(Breast Cancer) Is Keytruda + Chemotherapy Effective?
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- March 7, 2022
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On February 10, 2022, Peter Schmid and colleagues from Imperial College London published results from the MK-3475-522/KEYNOTE-522 Phase III clinical trial in The New England Journal of Medicine, evaluating the efficacy and safety of the anti-PD-1 antibody Keytruda plus chemotherapy as neoadjuvant therapy in previously untreated early triple-negative breast cancer patients.
The MK-3475-522/KEYNOTE-522 Phase III clinical trial was a double-blind trial. Previously untreated early triple-negative breast cancer patients (N=1,174) were randomized 2:1 after 4 cycles of Keytruda 200 mg plus chemotherapy as neoadjuvant therapy (3-week cycles) into two groups: the Keytruda group (Keytruda 200 mg plus chemotherapy for 4 cycles in 3-week cycles, N=784) and the placebo group (placebo plus chemotherapy for 4 cycles then chemotherapy alone for 4 cycles in 3-week cycles, N=390). Primary endpoints were pathological complete response rate and event-free survival.
At a median follow-up of 39.1 months, the primary endpoint 36-month event-free survival rate was 84.5% for the Keytruda group vs. 76.8% for the placebo group. The Keytruda group had a 37% reduction in event risk.
Regarding safety, adverse events confirmed during neoadjuvant chemotherapy were consistent with the existing safety profile; no new adverse events were identified.
Based on the MK-3475-522/KEYNOTE-522 trial results, Peter Schmid and colleagues concluded: In previously untreated early triple-negative breast cancer patients, the use of anti-PD-1 antibody Keytruda plus chemotherapy as neoadjuvant therapy followed by postoperative Keytruda plus chemotherapy significantly improved event-free survival.
Source: Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer (N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.)
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