GPS is also being investigated in a Phase I/II as a combination therapy with MSD’s Keytruda for other advanced cancers. Credit: Kateryna Kon / Shutterstock.

Sellas Life Sciences Group (Sellas) has reported positive topline Phase I results for its cancer vaccine, galinpepimut-S (GPS), in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in relapsed or refractory malignant pleural mesothelioma (MPM).

Sellas CEO Angelos Stergiou stated: “In our GPS trials completed in previous years, we have observed and reported increased survival in the maintenance therapy setting, which is the primary setting for our GPS therapy.

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“This year, we have seen in two studies where GPS appears to increase the survival benefit in active disease when combined with checkpoint blockade drugs, one with relapsed/refractory WT1 positive ovarian cancer and now in relapsed/refractory WT1 positive mesothelioma.”

GlobalData forecasts the global sales for therapeutic cancer vaccines to reach $4bn by 2028.

GlobalDala is the parent company of Clinical Trials Arena.

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GPS is also being investigated in an open-label Phase I/II study (NCT03761914) as a combination therapy with MSD’s Keytruda for other advanced cancers, including acute myelogenous leukaemia, and ovarian cancer.

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Phase I data

The open-label, single-group Phase I study (NCT04040231) enrolled ten patients with MPM in the US, nine of whom received the study-specified combination therapy.

The median survival rate was 17.6 months in the nine patients, with a median overall survival of 15.6 months in patients with stage IV MPM (four patients) at the start of the study.

A number of adverse events were observed by all the patients during the study. Treatment-related toxicities were observed in seven patients, with six reporting Opdivo toxicity. Severe adverse events requiring hospitalisation were reported in three cases. Three GPS-related mild adverse events were also observed.

Additional immune response data is expected by the fourth quarter of 2023.