Keytruda, the Merck & Co.’s drug against bladder cancer has marked a breakthrough in the trial tests that led to their ending early.
The U.S. pharmaceutical company Merck & Co. have been conducting a Phase III trial study, the KEYNOTE-045, that set out to establish the effects of their Keytruda drug in the treatment of advanced forms of bladder cancer.
Keytruda (pembrolizumab) is part of the PD-1 inhibitors class of medicines which are meant to help the immune system detect and fight hidden cancer cells. The drug has already received the FDA mark of approval in the treatment of lung cancer, and more recently head and neck melanoma and cancer.
The Phase III trial study of the drug reached both its overall survival endpoint score and also respected the safety profile imposed by previous studies regarding advanced urothelial cancer, or bladder cancer.
An upcoming meeting will feature the complete presentation of the study’s results, but an independent DMC has already favored an early stop to the trial.
The independent DMC (Data Monitoring Committee) based its results on the analysis of the pre-specified interim.
The president of the Merck Research Laboratories, Roger Perlmutter, also stated that the company is looking forward to disclosing the test results that represent Keytruda-045 breakthrough in the area, and more importantly, to release the drug that will come as an alternative for patients who went through previous treatments for urothelial cancer.
The study also revealed that the Keytruda-045 garnered superior results as compared to the choice sole chemotherapy treatment results.
The primary points of the study were the survival and also progression-free survival in the fight against metastatic, locally advanced, or inoperable bladder cancer. The patients, which were selected at random, suffered from recurring or progressive urothelial cancer that had been previously treated with platinum-based chemotherapy.
The trial’s secondary objectives also targeted the response duration to the drug, its overall rates of response, and the patients’ safety.
Merck, the drug’s producer, has the largest program of immune-oncology bladder cancer treatments, the Keytruda being involved in 27 trials that study its effects as monotherapy or in a combination of drugs. Four of the studies feature registration-enabling products.
The general clinical development of the Keytruda includes over 360 clinical trials which target over 30 different tumor types. Almost 200 of the studies feature the use of Keytruda in combination with another drug.
Image Source: Wikimedia