Keytruda, a melanoma treatment developed by Merck & Co. Inc., has met its primary endpoints and therefore testing has stopped early, according to a news release from the pharmaceuticals company.1
Merck is ending the research based on a recommendation from the study’s independent Data Monitoring Committee, and notes that the drug provides statistically and clinically proven improvement in overall and progression-free survival when compared to ipilmumab, a drug produced by Bristol-Myers Squibb Co.
Merck plans to reveal its findings at the yearly meeting of the American Association for Cancer Research in April.
Road to Approval
In the field of pharmacy technology, Keytruda is providing a promising treatment option for cancer patients in the advanced stages of melanoma. The drug was approved by the U.S. Food and Drug Administration in September 2014, but Keytruda was still undergoing phase III study. According to the FDA, melanoma accounts for five percent of new cancers in the U.S.2
The drug is one of several melanoma treatments that has been developed over the last few years, bringing more options to patients suffering from this form of cancer.
Keytruda additionally received a Promising Innovative Medicine designation in the U.K. in October 2014, before eventually being accepted as the first drug under the Early Access to Medicines Scheme (EAMS) in March 2015.3 As of March 10, 2015, Merck had provided early access of the melanoma drug to approximately 3,500 people across 40 countries. In trials, Merck has tested Keytruda alone and in combination with other treatments.
“Merck has charted a path to accelerate the development of pembrolizumab, and is collaborating with governments around the world to bring our anti-PD-1 therapy to cancer patients,” Dr. Roger Perlmutter, president of Merck Research Laboratories, explained in a press release. “This acceptance of pembrolizumab into the Scheme will enable many patients in the U.K. with advanced melanoma to gain earlier access to pembrolizumab, and underscores the importance of creating new mechanisms to bring promising medicines to patients for whom there are limited options.”3
A Trend in Anti-PD-1s
Keytruda is one of a recent number of developing drugs known as anti-PD-1s. These drugs attack the PD-1 protein, which is responsible for preventing the immune system from attacking melanoma cells.2 Keytruda works by blocking PD-1 from interacting with receptor ligands, which in turn allows the immune system to respond to tumors.1
According to Merck’s new release, “Keytruda is the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma.”1
Trials of Keytruda showed that using the drug in recommended dosages reduced the size of tumors in 24 percent of participants for at least 1.4 to 8.5 months, and often a longer duration of time. Another group of participants was given a larger dosage of Keytruda to similar results.
The drug is considered safe, though some side effects occurred in trial participants, including rare cases that affected healthy organs.2 Moving forward, Keytruda may play a major role in bettering outcomes for melanoma patients. Moreover, anti-PD-1s have been showing promising medical results and may contribute to potentially wider-ranging treatment options in time.
1 “Merck’s Pivotal KEYNOTE-006 Study in First-Line Treatment for Advanced Melanoma Met Co-Primary Endpoints and Will be Stopped Early,” Merck News Release, March 24, 2015. http://www.mercknewsroom.com/news-release/oncology-newsroom/mercks-pivotal-keynote-006-study-first-line-treatment-advanced-melano
2 “FDA approves Keytruda for advanced melanoma,” U.S. Food and Drug Administration Press Release, Sept. 4, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm
3 “KEYTRUDA® (pembrolizumab) is First Medicine to be Made Available to Patients Through U.K. Early Access to Medicines Scheme (EAMS) for Advanced Melanoma: EAMS Aims to Give U.K. Patients Access to Promising, Innovative Treatments Prior to European License,” Business Wire, March 10, 2015. http://www.businesswire.com/news/home/20150310006742/en/KEYTRUDA%C2%AE-pembrolizumab-Medicine-Patients-U.K.-Early-Access#.VRGWqY54qGI