Investigational Keytruda Combination Therapy Explored in Lung Cancer

Biothera Pharmaceuticals recently announced the Big Ten Cancer Research Consortium has started dosing patients in a phase 1b/2 clinical trial investigating a combination of Imprime PGG plus pembrolizumab (Keytruda) in patients with lung cancer.

The experimental combination therapy is being evaluated as a second-line treatment in patients with non-small cell lung cancer (NSCLC), according to a press release. The University of Illinois at Chicago is the first of 5 sites to start patient enrollment.

The goal of the clinical trial is to determine if Imprime PGG can increase patient response to treatment with pembrolizumab.

Imprime PGG is an investigational pathogen-associated molecular pattern drug. Imprime PGG acts as an immunological switch that ramps up the immune system through T cell activation and cancer cell death, according to the release.

Preclinical studies showed that the experimental drug increases the efficacy of immune checkpoint inhibitors, according to the release. These findings suggest pembrolizumab, a checkpoint inhibitor, plus Imprime PGG may be a beneficial combination.

“While we have seen great advances in the field of cancer immunotherapy, we want to address the significant continuing need among patients, including those with refractory disease,” said principal investigator Lawrence E. Feldman, MD. “This new trial brings together a promising combination approach that we believe may increase patient responses to Keytruda and ultimately improve the lives of patients with non-small cell lung cancer.”

The multi-center clinical trial is expected to enroll up to 36 patients with metastatic NSCLC whose disease worsened on or after platinum-based chemotherapy, according to the release.

The phase 1b dose-escalation portion of the study includes 12 patients receiving the combination, while the phase 2 portion will examine progression-free survival and overall survival in 24 patients.

The clinical trial is part of the Big Ten Cancer Research Consortium, which creates a team-based research community to translate ideas from conception to clinical practice, according to the release. Within the program, research leaders collaborate with other leaders to improve treatment of cancer.

Currently, Keytruda is indicated to treat NSCLC, melanoma, head and neck cancer, classical Hodgkin lymphoma, microsatellite instability-high cancer, and bladder cancer.

If the combination therapy improves immune response, patients with NSCLC could benefit from improved survival.

“Our extensive translational research indicates there is a significant opportunity for the combination of Imprime PGG and Keytruda to benefit second-line patients with non-small cell lung cancer,” said Bruno Osterwalder, MD, chief medical advisor of Biothera Pharmaceuticals. “We are very pleased to be working with the Big Ten Cancer Research Consortium and Merck on this study.”