Patients with advanced lung cancer may not need chemotherapy in the future, thanks to new immunotherapy drug called Keytruda (pembrolizumab). The medicine developed by Merck was recently tested in the laboratory and the results are promising.
On Saturday, Dec. 19, Merck announced the second set of findings of the three-phase trial study involving the drug. The said investigation is the first to assess the potential of immunotherapy compared to chemotherapy based on the levels of programmed death ligand 1 (PD-L1). PD-L1 is a protein that gives valuable information regarding an individual's response to certain anti-cancer treatments.
Treatments for advanced non-small-cell lung cancer have exhibited decent improvements, but the need for options to treat the progressive disease remains. In the study dubbed KEYNOTE-010, international researchers evaluated the efficacy of Keytruda in patients, who recovered from PD-L1-positive, advanced non-small-cell lung cancer.
The study was conducted in 202 academic medical institutions across 24 countries, and was performed from August 2013 to February 2015.
A total of 1,034 participants were enrolled and randomly assigned to receive either pembrolizumab (345) or chemotherapeutic drug docetaxel (343) every three weeks. All of the study subjects have had disease progression following systemic treatments that contain platinum substances. They were also classified based on their levels of PD-L1.
Findings Of The Study
By Sept. 30, 521 patients have already died. Across the entire study population, the median rate of survival was 10.4 months for the group that received 2 mg/kg of pembrolizumab, 12.7 months for those who had 10 mg/kg dose of pembrolizumab and 8.5 months for docetaxel.
The median period of patients having no disease-progressive findings was 3.9 months for the lower-dose pembrolizumab and 4.0 for both high-dose immunotherapy and docetaxel.
For participants who expressed PD-L1 in at least 50 percent of tumor cells, the general survival rate was longer in lower-dose pembrolizumab than docetaxel, with a median rate of 14.9 months and 8.2 months respectively. The longest survival rate, however, is attributed to pembrolizumab 10 mg/kg dose as it showed a median rate of 17.3 months. Progression-free survival rates followed the same rankings.
The findings of the study imply that pembrolizumab indeed can lengthen the overall survival rates and cause highly favorable outcomes for patients with previously treated advanced non-small-cell lung cancer that expressed PD-L1.
"The topline results show that both groups of patients receiving pembrolizumab experience a survival benefit compared to docetaxel," said Roy Herbst, co-author from Yale University.
Aside from the more favorable outcomes, adverse effects related to treatment were also lower in the two pembrolizumab groups compared to the docetaxel group.
Subsequent Plans For Keytruda
Merck president Dr. Roger Perlmutter said the pharmaceutical company's development program was fundamentally based on "understanding the role that Keytruda can play in helping patients." He added that, despite this, developing effective treatments for lung cancer remains challenging.
The company plans to send a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for Keytruda, highlighting the key results of the recent study before 2015 ends.
As for marketing, Merck is looking at submitting a Marketing Authorization Application to the European Medicines Agency during the early part of 2016.
The study was published in The Lancet on Saturday, Dec. 19, and the results will be presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress.
Photo : Ed Uthman | Flickr