- Updated results from Sellas Life Sciences' small Phase 2 study of its lead candidate galinpepimut-S in multiple myeloma point to clinical benefit in high risk patients. Overall survival (OS) was 88% in 18 patients at 18 months, with median progression-free survival of 23.6 months. Median OS hasn't yet been reached.
- Compared with a similar high risk group of multiple myeloma patients, the patients treated with the galinpepimut-S peptide antigen mix had a 2.5-fold higher median PFS. The Phase 2 trial, which has been running since June 2014, has enrolled 20 patients, and is following them long term.
- Galinpepimut-S is expected to head into Phase 3 trials this year, with acute myeloid leukemia (AML) in the first half of 2017, and mesothelioma in the second half.
Sellas Life Sciences is pushing ahead with its plan to gain approval for its lead immuno-oncology candidate, galinpepimut-S, in as broad a range of hematologic and solid cancers. As well as the ongoing Phase 2 study in multiple myeloma, there is a Phase 1/2 study under way in combination with checkpoint inhibitor Bristol-Myers Squibb's Opdivo (nivolumab). Plans for 2017 include Phase 3 studies in AML and mesothelioma, a Phase 2 study for chronic myelogenous leukemia, and a Phase 1 study in glioblastoma.
"We are encouraged by continued indications that Sellas’ galinpepimut-S therapy notably delays disease progression in high-risk multiple myeloma patients," said Nicholas Sarlis, CMO of Sellas.
The 18 patients evaluated had minimal residual disease (MRD+) after autologous stem cell transplantation (ASCT), and 15 had high-risk cytogenetics at diagnosis. On maintenance therapy, these high-risk patients would normally be expected to have low progression-free survival (PFS) of no longer than 12 months following ASCT.
"This new data further underscores the potential for galinpepimut-S to target an array of tumor types. The data both validate our focus on targeting malignancies with subclinical disease with galinpepimut-S monotherapy, and also support the expansion of our clinical trial program to include combination approaches in addressing a wide variety of cancers," said Angelos Stergiou, vice chair and CEO of Sellas.
Last week Sellas hooked up with Advaxis to create a targeted immuno-oncology drug combining galinpepimut-S with Advaxis' Lm-based antigen delivery technology.