The gist: A new treatment called ImmunoPulse has shown promise for improving the long-term survival of metastatic melanoma patients. ImmunoPulse delivers instructions for making a protein called IL-12 into a patient’s tumor; the patient’s cells then make IL-12, which boosts the immune system to kill cancer cells. It was tested in 24 volunteer patients in a clinical trial in 2007. Now, long-term follow-up data has been analyzed. The researchers found that the median length of time patients lived after treatment was 23.9 months.
“OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based cancer immunotherapies, released long-term survival results from its Phase I study in patients with metastatic melanoma, evaluating a single treatment cycle of intratumoral plasmid IL-12 (pIL-12) injection with electroporation (EP). Dr. Robert Pierce, Chief Scientific Officer at OncoSec, a co-author of the abstract presented these data today at the Melanoma Bridge 2014 conference in Naples, Italy.
“The Phase 1 dose-escalation study, which completed enrollment in February 2007 and was first published in the Journal of Clinical Oncology (Daud et al., 2008), established that a single treatment cycle of intratumoral pIL-12 EP, administered on Days 1, 5 and 8, has an acceptable safety profile and is well-tolerated. Escalating concentrations of pIL-12 were administered in cohorts of three patients. No dose-limiting toxicities, treatment-related serious adverse events, or treatment-related Grade 4 or 5 adverse events were reported. Importantly, the study also demonstrated that local intratumoral pIL-12 EP can induce systemic responses, as evidenced by stable disease or objective regression in non-injected, non-electroporated lesions. Moreover, pIL-12 EP monotherapy was shown to achieve objective responses in this initial Phase 1 trial in patients with metastatic melanoma, with three complete responses (CRs) observed after only one treatment cycle.
“OncoSec collected data from long-term follow-up and determined that the median overall survival for the patients in the Phase 1 study was 23.9 months. In addition, a statistically significant difference (p = 0.0054) was observed when comparing overall survival between patients who had a best overall response of at least stable disease or better (median OS = 49.1 months) versus patients who only had disease progression while on study (median OS = 10.9 months).”