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Perioperative nivolumab plus neoadjuvant chemotherapy improved outcomes for patients regardless of whether their cancer had spread to their lymph nodes.
- These findings suggest that N2 status may not be as limiting for treatment as previously thought and support a paradigm shift toward combined chemotherapy plus immunotherapy
Adding immunotherapy before and after surgery (perioperative) improved outcomes over pre-surgical (neoadjuvant) chemotherapy alone for certain patients with stage III non-small cell lung cancer (NSCLC) with or without lymph node metastases (N2), according to researchers from The University of Texas MD Anderson Cancer Center.
Results from the exploratory analysis of the CheckMate 77T trial, published today in Nature Cancer, found that clinical outcomes were similar in patients with and without N2 NSCLC. This suggests N2 status does not pose a treatment challenge for these patients and provides evidence supporting perioperative nivolumab plus neoadjuvant chemotherapy as a potentially effective therapeutic strategy.
“It’s encouraging that patients with N2 non-small cell lung cancer – who are often considered challenging to treat – can still benefit from this multidisciplinary approach,” said principal investigator Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head & Neck Medical Oncology. “Our findings add to growing evidence that this treatment regimen may be a safe and effective option for individuals with operable non-small cell lung cancer, regardless of nodal status.”
What is the CheckMate 77T trial?
The randomized, double-blind CheckMate 77T trial, which began in 2019, included more than 450 NSCLC patients over the age of 18. Participants were randomized to treatment with either neoadjuvant nivolumab with chemotherapy followed by surgery and post-surgical nivolumab or neoadjuvant chemotherapy followed by surgery and post-surgical placebo.
Previous results showed that the addition of perioperative immunotherapy significantly improved event-free survival (EFS) in patients compared to those who received pre-surgical chemotherapy alone.
What were the results of this exploratory analysis?
This analysis considered patient outcomes by nodal status, which indicates if cancer cells have spread to nearby lymph nodes. Specifically, the focus was on patients with locally advanced NSCLC with N2, whose cancer has spread to the nodes located at the same side of the cancer or in the center of the chest between the lungs. These patients typically are considered difficult to treat and have a poor prognosis, in part because there is no unified approach regarding their treatment.
Among patients with N2 status, perioperative nivolumab demonstrated an EFS rate of 70% after one year compared to 45% in the placebo group. Patients receiving nivolumab also had higher rates of pathological complete response (pCR) – no tumor remaining at surgery – compared with those who received placebo (22% vs. 5.6%).
Additionally, patients who had multi-station N2 NSCLC, which means the cancer had spread to multiple lymph node groups, also had improved outcomes with perioperative nivolumab compared to placebo (EFS: 71% vs. 46%; pCR: 29% vs. 2.7%).
What does this mean for patients with operable stage III N2 NSCLC?
These clinical outcomes overall are similar to those found in patients with locally advanced stage III disease without N2 involvement, suggesting that N2 lymph node metastases may not be a challenge for this multidisciplinary treatment approach, as previously believed.
Researchers suggest the outcomes support the use of perioperative immunotherapy plus neoadjuvant chemotherapy to improve potential outcomes for patients with operable stage III N2 NSCLC. Multidisciplinary and patient-provider discussions should be considered to determine the best tailored treatment option.
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The CheckMate 77T study was sponsored by Bristol Myers Squibb. For a full list of collaborating authors, disclosures and funding sources, see the full paper in Nature Cancer.
