Pembrolizumab for EarlyTriple-Negative Breast Cancer

“High-risk early triple-negative breast cancer is frequently associated with early recurrence and high mortality. Neo-adjuvant chemotherapy is the preferred treatment approach. In addition to potentially increasing the likelihood of tumor resectability and breast conservation, patients who have a pathological complete response after neoadjuvant therapy have longer event-free survival (defined as the time from randomization to the date of disease progression that precluded definitive surgery, the date of local or distant recurrence or the occurrence of a second primary tumor, or the date of death from any
cause) and overall survival. Accordingly, regulatory guidance supports the use of the pathological complete response as an end point for clinical testing of neoadjuvant treatment in patients with early triple-negative breast cancer.”

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Article of Interest: Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma

Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185. Free full-text.

Results: The median progression-free survival was 11.5 months (95% confidence interval [CI], 8.9 to 16.7) with nivolumab plus ipilimumab, as compared with 2.9 months (95% CI, 2.8 to 3.4) with ipilimumab (hazard ratio for death or disease progression, 0.42; 99.5% CI, 0.31 to 0.57; P<0.001), and 6.9 months (95% CI, 4.3 to 9.5) with nivolumab (hazard ratio for the comparison with ipilimumab, 0.57; 99.5% CI, 0.43 to 0.76; P<0.001). In patients with tumors positive for the PD-1 ligand (PD-L1), the median progression-free survival was 14.0 months in the nivolumab-plus-ipilimumab group and in the nivolumab group, but in patients with PD-L1-negative tumors, progression-free survival was longer with the combination therapy than with nivolumab alone (11.2 months [95% CI, 8.0 to not reached] vs. 5.3 months [95% CI, 2.8 to 7.1]). Treatment-related adverse events of grade 3 or 4 occurred in 16.3% of the patients in the nivolumab group, 55.0% of those in the nivolumab-plus-ipilimumab group, and 27.3% of those in the ipilimumab group.

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