On May 6, 2020 Oncosec Medical Incorporated (the "Company" or "Oncosec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported published data in Clinical Cancer Research, linked here, that demonstrated its lead product candidate, TAVO (interleukin-12 or "IL-12" plasmid), in combination with the anti-PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab), produced a 41% overall response rate (ORR), with 36% complete response in a Phase 2, single arm study evaluating patients with metastatic melanoma selected to be anti-PD-1 checkpoint resistant (Press release, OncoSec Medical, MAY 6, 2020, View Source [SID1234557150]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Combining pembrolizumab with TAVO electroporation improved responses for these patients who were predicted to have very poor responses to single-agent immune checkpoint inhibition," said Adil Daud, MD, clinical professor at the University of California San Francisco (UCSF) and director of melanoma clinical research at the UCSF Helen Diller Family Comprehensive Cancer Center. "By using electroporation to deliver TAVO locally, we were able to avoid many of the toxicities associated with systemic IL-12 administration, while still attaining clinical responses and inducing immune-cell infiltration in treated and untreated melanoma lesions."
In the trial, responses were observed in nine of 22 evaluable patients, for an objective response rate of 41 percent. Thirty-six percent of patients experienced a complete response. Median progression-free survival was 5.6 months, with median overall survival not yet reached after a median follow-up of 19.6 months. Grade 3 or higher adverse events were limited and included pain, chills, sweat and cellulitis, as well as certain toxicities usually observed with immune checkpoint inhibitors such as pembrolizumab.
The results published in Clinical Cancer Research were also highlighted in a recent press release issued by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), linked here.
"AACR’s choosing to feature this data in their publication, Clinical Cancer Research, highlights its importance and relevance today. This study provided evidence of how TAVO may convert immunologically ‘cold’ melanomas to ‘hot’ and enable checkpoint monotherapies, like KEYTRUDA, to be more effective with minimal side effects," said Daniel J. O’Connor, President and CEO of OncoSec. "These findings provided the clinical rational for our ongoing pivotal KEYNOTE-695 study of TAVO and KEYTRUDA combination therapy in patients with anti-PD-1 checkpoint resistant metastatic melanoma. Because KEYNOTE-695 is treating patients with late-stage metastatic melanoma who have no FDA approved treatment options, nearly all study sites remain open and are actively recruiting patients during the current COVID-19 pandemic. We are targeting complete enrollment this year and look forward to providing an interim data update from this pivotal study at an appropriate scientific meeting or otherwise appropriate time this year."
The KEYNOTE-695 study is a pivotal, global, open-label trial of TAVO in combination with KEYTRUDA in patients with anti-PD-1 checkpoint resistant metastatic melanoma. TAVO has been designated fast track and orphan drug status by the U.S. FDA and following completion of the KEYNOTE-695 study OncoSec intends to file for accelerated U.S. approval. For more information on the KEYNOTE-695 study, please visit View Source