Triple-Negative Breast Cancer

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Certain Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Retrieved on:

Friday, October 22, 2021

Health, Diabetes, Clinical Trials, General Health, Radiology, Pharmaceutical, Triple-Negative Breast Cancer, Merck, TRIPLE-NEGATIVE BREAST CANCER, MERCK

Patients were randomized 2:1 to receive KEYTRUDA (200 mg every three weeks) plus chemotherapy (investigators choice of paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) or placebo plus chemotherapy.

Key Points:

Patients were randomized 2:1 to receive KEYTRUDA (200 mg every three weeks) plus chemotherapy (investigators choice of paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) or placebo plus chemotherapy.
Selected KEYTRUDA (pembrolizumab) Indications in the U.S.
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
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 and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Reduced Risk of Death by 27% Versus Chemotherapy as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer Whose Tumors Expressed PD-L1 (CPS ≥10)

Retrieved on:

Sunday, September 19, 2021

Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, KEYNOTE-355, Triple-Negative Breast Cancer, Merck, KEYNOTE-355, TRIPLE-NEGATIVE BREAST CANCER, MERCK

Treatment-related adverse events led to discontinuation in 18.3% of patients in the KEYTRUDA plus chemotherapy arm and 11.0% of patients in the chemotherapy arm.

Key Points:

Treatment-related adverse events led to discontinuation in 18.3% of patients in the KEYTRUDA plus chemotherapy arm and 11.0% of patients in the chemotherapy arm.
Immune-mediated adverse reactions (AEs) of any grade occurred in 26.5% of patients receiving KEYTRUDA plus chemotherapy and 6.4% of patients receiving chemotherapy alone.
For patients receiving KEYTRUDA plus chemotherapy, the most common immune-mediated AE (occurring in 10% of patients) was hypothyroidism (15.8%).
Selected KEYTRUDA (pembrolizumab) Indications in the U.S.
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy for Certain Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)

Retrieved on:

Friday, September 17, 2021

Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Triple-Negative Breast Cancer, Merck, TRIPLE-NEGATIVE BREAST CANCER, MERCK

This positive CHMP opinion is an important step forward in bringing a new immunotherapy treatment option with KEYTRUDA to appropriate patients in Europe with metastatic triple-negative breast cancer.

Key Points:

This positive CHMP opinion is an important step forward in bringing a new immunotherapy treatment option with KEYTRUDA to appropriate patients in Europe with metastatic triple-negative breast cancer.
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

Merck Announces Phase 3 KEYNOTE-355 Trial Met Primary Endpoint of Overall Survival (OS) in Patients with Metastatic Triple-Negative Breast Cancer Whose Tumors Expressed PD-L1 (CPS ≥10)

Retrieved on:

Tuesday, July 27, 2021

These new overall survival results confirm that KEYTRUDA in combination with chemotherapy represents an important treatment option for certain patients with metastatic TNBC.

Key Points:

These new overall survival results confirm that KEYTRUDA in combination with chemotherapy represents an important treatment option for certain patients with metastatic TNBC.
The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery

Retrieved on:

Tuesday, July 27, 2021

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points:

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.