The combination of galinpepimut-S and nivolumab is showing promising results for mesothelioma. The study looked at patients who were refractory or relapsed after at least one standard treatment. The combination met safety and efficacy standards for treatment, leading to a completed phase one trial. The median overall survival, which was measured as the time of cessation of the most recent therapy session or until a confirmed death or the most recent data update, was 17.6 months in patients who received the therapy combination. There were 10 patients in the study, with nine receiving the combination treatment and one receiving the cancer vaccine alone.
The median overall survival for all 10 patients was 13.5 months. The patients who entered the study with stage IV cancer had a median overall survival of 15.6 months. The median progression free survival was 11.9 weeks for all patients. The disease control rate of the group was 30 percent, so three patients had stable disease according to RECIST criteria. The three patients had a reduced tumor volume up to 17 percent.
Seventy percent of the patients had treatment related adverse effects. Sixty percent of the patients had nivolumab related adverse effects and 30 percent had adverse events related to the vaccine. The adverse events include injection site reaction, fatigue, dizziness, and chest pain. The trial is seen to be safe since the safety outcomes are similar to the checkpoint inhibitor alone. It was observed by the researchers that the patients with low toxicities had median or higher survival times.
The phase one trial took place at Memorial Sloan Kettering and had patients with pleural mesothelioma. Eligibility criteria included: needing to be at least 18 years old, having a Karnofsky performance status of at least 70 percent, having measurable or evaluable disease, and being positive for WT1 on immunohistochemistry tests. Patients also had to have received a prior treatment regimen of pemetrexed-based chemotherapy and have progressed or been refractory to the treatment. Patients could not have previously received an immune checkpoint inhibitor or have hepatitis B or C or another autoimmune disease that requires systemic steroids within the last two years. The main goal was to find the largest allowable dose and to find preliminary effectiveness values.
The median age of patients was 69 years. Eight patients were male and two patients were female. Six of the patients had stage III or IV cancer when they entered. One patient had stage I while three patients had stage II disease. All patients had epithelioid and/or sarcomatoid mesothelioma, which are known to express WT1.
