Abstract 4344
Background
CV301 is an MVA-based vaccine encoding human transgenes MUC1, CEA and TRICOM. A phase I dose-escalation trial (Gatti-Mays E, et al. CCR 2019) concluded that CV301 is safe in advanced cancer patients and generated specific T cell responses against the encoded antigens. Preclinical data supports the rational for combining CV301 with PD-1 inhibitors. The primary objective of this trial was to evaluate safety and tolerability of this combination.
Methods
Patients with advanced non-squamous-NSCLC without actionable alterations in EGFR, ALK and ROS1 were eligible. Two priming doses of MVA-BN-CV301 (MVA) were administered in 4 separate subcutaneous (SC) injections of 4x10^8 IU, 4 weeks apart, followed by boosting doses of Fowlpox-CV301 (FPV) given as a single injection of 1x10^9 IU SC q2w for weeks 9-15, q4w for weeks 19-51 and q13w up to 17 doses for Cohort 1 (C1), q3w for weeks 7-22, q6w for weeks 28-52 and q12w up to 15 doses for Cohort 2 (C2). C1 included patients pre-treated with platinum-containing chemotherapy, who were considered eligible for nivolumab (N; 240 mg IV q2w). C2 included patients receiving frontline treatment with pembrolizumab (P; 200 mg IV q3w) after a minimum of 11 weeks of SD per RECIST.
Results
Between Oct-2017 and Sep-2018, 12 pts were recruited, 4 in C1 and 8 in C2. Median age was 64, and 9 pts were F. Majority of patients were former-smokers (9, 1 current, 2 never). As of Mar-2019 data cut-off, mean treatment duration was 272 days in C1 and 193 days in C2, with 7 pts continuing and 5 discontinuing treatment. Both doses of MVA were administered to 3/4 pts in C1 and 7/8 pts in C2. Median FPV doses/pt: C1=12 and C2=6. CV301 injection-site reactions and flu-like symptoms were observed in all C1 and 7/8 C2 pts. CTCAE ≥ grade 3 AEs were observed in 3/4 C1 and 3/8 C2 pts with 1 fatal TEAE. IRAEs included 1 autoimmune hepatitis, and 1 pneumonitis fulfilling criteria of DLT. As of data-cut, we observed 1 CR (C1), 10 SD, and 1 discontinuation prior to first scheduled RECIST assessment.
Conclusions
The treatment of NSCLC with CV301 + N or P is feasible and tolerated, with no observed increase in the frequency or severity of expected AEs or IRAEs for each component of the combination.
Clinical trial identification
NCT02840994.
Editorial acknowledgement
Legal entity responsible for the study
Bavarian Nordic Inc.
Funding
Bavarian Nordic Inc.
Disclosure
C. Heery: Honoraria (self), Leadership role: Bavarian Nordic. C. Pico-Navarro: Honoraria (self): Bavarian Nordic. M. Piechatzek: Full / Part-time employment: Bavarian Nordic. E. Wagner: Full / Part-time employment: Bavarian Nordic. E. Menius: Full / Part-time employment: Bavarian Nordic. All other authors have declared no conflicts of interest.
Resources from the same session
2888 - Development and validation a nomogram based on pathological microscopic features to predict survival in nasopharyngeal carcinoma and guide treatment decision
Presenter: Kuiyuan Liu
Session: Poster Display session 3
Resources:
Abstract
3607 - Deep learning in nasopharyngeal carcinoma: a retrospective cohort study of 3D convolutional neural networks on magnetic resonance imaging
Presenter: Meng Yun Qiang
Session: Poster Display session 3
Resources:
Abstract
5848 - Combined androgen blockade in patients with advanced androgen receptor–positive salivary gland carcinoma: Exploratory biomarker analyses
Presenter: Chihiro Fushimi
Session: Poster Display session 3
Resources:
Abstract
4484 - Classification of esthesioneuroblastoma (ENB) based on chromosome (chr) arm gain and loss (CNA) in the setting of a hypomutated genomic landscape
Presenter: Russell Madison
Session: Poster Display session 3
Resources:
Abstract
5753 - Trastuzumab plus docetaxel in patients with advanced HER2–positive salivary duct carcinoma: Exploratory biomarker analyses
Presenter: Hideaki Takahashi
Session: Poster Display session 3
Resources:
Abstract
3373 - Development and characterization of salivary gland cancer organoid cultures
Presenter: Wim Boxtel
Session: Poster Display session 3
Resources:
Abstract
3118 - A parent-of-origin effect of the RB1 mutations in retinoblastoma with low penetrance and variable expressivity
Presenter: Ekaterina Alekseeva
Session: Poster Display session 3
Resources:
Abstract
4512 - The humanistic burden reported by patients diagnosed with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) in Europe
Presenter: Prianka Singh
Session: Poster Display session 3
Resources:
Abstract
3961 - Concurrent Chemotherapy and External Radiation Therapy: An Open Label Non-Inferiority Phase III Randomized Controlled Trial of Weekly versus Three Weekly Cisplatin and Radical Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: CONCERT trial
Presenter: ATUL SHARMA
Session: Poster Display session 3
Resources:
Abstract
3973 - A randomized phase II study on the OPTimization of IMmunotherapy in squamous carcinoma of the head and neck (SCCHN) – OPTIM (AIO-KHT-0117)
Presenter: Viktor Grünwald
Session: Poster Display session 3
Resources:
Abstract