Together, the companies will develop Tumor Treating Fields with Merck’s anti-PD-1 therapy, Keytruda for the treatment of non-small cell lung cancer (NSCLC).
NovoCure announced today that it has entered a clinical trial collaboration agreement with Merck. Together, the companies will develop Tumor Treating Fields with Merck’s anti-PD-1 therapy, Keytruda for the treatment of non-small cell lung cancer (NSCLC).
A Phase II pilot study of Tumor Treating Fields concomitant with Keytruda will be conducted for the potential treatment of intrathoracic advanced or metastatic PD-L1 positive NSCLC. Approximately 66 patients in the U.S. will be enrolled in the study, which is set to begin in the second half of 2020. The primary endpoint will be objective response rate, and secondary endpoints will include progression free survival and overall survival.
“We are very pleased to collaborate with MSD, a global leader in oncology, in this important combination study as we strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields,” said William Doyle, Novocure’s Executive Chairman. “Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control. We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with Keytruda in first-line NSCLC.”
Tumor Treating Fields is a cancer therapy that utilizes electric fields tuned to specific frequencies to disrupt cell division. The end result is inhibited tumor growth and the death of cancer cells. The most common side effect of Tumor Treating Fields is mild to moderate skin irritation, and the use of it for the treatment of NSCLC is still investigational.
Preclinical data released back in March by Novocure showed that Tumor Treating Fields in combination with anti-PD-1 therapy can induce an anticancer immune response within the body. This was based on a study specifically designed to evaluate whether Tumor Treating Fields-mediated cell death could elicit antitumor immunity.
Data from the study showed that damage-associated molecular patterns were released in Tumor Treating Fields-treated cancer cells. In addition, calreticulin was exposed on the cell surface, and Tumor Treating Fields therapy promoted the engulfment of cancer cells by dendritic cells.
Following the study, Novocure announced that it was testing the combination of Tumor Treating Fields with immune checkpoint inhibitors in its Phase III LUNAR trial in patients with stage 4 NSCLC. Specifically, it was being explored in patients who progressed during or after platinum-based therapy.
On July 7, Novocure also announced that it was examining the use of Tumor Treating Fields in combination with sorafenib for the treatment of advanced liver cancer. Specifically, an open-label trial with 25 patients has been launched to examine how the combination therapy could potentially benefit those with advanced hepatocellular carcinoma who are not eligible for surgical resection or local treatments.
Tumor Treating Fields have already demonstrated efficacy in in vitro and in vivo models of hepatocellular carcinoma. At the moment, treatment with Tumor Treating Fields is not approved for liver cancer, as the safety and efficacy of treatment have not been established.
In December 2019, Novocure and the American Association for Cancer Research (AACR) announced their second annual AACR-Novocure Grants for Tumor Treating Fields Research program. The goal is to promote and support research of Tumor Treating Fields to deepen the understanding of the mechanism of action. The program’s research grants and career development awards total more than $2 million.
