medwireNews: Adding nivolumab to neoadjuvant chemotherapy significantly improves the pathologic complete response (pCR) rate in patients with resectable non-small-cell lung cancer (NSCLC), shows the CheckMate 816 trial reported at the virtual AACR Annual Meeting 2021.
“We are highly encouraged by the marked improvement in pCR, the overall good tolerability, and the absence of impact on surgery feasibility” with the addition of nivolumab, presenting author Patrick Forde (Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, USA) said in a press release.
These findings indicate that the combination “is a viable option for patients with resectable NSCLC at high risk of recurrence,” he added. “While neoadjuvant therapy has historically been less commonly used than adjuvant therapy for this patient population, I believe that CheckMate-816 has the potential to change that treatment paradigm.”
In the phase 3 study, the co-primary endpoint of pCR (0% of viable tumor cells in lung and lymph node samples) was achieved by 24.0% of the 179 patients with stage IB–IIIA disease and no EGFR or ALK alterations who were randomly assigned to receive nivolumab at a dose of 360 mg every 3 weeks alongside platinum-doublet chemotherapy.
This was significantly higher than the rate of 2.2% observed among their 179 counterparts who received chemotherapy alone, equating to a nearly 14-fold increase in the likelihood of attaining pCR with the addition of the PD-1 inhibitor.
Forde pointed out that this improvement in pCR with nivolumab “was consistent across key subgroups,” including by sex, disease stage, PD-L1 expression levels, and tumor mutational burden.
Data for the other primary endpoint of event-free survival were not mature at the time of analysis, but the combination of nivolumab and chemotherapy was also associated with improvements in the secondary endpoint of major pathologic response (≤10% viable tumor cells), at 36.9% versus 8.9% with chemotherapy alone (odds ratio=5.70).
And the rates of objective response and radiographic downstaging were also higher with versus without nivolumab, at 54% versus 37% and 31% versus 24%, respectively.
Of note, adding the PD-1 inhibitor to chemotherapy “did not compromise the feasibility of surgery,” with definitive surgery conducted in 83% of patients in the combination group and 75% of those in the chemotherapy alone group, reported Forde.
He added that the safety profiles were “quite similar across the two treatment arms,” and the addition of nivolumab did not appear to increase the rates of adverse events (AEs). Grade 3–4 treatment-related AEs occurred in a comparable 34% and 37% of the combination and chemotherapy alone arms, respectively, while the corresponding rates of grade 3–4 AEs related to surgery were 11% and 15%.
The rate of discontinuation due to treatment-related AEs was 10% in both groups, and there were no and three deaths attributable to treatment in the combination and chemotherapy alone groups, respectively.
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