Dive Brief:
- 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.
Dive Insight:
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.