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09-08-2022 | WCLC 2022 | Conference coverage | News

NADIM II: Adding nivolumab to neoadjuvant chemo improves stage III NSCLC survival

Author: Shreeya Nanda

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medwireNews: The addition of nivolumab to neoadjuvant chemotherapy significantly improves the progression-free survival (PFS) and overall survival (OS) of individuals with resectable stage IIIA–B non-small-cell lung cancer (NSCLC), suggest data from NADIM II.

The phase 2 study has already shown a significant improvement in its primary endpoint of pathologic complete response among study participants who did versus did not receive nivolumab alongside chemotherapy, investigator Mariano Provencio (Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain) told delegates of the IASLC World Conference on Lung Cancer 2022 in Vienna, Austria.

And now it is the first trial with a neoadjuvant immunotherapy-based combination in this patient population to show improved OS, and “confirms superiority” of nivolumab plus chemotherapy, he added.

Provencio reported that median PFS was unreached for the 57 patients with stage IIIA–B disease lacking EGFR and ALK alterations who were randomly assigned to receive three cycles of neoadjuvant nivolumab 360 mg alongside paclitaxel plus carboplatin, where all drugs were administered every 3 weeks. After surgery the patients were given nivolumab 480 mg every 4 weeks for 6 months.

This was significantly better than the median of 18.3 months for their 29 counterparts given neoadjuvant chemotherapy alone and no adjuvant therapy, and equated to a 52% reduction in the risk for progression or death in favor of the PD-1 inhibitor. The PFS rates at 24 months were 66.6% and 42.3% in the nivolumab plus chemotherapy and chemotherapy alone arms, respectively.

The median OS duration was unreached in both study groups, but the addition of nivolumab to chemotherapy reduced the risk for death by a significant 60%. And the 24-month OS rates were 84.7% among nivolumab-treated participants and 63.4% among those treated with chemotherapy alone.

Discussant Corinne Faivre-Finn (The Christie NHS Foundation Trust, Manchester, UK) described the NADIM II results as “very impressive,” and said that the findings validate those of the CheckMate 816 trial also investigating neoadjuvant nivolumab plus chemotherapy in resectable NSCLC.

But she cautioned that OS was not a primary endpoint of NADIM II and longer-term follow-up data is needed.

Faivre-Finn also believes that there is a risk of neoadjuvant immunotherapy–chemotherapy to be given to patients who are not suitable for surgery in the real world, and there are also “major implementation challenges” that would require “major pathway changes,” such as upfront rapid next-generation sequencing and PD-L1 testing.

The discussant concluded that “the time is probably ripe for a clinical trial comparing a surgical to a nonsurgical approach, with good integration of biomarkers for patient selection.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

IASLC World Conference on Lung Cancer 2022; Vienna, Austria: 6–9 August

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