Interim Results of Phase 3 Trial Show Immune Therapy Eliminates Tumor Cells in Early Triple-Negative Breast Cancer; Combination of Anti-PD-1 Monoclonal Antibody Pembrolizumab Plus Chemotherapy Could Become A Standard of Care If Approved, Expert Says

Immune therapy added to chemotherapy improves pathological complete response in patients with early triple-negative breast cancer, according to late-breaking interim results from the KEYNOTE-522 trial presented at the European Society for Medical Oncology (EMSO) Congress 2019 in Barcelona, Spain ( (September 27-October 1). Interim results from the KEYNOTE-522 trial interim were presented by study first author Professor Peter Schmid, Barts Cancer Institute, Queen Mary University of London, UK, during the Presidential Symposium II on September 29, 2019, and published in Annals of Oncology, Volume 30, Supplement 5, October 2019. The title of the results presentation was “LBA8_PR 'KEYNOTE-522: Phase 3 Study of Pembrolizumab (Pembro) + Chemotherapy (Chemo) vs Placebo (Pbo) + Chemo As Neoadjuvant Treatment, Followed by Pembro vs Pbo As Adjuvant Treatment for Early Triple-Negative Breast Cancer (TNBC).” The interim results from the study, which is the first phase III trial of immunotherapy in early breast cancer, also indicated an improvement in event-free survival. "The data suggest that the improved pathological complete response with pembrolizumab translates into fewer recurrences," said Professor Schmid. Triple-negative breast cancer is the most aggressive sub-type of breast cancer and more often affects young women. Patients typically receive chemotherapy, followed by surgery to remove the tumor. This provides the best chance of pathological complete response, meaning no cancerous cells remaining on the resected tumor. Women with a pathological complete response have an 85-90% likelihood of being cured, while those with residual viable tumor tissue have a 40-50% probability of recurrence, which often occurs within three years.
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