The advantages of the KEYNOTE 10 trial is thatits comparative of three treatment arms (Pembrolizumab 2 mg/kg, Pembrolizumab10 mg/kg and Docetaxel), for advanced non-small-celllung cancer and assess the efficacy of Pembrolizumab for patients withpreviously treated non-small-cell lung cancerand PD-L1-positive, thus providing a larger set of results, of threearms, that would otherwiserequire several trials.
This design evaluatesnon-inferiority and superiority of Pembrolizumab 10 mg/kg, Pembrolizumab2 mg/kg, and Docetaxel treatments, and allows for marginal intra-trial validation of non-inferiority. Another advantage of KEYNOTE 10 three arm trial is the reduction of administrativeburden and is costs effective as the trials are being run simultaneouslyand uses the same control group and protocol therefore relevant features of thestudy, such as inclusion and exclusion criteria, are consistent within thetrial. An immediate advantage of this approach is the improved efficiency by using shared information that can be used increasesupport to display effective treatment i.e. Pembrolizumab 10 mg/kg treatments was better than Pembrolizumab 2mg/kg and Docetaxel. However, three arm trials are resource-intensive, time-consuming and complex to run as there are morevariations to oversee compared to single/double arm trials. Furthermore,the disadvantages of three arm trials that are run parallel is that it can require a large sample sizes due to theexistence of three treatment variation.
KEYNOTE10 oncology trial only provides possible treatments to the participants, thereforeincreases the chance that the patients are able toreceive effective treatment (three possibilities), thus the trial appears attractiveand the trial is able to recruit more participants, (KEYNOTE 10 used 202 academic medicalcentres in 24 countries and enrolled 1034 patients). Therefore, the additionalinformation provided by the large number of participants allows the trial toreach a more reliable conclusion. Moreover, early interim analysis of results providesbetter directional conclusions, i.e which treatment of Pembrolizumab 10 mg/kg, Pembrolizumab 2 mg/kg and Docetaxel wasbetter for patients. Assessment of evidence is sufficient to claim superiorityof the Pembrolizumab 10 mg/kg treatment and warrant further experimentation.