“These patients had very rapid cancer progression after platinum-based chemotherapy,” Dr.
4D PHARMA ONCOLOGY TRIAL
In patients with advanced disease treated in the first-line setting, the median time from the last chemotherapy dose to trial screening was 1.6 months. Key secondary endpoints included safety, duration of response, progression-free survival, and overall survival.Ībout half of all enrolled patients had been treated with neoadjuvant or adjuvant platinum-based chemotherapy. The primary endpoint was objective response rate according to investigator review. Treatment was continued until the development of unacceptable toxicity or disease progression. Patients enrolled in Cohort 3 were treated with sacituzumab govitecan at 10 mg/kg on days 1 and 8 every 21 days and 200 mg of pembrolizumab on day 1 every 21 days. A total of 49% had at least one Bellmunt risk factor, and 27% had two risk factors. A total of 83% were male 54% were White the median age of patients was 67 61% had an Eastern Cooperative Oncology Group performance status of 1 78% had distant metastasis 68% had visceral metastasis. Grivas reported interim safety and efficacy results of Cohort 3.Ĭohort 3 enrolled 41 patients with metastatic urothelial cancer who were checkpoint inhibitor–naive and experienced progressive disease soon following treatment with platinum-based therapies. Grivas and colleagues sought to evaluate sacituzumab govitecan in combination with an immune checkpoint inhibitor, pembrolizumab, as second-line therapy in Cohort 3 of the multicohort TROPHY-U-01 trial. Food and Drug Administration as a salvage therapy for previously treated metastatic urothelial cancer. Sacituzumab govitecan, a first-in-class antibody-drug conjugate against Trop2, is approved by the U.S. “Metastatic urothelial cancer is associated with a poor outcome, and treatment options are relatively limited, especially in the platinum-refractory setting,” Dr.
Petros Grivas, MD, PhD Tweet this quote “Additional follow-up for survival events and biomarkers is ongoing.” “These data support further evaluation of antibody-drug conjugate/checkpoint inhibitor combination in metastatic urothelial cancer in the platinum-refractory setting and probably in earlier lines of therapy in a different patient population,” stated lead author Petros Grivas, MD, PhD, of Seattle Cancer Care Alliance, the University of Washington School of Medicine, and Fred Hutchinson Cancer Research Center. There was 1 complete response, 13 partial responses, and 11 patients with stable disease (4 of the 11 had stable disease for at least 6 months). 1Īt a median follow-up of 5.8 months, patients treated with the combination had an objective response rate of 34%. The combination of the antibody-drug conjugate sacituzumab govitecan-hziy and the immune checkpoint inhibitor pembrolizumab yielded antitumor activity as second-line therapy in patients with platinum-refractory, checkpoint inhibitor–naive, metastatic urothelial cancer, according to the results of Cohort 3 of the phase II TROPHY-U-01 trial reported at the 2022 ASCO Genitourinary Cancers Symposium.
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