Kathleen N. Moore, MD, Associate Professor of Gynecologic Oncology and Director of the Oklahoma TSET Phase I Clinical Trials Program, Stephenson Cancer Center, Oklahoma City, underscored the importance of studying patients with stable disease and less robust partial response, not just those with complete or partial responses at the end of chemotherapy.
“As Dr. David O’Malley alluded to, VELIA is an important trial because it enrolled patients from the time of chemotherapy, irrespective of response,” she noted. “Because investigators did not know how patients would respond to chemotherapy, stratification factors are very different.”
According to Dr. Moore, it’s important to remember the survival curves for VELIA start with chemotherapy, not at the end of chemotherapy. They include the time-to-event data of all patients on the study, including those who experienced disease progression, had stable disease, or lacked sufficiently robust partial response to go on a switch maintenance study.
Although preclinical and early clinical data suggesting synergy between a poly (ADP-ribose) polymerase (PARP) inhibitor and platinum chemotherapy are interesting, said Dr. Moore, “it’s only really interesting if it’s clinically relevant.” Dr. Moore also called the higher CA-125 response in non-HRD [homologous recombination deficiency] patients “compelling” but noted data have yet to demonstrate improved outcomes.
“There does not seem to be any benefit to adding veliparib to chemotherapy on outcomes based on progression-free survival alone,” she said. “Although this group doesn’t include the non-HRD or homologous recombination–proficient patients, data presented so far do not seem to argue for this strategy. Given safety data that show increased hematologic toxicity as well as nausea and vomiting with the addition of veliparib,” Dr. Moore continued, “I question whether this combination is worth it in all comers if we cannot demonstrate longer progression-free survival.”
DISCLOSURE: Dr. Moore has served on advisory boards for AbbVie, Aravive, AstraZeneca, Clovis, Eisai, Genentech/Roche, GSK/Tesaro, ImmunoGen, Merck, Mersana, Tarveda, VBL Therapeutics, and Vavotar; has participated in educational programming with Research to Practice, Cue, Prime, and Curio; and has received institutional research funding from PTC Therapeutics, Merck, GSK/Tesaro, and Lilly.
An updated analysis of the phase III VELIA/GOG-3005 trial, presented during the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer Webinar Series,1 suggested synergy between the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib and platinum chemotherapy in the...