Merck announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. Additionally, KEYTRUDA as a monotherapy is approved for the treatment of patients with unresectable, advanced or recurrent high microsatellite instability (MSI-H) colorectal cancer, based on results of the Phase 3 KEYNOTE-177 trial. With these approvals, KEYTRUDA has 15 authorized uses in Japan, including indications in nine tumor types as well as MSI-H tumors.
“These approvals further demonstrate that KEYTRUDA and KEYTRUDA-based combinations have the potential to help certain patients in Japan who are facing cancers,” said Kyle Tattle, president, MSD Japan. “The prevalence of breast and colorectal cancer is particularly high in Japan, and we are committed to working with the government so that patients have access to these immunotherapy treatment options.”
KEYTRUDA Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer
The approval of KEYTRUDA for the treatment of patients with PD-L1-positive, hormone receptor-negative and HER2-negative, inoperable or recurrent breast cancer is based on results from the KEYNOTE-355 trial, in which KEYTRUDA in combination with chemotherapy – paclitaxel (pac), paclitaxel protein-bound (commonly known as nab-paclitaxel) or gemcitabine (gem) and carboplatin (carbo) – demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) for patients with metastatic triple-negative breast cancer (TNBC) whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10).
KEYTRUDA Approved for the Treatment of Patients With Unresectable, Advanced or Recurrent MSI-H Colorectal Cancer
The approval of KEYTRUDA as a monotherapy for the treatment of patients with unresectable, advanced or recurrent MSI-H colorectal cancer is based on results from the KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0002) and doubled median PFS (16.5 months [95% CI, 5.4-32.4] versus 8.2 months [95% CI, 6.1-10.2]) compared with chemotherapy agents, a current standard of care.
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