US-based late-stage clinical biopharmaceutical company, Sellas Life Sciences, has confirmed that its Phase I study (NCT02737787) of galinpepimut-S Combined with Opdivo (nivolumab) has hit its primary endpoint seeing increased overall survival in mesothelioma patients.
The cancer indication specialist firm announced follow-up clinical and immune response data from a Phase I investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), alongside the Bristol-Myers Squibb checkpoint inhibitor Opdivoin patients living with refractory and relapsed malignant pleural mesothelioma (MPM).
The combination therapy achieved a median overall survival of 70.3 weeks. The median overall survival rate for patients living with relapsed or refractory mesothelioma receiving standard treatment is around 28 weeks.
The trial also observed that the use of galinpepimut-S was able to increase the median overall survival for patients from nine months without it, to 27.8 months for patients with GPS-specific immune response, an increase of 208.3%.
The study enrolled ten patients, nine of whom would receive at least three doses of GPS, with the third dose given alongside the use of nivolumab. Nine out of ten of the patients then had sufficient samples collected to be analysed for GPS-specific immune response.
Angelos Stergiou, president of Sellas commented, “We are excited that in a bulky, measurable disease setting, such as in this relapsed/refractory advanced mesothelioma study, we have observed yet again strong GPS-specific immune responses which appear to be correlated with significant survival benefit in patients when combined with checkpoint inhibitors, a more than 200% survival benefit.
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“As we had hypothesised in the past, this increase in survival appears to be consistent with long-term immunity-mediated antitumor effect with our immunotherapy combination as we had seen in other studies with GPS, and, importantly, the positive survival outcomes seen in this study are accompanied with a safety profile which is similar to that of the checkpoint inhibitor alone.”
Previously, in June of 2023, the company reported positive topline data as part of its other Phase I study (NCT03761914) examining the use of galinpepimut-S, in combination with Opdivo.
Stergiou added, “We believe that these observed survival benefits in the active disease setting further confirm the strong biological effect of GPS in even the most challenging settings where GPS seems to contribute to stopping the progression of extremely aggressive cancers and demonstrates its utility as a potentially effective combination therapy.”