TY  - JOUR
T1  - Phase IIa SAKK 11/16 Trial Evaluating Overall Survival With MVX-ONCO-1 Cell Encapsulation-Based Immunotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Progression on One or More Lines of Systemic Therapy
A1  - Kristian Eriksen
A1  - Solveig Berg
A1  - Magnus Dahl
JF  - Archive of International Journal of Cancer and Allied Science
JO  - Arch Int J Cancer Allied Sci
SN  - 3108-4834
Y1  - 2024
VL  - 4
IS  - 2
DO  - 10.51847/fQefAJZoz0
SP  - 274
EP  - 286
N2  - Throughout the last two decades, the clinical advancement of most cancer vaccines has encountered significant setbacks. Insufficient activation of immune responses using tumor-specific antigens, along with suboptimal adjuvants, likely accounts for these disappointing outcomes. MVX-ONCO-1 represents an individualized cell therapy vaccine that merges inactivated patient-derived tumor cells with allogeneic human cells enclosed in capsules and modified to secrete granulocyte–macrophage colony-stimulating factor (GM-CSF). This design facilitates extended, localized release of a powerful adjuvant precisely at the site of administration. Combining these patient-specific tumor antigens with effective on-site adjuvant delivery targets two fundamental challenges and seeks to mirror the promising synergies documented in laboratory animal studies. SAKK 11/16 constituted a Phase IIa clinical study primarily assessing overall survival (OS). This marked the initial evaluation of MVX-ONCO-1’s therapeutic potential. Eligible participants included individuals with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease had advanced following a minimum of one systemic treatment regimen—the trial aimed to demonstrate that 50% of patients would remain alive at 26 weeks. Within this difficult-to-treat cohort, the study achieved its main goal, with 68.8% of enrolled patients alive at six months. The median overall survival was 11.4 months, and 32% of participants survived beyond 18 months. Instances of complete and partial tumor regressions occurred during treatment with MVX-ONCO-1 as a single agent. Notably, all individuals who exhibited a positive delayed-type hypersensitivity (DTH) reaction to their autologous tumor cells following immunization survived for at least 12 months. Those who survived past the one-year mark also showed elevated antibody levels against tumor-associated antigens. An additional exploratory review revealed a median OS of 21.7 months calculated from the beginning of anti-PD-1 therapy. Safety assessments revealed no unanticipated risks, no systemic treatment-related adverse events (AEs), and smooth manufacturing processes throughout this multi-center investigation. The data support MVX-ONCO-1’s ability to elicit an integrated immune response, translating into meaningful clinical improvements and extended patient survival when used independently. Prior treatment with immune checkpoint inhibitors may further augment these effects.
UR  - https://smerpub.com/article/phase-iia-sakk-1116-trial-evaluating-overall-survival-with-mvx-onco-1-cell-encapsulation-based-immu-im8ovy7vi9yjzvm
ER  -