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David S. Ettinger, MD, FACP, FCCP


Neoadjuvant Use of Ipilimumab Plus Nivolumab and Chemoradiotherapy for NSCLC

By: Justine Landin, PhD
Posted: Monday, November 7, 2022

Targeting cytotoxic T cells through the addition of ipilimumab plus nivolumab to neoadjuvant chemoradiotherapy may increase pathologic responses for patients with locally advanced non–small cell lung cancer (NSCLC), according to the results of the single-arm phase II INCREASE trial. In fact, the pathologic complete response following ipilimumab plus nivolumab therapy was found to be more than double that of the historic rate of chemoradiotherapy alone. These findings were presented by Idris Bahce, MD, PhD, of Amsterdam University Medical Centers, and colleagues during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 950O).

“Our results indicate that adding ipilimumab plus nivolumab to neoadjuvant chemoradiotherapy is safe, provides deep pathological responses, and enhances T-cell activation,” stated the study investigators.

Patients with resectable or borderline resectable stage III–IV NSCLC with limited mediastinal lymph node metastases were enrolled (n = 24). On day 1, patients received platinum doublet concurrent chemoradiotherapy along with intravenous ipilimumab (1 mg/kg) and nivolumab (360 mg). A flat dose of nivolumab was administered 3 weeks later. Surgical resection was performed 6 weeks after the final dose of radiation (50/60 Gy, once daily). Prespecified pathologic response thresholds were compared with previously established rates of chemoradiotherapy alone.

A pathologic complete response after neoadjuvant therapy was observed in 63% of patients, and 79% of patients exhibited a major pathologic response. These high pathologic response rates may be partially due to the observed increases in expression of proliferation markers on CD8-positive T cells in tumor-draining lymph nodes as well as CD4-positive and CD8-positive subsets in peripheral blood, although the investigators acknowledge this explanation is speculative. There were no delays in surgery because of treatment or any treatment-related deaths. The investigators found toxicity to be acceptable, with 56% of patients reporting grade 3 or 4 treatment-related adverse events.

Disclosure: For full disclosures of the study authors, visit

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