The addition of pembrolizumab showed a trend toward an improved hazard ratio for EFS across all clinical subsets, although with wide confidence intervals owing to variable sample sizes.
For example, an EFS event (ie, progression during neoadjuvant therapy, local or distant recurrence, second primary cancer, or death from any cause) occurred in 72.5% of pembrolizumab patients and 69.2% of placebo patients who had an RCB of 3, which represents extensive residual disease, whereas they occurred in 5.2% of pembrolizumab patients and 7.3% of placebo patients who had an RCB of 0, which is equivalent to a pCR. We also found that patients with a greater RCB after neoadjuvant chemotherapy had poorer EFS than patients with minimal residual disease or pCR. The final pCR rates were 63% in the pembrolizumab arm and 56% in the placebo arms.
Keynote 522 2022 trial#
LP I presented the final pCR rates, residual cancer burden (RCB) distribution results, and EFS rates by RCB categories in all 1174 patients accrued to the trial at the 2022 annual meeting of the American Society of Clinical Oncology. H&O Could you describe the updated data from KEYNOTE-522 that you recently presented? We used to consider TNBC to be a particularly poor prognosis subtype with limited treatment options, but this is no longer the case. This was a very encouraging finding because the pCR rate with pembrolizumab approached what we see in patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer treated with HER2-targeted neoadjuvant therapies. The analysis found a pCR of 64.8% in the pembrolizumab group and 51.2% in the placebo group (estimated treatment difference, 13.6 percentage points 95% CI, 5.4-21.8 P<.001). Previous results of KEYNOTE-522, from the first planned efficacy analysis of 602 patients, were published in the New England Journal of Medicine in 2020. Most importantly, the rate of distant recurrence was lower with pembrolizumab than with placebo, at 7.7% vs 13.1%, respectively. Owing to variable sample sizes, the confidence intervals were broad, but the hazard ratios consistently favored pembrolizumab in all groups. Not only was EFS better with pembrolizumab than with placebo overall, but subset analyses showed improvements in all clinical and biomarker (programmed death ligand 1 ) subsets. LP After a median follow-up of 39 months, according to results that we published in the New England Journal of Medicine earlier this year, the estimated 36-month EFS rate was 84.5% in the pembrolizumab/chemotherapy group vs 76.8% in the placebo/chemotherapy group, for a hazard ratio for event or death of 0.63 (95% CI, 0.48-0.82 P<.001). H&O What were the main published results of this trial? The primary goals of this study were to detect any differences in the rates of pathologic complete response (pCR) and event-free survival (EFS) between the 2 arms. The complete treatment lasted for 1 year. All patients underwent surgery followed by adjuvant treatment that consisted of approximately 27 weeks of either pembrolizumab or placebo.
Keynote 522 2022 plus#
This treatment was followed by 4 cycles of doxorubicin or epirubicin plus cyclophosphamide every 3 weeks, concurrent with pembrolizumab for patients in the experimental arm or placebo for patients in the control arm. A total of 1174 patients were randomly assigned in a 2:1 ratio to receive either pembrolizumab or placebo, administered in addition to 4 cycles of paclitaxel/carboplatin, every 3 weeks. LP KEYNOTE-522 was a large, randomized, placebo-controlled phase 3 trial that tested pembrolizumab (Keytruda, Merck) as neoadjuvant and adjuvant treatment in locally advanced, nonmetastatic, triple-negative breast cancer (TNBC). H&O Could you describe the design of the KEYNOTE-522 study?
0 kommentar(er)
