Oncosec Medical (ONCS) Commences KEYNOTE-890, a Phase 2 Clinical Trial of TAVO in Combination with Merck's (MRK) KEYTRUDA (pembrolizumab)
October 15, 2018 7:33 AM EDT
OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS) today announced that it has initiated KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck's (NYSE: MRK) KEYTRUDA® (pembrolizumab). The initiation of KEYNOTE-890 marks the second Phase 2 trial for OncoSec involving a combination of TAVO and KEYTRUDA®. The first, PISCES/KEYNOTE-695, is a global, multicenter Phase 2b trial of TAVO in combination with KEYTRUDA® for metastatic melanoma.
"Metastatic triple negative breast cancer represents an extreme unmet medical need, where pre-treated patients rarely achieve objective responses with PD-1/PD-L1 checkpoint treatments," said Dr. Pamela Munster, Professor of Medicine and Program Leader of Experimental Therapeutics at University of California San Francisco (UCSF). "The marked synergy of TAVO and checkpoint inhibition shown in previous clinical observations strongly suggests that IL-12 may prime the tumor microenvironment for PD-1/PD-L1 checkpoint treatments. This represents a highly promising therapeutic approach for TNBC."
KEYNOTE-890 is a multicenter Phase 2 open-label trial of TAVO in combination with KEYTRUDA® in patients with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least one prior line of approved systemic chemotherapy or immunotherapy.
Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of US breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women as well as African-American women,2 followed by Hispanic women.3
"The initiation of KEYNOTE-890 is an important milestone for OncoSec as it marks a significant expansion of our clinical pipeline as well as our expanding relationship with Merck," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "Our goal is to enroll this study as quickly as possible and provide preliminary topline data in 2019. Currently, overall survival for metastatic TNBC is one to two years from diagnosis, with therapies resulting in short-lived responses and/or significant toxicity. New approaches are desperately needed, and based on prior and ongoing clinical research, we beleive that TAVO in combination with KEYTRUDA® has the potential to be effective in treating this disease. Given the severe unmet medical need, it is possible that TAVO for the treatment of TNBC could be granted Fast Track designation, Breakthrough Therapy designation, and be a candidate for accelerated approval."
TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17
