The combination of galinpepimut-S and nivolumab (Opdivo) was found to extend survival in patients with malignant pleural mesothelioma who were either refractory to, or who had relapsed after, at least 1 line of standard therapy, according to updated data from a phase 1 trial (NCT04040231).
The median overall survival (OS), which was calculated as time from the cessation of the most recent prior therapy until confirmed death or most recent data update for those who are still alive, was 40.9 weeks for all 8 patients included in the trial, and 45.7 weeks for those who received the doublet (n = 7/8). Moreover, the median progression-free survival (PFS) was 11.1 weeks for all patients and 11.9 weeks for those who received the regimen.
The safety profile of the combination was comparable to that observed with single-agent nivolumab. The only difference was the temporary local reactions that occurred at the injection site for galinpepimut-S, which is consistent with what has been reported in prior studies evaluating the agent; however, these reactions were noted to be low grade.
Moreover, no grade 3 or 4 adverse effects (AEs) were reported with galinpepimut-S, nor were any dose-limiting toxicities observed.
“[These] updated data [are] very encouraging, as it not only confirms our data reported in June 2021, but now reflects an increased survival benefit even though almost all additionally enrolled patients had grade III and IV malignant mesothelioma,” Angelos Stergiou, MD, ScDhc, president and chief executive officer of SELLAS Life Sciences Group, Inc., stated in a press release.
Galinpepimut-S targets malignancies that are characterized by an overexpression of Wilms Tumor 1 (WT1) antigen; it is comprised of 4 peptide chains, 2 of which are modified chains that induce a strong, innate immune response against WT1 antigen and access a wide range of human leukocyte antigen types. The vaccine is hypothesized to have the potential to identify and eliminate cancer cells, as well as provide ongoing support and memory to the immune system so it can continue to target and eliminate recurring disease and residual cancer cells.
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