“We are excited to share updated data from our phase II clinical monotherapy trial with ImmunoPulse IL-12 in patients with stage III/IV melanoma,” said Punit Dhillon, CEO and President at OncoSec. "These data, along with the emerging clinical data from the phase II combination study, further support the rationale for our … phase IIb clinical trial, PISCES/KEYNOTE-695, from which we anticipate reporting initial data in mid-2018."
Alain Algazi, Associate Professor, MD, Department of Medicine (Hematology/Oncology), at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, gave an oral presentation contrasting monotherapy ImmunoPulse IL-12 to its combination with pembrolizumab. The presentation includes an assessment of clinical and immune biomarker data from the recently completed monotherapy phase II trial.
Dr. Algazi presented new clinical and immune monitoring data from patients treated with ImmunoPulse IL-12 as a monotherapy (n = 51) vs the combination of ImmunoPulse IL-12 and the approved anti–programmed cell death protein 1 (PD-1) therapy pembrolizumab (n =22) to better understand the mechanisms associated with each immunotherapy protocol.
In the 51 patients treated with ImmunoPulse IL-12 as monotherapy, the best overall response rate at 180 days averaged 33.5% by a modified skin Response Evaluation Criteria in Solid Tumors (RECIST). In addition, a favorable safety profile (no life-threatening or grade 4 adverse events) was demonstrated in this group. In the combination trial of 22 patients treated to date, a 48% best overall response rate was observed at 24 weeks.
Biomarker analyses suggest ImmunoPulse IL-12 drives a cellular response, leading to an inflamed tumor with an increased tumor-infiltrating lymphocyte frequency, whether as a monotherapy or combined with pembrolizumab, converting “cold” tumors to “hot” tumors.