Opdivo (nivolumab) is a safe and viable option for pre-treating patients with early stage lung cancer before surgery, according to data recently presented during the European Society for Medical Oncology (ESMO) 2016 Congress, Oct. 7-11, in Copenhagen, Denmark.
The finding may expand recommendations for drug, previously used only for advanced lung cancer.
“Until now nivolumab and the other anti-PD-1 and anti-PD-L1 drug studies have only been reported in metastatic or advanced lung cancer,” Dr. Patrick Forde, an assistant professor of oncology at the Sidney Kimmel Comprehensive Cancer Centre at Johns Hopkins University, and lead author of the study, said in a news release. “This was the first study of neoadjuvant PD-1 blockade in early stage lung cancer.”
The study evaluated the safety and feasibility of the treatment in patients with early stage non-small cell lung cancer who were planned for surgery. Pre-treatment before surgery, called neoadjuvant therapy by clinicians, is used to shrink a tumor before the operation. Researchers deemed the treatment “feasible” if it did not delay surgery.
Before treatment, the 20 study patients had a tissue sample removed from their tumor. They were then treated with Opdivo on two occasions — four weeks and two weeks before surgery.
Data from 16 of the 20 patients showed that the drug did not impact the time to surgery and that the patients had no significant side effects.
In 40 percent of the patients, the tumors had regressed were filled with immune cells. Among those patients, the researchers saw either a complete response to treatment or only isolated cells remaining.
Five additional patients had a partial response. Analyses showed that the treatment had attracted cytotoxic T-cells to the tumor that were not present in the pre-treatment biopsies.
Early data showing that the treatment is likely beneficial for patients, spurred researchers to expand the study. The expanded study will compare two groups of patients: one will receive Opdivo before surgery, and the other will get a combination of Opdivo and Yervoy (ipilimumab) before surgery. The study will continue in collaboration with scientists at the Memorial Sloan-Kettering Cancer Center.
Pieter Postmus, professor and chair of Thoracic Oncology at the University of Liverpool in the U.K., however, cautioned that the study may be overestimating the impact of the treatment because the small biopsy taken before treatment may not be representative of the whole tumor. Comparing the biopsy to the surgically removed tumor may give a skewed result.
“This is not a validated way to measure response to a treatment. It describes a biological effect but whether that has any clinical impact on survival is unproven,” said Postmus. He added that long-term survival data will be the ultimate proof that neoadjuvant immunotherapy may be beneficial in the patients.