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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"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"

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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.

On May 17, 2018 Oncolytics Biotech Inc. (TSX:ONC) (OTCQX:ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported an investigator sponsored study (IST) supported by Merck Inc (Press release, Oncolytics Biotech, MAY 17, 2018, View Source [SID1234534183]). (Merck), Northwestern University (Northwestern) and Oncolytics. This study is an extension of the previously reported phase 1 study (REO 024) that will investigate pelareorep in combination with Merck’s anti-PD1 checkpoint inhibitor Keytruda, to treat second line pancreatic cancer patients. The study, run by the principal investigator of REO 024, Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

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"This study using Merck’s Keytruda is our second I-O combination in human trials after our multiple myeloma study in combination with Celgene’s Imnovid and Revlimid," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We’re very happy with Merck’s increased involvement in our pancreatic studies and believe combining pelareorep with Keytruda poses an exciting opportunity to lay additional groundwork towards our ultimate goal – to expand the use of check point inhibitors as anti-cancer agents by promoting an inflamed phenotype in the tumor, or turning cold tumors hot."

"REO 024, a phase 1b study combining pelareorep and Keytruda in second line pancreatic patients, was designed to evaluate safety and tolerability of the combination," said Dr. Mahalingam, Associate Professor of Medicine (Hematology and Oncology), Northwestern University Feinberg School of Medicine. "The results from that study demonstrated that the combination is safe, but also that there was early evidence of clinical activity, including one patient that had a partial response lasting 17.4 months and two with stable disease of 126 days and 277 days. This new phase two study will enroll patients with advanced pancreatic cancer failing front line chemotherapy and will primarily evaluate overall response rate of the combination therapy. The study will also provide important biomarker data determined by analysis of pre- and post-treatment biopsies and blood-based immune markers."

Final study design and other details will be announced upon enrollment of the first patient, expected in the third quarter 2018.

On May 17, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported the appointment of Roger D. Dansey, M.D., as Chief Medical Officer (Press release, Seattle Genetics, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349629 [SID1234526766]). Dr. Dansey brings extensive experience in cancer drug development, most recently from Merck Inc. where he was Therapeutic Area Head for Late Stage Oncology, responsible for the ongoing registration efforts for KEYTRUDA (pembrolizumab) across multiple tumor types.

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"Roger’s appointment reflects the growing importance of late-stage clinical drug development at Seattle Genetics as we transition to a global, multi-product oncology company," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Roger’s drug development and approval experience at industry leaders, including Merck, Gilead and Amgen, his deep oncology background and proven ability to collaborate and lead teams, make him an ideal fit for Seattle Genetics as we strive to bring transformative therapies to people with cancer."

Dr. Dansey stated, "This is an exciting time at Seattle Genetics with both a growing, approved drug in ADCETRIS as well as a product pipeline with important new opportunities, including three solid tumor programs in ongoing or planned pivotal trials. I look forward to working with the many talented individuals at Seattle Genetics to bring these new therapies to patients."

Roger D. Dansey was Senior Vice President at Merck Inc. from January 2015 to April 2018, where he led the company’s late-stage oncology development efforts including the approved PD-1 inhibitor, KEYTRUDA. Prior to joining Merck, Dr. Dansey was Vice President, Oncology Clinical Research at Gilead Sciences. He initially joined the industry at Amgen working in roles of increasing responsibility in Amgen’s oncology and hematology therapeutic area, including as Global Development Leader for XGEVA. He received his Medical Degrees from the University of Witwatersrand, Johannesburg, South Africa.

Dr. Dansey succeeds Jonathan Drachman, M.D., who will remain with Seattle Genetics as a strategic advisor for innovation. Dr. Siegall added, "Jonathan has been a key contributor and leader at Seattle Genetics since joining the company nearly 14 years ago. He has been instrumental in the development of ADCETRIS, the expansion of Research and Development and advancement of our robust pipeline of both antibody-drug conjugates and novel immuno-oncology programs. I look forward to working with Jonathan on innovation initiatives that can ultimately benefit cancer patients."

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.

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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

On May 17, 2018 During the Congress of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will be held form the 1st to the 5th of June in Chicago (USA), PharmaMar reported it will present the data obtained from various clinical studies of the molecules Yondelis , lurbinectedin (PM1183) and plitidepsin (Press release, PharmaMar, MAY 17, 2018, View Source [SID1234526748]).

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Two studies carried out with Yondelis (trabectedin) will be presented, including an oral presentation by the French Sarcoma Group on the results of aprospective phase III study comparing trabectedin versus best supportive care in patients with soft tissue sarcoma. And the design of the phase I/II safety and efficacy study
using the triple combination of trabectedin, ipilimumab and nivolumab for the first line treatment of soft tissue sarcoma. PharmaMar will also have data for lurbinectedin (PM1183), presenting the clinical
advances made in indications such as Ewing´s sarcoma, breast cancer and smallcell lung cancer, which is currently in a pivotal phase III clinical trial called ATLANTIS that should complete recruitment in Q3.

The studies that will be presented during the meeting are available at View Source Studies highlighted at ASCO (Free ASCO Whitepaper) 2018

Lurbinectedin

Lurbinectedin is a compound under clinical investigation which is an inhibitor of the RNA polymerase II enzyme which is essential for the transcription process. It’s inhibition suppresses tumor growth, and results in tumor death. The antitumor efficacy of PM1183 is being investigated in various types of solid tumors.

• Efficacy and safety of lurbinectedin (PM1183) in Ewing sarcoma:
Final results from a phase 2 study. (Abstract #11519)
Poster Board: #264. Saturday, June 2. 15:00 to 16:15. Hall A
Discussed at the Poster Discussion Sessuon on Satuday, June 2, from 15:00
to 16:15 at S404
Lead author: Vivek Subbiah, MD. The University of Texas MD Anderson
Cancer Center

• Antitumor activity of PM1183 (lurbinectedin) in combination with capecitabine in metastatic breast cancer patients: results from a Phase I trial. (Abstract #1072)
Poster board: #153. Saturday, June 2. 8:00 a.m. to 11:30 a.m. Hall A.
Lead author: Ahmad Awada, MD, PhD. Medical oncology Clinic, Institut Jules
Bordet, Université Libre de Bruxelles

• Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study. (Abstract #8570)
Poster board: #176. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
Lead author: Jose Manuel Trigo Perez, MD. Hospital Virgen de la Victoria,
Spain.

• ATLANTIS: Global, randomized phase III study of lurbinectedin (L) with doxorubicin (DOX) vs. CAV or topotecan (T)in small-cell lung
cancer after platinum therapy. (Abstract #TPS8587)
Poster board: #189b. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
Lead author: Anna F. Farago, MD, PhD. Massachusetts General Hospital

• Phase I trial of lurbinectedin (PM1183) in Japanese patients with advanced tumors: results of the dose escalation part. (Abstract
#2551)
Poster board: #377. Monday, June 4. 8:00 a.m. to 11:30. Hall A
Lead author: Shunji Takahashi, MD. Cancer Institute Hospital of JFCR
Yondelis (trabectedin)
Trabectedin is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair.

• Whole exome sequencing (WES) od metastatic leiomyosarcoma (LMS) and liposarcoma (LPS) and correlation of genomic aberrations
with clinical outcomes in the phase III randomized trial of trabectedin (T) vs. dacarbazine (D). (Abstract #11513)
Poster board: #258. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Gurpreet Kapoor. Scientific Operations, LabConnect LLC.

• Multi-institutional European phase I/II trial of trabectedin plus radiotherapy in metastatic soft tissue sarcoma (STS) patients. A Collaborative Spanish (GEIS), Italian (ISG) and French (FSG)
Sarcoma Groups study. (Abstract #11544)
Poster board: #289. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Javier Martin Broto MD, PhD. Hospital Universitario Virgen del Rocio, Instituto de Investigación Biomédica, Universidad de Sevilla, Spain.

• Impact of pathological stratification of advanced well differentiated/dedifferentiated (WD/DD) liposarcoma (LPS) on theresponse to trabectedin (T). (Abstract #11566)
Poster board: #311. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Roberta Sanfilippo, MD. Departamento de Oncología Médica, Fondazione IRCCS Istituto Nazionale dei Tumori

• Phase 1/2 study of safety/efficacy using trabectedin, ipilimumab and nivolumab triple therapy as first line of treatment of advanced soft tissue sarcoma. (Abstract #TPS11591)
Poster board: #333b. Saturday, June 2. 15:00 to 16:15. Hall A

Lead author: Erlinda Maria Gordon, MD. Sarcoma Oncology Center
• Results of a prospective randomized phase III T-SAR trial comparing trabectedin (T) vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS): A French Sarcoma
Group (FSG) trial. (Abstract #11508)
Oral sesión. Monday, June 4. 8:00 a.m. to 11:00. S100a
Lead author: Axel Le Cesne, MD. Gustave Roussy Cancer Campus Plitidepsin

• Overall survival (OS) results of randomized phase III study (ADMYRE trial) of plitidepsin and dexamethasone (DXM) vs. DXM alone in patients with relapsed/refractory multiple myeloma (RRMM): Evaluation of the crossover impact. (Abstract #8018)
Poster board: #27. Monday, June 4. 8:00 to 11:30. Hall A
Discussed ta the poster discussion session on Monday, June 4, 15:00 to
16:15 at E450
Lead autor: Javier Gómez, PharmaMar

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin
Lurbinectedin is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.