CheckMate-77T: A Deeper Look at a Nivolumab-Based Regimen in NSCLC

Tina Cascone, MD, PhD, assistant professor, in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, delves into who was included in the phase 3 CheckMate-77T trial (NCT04025879), which assessed the perioperative regimen of neoadjuvant nivolumab (Opdivo) plus chemotherapy followed by surgery and adjuvant nivolumab for the treatment of patients with stage IIA to IIIB non–small cell lung cancer (NSCLC), and end points of the study.

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0:09 | This study included patients with resectable stage IIA/IIIB disease at presentation according to the AJCC eighth edition. Patients also had to have no prior systemic anti-cancer treatment, an ECOG performance status from 0-1, and no EGFR mutations or ALK alterations. Stratification factors were a tumor histology, disease stage, and tumor PD-L1 expression, and a total of 461 patients were randomized 1:1 to receive neoadjuvant nivo plus chemo every 3 weeks for 4 cycles, followed by adjuvant chemo every 4 weeks for 1 year, or neoadjuvant placebo plus chemo followed by adjuvant placebo. Following the last neoadjuvant treatment and radiological staging, surgery had to be performed within 6 weeks. The primary end point of the study was the [event-free survival (EFS)] by blinded independent central review, and the secondary end points were [pathologic complete response (pCR)], [major pathologic response (MPR)], [overall survival (OS)], and safety, and exploratory analysis presented at the ESMO Congress, including EFS by pCR and MPR status and EFS by adjuvant treatment status.

1:25 | The data presented at the ESMO Congress were based on the database lock of September 6, 2023, with a median follow-up of 25.4 months, and the prespecified interim analysis was scheduled to take place when 185 events occurred, and as of the database lock 189 year first events occurred. And as of this database lock, overall survival has not yet been formally tested, and continues to mature.

2:01 | As far as baseline patient characteristics, these were generally balanced between treatment arms. More than 50% of patients were from Europe, more than 20% were from Asia, approximately 2 thirds of patients have stage III disease, and about 90% of patients currently smoke or have smoked in the past. More than 50% of patients had tumor PD-L1 expression of 1% or more, and about 40% of patients at tumor PD-L1 expression of less than 1% and most patients received carboplatin based chemotherapy in both arms.

2:38 | Almost all patients in each arm received neoadjuvant treatment with at least 85% completing 4 treatment cycles. Study drug toxicity was the most common reason for neoadjuvant treatment discontinuation in both arms. Seventy-eight percent of patients in the nivo arm and the 77% of patients in the chemo arm received definitive surgery, and the most common reason for cancellation of surgery was disease progression in both arms. But more cancellations were seen in the chemo arms, and only 3% of patients in the nivo arm, and 2% of patients in the chemo arm canceled surgery due to adverse events.

3:20 | Nearly two thirds of patients across both arms received adjuvant treatment with a median number of 13 doses administered in both arms. Toxicity was the most common reason for not receiving adjuvant nivo, while disease progression was the most common reason for not receiving adjuvant placebo. Of these patients who received adjuvant treatment, 60% of those in the nivo arm and in the chemo arm completed 1 year of therapy. The most common reasons for discontinuing adjuvant therapy were study drug toxicity in the nivo arm and disease progression in the chemo arm.