Merck and OncoSec Medical have announced an upcoming collaboration on a clinical trial eDr. Cecil Fox xamining two of their immunotherapies in metastatic triple-negative breast cancer.
OncoSec will sponsor and fund the study, while Merck will provide its anti-PD-1 therapy Keytruda (pembrolizumab). This will be combined with OncoSec’s ImmunoPulse interleukin-12 (IL-12), and will be examined in patients with locally advanced and inoperable or metastatic disease following the failure of systemic chemotherapy or immunotherapy.
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ImmunoPulse is Oncosec’s immunotherapy platform designed to deliver IL-12, a protein that works to stimulate the immune system. The treatment produces a controlled, localised expression of IL-12 in the tumour microenvironment, which helps the immune system to identify and attack tumours throughout the body.
The trial follows a similar collaboration between the companies announced last year, a Phase II study examining the same drugs in combination as a melanoma treatment. Approximately 50 late-stage metastatic melanoma patients who have had an anti-PD-1 therapy will be enrolled. Completion of this trial is expected in late 2020.
Though checkpoint inhibitors, such as Keytruda, have shown efficacy in improving progression-free and overall survival in certain cancers, single-agent therapies alone are often ineffective in patients. As such, OncoSec has predicted its IL-12 agent will increase the efficacy of PD-1 therapies through stimulating the body’s immune system when injected directly into the tumour.
Anti-PD-1 and anti-PD-L1 treatments do not kill cancer cells, but are designed to block a pathway that protects tumour cells from immune system attacks. The pathway consists of two proteins; programmed death-1 (PD-1) and programmed death ligand-1 (PD-L1). The former is found on the surface of immune cells, while the latter is expressed on cancer cells. Combined, these proteins form a protective shield, which prevents the immune system from destroying tumour cells.
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By GlobalDataTreatments that target PD-1 and PD-L1 have become increasingly popular in recent years, catalysing numerous oncology trials in a bid to find effective and successful combinations of immunotherapy permutations.
Keytruda has been a particularly popular antibody used in such trials, reporting mixed results. A recent Phase I study combined it with Checkmate Pharmaceuticals’ CMP-001, and found the combination to reverse anti-PD-1 drug resistance in advanced melanoma patients. Conversely, a Phase III study of Keytruda in combination with Incyte’s IDO1-inhibitor epacadostat did not show any improvement in progression-free survival compared to Keytruda alone.
Triple-negative breast cancer is characterised by tumours that do not express oestrogen receptor (ER), progesterone receptor (PR), or HER-2 genes. This type of cancer proves difficult to treat as endocrine therapy and other targeted agents often prove ineffective against it. Metastatic triple-negative breast cancer tumours are associated with a shorter average time to relapse and death, making the development of effective treatments an urgent need.
