Merkel-cell carcinoma

FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Tuesday, June 30, 2020 - 11:45pm

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

Key Points: 
  • For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.
  • BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
  • A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIOplus best supportive care (BSC) as first-line maintenance treatment.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation

Wednesday, June 24, 2020 - 10:29pm

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

Key Points: 
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Merck’s KEYTRUDA® (pembrolizumab) Approved in China for Second-Line Treatment of Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma Whose Tumors Express PD-L1 (CPS ≥10)

Monday, June 22, 2020 - 11:30am

This approval represents an important advancement for certain patients with esophageal squamous cell carcinoma who now have an immunotherapy treatment option.

Key Points: 
  • This approval represents an important advancement for certain patients with esophageal squamous cell carcinoma who now have an immunotherapy treatment option.
  • Selected KEYTRUDA (pembrolizumab) Indications in the U.S.
    KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Exicure Announces First Patient Dosed in Phase 2 Merkel Cell Carcinoma Trial of Cavrotolimod (AST-008)

Tuesday, June 16, 2020 - 12:00pm

The Phase 2 dose expansion stage includes two cohorts of patients with advanced or metastatic cancer: patients with Merkel cell carcinoma (MCC) and patients with cutaneous squamous cell carcinoma (CSCC).

Key Points: 
  • The Phase 2 dose expansion stage includes two cohorts of patients with advanced or metastatic cancer: patients with Merkel cell carcinoma (MCC) and patients with cutaneous squamous cell carcinoma (CSCC).
  • In December 2019, Exicure announced preliminary results from the Phase 1b stage of the clinical trial including potential signs of anti-tumor activity with cavrotolimod in combination with pembrolizumab in patients with MCC.
  • To date, 20 patients in the Phase 1b stage of the clinical trial have been dosed, and no cavrotolimod-related serious adverse event or dose-limiting toxicity has been reported.
  • Exicure's drug candidate AST-008 is currently in a Phase 1b/2 clinical trial in patients with advanced solid tumors.

Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients with Advanced or Metastatic Urothelial Carcinoma

Tuesday, June 9, 2020 - 9:05pm

KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.

Key Points: 
  • KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Demonstrated Clinically Meaningful Tumor Response Rates in Unresectable Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma

Thursday, May 28, 2020 - 11:37pm

In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively.

Key Points: 
  • In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively.
  • The tumor response rates demonstrated with KEYTRUDA plus LENVIMA in these studies underscore the potential of this combination regimen in certain types of hepatocellular and renal cell carcinoma, said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories.
  • 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 Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

Tuesday, April 28, 2020 - 9:35pm

This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W).

Key Points: 
  • This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W).
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications.

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

Wednesday, February 12, 2020 - 11:45am

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Key Points: 
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • 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) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

Friday, December 20, 2019 - 11:45am

The new approvals of KEYTRUDA in advanced renal cell carcinoma and head and neck cancer build on previous approvals in melanoma, advanced non-small cell lung cancer and advanced MSI-H cancers, allowing us to bring KEYTRUDA to even more patients in Japan.

Key Points: 
  • The new approvals of KEYTRUDA in advanced renal cell carcinoma and head and neck cancer build on previous approvals in melanoma, advanced non-small cell lung cancer and advanced MSI-H cancers, allowing us to bring KEYTRUDA to even more patients in Japan.
  • KEYTRUDA, in combination with platinum and fluorouracil (FU), 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 treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (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).

Data from Exploratory Analysis Show Merck’s KEYTRUDA® (pembrolizumab) Improved Overall Survival as Monotherapy for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer Regardless of KRAS Mutational Status

Thursday, December 12, 2019 - 11:45am

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases.

Key Points: 
  • Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases.
  • Lung cancer can also be characterized by the presence of different biomarkers, including PD-L1, KRAS, ALK, EGFR and ROS1.
  • 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.