Merck...announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW)...KEYTRUDA in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer at high risk of recurrence

Merck...announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated…Triple-Negative Breast Cancer (TNBC)…for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

The UK's National Institute for Health and Care Excellence (NICE) on Tuesday recommended Merck's Keytruda (pembrolizumab) with chemotherapy as a neoadjuvant treatment and single-agent Keytruda as an adjuvant treatment for patients with early or locally advanced triple-negative breast cancer. NICE issued a draft guidance recommending the treatments after reviewing data from the Phase III KEYNOTE-522 trial, in which 63 percent of TNBC patients receiving neoadjuvant and adjuvant treatment with Keytruda responded compared to 55.6 percent in the placebo plus chemo arm.

For patients with T1cN1-2 or T2-4N0 (stage II or III), early-stage TNBC, the Panel recommends use of pembrolizumab (200 mg once every 3 weeks or 400 mg once every 6 weeks) in combination with neoadjuvant chemotherapy, followed by adjuvant pembrolizumab after surgery.

Preferred regimens: High-risk triple negative breast cancer (TNBC): Preoperative pembrolizumab + carboplatin + paclitaxel, followed by peroperative pembrolizumab + cyclophosphamide + doxorubicin or epirubicin…

The HRs (95% CI) for EFS were 0.70 (0.38 - 1.31) for RCB-0 (equivalent to pCR), 0.92 (0.39 - 2.20) for RCB-1, 0.52 (0.32 - 0.82) for RCB-2, and 1.24 (0.69 - 2.23) for RCB-3. The most common EFS event in both arms was distant recurrence, which occurred in fewer pts in the pembro arm in all RCB categories. Pembro + chemo prolonged EFS vs chemo alone in the RCB-0, -1, and -2 categories...These results highlight the importance of neoadjuvant treatment with pembro for improving survival in pts with early TNBC…

Merck...announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced, or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence....The CHMP’s recommendation was based on results from the pivotal KEYNOTE-522 trial, which was the first Phase 3 study with an immunotherapy to show positive event-free survival (EFS) results in high-risk early-stage TNBC.

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.

Merck...announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase 3 study KEYNOTE-522...After a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result.

Merck...announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery. KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC).

Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy. 

Among 602 pts evaluable for the definitive pCR analysis, pembro + chemo showed a statistically significant improvement in pCR (ypT0/Tis ypN0)...Addition of pembro to neoadjuvant chemo significantly increased the pCR rate in pts with early TNBC.