A Phase II clinical trial supervised by Joshua Bauml of Penn’s Abramson Cancer Center will assess whether Pembrolizumab, a drug already in use for melanoma treatment, can improve survival in non-small cell lung cancer (NSCLC) patients. The trial will enroll 42 patients who have completed conventional treatments (surgery, chemotherapy, radiation and other ablative therapies) and have no signs of cancer.
Pembrolizumab (marketed by Merck as Keytruda) targets programmed cell death 1 (PD-1) receptors, activating the immune system to fight tumors. This drug has anti-tumor activity in patients with NSCLS, as reported in last year’s American Society of Clinical Oncology annual meeting, and was approved by the U. S. Food and Drug Administration in 2014.
The trial, funded by Merck, is designed for patients with oligometastatic lung cancer — a state characterized by a limited number of metastases in a confined area. The survival for these patients is 20 months, while overall survival for patients with metastatic disease is six to 12 months.
Oligometastic lung cancer patients considered free of active disease remain at a high risk for recurrence, but there is few data to guide clinicians in treating these patients. In this trial, four to twelve weeks after finishing their other therapies, the patients will be treated with pembrolizumab every three weeks, and continue for at least six months. The trial, which will last three years, aims to assess drug toxicity, whether patients remain free of disease and their quality of life, and overall survival.
“NSCLC has historically been resistant to most immunotherapies, but PD-1 directed therapies have promise, yielding some impressive clinical responses in patients,” said Bauml to Penn Medicine News. “Use of the drug in this group could be ideal since the overall burden of disease is low—they have been deemed nearly cancer-free—and the patients are generally fit and more able to tolerate the therapy. We want to find out if we may be able to utilize this ‘window of opportunity’ to rev up the immune system and keep metastatic cancer at bay.”