While multidisciplinary evaluation and management is critical for patients being selected for neoadjuvant chemo-immunotherapy, it is often the surgical oncologist who has first contact with patients with breast cancer who may be eligible for treatment with neoadjuvant therapy. 76.8%), resulting in FDA approval based on positive results for both primary endpoints. 5 The fourth planned interim analysis demonstrated improved EFS in patients treated with pembrolizumab (84.5% vs. At a preplanned interim analysis, patients treated with pembrolizumab had a statistically significantly higher rate of pCR (64.8%) compared with those treated with placebo (51.2%). The coprimary endpoints were pathologic complete response (pCR) and event-free survival (EFS). All patients proceeded to surgery, followed by completion of nine additional cycles (27 weeks) of adjuvant pembrolizumab or placebo (Fig.
#Keynote 522 2022 trial#
The trial randomized 1174 patients with clinical T1cN1–2 or T2–4N0–2 TNBC to preoperative pembrolizumab (eight cycles given every 3 weeks) plus chemotherapy (paclitaxel and carboplatin, followed by doxorubicin or epirubicin, and cyclophosphamide), or placebo plus chemotherapy. placebo + chemotherapy, followed by adjuvant pembrolizumab vs.Subsequent to the approval of pembrolizumab in the metastatic setting, the KEYNOTE-522 study evaluated the role of preoperative immunotherapy combined with chemotherapy for early-stage TNBC. KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs.Welcome and introduction, Scientific background and contextįabrice André, Gustave Roussy, Villejuif, France.Neoadjuvant pembro + chemo followed by adjuvant pembro showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone in pts with early-stage TNBC.
0.3%, respectively) immune-mediated AEs of any grade occurred in 43.6% vs. Grade ≥3 treatment-related AE rates were 77.1% in the pembro group and 73.3% in the pbo group (death incidence, 0.5% vs. Pembro showed a favorable trend in OS (HR 0.72 ) follow-up is ongoing. The most common EFS event was distant recurrence, in 60 pts (7.7%) in the pembro group vs. 76.8% (95% CI, 72.2-80.7) in the pbo group median was not reached in either group. At the Madata cutoff (median follow-up, 37.8 mo ), 123 pts (15.7%) in the pembro group and 93 pts (23.8%) in the pbo group had an EFS event, defined as disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (HR 0.63 P=0.0003). Resultsġ174 pts were randomized to pembro (n=784) or pbo (n=390). Dual primary endpoints are pCR (ypT0/Tis ypN0) and EFS. T3/T4), and carboplatin schedule (Q3W vs. Pts were stratified by nodal status (+ vs.
After definitive surgery, pts received adjuvant pembro or pbo for 9 cycles or until recurrence or unacceptable toxicity. Pts with previously untreated, non-metastatic, centrally confirmed TNBC (stage T1c N1-2 or T2-4 N0-2 per AJCC) were randomized 2:1 to neoadjuvant pembro 200 mg Q3W or pbo, both given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide.
We present results from a prespecified interim analysis of KEYNOTE-522.
In prior interim analyses, pembro + chemo showed a significant improvement in pCR and a favorable trend in EFS. pbo in patients (pts) with early-stage TNBC. placebo (pbo) + chemo followed by adjuvant pembro vs. KEYNOTE-522 ( NCT03036488) is a phase III study of neoadjuvant pembrolizumab (pembro) + chemotherapy (chemo) vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. Abstract VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs.
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