On May 16, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that updated interim data from CRB-401, its Phase 1 study of bb2121, an anti-BCMA CAR T cell therapy being developed by the company and Celgene, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, bluebird bio, MAY 16, 2018, View Source [SID1234526698]).

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"Since we first presented data for bb2121 in heavily pretreated patients with multiple myeloma, we have been hopeful about its potential to markedly improve the outcomes and expectations for this incurable disease," said David Davidson, M.D., chief medical officer, bluebird bio. "One of the most striking changes has been to see patients testing negative for minimal residual disease (MRD), which was previously unexpected in this population with advanced disease. As the data from the Phase 1 study continue to advance our understanding of the bb2121 dose response and safety profiles, we and Celgene are applying these lessons to optimize outcomes in KarMMA, the ongoing registration-enabling study of bb2121 in patients with relapsed/refractory multiple myeloma."

Oral Presentation
bb2121 anti-BCMA CAR T-cell therapy in patients with relapsed/refractory multiple myeloma: Updated results from a multicenter phase I study. (Abstract 8007)

Presenter: Noopur S. Raje, M.D., Massachusetts General Hospital, Boston, Massachusetts
Date & Time:Friday, June 1, 2018, 2:45-5:45 p.m. CT (3:45-6:45 p.m. ET)
Location: E450
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Poster Presentation
Early MRD negativity to predict deepening myeloma response in relapsed/refractory multiple myeloma (RRMM) patients treated with bb2121 anti-BCMA CAR T cells. (Abstract 8024)

Presenter: Nikhil C. Munshi, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts
Poster Session Date & Time:Monday, June 4, 2018, 8:00 – 11:30 a.m. CT (9:00 a.m. – 12:30 p.m. ET)
Location: Poster Area Hall A
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Conference Call & Webcast Information

bluebird bio will host a conference call and live webcast at 6:30 p.m. CT (7:30 p.m. ET) on Friday, June 1, 2018. To access the live webcast, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source Alternatively, investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 1489304. A replay of the webcast will be available on the bluebird bio website for 90 days following the call.

On May 16, 2018 BerGenBio ASA (OSE: BGBIO) reported that the company and its collaborators will present new interim clinical and biomarker data from its extensive Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) at McCormick Place in Chicago, IL (1-5 June 2018) (Press release, BerGenBio, MAY 16, 2018, View Source [SID1234526697]). Abstracts are now available online at View Source and details of the presentations are below. The posters presented at ASCO (Free ASCO Whitepaper) will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.

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Presentations at ASCO (Free ASCO Whitepaper)
Monday 4 June, 8:00 AM – 11:30 AM Central Daylight Time (Hall A)

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC.
James Lorens, PhD et al
Session: Developmental Therapeutics – Immunotherapy
Poster Board: #292, Abstract 3078
Identification of predictive and pharmacodynamic biomarkers associated with the first-in-class selective AXL inhibitor bemcentinib across multiple Phase II clinical trials.

Robert J Holt, PhD et al
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster Board: #385, Abstract 2559
Analysis of anti-leukemic activity, predictive biomarker candidates, immune activation and pharmakodynamics in R/R AML and MDS in response to treatment with bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a Phase II open-label, multi-centre study.

Bjørn T. Gjertsen, MD, PhD et al
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Poster Board: #80, Abstract 7020
To be discussed at the Poster Discussion Session on Monday 4 June, 11:30 AM – 12:45 PM, at E450
Monday 4 June, 1:15 PM – 4:45 PM CDT (Hall A)

A randomized Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma.
Oddbjørn Straume, MD, PhD et al
Session: Melanoma/Skin Cancers
Poster Board: #375, Abstract 9548
BerGenBio reception
Coinciding with ASCO (Free ASCO Whitepaper), BerGenBio will host a reception for collaborators, investors, analysts, media and other interested parties on 2 June at The School of the Art Institute Ballroom in Chicago. At this event, short presentations will be given by clinical investigators participating in the bemcentinib clinical trials and by KOL experts in AXL kinase function. For further details and to receive an invitation, please click here.

The presentations will be made available on BerGenBio’s website in the Investors / Presentations section following the event.

On May 16, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that a wide selection of abstracts highlighting the Company’s diverse oncology portfolio across a broad range of cancers have been accepted for oral and poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 1-5 in Chicago (Press release, Astellas Pharma US, MAY 16, 2018, View Source [SID1234526696]). Highlights of the data and studies being presented include findings for: men with non-metastatic Castration-Resistant Prostate Cancer (CRPC) taking enzalutamide* and androgen deprivation therapy; patients with locally advanced or metastatic urothelial cancer taking enfortumab vedotin**, an investigational antibody-drug conjugate (ADC); and patients taking gilteritinib in Phase 3 trial in FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML).

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

"The Astellas abstracts accepted for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting demonstrate the depth and breadth of our growing leadership in oncology across a broad range of cancers," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "These data demonstrate the strength and progress of our oncology pipeline driven by investment in R&D and collaborative partnerships."

The following will be presented during an oral presentation:

Title: (Abstract 4504) Updated Results from the enfortumab vedotin Phase 1 (EV-101) Study in Patients with Metastatic Urothelial Cancer (mUC)

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 3, 9:12 AM – 9:24 AM CDT
Oral Abstract Session: Genitourinary (Nonprostate) Cancer
Location: Arie Crown Theater
Additionally, the following data will be shared during poster presentations:

Title: (Abstract TPS4590) EV-201 Study: A Single-Arm, Open-Label, Multicenter Study of enfortumab vedotin for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer who previously Received Immune Checkpoint Inhibitor Therapy

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 2, 8:00 AM – 11:30 AM CDT
Poster Session: Genitourinary (Nonprostate) Cancer
Location: Hall A
Title: (Abstract 5010) Health-Related Quality of Life (HRQoL) Deterioration and Pain Progression in Men with Non-Metastatic Castration-Resistant Prostate Cancer (M0-CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2, 1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Poster Discussion Session on June 2, 2018, 4:45 PM – 6:00 PM CDT, at S406
Title: (Abstract 5043) Association Between Health-Related Quality of Life (HRQoL) and clinical outcomes in non-metastatic castration-resistant prostate cancer (M0 CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2,1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Title: (Abstract TPS7075) A Phase 3, Trial of Gilteritinib, as Maintenance Therapy after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD + AML

Presenter: Mark J. Levis, MD, PhD

Session Date/Time: June 4, 8:00 AM – 11:30 AM CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A
*Enzalutamide is developed through a collaboration between Pfizer and Astellas and commercialized under the brand name XTANDI.
**Enfortumab vedotin is developed through a collaboration between Seattle Genetics and Astellas

On May 16, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that new data from its isocitrate dehydrogenase (IDH) programs will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1-5, 2018 in Chicago (Press release, Agios Pharmaceuticals, MAY 16, 2018, View Source [SID1234526695]).

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In total, five abstracts led by Agios describing new data from the company’s IDH programs have been accepted for presentation at ASCO (Free ASCO Whitepaper), as well as one abstract led by Celgene Corporation. IDHIFA (enasidenib) is being commercialized in collaboration with Celgene.

The accepted abstracts are listed below and are available online on the ASCO (Free ASCO Whitepaper) conference website: View Source

Oral presentations by Agios:

Title: Phase 1 Study of AG-881, an Inhibitor of Mutant IDH1/IDH2, in Patients with Advanced IDH-mutant Solid Tumors, Including Glioma
Date & Time: Friday, June 1, 2018 from 3:09-3:21 p.m. CT
Oral Abstract Session: Central Nervous System Tumors
Abstract: 2002
Location: S102
Presenter: Ingo K. Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center

Title: Ivosidenib (IVO; AG-120) in Mutant IDH1 Relapsed/Refractory AML: Results of a Phase 1 Study
Date & Time: Saturday, June 2, 2018 from 3:00-3:12 p.m. CT
Oral Abstract Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7000
Location: E450
Presenter: Daniel Aaron Pollyea, M.D., M.S., University of Colorado School of Medicine
This abstract has been selected as part of the "Best of ASCO (Free ASCO Whitepaper)" program to be presented in cities across the country. "Best of ASCO (Free ASCO Whitepaper)" features the top abstracts, highlighting the most cutting-edge science and education from the annual meeting.

Poster presentations by Agios and/or Celgene:

Title: Mutant IDH (mIDH) Inhibitors, Ivosidenib or Enasidenib, with Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML)
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7042
Poster Board: 102
Poster Location: Hall A
Author: Courtney Denton DiNardo, M.D., University of Texas MD Anderson Cancer Center

Title: AGILE: A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of Ivosidenib in Combination with Azacitidine in Adult Patients with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: TPS7074
Poster Board: 133b
Poster Location: Hall A
Author: Eytan Stein, M.D., Memorial Sloan Kettering Cancer Center

Title: Pharmacokinetics/pharmacodynamics (PK/PD) of Ivosidenib in Patients with IDH1-mutant Advanced Solid Tumors from a Phase 1 Study
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Abstract: 2577
Poster Board: 403
Poster Location: Hall A
Author: Bin Fan, Ph.D., Agios Pharmaceuticals

Title: Clinical pharmacokinetics/pharmacodynamics (PK/PD) of Ivosidenib in Patients with IDH1-mutant Advanced Hematologic Malignancies from a Phase 1 Study
Poster Session Date & Time: Monday, June 4, 2018 from 8:00-11:30 a.m. CT
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Abstract: 2581
Poster Board: 407
Poster Location: Hall A
Author: David Dai, Ph.D., Agios Pharmaceuticals

On May 16, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported it will release updated data from ongoing clinical studies at the annual ASCO (Free ASCO Whitepaper) meeting at McCormick Place in Chicago, Illinois (Press release, Adaptimmune, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349493 [SID1234526694]).

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Data from the ongoing pilot study of NY-ESO SPEAR T-cells in myxoid/round cell liposarcoma (MRCLS) will be presented during an oral presentation by Dr. Sandra P. D’Angelo of the Memorial Sloan Kettering Cancer Center. GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) exercised its option to exclusively license the right to research, develop, and commercialize NY‑ESO SPEAR T-cell therapy program in September 2017. Transition of this program to GSK is ongoing.

In addition, data from Adaptimmune’s ongoing MAGE‑A10 pilot studies will be presented at a poster session.

Oral presentation of updated MRCLS data:

Title: Pilot Study of NY-ESO-1c259T Cells in Advanced Myxoid/Round Cell Liposarcoma
Abstract #: 3005
Oral session: Developmental Therapeutics—Immunotherapy
Date: Saturday June 2, 2018
Time: 4:24 PM – 4:36PM (CDT)
Location: McCormick Place South, Hall B1
Poster presenting MAGE-A10 safety data

Title: Initial safety assessment of MAGE-A10c796TCR T-cells in two clinical trials
Abstract #: 3056
Poster session: Developmental Therapeutics—Immunotherapy
Date: Monday June 4, 2018
Time: 8:00 AM-11:30 AM (CDT)
Location: McCormick Place South, Hall A