Neon Therapeutics has reported that the combination of its neoantigen vaccine candidate NEO-PV-01 and Opdivo led to improved progression-free survival (PFS) in three different cancer types in a Phase Ib clinical trial.
The trial involved 82 patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC), or bladder cancer.
NEO-PV-01 is custom-designed and manufactured depending on the mutational fingerprint of individual patients. It includes up to 20 neoantigen-targeting peptides to induce an anti-tumour immune response.
Opdivo is Bristol-Myers Squibb’s checkpoint inhibitor drug.
According to the Phase Ib top-line results, the PFS improvements were observed to be prolonged, consistent, and favourable compared to historical data of checkpoint inhibitor monotherapy.
A follow-up at 13.4 months showed median PFS of 5.6 months in 27 metastatic NSCLC patients and 21 metastatic bladder cancer patients. However, the measure has not been reached in 34 metastatic melanoma patients over the same period.
The safety profile observed in the trial was consistent with that of Opdivo monotherapy. No combination therapy-related adverse events were reported in the 60 subjects who received at least one vaccine dose.
Neon Therapeutics Research and Development president Richard Gaynor said: “By targeting neoantigens that are specific to each patient’s tumour, we believe that our NEO-PV-01 personal cancer vaccine candidate is helping direct a patient’s immune system to these new cancer targets, which can lead to prolonged clinical benefit.
“Consequently, we believe that the evidence we are seeing in this clinical trial of broadened neoantigen immune response, epitope spread and histological responses suggest that NEO-PV-01 may play an important role in prolonging clinical benefit in combination with checkpoint inhibition, as evidenced by the extended PFS reported in this trial.”
These results are said to support further development of the company’s vaccine candidate, including Phase II trials in metastatic disease settings.