Phase III ASCENT study of Trodelvy shows improved survival in triple negative breast cancer.- Immunomedics

Immunomedics announced that results from the confirmatory Phase III ASCENT study showed that Trodelvy (sacituzumab govitecan-hziy) significantly extended overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared to treatment of choice (TPC) standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had previously received at least two prior therapies for metastatic disease. Despite having received a median of four prior anticancer regimens, patients treated with Trodelvy in the ASCENT study showed a statistically significant and clinically meaningful improvement in OS with a median of 12.1 months (95% confidence interval (CI), 10.7-14.0) versus 6.7 months (95% CI, 5.8-7.7) for chemotherapy, with a hazard ratio of 0.48 (95% CI, 0.38-0.59; p<0.0001). trodelvy also demonstrated a statistically significant improvement in orr 35 and cbr 45 compared to chemotherapy 5 and 9 respectively. ten complete responses were observed 4 in the trodelvy arm compared with two 1 in the control group. as of data cutoff on march 11 2020 15 patients continued to receive trodelvy treatment while no patient remained on study in the tpc control arm. trodelvy was well tolerated by patients in the ascent study with a manageable safety profile consistent with the fda-approved label no new safety signals were observed in the ascent study. adverse events leading to treatment discontinuation were low and similar trodelvy 4.7 vs tpc 5.4 in both arms of the study. these results will be presented as a late-breaking abstract abstract lba17 at the european society for medical oncology esmo virtual congress 2020.>