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The KEYNOTE-522 trial presents final overall survival results for early-stage triple-negative breast cancer (TNBC) patients treated with pembrolizumab plus chemotherapy. This phase 3 study demonstrates significant improvements in overall survival when adding pembrolizumab to standard neoadjuvant chemotherapy followed by adjuvant pembrolizumab, compared to chemotherapy alone. The trial included 1,174 patients with previously untreated stage II or III TNBC, followed for a median of 75.1 months.
Key Points:
- The 5-year overall survival rate was 86.6% in the pembrolizumab-chemotherapy group versus 81.7% in the placebo-chemotherapy group (P=0.002)
- Event-free survival at 5 years was 81.2% with pembrolizumab-chemotherapy versus 72.2% with chemotherapy alone (hazard ratio 0.65)
- Distant recurrence, the most common first event, occurred in 9.8% of pembrolizumab-chemotherapy patients versus 14.4% of placebo-chemotherapy patients
- Grade 3+ treatment-related adverse events occurred in 77.1% of pembrolizumab-chemotherapy patients versus 73.3% of placebo-chemotherapy patients
- Immune-mediated adverse events occurred in 35.0% of pembrolizumab-chemotherapy patients versus 13.1% of placebo-chemotherapy patients, with grade 3+ events in 13.0% versus 1.5%
TNBC accounts for 15–25% of all breast cancers. The TNBC proportion in all age groups followed a similar trend. However, younger and older women have increased rates of BRCA and basal TNBC and apocrine and neuroendocrine TNBC. African American and Hispanic women are found to be at high risk of TNBC, and African Americans have a worse prognosis compared to other groups. (Frontiers in Molecular Biosciences)
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