![]() ![]() Regarding histology, 92% had squamous cell carcinoma, 6% had adenocarcinoma, and 1% had adenosquamous carcinoma. Thirty-five percent of patients had 1 prior line of treatment for recurrent or metastatic disease, and 65% had ≥2 prior lines. Eighty-one percent of patients were white, 14% were Asian, and 3% were black. “The approval of Keytruda in this indication is important news-and as an oncologist, it is exciting to see a much needed option made available to these patients,” added Monk.Īmong the 77 PD-L1-positive patients, the median age was 45 years (range 27-75), 32% had an ECOG performance status (PS) of 0, and 68% had an ECOG PS of 1. "Even with the many advances observed across gynecologic cancers, new treatment options have been lacking for previously treated patients with advanced cervical cancer,” Bradley Monk, oncologist with Arizona Oncology, medical director of US Oncology Research Gynecology Program and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine, said in a statement. There were no responses reported for patients with PD-L1 expression of CPS <1. The median duration of response was not reached (range, 4.1-18.6+), and 91% of responders had a response duration of 6 months or longer. The ORR comprised a complete response rate of 2.6% and a partial response rate of 11.7%. The global, open-label, nonrandomized, multicohort, multicenter study evaluated pembrolizumab in patients with multiple types of advanced solid tumors who progressed on standard of care therapy.Īt a median follow-up of 11.7 months (range, 0.6-22.7), the overall response rate (ORR) was 14.3% (95% CI, 7.4-24.1) in 77 PD-L1-positive patients (CPS ≥1) previously treated with ≥1 line of chemotherapy in the metastatic setting. The FDA based its decision on data from 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort in the phase II KEYNOTE-158 trial. The approval defines PD-L1 positivity as a combined positive score (CPS) of ≥1 as measured by an FDA-approved test. Presented at the 2023 San Antonio Breast Cancer Symposium December 5-9, 2023 San Antonio, TX abstract LBO1-01.The FDA has granted pembrolizumab (Keytruda) an accelerated approval for the treatment of patients with advanced, PD-L1-positive cervical cancer with disease progression on or after chemotherapy. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer: updated event-free survival results from the phase 3 KEYNOTE-522 study. We clearly have a standard of care in neoadjuvant therapy with chemotherapy and pembrolizumab for patients with stage II and stage III triple-negative breast cancer. It seems to be the tumors around to train the immune system as to what the enemy is and launch that T-cell response to the cancer cells. What is interesting to see is, if you start immunotherapy after surgery, it seems to be ineffective. This time, chemotherapy and immunotherapy were given after surgery. If you also look at the wider context of, there was an interesting trial in patients with the same : stage II/III triple-negative breast cancer. I would hope that the 5-year data have demonstrated in a very clear way that the addition of pembrolizumab to neoadjuvant chemotherapy is the new standard of care for patients with stage II or III. The median EFS was not reached in either treatment arm (HR, 0.63 95% CI, 0.49-0.81). ![]() In the KEYNOTE-522 trial, the 60-month EFS rate was 81.3% (95% CI, 78.4%-83.9%) in patients who received pembrolizumab before and after surgery compared with 72.3% (95% CI, 67.5%-76.5%) in those who received matched placebo. He described the importance of training the immune system with neoadjuvant immunotherapy to launch a T-cell response to the cancer cells. Schmid, a medical oncologist at Barts Cancer Institute of Queen Mary University of London, suggested that beginning immunotherapy following surgery in patients with stage II or III TNBC does not appear to be as effective compared with initiating treatment in the neoadjuvant setting. CancerNetwork ® spoke with Peter Schmid, MD, PhD, about how 5-year event-free survival (EFS) data from the phase 3 KEYNOTE-522 study (NCT03036488) presented at the 2023 San Antonio Breast Cancer Symposium (SABCS)support neoadjuvant pembrolizumab (Keytruda) plus chemotherapy followed by adjuvant pembrolizumab as a standard of care in early-stage triple-negative breast cancer (TNBC). ![]()
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