K drug approved for treatment of triple negative breast cancer in combination with chemotherapy to reduce the risk of disease progression by 35%

About 15-20% of breast cancer patients were diagnosed with TNBC, characterized by negative expression tests for estrogen -ER, progesterone-like (PR) and human skin growth factor 2 (HER2) expression tests in tumors.
patients are unable to receive targeted therapy for these receptors because these receptors are not expressed, and treatment options are limited.
TNBC is the most dangerous type of breast cancer, aggressive, easy to metastasis, very poor prognostication, patients are usually diagnosed after the survival of no more than 20 months, five-year survival rate of less than 15%.
the PD-1 inhibitor Keytruda, developed by Mercedon, activates the T-cell's anti-cancer immune response by blocking its interaction with lilogs PD-L1 and PD-L2 by combining with the PD-1 immuno checkpoint protein expressed on the surface of T cells.
the drug has been approved by the FDA to treat more than 20 adaptations such as melanoma and non-small cell lung cancer.
this accelerated approval is based on a Phase 3 clinical trial called KEYNOTE-355.
in this trial, a total of 323 TNBC patients with tumor expression PD-L1 were treated with a combination of Keytruda and chemotherapy, or a combination of placebo and chemotherapy.
Keytruda group reduced disease progression and risk of death by 35% compared to the placebo group (HR=0.65,95% CI, 0.49,0.82; p=0.0012).
progress-free lifetime (PFS) in the Keytruda group was 9.7 months, compared with 5.6 months in the control group.
DOR in the Keytruda group was 19.3 months, compared with 7.3 months in the control group.
15-20% of breast cancer patients are diagnosed with triple-negative breast cancer, an invasive cancer that is difficult to treat, " the study said.
"It's worth noting that in KEYNOTE-355, Keytruda was used in combination with three different chemotherapy options: yew alcohol, albumin-binding yew alcohol, or gistabin and carptonin," said Dr. Hope Rugo of the University of California, San Francisco (UCSF).
the approval of Keytruda combined chemotherapy, providing doctors with an important new option for patients.
is an important milestone and represents Keytruda's first approval in breast cancer adaptation.
, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer of Mercedon Laboratories, added.
Keytruda combined chemotherapy as a new pre-surgery ancillary therapy (neoadjuvant) and single drug as an after-surgery ancillary therapy, also significantly improved full pathological remission in early TNBC patients in a clinical trial called KEYNOTE-522.
for a supplemental biologics license based on the results of this clinical trial is currently being reviewed by the FDA and is expected to be answered in March next year.
references: .1 FDA Approved Merck's KEYTRUDA® (pembrolizumab) in With For Patients With Local Local Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Whats Tumors Express PD-L1 (CPS ≥10). Retrieved November 13, 2020, from [2] Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC). Retrieved November 13, 2020, from。