Key Points
Question
What are the diagnostic accuracy and negative predictive value of novel biparametric magnetic resonance imaging (MRI) in biopsy-naive men in detecting and ruling out significant prostate cancer?
Findings
In this cohort study of 1020 men who underwent both biparametric targeted and standard transrectal ultrasound-guided biopsies, low-suspicion biparametric MRI had a high negative predictive value (97%) in ruling out significant prostate cancer on confirmatory biopsies.
Meaning
The biparametric MRI used as a triage test in this study was associated with improved prostate cancer risk stratification and may be used to exclude aggressive disease and avoid unnecessary biopsies in 30% of men with clinical suspicion of prostate cancer, although further studies are needed to fully explore this new diagnostic approach.
The majority of neoantigens arise from unique mutations that are not shared between individual patients, making neoantigen-directed immunotherapy a fully personalized treatment approach. Novel technical advances in next-generation sequencing of tumor samples and artificial intelligence (AI) allow fast and systematic prediction of tumor neoantigens. This study investigates feasibility, safety, immunity, and anti-tumor potential of the personalized peptide-based neoantigen vaccine, EVX-01, including the novel CD8
+
T-cell inducing adjuvant, CAF®09b, in patients with metastatic melanoma (NTC03715985). The AI platform PIONEER
TM
was used for identification of tumor-derived neoantigens to be included in a peptide-based personalized therapeutic cancer vaccine. EVX-01 immunotherapy consisted of 6 administrations with 5–10 PIONEER
TM
-predicted neoantigens as synthetic peptides combined with the novel liposome-based Cationic Adjuvant Formulation 09b (CAF®09b) to strengthen T-cell responses. EVX-01 was combined with immune checkpoint inhibitors to augment the activity of EVX-01-induced immune responses. The primary endpoint was safety, exploratory endpoints included feasibility, immunologic and objective responses. This interim analysis reports the results from the first dose-level cohort of five patients. We documented a short vaccine manufacturing time of 48–55 days which enabled the initiation of EVX-01 treatment within 60 days from baseline biopsy. No severe adverse events were observed. EVX-01 elicited long-lasting EVX-01-specific T-cell responses in all patients. Competitive manufacturing time was demonstrated. EVX-01 was shown to be safe and able to elicit immune responses targeting tumor neoantigens with encouraging early indications of a clinical and meaningful antitumor efficacy, warranting further study.
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