New results released by Neon Therapeutics1 have shown promising, early results for their NEO-PV-01 personalized neoantigen vaccine in combination with nivolumab across 3 different types of advanced cancer.

In May 2019, Cancer Therapy Advisor reported on results presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting of NEO-PV-01 in a small cohort of 23 patients with advanced melanoma.2 The new report shows 12-month median follow-up outcomes in 82 patients with advanced melanoma, smoking-associated non-small cell lung cancer (NSCLC), or advanced bladder cancer.

In all 3 cancer types, progression-free survival (PFS) was favorable compared with historical results in these cancer types with just nivolumab treatment alone.

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“Collectively, these data demonstrate a promising new approach in the field of cancer immunotherapy with the potential to further broaden and extend the benefits of checkpoint inhibitor treatment to improve patient outcomes in multiple cancer settings,” said Patrick Ott, MD, PhD, clinical director of the melanoma center, center for immuno-oncology at Dana-Faber Cancer Institute, Boston, Massachusetts, and a lead investigator in the NT-001 trial.

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In 34 patients with advanced metastatic melanoma, median PFS had not been reached at 13.4 months of follow-up. In both metastatic NSCLCs and bladder cancers, median PFS was 5.6 months in 27 and 21 patients, respectively. All patients had received at least 1 dose of nivolumab in the phase 1b NT-001 trial.3

“Monotherapy checkpoint inhibitors have historically shown a range in median progression-free survival in metastatic melanoma, NSCLC, and bladder cancers of approximately 3 to 7 months, 2 to 4 months, and 2 to 3 months, respectively. With these NT-001 results, we are observing consistent prolongation of PFS across all 3 tumor types compared with historical checkpoint inhibitor monotherapy studies involving patients with similar baseline characteristics,” said Dr Ott.

NEO-PV-01 is tailored to neoantigens found on an individual’s tumor. Each bespoke vaccine contains up to 20 neoantigen peptides selected for each patient by a specialized bioinformatics pipeline with the aim of boosting T-cell responses. The phase I trial monitored patients for a median of 12 months and used PFS as a measure of the efficacy of the drug — but how much can truly be learned from these experimental end points?