Jeanny Aragon-Ching, MD: Remember, the primary end point of JAVELIN Bladder 100 was overall survival; it was positive, and they met the primary end point. It was superior in the avelumab arm, which yielded 21.4 months of overall survival compared with the best supportive care arm, which was 14.3 months. If you look further in PD-L1 population and subpopulation of patients, it was even better.
The overall survival was not yet estimated and not reached versus 17.1 months in the best supportive care arm. In terms of progression-free survival, that was also positive across the board between the overall population, which was about 3.7 months, compared with 2 months for the best supportive care arm. In the PD-L1 subpopulation, it was also a little better—5.7 months compared with the best supportive care arm at 2.1 months.
The end point that is meaningful in this study is overall survival. This is the 1 that resonates with everybody—to physicians, to patients on board—because overall survival is the key end point that we need to achieve to translate into clinically meaningful survival benefit.
Shilpa Gupta, MD: A survival outcome tested across various subgroups showed that avelumab was better than best supportive care, regardless of age, ECOG performance status, and first-line chemotherapy, whether it was carboplatin based or cisplatin based in the sites of metastases and PD-L1 status, as well as renal function status. The hazard ratio favored use of avelumab across the board.
Jeanny Aragon-Ching, MD: The results of the JAVELIN trial resonate and are clinically meaningful. In terms of upfront chemotherapy used for bladder cancer, there are some patients who fall at the end of the curve where we might say that they may have achieved good response, good remission, and maybe cures. That’s not everybody, but there is still a subpopulation of patients who are considered great responders to chemotherapy.
Those are also the patients for whom we want to be able to maintain those good responses. That’s why a switch maintenance strategy would be clinically meaningful, because we know in the field of bladder cancer that progression can sometimes be rapid in these patients. It’s a very aggressive disease.A subgroup of patients may derive a lot benefit from this maintenance approach with avelumab, and that would translate into clinically meaningful survival and benefit in terms of quality of life as well.
Transcript Edited for Clarity