Results from the phase 3 CheckMate 816 trial showed the combination of nivolumab plus chemotherapy provided benefits for patients with resectable non-small cell lung cancer.  

According to a release from the manufacturer, the trial included 358 patients who were randomized to receive either 360 mg of nivolumab plus histology-based platinum doublet chemotherapy every three weeks for three doses or platinum doublet chemotherapy every three weeks for three doses, followed by surgery.  

The combination treatment significantly improved pathologic complete response compared to patients who received only chemotherapy.  

The release noted that 24% of patients who received the combination had improved PCR compared to just 2.2% of patients treated with chemotherapy alone (OR 13.94, CI: 3.49-55.75; p<0.0001). Pathologic complete response was defined as no evidence of cancer cells in resected tissues.  

In addition to meeting the primary endpoint, the treatment also showed improvement in the trial’s secondary endpoints, including major pathological response.  

The release noted that four times as many patients on the combination therapy reached that milestone compared to chemotherapy alone (36.9% vs. 8.9%; OR 5.70, 95% CI: 3.16-10.26).  

“The ultimate goal of treatment in earlier stages of cancer is to prevent the disease from coming back as we work towards a cure for these patients. Nicolas Girard, MD, from the Institut Curie, said in the release. “Unfortunately, even when patients with resectable non-small cell lung cancer undergo surgery, the cancer returns in more than half of patients, and many of them die from their disease.”  

Dr Girard said the pathologic complete response data from the trial gives providers an early indication that the combination treatment could be a useful neoadjuvant tool for patients.  

The safety profile after three cycles of nivolumab was also well-tolerated, with no new safety signals observed. Grade 3-4 treatment-related adverse events were reported in 34% of patients in the combination arm compared to 37% in the single therapy group. 

The release noted that surgery was “rarely canceled due to adverse events,” with only two patients in each arm canceling their scheduled procedures.  

The release said that 83% of patients who received the neoadjuvant therapy underwent surgery compared to 75% in the chemotherapy arm, with 83% of patients having their tumors completely resected in the combination group compared to 78% in the solo group.  

The rates of surgery-related adverse events were similar between the two groups.  

Initial results from the trial were presented at the American Association for Cancer Research 2021 Annual Meeting.  


By Adam Hochron