CheckMate 816 surgical outcomes support neoadjuvant nivolumab in NSCLC
medwireNews: Adding nivolumab to neoadjuvant chemotherapy for resectable non-small-cell lung cancer (NSCLC) is not associated with surgical delays or complications, show CheckMate 816 data presented at the 2021 ASCO Annual Meeting.
Jonathan Spicer, from McGill University Health Center in Montréal, Québec, Canada told delegates: “The safety and surgical outcome data reported thus far from CheckMate 816, along with significant improvement in pathologic complete response, support nivolumab in combination with chemotherapy as a potential neoadjuvant option for patients with resectable non-small-cell lung cancer.”
Spicer reported that 83% of 179 individuals with stage IB–IIIA resectable NSCLC and no known EGFR/ALK alterations underwent definitive surgery following 3 cycles of neoadjuvant treatment with nivolumab plus chemotherapy every 3 weeks.
By comparison, the definitive surgery rate was 75% among the 179 participants who were randomly assigned to receive chemotherapy alone.
Surgery took place a median 5.3 weeks after the end of neoadjuvant therapy in the nivolumab group, and after a median 5.0 weeks in the no nivolumab group, with median surgical durations of 184 and 217 minutes, respectively.
Spicer commented: “This half hour difference in procedure time may indicate that surgical complexity was not increased by virtue of addition of nivolumab to the preoperative treatment regimen.”
When subgrouped by stage, the trial investigators found that definitive surgery rates were 85% and 83% for individuals with stage IB/II and stage IIIA disease, respectively, with nivolumab, and 82% and 72%, respectively, without nivolumab.
Reasons for cancelled surgery included disease progression (7 vs 10% with vs without nivolumab), AEs related to neoadjuvant therapy (1% in each arm), and other reasons including patient refusal, unresectability, and poor lung function (8 vs 11%).
Lobectomy was the most common type of surgery, performed in 77% and 61% of patients who did and did not receive nivolumab, respectively. Spicer described the difference between the two groups as “clinically important” and said it was “largely attributed to higher pneumonectomy rates in the group that did not receive nivolumab,” at 17% in the nivolumab group versus 25% in the chemotherapy only group.
Minimally invasive surgery rates were 30% for nivolumab plus chemotherapy and 22% for chemotherapy alone, with a corresponding 11% and 16% of patients converting from minimally invasive to open surgery.
Complete resection was achieved in 83% and 78% of patients, respectively, and rates were similar regardless of baseline disease stage in both treatment arms.
AEs led to surgical delays in 4% of patients who received nivolumab and in 7% of those who did not, and Spicer also reported that the “addition of nivolumab to chemotherapy did not increase surgery-related adverse events in CheckMate 816.”
Specifically, any-grade surgery-related AEs occurred in 41% and 47% of individuals in the nivolumab plus chemotherapy and chemotherapy only arms, respectively, while the corresponding grade 3 or 4 AE rates were 11% and 15%.
“Such complication rates are well within expected ranges previously described from large surgical series of real-world data in neoadjuvant treated or treatment-naïve patients,” Spicer remarked.
He noted that two grade 5 surgery-related AEs (one pulmonary embolism and one aortic rupture) occurred in the nivolumab plus chemotherapy group but were deemed unrelated to the study drug.
The CheckMate 816 pathologic complete response data, which showed a significant improvement with the addition of nivolumab, were presented at the virtual AACR Annual Meeting 2021 and reported by medwireNews.
Event-free survival data will be reported when mature, Spicer said.
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