20 September 2021 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Keytruda, US-based pharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease, the company said.

The positive opinion is based on progression-free survival and overall survival results from the Phase 3 KEYNOTE-355 trial, which showed that treatment with Keytruda in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin), as compared to chemotherapy alone, significantly improved PFS and OS in these patients.

Overall survival data from KEYNOTE-355 will be presented at the European Society for Medical Oncology Congress 2021 on Sept. 19.

The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union.

Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers through an extensive clinical development program for Keytruda and several other investigational and approved medicines across these areas.

Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen hormone receptors, progesterone hormone receptors and overexpression of human epidermal growth factor receptor 2.

It is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis.

Approximately 10-15% of patients with breast cancer are diagnosed with TNBC, which tends to be more common in people who are younger than 40 years of age, who are African American or who have a BRCA1 mutation.

Keytruda is an anti-programmed death receptor-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying Keytruda across a range of cancers and treatment settings.

The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.

Keytruda, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.

Keytruda, in combination with platinum and fluorouracil, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

Keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS ≥1)] as determined by an FDA-approved test.

Keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Keytruda is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.

Keytruda is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Keytruda is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.