Recommendation supported Data From Phase 3 KEYNOTE-355 Trial
Merck, referred to as MSD outside the us and Canada, today announced the Committee for Medicinal Products for Human Use (CHMP) of the ecu Medicines Agency (EMA) has recommended approval of KEYTRUDA, Merck’s anti-PD-1 therapy, together with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative carcinoma (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who haven’t received prior chemotherapy for metastatic disease.
The positive opinion is predicated on progression-free survival (PFS) and overall survival (OS) results from the Phase 3 KEYNOTE-355 trial, which showed that treatment with KEYTRUDA together 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 are going to be presented at the ecu Society for Medical Oncology (ESMO) Congress 2021 on Sept. 19. The CHMP’s recommendation will now be reviewed by the ecu Commission for marketing authorization within the European Union .
“Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. “This positive CHMP opinion is a crucial breakthrough in bringing a replacement immunotherapy treatment option with KEYTRUDA to appropriate patients in Europe with metastatic triple-negative carcinoma . Importantly, this treatment regimen are often utilized in combination with different chemotherapy agents. we glance forward to the ecu Commission’s decision within the coming months.”
Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers through an in depth clinical development program for KEYTRUDA and a number of other other investigational and approved medicines across these areas.
About Triple-Negative carcinoma
Triple-negative carcinoma may be a sort of carcinoma that tests negative for estrogen hormone receptors, progesterone hormone receptors and overexpression of human epidermal protein receptor 2 (HER2). it’s an aggressive sort of carcinoma that characteristically features a high recurrence rate within the primary five years after diagnosis. Approximately 10-15% of patients with carcinoma are diagnosed with TNBC, which tends to be more common in people that are younger than 40 years aged , who are African American or who have a BRCA1 mutation.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the power of the body’s system to assist detect and fight tumor cells. KEYTRUDA may be a humanized antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which can affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently quite 1,600 trials studying KEYTRUDA across a good sort of cancers and treatment settings. The KEYTRUDA clinical program seeks to know the role of KEYTRUDA across cancers and therefore the factors which will predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
About Merck
For over 130 years, Merck, referred to as MSD outside of the us and Canada, has been inventing for all times , bringing forward medicines and vaccines for several of the world’s most challenging diseases in pursuit of our mission to save lots of and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to stop and treat diseases that threaten people and animals – including cancer, infectious diseases like HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company within the world.
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