Oncosec Medical announced positive interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial evaluating TAVO (tavokinogene telseplasmid) in combination with Keytruda (pembrolizumab) in rigorously defined anti-PD1 checkpoint resistant metastatic melanoma patients. TAVO plus Keytruda led to a 30% overall response rate (ORR) in the first 54 out of 100 planned patients. This interim investigator assessed ORR surpasses the primary efficacy endpoint for the study, which is a 20% ORR determined by blinded independent review. The data were selected for a Poster Walk discussion and will be additionally presented in the virtual Poster Hall on Wednesday, November 11 and Friday November 13 and as part of a Company Symposium on November 11th at the Society for Immunotherapy of Cancer (SITC)’s 35th Anniversary Annual Meeting.
KEYNOTE-695 is an open label, single arm trial and plans to enroll up to 100 patients with refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with Keytruda (pembrolizumab) or Opdivo (nivolumab).
Additional presented data include the following: ORR was 35% (n=6/17) in patients with Stage IV M1c/M1d disease. ORR was 40% (n=6/15) in patients with prior exposure to ipilimumab. Median duration of response (mDOR) is currently 12.2 months. Median study follow-up was 13.5 months. TAVO plus Keytruda had an excellent safety profile resulting from intramural treatment approach. There were only 5.4% Grade 3 treatment-related adverse events and no grade 4/5 treatment-related adverse events.
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials.
TAVO has received Orphan Drug and Fast-Track Designation by the U.S. FDA for the treatment of metastatic melanoma following progression on Keytruda or Opdivo.
About Advanced Metastatic Melanoma
Metastatic melanoma refers to stage IV melanoma, which has typically spread through the lymph nodes to distant sites in the body such as the liver, lungs, bones and brain. Every year, approximately 100,000 adults in the United States are diagnosed with metastatic melanoma. Due to this metastatic tumor burden, stage IV melanoma is often very difficult to treat. Available treatment options frequently combine surgery with immunotherapy or targeted therapy. The 5-year survival rate for metastatic melanoma is approximately 25%.