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merck & co. inc. (MRK) Key Developments

Merck Announces Encouraging Data from Breast Cancer Study

Merck has announced early study findings demonstrating an overall response rate of 18.5% with KEYTRUDA, the company's anti-PD-1 therapy, as assessed by RECIST v1.1, central review, or n=5/27, in PD-L1 positive, advanced triple-negative breast cancer. At the time of analysis, the median duration of response had not been reached with three of five responders on therapy for 11 months or more (range, 15 to 40+ weeks). Phase II study planned for the first half of 2015 will be an important next step for breast cancer clinical program. Data presented were from a cohort of the ongoing Phase Ib KEYNOTE-012 study which evaluated KEYTRUDA monotherapy at 10 mg/kg every two weeks in patients with advanced TNBC whose tumors were determined to be positive for PD-L1 expression (n=32). As measured by Merck's proprietary PD-L1 immunohistochemistry (IHC) clinical trial assay, tumors were considered to be PD-L1 positive if staining was present in the stroma or in greater than or equal to 1% of tumor cells. In the study, 58 % of patients screened had tumors determined to be positive for PD-L1 expression. Most patients enrolled in this study had received two or more prior chemotherapies for metastatic disease and 87.5 % had received prior neo-adjuvant or adjuvant therapy. The median time to response was 18 weeks (range, 7-32 weeks). In the study, 33 % of patients with KEYTRUDA achieved tumor shrinkage. At six months, the progression-free survival rate with KEYTRUDA was 23.3 %. Adverse events were consistent with previously reported safety data for KEYTRUDA. The most common treatment-related adverse events (occurring in greater than or equal to five % of patients) included arthralgia (n=6), fatigue (n=6), myalgia (n=5), nausea (n=5), ALT increased (n=2), AST increased (n=2), diarrhea (n=2), erythema (n=2) and headache (n=2). Grade 3-5 treatment-related adverse events occurred in a total of five patients and included anemia, disseminated intravascular coagulation (DIC), headache, meningitis aseptic, decreased blood fibrinogen, and pyrexia. Two patients discontinued KEYTRUDA due to adverse events. One treatment-related death was reported in a patient with rapidly progressive disease and was due to DIC with thrombocytopenia and decreased blood fibrinogen. KEYNOTE-012 is an ongoing multi-center, non-randomized Phase Ib trial evaluating the safety, tolerability, and anti-tumor activity of KEYTRUDA monotherapy in patients with advanced triple-negative breast cancer (TNBC), advanced head and neck cancer, advanced urothelial (bladder) cancer, or advanced gastric cancer. The primary endpoints of the study include overall safety, tolerability and anti-tumor activity (as measured by RECIST v1.1 assessed by independent radiology review) in PD-L1 positive tumors; secondary endpoints include progression-free survival (PFS), overall survival (OS) and duration of response. In 2014, early findings were presented for all four cohorts of the Phase Ib KEYNOTE-012 study.

Merck & Co. Inc. Receives Approval for an Updated Version of Gardasil Vaccine

Merck & Co. Inc. has received approval for an updated version of its Gardasil vaccine that protects against an additional five strains of the virus that causes most cases of cervical cancer. The Food and Drug Administration approved the company's Gardasil 9, which protects against nine strains of the virus called HPV, or human papillomavirus. That's up from four strains covered by the original Gardasil vaccine approved in 2006. The FDA announced the updated Gardasil has the potential to prevent roughly 90% of cervical, vulvar, vaginal and anal cancers. Original Gardasil protected against strains blamed for 70% of U.S. cervical cancers. Like its predecessor, Gardasil 9 also guards against two viral strains that cause genital warts. About 75 to 80% of men and women are infected with HPV during their lifetime. Most don't develop symptoms and clear it on their own. But some infections lead to genital warts, cervical cancer and other cancers.

Merck Announces Promising Early Results, Will Advance Immuno-Oncology Drug for Breast Cancer

Merck & Co. Inc. announced that it will advance a new cancer drug into bigger patient tests, after promising findings in an early study against a very aggressive, common type of breast cancer. Merck said its Keytruda shrank tumors to some extent in one-third of 27 patients evaluated in a study called KEYNOTE-012. All had what's called triple-negative breast cancer that had spread outside the breast, and about 85% had worsened after multiple rounds of chemotherapy and other treatments - some five or more treatments. The drug is in a hot new class of medicines, mostly still experimental, called immuno-oncology drugs. They harness the body's immune system to fight cancer through a mechanism that 'uncloaks' a substance called PD-1 on hidden cancer cells so they can be spotted and attacked by key immune cells called T cells.

Merck Appoints Julie Gerberding as Executive Vice President for Strategic Communications, Global Public Policy and Population Health

Merck announced the appointment of Dr. Julie Gerberding, as executive vice president for strategic communications, global public policy and population health, effective Dec. 15, 2014. In this newly created Executive Committee position, Gerberding, who most recently served as president of Merck Vaccines, will be responsible for it’s global public policy, corporate responsibility and communications functions, as well as the Merck Foundation and the Merck for Mothers program. Gerberding will also lead new partnership initiatives that accelerate it’s ability to contribute to improved population health, a measure of impact that is increasingly valued by governments and other global health organizations. Gerberding joined Merck as president of Merck Vaccines in January 2010.

Merck & Co To Acquire Small Companies

Merck & Co. Inc. (NYSE:MRK) is looking to acquire smaller companies rather than focusing on bigger deals.


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