Keynote 522 trial#
Keynote 522 plus#
Keynote 522 free#

“But it can carry a high risk of relapse, and 30% of high-risk patients eventually die of metastatic disease.” “HR+, HER2- EBC has a long natural history and, if diagnosed early, is quite curable,” Dr. Adjuvant use requires a companion diagnostic to assess Ki-67 level. “Combining immune checkpoint inhibitors with neoadjuvant chemotherapy has been demonstrated to improve pCR rates,” he said, “and KEYNOTE-522 shows improvement of both EFS and OS with the addition of pembrolizumab with manageable toxicities.”Ībemaciclib is the first oral cyclin-dependent kinase (CDK) 4/6 inhibitor approved in the adjuvant setting and was the first agent approved in roughly 20 years to treat HR+ breast cancer, said Melanie Royce, MD, PhD, oncologist in the FDA Office of Oncologic Disease. Patients with pCR following neoadjuvant treatment have greater than 90% five-year survival. The lack of clear benefit for patients with pCR is not surprising, he added. “Patient education and early intervention is key,” Dr.

Most adverse events are driven by chemotherapy, with pembrolizumab adding immune-mediated events. The pembrolizumab arm had about 5% more adverse events compared to the placebo arm, he continued. Montero, MD, MBA, Diana Hyland Chair for Breast Cancer, Professor of Medicine and Clinical Director, Breast Cancer Medical Oncology Program and the Case Comprehensive Cancer Center. 51.2% for chemotherapy alone (p<0.001), noted Alberto J.

Keynote 522 trial#

Trial results show a clinically and statistically significant benefit of increased pCR, 64.8% for pembrolizumab vs. “The OS data are still immature but not a detriment to regular approval for patients with high-risk, early-stage TNBC.” “The EFS benefit was clear regardless of tumor PDL-1 expression,” Dr.

Keynote 522 plus#

The KEYNOTE-522 compared neoadjuvant pembrolizumab plus chemotherapy, followed by surgery and adjuvant pembrolizumab against neoadjuvant chemotherapy plus placebo followed by surgery and placebo.Īn interim analysis at four years showed an EFS benefit of 0.63 (p=0.00031) favoring pembrolizumab and an OS benefit of 0.72, Dr. At the trial level, an improvement in pCR does not necessarily translate to improvement in EFS or OS.” Alberto J.

Keynote 522 free#

“At the patient level, individuals who experienced pCR have improved EFS (event free survival) and OS (overall survival) compared to patients with residual disease. The 2021 approval for neoadjuvant and adjuvant treatment in addition to standard chemotherapy was based in part on pathological complete response, pCR, a measure she noted is more useful at the patient level than in clinical trials. Shah discussed the FDA approval of pembrolizumab, an anti-PDL-1 monoclonal antibody, during Regulatory Insights to the 2021 Early Stage Breast Cancer Approvals on Wednesday. Five-year survival is about 77%, leaving a significant population in need of treatment to improve long term outcomes.ĭr. Patients with early-stage TNBC typically get neoadjuvant or adjuvant (dd)AC+T (dose-dense doxorubicin and cyclophosphamide, plus paclitaxel), noted Mirat Shah, MD, oncologist in the FDA Office of Oncologic Diseases. Clinicians are integrating both agents into treatment regimens. Both agents had earlier approvals, pembrolizumab for metastatic breast cancer in 2020 and abemaciclib for metastatic breast cancer in 2018. The Food and Drug Administration approved two new breast cancer indications in 2021, pembrolizumab for high-risk, early-stage triple negative breast cancer (TNBC) in both neoadjuvant and adjuvant use, and adjuvant abemaciclib for hormone receptor-positive, HER2-negative early breast cancer (EBC).