OncoSec Medical has started the Phase II KEYNOTE-890 clinical trial of Tavo for the treatment of late-stage triple negative breast cancer (TNBC).

Tavo (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) will be trialled in combination with Merck’s Keytruda (pembrolizumab).

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The multicentre, open-label trial is expected to enrol patients with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC, and at least one prior line of approved systemic chemotherapy or immunotherapy.

It represents the second Phase II OncoSec trial involving a combination of Tavo and Keytruda.

OncoSec’s first Phase II trial of Tavo and Keytruda, PISCES/KEYNOTE-695, is a global and multicentre study that examined the drug combination for metastatic melanoma.

Currently, overall survival for metastatic TNBC is one to two years from diagnosis, with therapies resulting in short-lived responses and/or significant toxicity.

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“We believe that Tavo, in combination with Keytruda, has the potential to be effective in treating this disease.”

OncoSec Medical president and CEO Daniel O’Connor said: “Our goal is to enrol this study as quickly as possible and provide preliminary topline data in 2019.

“New approaches are desperately needed, and based on prior and ongoing clinical research, we believe 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 is a poor-prognosis breast cancer subtype, with limited treatment options for the patients.

OncoSec has been developing Tavo as a potential treatment for a number of cancer indications, either as a monotherapy or in combination with checkpoint inhibitors such as Keytruda.

Recently revealed results from clinical studies of Tavo have shown the drug as a local immune response and, subsequently, a systemic effect as either a monotherapy or combination treatment.