With approximately 43,000 Americans diagnosed each year and 37,000 annual deaths from the disease, pancreatic cancer has a dismal prognosis and few therapeutic alternatives. Current therapies include chemoradiation and surgery. Few drugs have been approved for pancreatic cancer in the last two decades, yielding extremely modest improvements in patient outcomes. Aggressive treatments such as FOLFIRINOX or gemcitabine/nab-paclitaxel yield median survival of less than one year and significant toxicity. Pancreatic cancer represents a dire, unmet medical need.
PaTK-02: Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma
We have commenced a follow-on clinical study with the current more aggressive standard of care chemotherapy and radiation for patients with borderline resectable and locally advanced pancreatic cancer. The current protocol is designed to deliver multiple courses of GMCI timed with a series of neoadjuvant debulking therapies - modified FOLFIRINOX (mFX) chemotherapy followed by gemcitabine-radiation (GR) followed by surgery - to capitalize on the synergies with the different treatment modalities. The primary endpoints of the study will be resection rate at four months compared between the two arms. Secondary endpoints will be progression free and overall survival.
A Phase II study was completed and demonstrated the safety and potential efficacy of GMCI as adjuvant to surgery for resectable disease. Results from the study showed massive increased CD8(+) T cell infiltration in the tumors compared with baseline (p = 0.0021) and significant increase in PD-L1 expression in tumor tissue. Overall survival data was promising, with one node-positive resected patient alive > 66 months without recurrence (and has remained cancer free to date). The results of the study were published in Cancer Immunology and Immunotherapy in June 2015.