00602-1/asset/18912c36-6cb7-4017-a6e2-544bf62f9841/main.assets/gr3_lrg.jpg "KEYNOTE-B96 Trial Authors' Reply on Platinum-Resistant Ovarian Cancer")
KEYNOTE-B96 Trial Authors’ Reply on Platinum-Resistant Ovarian Cancer
- Researchers publishing in The Lancet have addressed questions regarding the clinical outcomes of pembrolizumab combined with weekly paclitaxel, with or without bevacizumab, for platinum-resistant ovarian cancer.
- The study authors explained that the ENGOT-ov65/KEYNOTE-B96 trial was not structured to support unplanned subgroup analyses.
Researchers publishing in The Lancet have addressed questions regarding the clinical outcomes of pembrolizumab combined with weekly paclitaxel, with or without bevacizumab, for platinum-resistant ovarian cancer. Authors Nicoletta Colombo, Emese Zsíros, Kosei Hasegawa, and Robert L. Coleman responded to a correspondence by Stanislas Quesada and colleagues concerning the ENGOT-ov65/KEYNOTE-B96 trial.
Trial Design and Subgroup Analysis Constraints
The study authors explained that the ENGOT-ov65/KEYNOTE-B96 trial was not structured to support unplanned subgroup analyses. Because of this trial design limitation, the response from Colombo and colleagues focuses strictly on prespecified analyses and results that fit within the established parameters of the protocol. While acknowledging the points raised by Quesada and coworkers regarding the clinically meaningful benefit of the therapy regimens, the authors emphasized that data interpretation must remain anchored to the prespecified endpoints defined during the initial trial setup.