NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

SNO publishing the DcVax L phase 3 trial abstract (see below) at 7 am on 11/11/22 would not have been done without out a journal's guarantee to SNO that the manuscript would be published before Dr .Liau's Plenary presentation at 8:20 a.m. on 11/20 /22.



CTIM-27 - Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial
Sunday, November 20, 2022 8:20 AM – 8:30 AM ET Location: East Hall
CME-2

https://www.eventscribe.net/2022/SNO/agenda.asp?startdate=11/20/2022&enddate=11/20/2022&BCFO=&pfp=Browse%20By%20Day&mode=&fa=&fb=&fc=&fd=

Plenary Abstract Presenter(s)
Linda M. Liau, MD PhD (she/her/hers) photo
Linda M. Liau, MD PhD (she/her/hers)
University of California, Los Angeles
Los Angeles, United States

Author(s)
KA
Keyoumars Ashkan
King's College Hospital
London, United Kingdom

SB
Steven Brem, MD
Hospital of the University of Pennsylvania
Philadelphia, United States

Jian L. Campian, MD, PhD photo
Jian L. Campian, MD, PhD
Mayo Clinic, Department of Oncology
Rochester, United States

JT
John Trusheim, MD
Abbott Northwestern Hospital
Minneapolis, United States

FI
Fabio Iwamoto
Columbia University Medical Center
New York, United States

David D. Tran, MD, PhD photo
David D. Tran, MD, PhD
University of Southern California, United States

GA
George Anstass, MD
Washington University
St. Louis, United States

CC
Charles Cobbs
Swedish Hospital
Seattle, United States

JH
Jason Heth
University of Michigan
Ann Arbor, United States

MS
Michael E. Salacz, MD
Rutgers University
New Brunswick, United States

SD
Stacy D'Andre
Mayo Clinic
Rochester, United States

RA
Robert Aiken, MD
Rutgers
new jersey, United States

YM
Yaron Moshel
Atlantic Healthcare
Summit, United States

JN
JooYeon Nam
Rush Medical College
Chicao, United States

CP
Clement Pillainayagam
The Ohio State University
Columbus, United States

SW
Stephanie Wagner
Columbus Regional Health
Columbus, United States

KW
Kevin A. Walter
University of Rochester
Rochester, United States

RC
Rekha Chaudary
University of Cincinnati
Cincinnati, United States

SG
Samuel A. Goldlust, MD
Hackensack University
Hackensack, United States

IL
Ian Y. Lee, MD
Henry Ford Health
Detroit, United States

DB
Daniela A. Bota, MD, PhD
University of California Irvine
Irvine, United States

HE
Heinrich Elinzano, MD
Rhode Island Hospital
Providence, United States

JG
Jai Grewal, MD
Mount Sinai South Nassau Hospital, Oceanside, NY
Oceanside, United States

KL
Kevin Lillehei
University of Colorado
Denver, United States

TM
Tom Mikkelsen, MD
Henry Ford Health System
Detroit, United States

Tobias Walbert, MD, PhD. photo
Tobias Walbert, MD, PhD.
Henry Ford Health
Detroit, United States

SA
Steve R. Abram, MD
St. Thomas Hospital
Nashville, United States

Andrew J. Brenner, MD.,Ph.D photo
Andrew J. Brenner, MD.,Ph.D
UT Health San Antonio
San Antonio, United States

ME
Matthew Ewend
University of North Carolina
Durham, United States

Simon Khagi, MD photo
Simon Khagi, MD
University of North Carolina Chapel Hill
Chapel Hill, United States

DL
Darren Lovick
Advent Health
Kansas City, United States

JP
Jana L. Portnow, MD
City of Hope
Duarte, United States

LK
Lyndon Kim, MD
Mount Sinai Hospital
New York, United States

WL
William Loudon
St. Joseph's Hospital
Orange, United States

NM
Nina Martinez, MD
Jefferson University
Philadelphia, United States

RT
Reid C. Thompson, M.D.
Vanderbilt University Medical Center
Nashville, United States

DA
David Avigan
Beth Israel Deaconess Medical Center
Cambridge, United States

KF
Karen L. Fink, MD, PhD
Baylor University Medical Center
Dallas, United States

FG
Francois Geoffroy
Illinois Cancer Care
Peoria, United States

PG
Pierre Giglio, M.D.
Ohio State University Comprehensive Cancer Center
Columbus, United States

OG
Oleg Gligich
Mount Sinai Medical Center
Miami Beach, United States

Dietmar Krex, M.D. photo
Dietmar Krex, M.D.
Department of Neurosurgery, University of Dresden
Dresden, Germany

SL
Scott M Lindhorst, M.D.
Medical University of South Carolina
Charleston, United States

JL
Jose Lutzky
University of Miami
Miami, United States

HM
Hans-Joerg Meisel
Bergmannstrost
Halle, Germany

MN
Minou Nadji-Ohl
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, Germany

LS
Lhagva Sanchin
Bergmannstrost
Halle, Germany

Andrew E. Sloan, MD MBA FACS photo
Andrew E. Sloan, MD MBA FACS
Department of Pathology and Department of Neurosurgery, Case Western Reserve University and University Hospitals Cleveland Medical Center; Seidman Cancer Center and Case Comprehensive Cancer Center
Cleveland, United States

MB
Marnix Bosch
Northwest Biotherapeutics, Inc
Bethesda, United States

Background: Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years. We evaluated in a phase 3 trial whether adding an autologous tumor lysate-loaded dendritic cell vaccine (murcidencel) to SOC extends survival.

Methods: Newly diagnosed glioblastoma patients were randomized 2:1 to either murcidencel or placebo. Under a crossover design, all patients could receive murcidencel following tumor recurrence. All parties remained blinded regarding treatments before recurrence. Patients thus received murcidencel at new diagnosis (nGBM) or at recurrence (rGBM) following crossover from placebo. The primary and secondary endpoints compare overall survival (OS) with contemporaneous, matched external controls. Four sets of analyses were conducted to ensure rigorous matching of the controls, reduce biases, and confirm the robustness of the results.

Results: 331 patients were enrolled. With the crossover, 89% received murcidencel. Median OS (mOS) for nGBM patients (n = 232) was 19.3 months from randomization (22.4 months from surgery) with murcidencel vs. 16.5 months from randomization in the controls (HR = 0.80, p = 0.002). Survival at 48 months from randomization was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%. For rGBM (n = 64), mOS was 13.2 months from relapse vs. 7.8 months in the controls (HR = 0.58, p < 0.001). Survival at 24 months post-recurrence was 20.7% vs. 9.6%, and at 30 months post-recurrence was 11.1% vs 5.1%. In nGBM patients with methylated MGMT (n = 90), mOS was 30.2 months from randomization (33 months from surgery) with murcidencel vs. 21.3 months from randomization in the controls (HR = 0.74, p = 0.027). The treatment was well tolerated, with only 5 serious adverse events deemed at least possibly related to the vaccine.

Conclusion: Clinically meaningful and statistically significant survival extension was seen in both nGBM and rGBM patients treated with murcidencel and SOC compared with contemporaneous, matched external controls who received SOC alone.

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