April 20, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PHILADELPHIA—Successful clinical trials for Merck & Co., Inc. ‘s Keytruda showed the drug effective in treating patients with three types of cancer, melanoma, lung cancer and mesothelioma. Merck presented its trial results at a meeting of the American Association for Cancer Research, which BioSpace is covering via live coverage on Twitter at @BioSpace, #AACR15.
The company said it will file for approval from the U.S. Food and Drug Administration to treat patients with non-small cell lung cancer (NSCLC) whose disease has worsened despite previous treatment.
Keytruda, also known as pembrolizumab, is a humanized monoclonal antibody that blocks the interaction between the protein PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, the company said.
In its study of Keytruda’s effectiveness on NSCLC, Merck found 45 percent of patients with high levels of PD-L1 responded to Keytruda, in comparison with 16.5 percent of patients with PD-L1 levels of 1 to 49 percent.
“The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to Keytruda in this tumor type,” said Roger Perlmutter, president of Merck Research Laboratories.
Lung cancer, which kills nearly 160,000 Americans annually, is seen as the biggest opportunity for the PD-1 drugs, which analysts expect to reach billions of dollars in sales, Reuters reported this morning.
Keytruda will compete with a drug currently being developed by Bristol-Meyers Squibb Co. Last week BMS said a trial of its PD-1 inhibitor, Opdivo, was stopped after the drug proved to work better than chemotherapy in previously treated patients with non-squamous NSCLC. Opdivo is already approved for treating the less-common squamous NSCLC, as well as metastatic melanoma, Reuters reported.
In its melanoma study, data showed Keytruda was statistically superior to treatment with ipilimumab. Keytruda improved the length of time before the skin cancer worsened by 42 percent. The trial data also showed the drug extended patient survival by 34 percent compared to ipilimumab, which is marketed by BMS as Yervoy. Melanoma is the most serious type of skin cancer.
For patients battling mesothelioma, early trial data of patients not responding to chemotherapy showed Keytruda helped 76 percent of patients. Data showed 28 percent of patients had tumors shrink and 48 percent had tumors cease growing. Mesothelioma is an aggressive and deadly form of cancer. There are treatments for the disease, but for many people with mesothelioma, a cure is not possible, according to the Mayo Clinic. Mesothelioma most often affects the tissue that surrounds the lungs (pleura). Other types of mesothelioma affect tissue in the abdomen (peritoneal mesothelioma), around the heart and around the testicles.
“These early data in advanced pleural mesothelioma reinforce the clinically meaningful results we are seeing with KEYTRUDA across multiple cancers,” Roger Dansey, Merck’s senior vice president of oncology late stage development, said in a statement.
Merck is advancing a broad clinical development program for Keytruda with more than 85 clinical trials across more than 30 tumor types and over 14,000 patients.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
