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ASCO 2019: Neoadjuvant Combination Checkpoint Blockade in Early-Stage NSCLC

By: Sarah Campen, PharmD
Posted: Tuesday, June 11, 2019

Neoadjuvant treatment with nivolumab plus ipilimumab resulted in an overall major pathologic response rate of 33% in treated patients with early-stage, resectable non–small cell lung cancer (NSCLC), according to the findings of the phase II NEOSTAR study. The combination therapy met this prespecified trial efficacy endpoint, indicating these patients had up to 10% viable tumor remaining at surgery. The results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 8504).

“The NEOSTAR trial results definitely tell us this combination is clinically promising and warrants further investigation, possibly in combination with other therapies,” stated Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, in an MD Anderson press release.

Patients with stages I to IIIA, single N2, resectable NSCLC were randomly assigned to either nivolumab (n = 23) or nivolumab plus ipilimumab (n = 21) followed by surgery. A total of 34 patients underwent resection after treatment with immune checkpoint inhibitors; among the resected patients, 43% of patients treated preoperatively with the combination therapy achieved a major pathologic response compared with 20% of patients treated with nivolumab alone. Additionally, 38% of patients who received combination therapy and underwent surgery achieved a complete pathologic response versus 10% of patients receiving nivolumab alone. The median pretreatment tumor PD-L1 expression was higher in responders than nonresponders (80% vs. 1%, P = .024).

The treatments were generally well tolerated, according to the investigations, with three patients receiving less than three doses due to treatment-related adverse events. “By learning from these results,” concluded Dr. Cascone, “we can identify the best combination and make a major step forward in the field to limit tumor recurrence for our early-stage lung cancer patients.”

Disclosure: The study authors’ disclosure information may be found at coi.asco.org.



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