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
5822 - Greek nursing students experience facing death in clinical practice
Presenter: Maria Dimoula
Session: Poster Display session 3
Resources:
Abstract
2866 - HOPEVOL: Hospice care appropriate to the wishes and needs of patients in the palliative terminal phase.
Presenter: Merel van Klinken
Session: Poster Display session 3
Resources:
Abstract
829 - Mindfulness-based stress reduction in early palliative care for advanced cancer patients : an italian single-centre study. MINDEEP
Presenter: Emilia Gianotti
Session: Poster Display session 3
Resources:
Abstract
2702 - Optimising Inpatient Oncology Care
Presenter: Lisa Judge
Session: Poster Display session 3
Resources:
Abstract
1527 - Analysis on the Implementation Results of Family Sickbed for Oncology Patients in Dongshi Township Health Centers from 2015 to 2017
Presenter: Yayu Huang
Session: Poster Display session 3
Resources:
Abstract
2054 - Exploring needs for palliative care and quality of life for oncology patients with advanced disease who undergo radiotherapy
Presenter: Foteini Antonopoulou
Session: Poster Display session 3
Resources:
Abstract
5605 - Cytotoxic contamination in cancer care settings – Risks and safety awareness among cancer nurses
Presenter: Sandra Lundman Vikberg
Session: Poster Display session 3
Resources:
Abstract
5769 - Understanding Chemotherapy - group education sessions prior to commencing chemotherapy
Presenter: Aileen McHale
Session: Poster Display session 3
Resources:
Abstract
2620 - Estimation of HPQ-based absenteeism and presenteeism in cancer patients via ResearchKit
Presenter: Shunsuke Kondo
Session: Poster Display session 3
Resources:
Abstract
4705 - Identifying falls-related variables and risk factors in hospitalised cancer patients
Presenter: Maria Montserrat Martí Dillet
Session: Poster Display session 3
Resources:
Abstract