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CheckMate 816 Shows Benefit Of Neoadjuvant Nivolumab–Chemotherapy For Operable NSCLC

Neoadjuvant nivolumab plus chemotherapy could be an option for individuals with early-stage, resectable non-small-cell lung cancer
13 Apr 2021
Cytotoxic Therapy;  Immunotherapy
Non-Small Cell Lung Cancer

Author By Shreeya Nanda, Senior medwireNews Reporter 


medwireNews: Among patients with operable non-small-cell lung cancer (NSCLC), supplementing neoadjuvant platinum-doublet chemotherapy with nivolumab leads to a significant boost in pathological complete response (pCR) rate, indicate trial data. 

“CheckMate 816 is the first phase III study to show benefit of an immunotherapy plus chemo combination for resectable non-small-cell lung cancer”, said presenting author Patrick Forde, from the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, USA, at the virtual AACR Annual Meeting 2021. 

“And nivolumab in combination with chemotherapy represents a potential new neoadjuvant option for these patients”, he added. 

The trial included 358 patients with a new diagnosis of stage IB–IIIA, resectable NSCLC and no known sensitising alterations in EGFR or ALK; participants were randomly assigned to receive three cycles of nivolumab 360 mg alongside platinum-doublet chemotherapy, both given every 3 weeks, or chemotherapy alone. 

After a minimum follow-up of 7.6 months, the co-primary endpoint of pCR – defined as 0% viable tumour cells in both primary tumour and lymph node samples by blinded independent pathological review – was 24.0% for the patients who received nivolumab plus chemotherapy and 2.2% for those given chemotherapy alone. This equated to a significant odds ratio (OR) of 13.94 in favour of the combination. 

The pCR benefit offered by the addition of nivolumab to chemotherapy was maintained regardless of patient age or sex, disease stage, histology, PD-L1 expression and tumour mutational burden, reported Patrick Forde, adding that “the study continues to mature” for the other primary endpoint of event-free survival. 

Combining nivolumab with chemotherapy also significantly improved the secondary endpoint of major pathological response (≤10% residual viable tumour cells), at a rate of 36.9% versus 8.9% for chemotherapy alone (OR=5.70). 

And the exploratory endpoint of objective response rate, assessed by blinded independent review at the presurgical scan, was also higher in the combination than the chemotherapy alone group, at 54% versus 37%. 

Patrick Forde noted that the addition of nivolumab to chemotherapy “did not compromise the feasibility of surgery”, with 83% of patients in the combination group undergoing surgery versus 75% of those in the chemotherapy alone group. 

The toxicity profile of nivolumab–chemotherapy “was consistent with the known profile of this combination regimen”, said the presenter. Treatment-related adverse events (TRAEs) of grade 3 or 4 occurred in 34% of patients in the combination arm and 37% of those in the chemotherapy alone arm, with neutropenia (8 vs 12%) and decreased neutrophil count (7 vs 11%) the most common events. 

Ten percent of patients in each group discontinued due to TRAEs; there were no treatment-related deaths in the combination group versus three in the chemotherapy alone group. 

Immune-mediated AEs in the combination arm “were generally infrequent and similar to what has been previously reported”, said Patrick Forde. Rash occurred in around 8% of participants, “however it was generally low grade”, and pneumonitis occurred in 1%, but both events were of grade 1 or 2 and did not prevent surgery, he highlighted. 


Abstract CT003. Forde PM, Spicer J, Lu S, et al. Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as neoadjuvant treatment (tx) for resectable (IB-IIIA) non-small cell lung cancer (NSCLC) in the phase 3 CheckMate 816 trial. AACR Annual Meeting 2021; 10–15 April.  

medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2021 Springer Healthcare part of the Springer Nature group

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