Here is a report about a Trodelvy trial failure from the San Antonio Breast Cancer Symposium.
https://www.medpagetoday.com/meetingcoverage/...definition
Quote:SAN ANTONIO -- The antibody-drug conjugate (ADC) sacituzumab govitecan (Trodelvy) failed to outperform chemotherapy as first treatment after endocrine therapy for metastatic hormone receptor-positive/HER2-negative breast cancer, a randomized trial showed.
Median progression-free survival (PFS) by blinded independent committee review (BICR) was an identical 8.3 months for both treatment groups. Investigator-assessed PFS, a secondary endpoint, showed a statistically significant 2-month improvement with sacituzumab govitecan (8.4 vs 6.4 months, P=0.008).
A preliminary overall survival (OS) analysis also showed a statistically significant advantage for the ADC, although the median value had yet to be reached in either treatment group, reported Komal Jhaveri, MD, of Memorial Sloan Kettering Cancer Center in New York City, at the San Antonio Breast Cancer Symposium (SABCS).
The trial outcome turned on the discordance between BICR and investigator assessment, and Jhaveri offered several potential explanations for the discordance. One potential contributing factor was censoring during the first 4 months, 8% with sacituzumab govitecan and 11% with the chemotherapy group. In both groups, the principal reason for censoring was start of a new therapy.
"When we looked at patients who were censored and who started a new anticancer therapy, more patients received an antibody-drug conjugate in the chemotherapy arm compared to the [sacituzumab govitecan] arm," Jhaveri said during an SABCS press briefing. "It's possible that there were discordances with how the assessments were done locally versus BICR, which we see routinely, and the same thing could have happened here."
The results of the ASCENT-07 trial surprised press briefing moderator Kate Lathrop, MD, of UT Health San Antonio.
"It's a surprise because every [prior] study of sacituzumab has been positive," she told MedPage Today. "I think it shows that in this patient population, which was endocrine-resistant, hormone receptor-positive breast cancer, that potentially TROP-2-directed therapy [like sacituzumab govitecan] may not have as much of an impact as it has in other tumor types, like triple-negative breast cancer."
"That's just my assumption. Maybe we're going to be able to find that high-TROP-expressing group that might actually do super well on that drug upfront, whereas in the triple-negative studies, or the more advanced-stage studies, patients that had already progressed through other lines of chemotherapy, that TROP expression didn't seem to matter. But it might matter in the early setting. We don't really know at this point."
https://www.medpagetoday.com/meetingcoverage/...definition
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