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AACR 2021: Adding Nivolumab to Neoadjuvant Platinum-Doublet Chemotherapy for NSCLC

By: Julia Fiederlein
Posted: Tuesday, April 20, 2021

According to Patrick M. Forde, MBBCh, of the Johns Hopkins Kimmel Cancer Center, Baltimore, and colleagues, neoadjuvant treatment with the anti–PD-L1 immunotherapeutic agent nivolumab plus platinum-doublet chemotherapy seemed to significantly improve pathologic complete response compared with chemotherapy alone in patients with resectable non–small cell lung cancer (NSCLC). The final analysis of this primary endpoint of the phase III CheckMate 816 trial was presented during the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract CT003).

“The safety profile of nivolumab plus chemotherapy was consistent with the known profile of this combination regimen,” the investigators remarked. “The addition of nivolumab did not decrease the ability to perform surgery.”

In this trial, a total of 358 patients with newly diagnosed stage IB to IIIA disease were randomly assigned to receive platinum-doublet chemotherapy with or without nivolumab. Within 6 weeks of therapy, they underwent radiologic staging and surgery.

The pathologic complete response rates seemed to be significantly higher with nivolumab in the intention-to-treat population than without (24.0% vs. 2.2%; odds ratio = 13.94; P < .0001); this improvement seemed to be consistent across disease stage, PD-L1 status, and tumor mutational burden subgroups. Compared with chemotherapy alone, nivolumab plus chemotherapy also was reported to have improved the major pathologic response (36.9% vs. 8.9%), radiographic downstaging (30.7% vs. 23.5%), and objective response (53.6% vs. 37.4%) rates in the intention-to-treat population. Definitive surgery was performed in 83.2% of patients treated with nivolumab and 75.4% of those treated with chemotherapy alone. The rates of grade 3 or 4 treatment-related (33.5% vs. 36.9%) and surgery-related (11.4% vs. 14.8%) adverse events were lower with nivolumab than without.

Disclosure: For full disclosures of the study authors, visit abstractsonline.com.



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