MLHW (Japan) approves Keytruda + chemotherapy to treat triple negative breast cancer
Merck Inc., announced that Keytruda Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW) including 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, based on data from the KEYNOTE-522 trial
The approval of Keytruda plus chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and HER2-negative breast cancer at high risk of recurrence is based on results from the Phase III KEYNOTE-522 trial, in which Keutruda in combination with chemotherapy before surgery and continued as a single agent after surgery resulted in a statistically significant and clinically meaningful improvement in event-free survival (EFS), reducing the risk of disease progression that precludes curative surgery, local or distant recurrence, second primary malignancy or death by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) compared to neoadjuvant placebo in combination with chemotherapy and adjuvant placebo alone after surgery in these patients.
The Japanese package insert states that in KEYNOTE-522, adverse reactions were observed in 774 patients (98.9%) out of the safety analysis set of 783 patients (including 45/45 Japanese patients) receiving Keytruda at a dose of 200 mg every three weeks in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. The most common adverse reactions (?20%) were nausea (63.2%), alopecia (60.2%), anemia (54.8%), neutropenia (46.9%), fatigue (42.1%), diarrhea (30.4%), elevated alanine aminotransferase (26.1%), vomiting (25.5%), asthenia (25.3%), rash (25.0%), constipation (24.0%), decreased neutrophil count (23.6%) and elevated aspartate aminotransferase (20.1%).
Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer, which has the highest risk of recurrence within the first five years after diagnosis and is associated with worse outcomes compared to other forms of breast cancer. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three. Triple-negative breast cancer is known to be prevalent in Japan, as approximately 15% of patients with breast cancer in Japan are diagnosed with TNBC. Breast cancer is the most commonly diagnosed cancer in women in Japan, with more than 94,000 people diagnosed in 2020.
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