: Gastrointestinal (Colorectal) Cancer

Immune checkpoint inhibitor (ICI) treatment in advanced melanoma (aMel) patients (pts) with hepatic or renal dysfunction (dysf): Real-world patient characteristics and outcomes

Presenting Author: Susan Spillane (National Cancer Institute)
Date/Time: 6/4/2018, 1:15 – 4:45 PM
Abstract: #9569
Poster: #396
Session: Melanoma/Skin Cancers

Risk stratification using patient-reported outcomes (PROs) in patients (pts) with advanced cancer

Presenting Author: Shiven Patel (Huntsman Cancer Institute at the University of Utah)
Date/Time: 6/4/2018, 1:15 – 4:45 PM
Abstract: #10101
Poster: #89
Session: Patient and Survivor Care

Cellerant Therapeutics, Inc. to Present Results of Phase 2 Clinical Trial of CLT-008 at American Society of Clinical Oncology (ASCO) 2018 Annual Meeting and European Hematology Association (EHA) 23rd Congress

On May 17, 2018 Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, reported that investigators from Cellerant’s recently completed Phase 2 clinical trial of CLT-008 (romyelocel-L, human myeloid progenitor cells) will present key study results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1-5, 2018, and at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, June 14-17, 2018 (Press release, Cellerant Therapeutics, MAY 17, 2018, View Source [SID1234526782]).

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Cellerant is developing CLT-008, a universal, off-the-shelf cell therapy intended to prevent infections during neutropenia. Neutropenia is a serious side effect of myelosuppressive chemotherapy that leaves patients at high risk of serious, potentially life-threatening infections, leading to prolonged hospitalization and often reduced or delayed treatment doses. The Company conducted a randomized, controlled Phase 2 study of CLT-008 in patients newly diagnosed with acute myeloid leukemia (AML) who received induction chemotherapy.

"AML patients who undergo induction chemotherapy suffer severe and prolonged neutropenia, and the results from this study show significantly reduced infections in the CLT-008 group relative to control," said Ram Mandalam, Ph.D., CEO of Cellerant Therapeutics. "This product addresses a serious unmet need in AML patients. We are excited to present the study results at these two important medical meetings, and look forward to advancing CLT-008 to a Phase 3 study."

Presentation details are as follows:

ASCO Abstract #7043: Abboud, et al., A randomized controlled open label exploratory trial of CLT-008 myeloid progenitor cells (MPC) to decrease infections during induction for AML. Poster discussion on June 4, 2018, 8:00-11:30am CDT. Presenting author: Farhad Ravandi, M.D., Janiece and Stephen A. Lasher Professor of Medicine, University of Texas MD Anderson Cancer Center.

EHA Abstract #1405: Desai, et al., Decreased incidence of infection, use of antibacterials and days in hospital after administration of CLT-008 myeloid progenitor cells to subjects receiving AML induction therapy: Phase 2 Study Results. Oral presentation on June 16, 2018, 4:45-5:00pm CEST. Presenting author: Pinkal Desai, M.D., M.P.H., Assistant Professor of Medicine, Weill Cornell Medicine, New York.