Survival
There was a trend toward improved PFS with avelumab plus PLD, but the significance threshold was not met.
The median PFS was 1.9 months in the avelumab arm, 3.7 months in the combination arm, and 3.5 months in the PLD arm. With the PLD arm as a reference, the stratified hazard ratio was 1.68 for the avelumab arm (P greater than .999) and 0.78 for the combination arm (P = .0301).
The median OS was 11.8 months in the avelumab arm, 15.7 months in the combination arm, and 13.1 months in the PLD arm. The HR was 1.14 for the avelumab arm (P = .8253) and 0.89 for the combination arm (P = .2082).
“[A]velumab plus PLD showed clinical activity, but, in this unselected population, the trial did not meet the primary objective [of improving PFS or OS compared to PLD alone],” Dr. Pujade-Lauraine noted. “However, prespecified analyses indicate a potential role of PD-L1 expression as a predictor of clinical benefit.”
When Dr. Pujade-Lauraine and his colleagues looked at patients who were positive for PD-L1 (57%), the researchers found a significant improvement in PFS, but not OS, with avelumab plus PLD.
The median PFS was 1.9 months in the avelumab arm (HR,1.45, P = .0303), 3.7 months in the combination arm (HR, 0.65, P = .0143), and 3.0 months in the PLD arm.
The median OS was 13.7 months in the avelumab arm (HR, 0.83, P = .3580), 17.7 months in the combination arm (HR, 0.72, P = .0842), and 13.1 months in the PLD arm.
The researchers also found that PFS and OS were better with avelumab plus PLD versus PLD alone among patients who had received two or three prior treatment regimens at baseline. The HR was 0.62 for PFS and 0.64 for OS.
Dr. Pujade-Lauraine said further subgroup analyses are ongoing.
This trial was sponsored by Pfizer. Dr. Pujade-Lauraine reported relationships with AstraZeneca, Clovis Oncology, Incyte, Pfizer, Roche, and Tesaro.
SOURCE: Pujade-Lauraine E et al. SGO 2019, Abstract LBA1.