CTIM-26 - Phase II trial of SurVaxM plus temozolomide for newly diagnosed glioblastoma

Friday, November 18, 2022

4:25 PM – 4:35 PM ET

Location: Ballroom B

Oral Abstract Presenter(s)

Manmeet S. Ahluwalia, MD, MBA

Miami Cancer Institute, Baptist Health South Florida
Miami, United States

Author(s)

mC

michael J Ciesielski

Roswell Park
Buffalo, United States
David A. Reardon, MD

Dana-Farber Cancer Insitute
Boston, United States
AA

Ajay Abad, MD

Roswell Park
Buffalo, United States
WC

William T. Curry, Jr., MD

Massachusetts General Hospital, Harvard Medical School
Boston, United States
ew

eric T. wong, MD

Roswell Park
Buffalo, United States
David M. Peereboom, MD

Cleveland Clinic Foundation
Cleveland, United States
Sf

Sheila figel

Roswell Park
Buffalo, United States
ah

alan hutson

Roswell Park
Buffalo, United States
AG

Adrienne Groman

Roswell Park
Buffalo, United States
hw

henry withers

Roswell Park
Buffalo, United States
sl

song liu

Roswell Park
Buffalo, United States
Ab

Ahmed belal

Roswell Park
Buffalo, United States
Jq

Jingxin qiu

Roswell Park
Buffalo, United States
km

kathleen mogensen

Roswell Park
Buffalo, United States
cs

cathy schilero

Cleveland Clinic
Cleveland, United States
AK

Atulya A. Khosla, MD

Miami Cancer Institute, Baptist Health South Florida
Miami, United States
dc

danielle casucci

Mimivax
Buffalo, United States
lm

laszlo mechtler

Roswell Park
Buffalo, United States
RF

Robert A. Fenstermaker, MD

Roswell Park
Buffalo, United States

Background: Newly diagnosed glioblastoma (nGBM) has dismal outcomes with survival of 15-18 months. Tumor associated “survivin” is expressed in > 95% of nGBM and targetable by SurVaxM immunotherapy.

Methods: nGBM patients (pts) were enrolled in this Phase 2 study, age ≥ 18, KPS ≥ 70, IHC confirmed surviving-expression, expression of HLA-A*02, A*03, A*11 or A*24 MHC-I alleles and residual contrast enhancement of ≤1 cm³ by MRI. Pts were treated with standard TMZ chemoradiation followed by initiation of 4 priming doses of SurVaxM (500 mcg in emulsion with Montanide ISA 51, every 2 weeks) with 100 mcg sargramostim. Maintenance doses of SurVaxM-Montanide plus sargramostim given every 12 weeks with Adjuvant TMZ for at least 6 cycles. The primary endpoint was 70% progression free survival (PFS) at 6 mos. Primary analyses of median PFS (mPFS) and median overall survival (OS) were measured from the first immunization. Safety, tolerability, and immune responsiveness were also determined.

Results: 63 pts (38 males), median age, 60 years were treated at 5 sites. SurVaxM was well tolerated, with no serious adverse events. A strong positive correlation, accounting for censoring, was observed between PFS and OS of all pts (r = 0.79; 95% CI (0.66,0.87)). SurVaxM was immunogenic and produced survivin-specific CD8+ T-cells and antibody (IgG) titers in both methylated and unmethylated MGMT pts. Both groups showed clinical benefit with PFS of 11.4 months for the for the whole group, 7.0 months for unmethylated and 17.9 months for methylated group. OS of 25.9 months for the whole group, 16.5 months for unmethylated and 41.4 months for methylated group.

Conclusions: SurVaxM appeared to be safe and well-tolerated in pts with nGBM. SurVaxM was effective at stimulating survivin-specific immune responses and the primary endpoint was met. SurVaxM represents a promising therapy for nGBM, randomized trial is ongoing. Clinical trial information: NCT02455557.