medwireNews: The neoadjuvant combination of nivolumab and chemotherapy elicits a significantly higher pathologic complete response (pCR) rate than chemotherapy alone in people with resectable stage IIIA–B non-small-cell lung cancer (NSCLC), shows the phase 2 NADIM II study.
The findings were presented at the 2022 ASCO Annual Meeting in Chicago, Illinois, USA, by Mariano Provencio-Pulla (Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain) and discussed by Jessica Donington (University of Chicago Medical Center).
Donington said that she is “starting to see a full circle,” beginning with the single-arm NADIM trial, which provided the proof of concept for adding nivolumab to neoadjuvant chemotherapy in resectable NSCLC, continuing with the phase 3 CheckMate 816 study that confirmed the findings, and now closing with validation from NADIM II – the “second prospective randomized trial” in this setting.
In the NADIM II trial, which enrolled 86 patients with stage IIIA or stage IIIB disease and no known EGFR or ALK alterations, the pCR rate by blinded independent review was 36.8% for the 57 participants who were randomly assigned to receive three 3-weekly cycles of nivolumab 360 mg plus paclitaxel 200 mg/m2 and carboplatin AUC 5 before undergoing surgery.
This was significantly higher than the 6.9% rate observed among the 29 participants who received neoadjuvant chemotherapy alone, and equated to a 7.88-fold higher likelihood of response with the addition of the PD-1 inhibitor.
The rates of major pathologic response and overall response were also significantly higher in the nivolumab plus chemotherapy than the chemotherapy alone group, at 52.6% versus 13.8% and 75.4% versus 48.2%, respectively (odds ratios [ORs]=6.94 and 3.29, respectively).
Of note, the addition of nivolumab “did not impede the feasibility of surgery,” highlighted Provencio-Pulla, and in fact, a significantly higher proportion of patients given the combination underwent definitive surgery than those given chemotherapy alone (93 vs 69%; OR=5.96).
Continuing on to the safety data, he highlighted that the combination was associated with a higher rate of grade 3–4 adverse events than chemotherapy alone, at 24.6% versus 10.3%, but there were treatment-related grade 5 toxicities in either group.
Febrile neutropenia was the most common event of grade 3 or 4 in the combination arm, experienced by 7.1% of patients, followed by fatigue and diarrhea, each in 3.5%.
“NADIM II confirms superiority of [the] neoadjuvant nivolumab plus chemotherapy combination in patients with resectable stage IIIA–B NSCLC,” concluded Provencio-Pulla.
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