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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Tuesday, October 1, 2024
According to Iris Nederlof, MD, of Netherlands Cancer Institute, Amsterdam, and colleagues, the pathologic complete response rate for immunotherapy without chemotherapy for triple-negative breast cancer is currently unknown. To evaluate this further, these investigators performed the phase II BELLINI platform trial to demonstrate complete response rates among patients with high levels of tumor-infiltrating lymphocytes (TILs). The results from two new nonrandomized cohorts were presented during the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract LBA11).
“We present the first exploratory clinical trial with short-term neoadjuvant immunotherapy without chemotherapy for patients with triple-negative breast cancer with high TILs and observed a pathologic complete response rate of 33% with nivolumab/ipilimumab and 47% with nivolumab/relatlimab,” the authors concluded. These results “warrant further studies on the efficacy and toxicity of chemotherapy-free immunotherapy for immunogenic triple-negative breast cancer.”
A total of 30 patients with stage I to II, node-negative triple-negative breast cancer with TIL levels of at least 50% were enrolled. Participants received either 6 weeks of nivolumab plus ipilimumab (n = 15) or 8 weeks of nivolumab plus relatlimab (n = 15). Neoadjuvant chemotherapy was initiated in patients treated with nivolumab plus relatlimab if they did not respond to treatment at 6 weeks.
In the nivolumab-plus-ipilimumab cohort, five and eight patients achieved a pathologic complete response and major pathologic response, respectively. This rate was slightly improved among patients given nivolumab plus relatlimab, in which 7 individuals had a pathologic complete response and 11 had a major pathologic response.
Adverse events of grade 3 to 4 were reported in eight patients, six of whom were on the ipilimumab regimen. Hypothyroidism was the most commonly reported adverse event, affecting 40.0% and 33.3% of patients in the ipilimumab and relatlimab arms, respectively. Adrenal insufficiency affected more patients on ipilimumab than on relatlimab (26.7% vs 6.7%), and diabetes was reported only among those on relatlimab (6.7%).
Disclosure: Dr. Nederlof reported no conflicts of interest. For full disclosures of the other study authors, visit cslide.ctimeetingtech.com.
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