Nearly 30% of patients responded to treatment with TRODELVY1
ORR by IRA based on RECIST 1.1†
In the TROPHY trial, TRODELVY demonstrated a median DOR of more than 7 months1
Median DOR by IRA based on RECIST 1.1
(range 1.4+, 13.7)
(95% CI: 4.7-8.6)
# of responders: 31
+: denotes ongoing
ORR with TRODELVY was in select subgroups†‡
In Cohort 1 of the TROPHY Trial
Number of prior therapies for metastatic disease2
95% CI: 14.2-45.2)
95% CI: 17.7-38.6)
Presence of visceral metastases2
0 . 9 %
95% CI: 18.2-39.6)
95% CI: 13.4-43.1)
Presence of visceral liver metastases2
95% CI: 17.5-48.6)
95% CI: 16.0-36.7)
- The results of this exploratory subgroup analysis should be interpreted with caution due to the lack of formal statistical testing and modest patient numbers in each subgroup. These data are descriptive and should not be used to draw conclusions
- Subgroup analyses include All Treated Patients, defined as all enrolled patients who had received at least 1 dose of TRODELVY
- Subgroup data are not included in the Prescribing Information for TRODELVY
†ORR consisted of confirmed CR and PR per RECIST 1.1 as evaluated by independent review assessment. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.3
‡Median follow up was 9.1 months (range 0-19.9).
Change in individual patient target lesion measurement per BICR in Cohort 1 of the TROPHY trial2
In Cohort 1 of the TROPHY trial, the major efficacy outcome measures were ORR (consisting of confirmed CR and PR) and DOR evaluated by IRA based on RECIST 1.1 criteria.2,3§
- Bars represent best percent change from baseline in the sum of the diameters of the target lesions and may not correspond with the Best Overall Response (BOR), which is based on target and non-target lesions’ response to treatment. Bars that fall below the x-axis represent target lesions with a response of CR, PR, or stable disease (SD) in which target lesions decreased in size more than 0% but less than 30%. Based on RECIST v1.1, SD was defined as neither sufficient shrinkage of the target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as ≥20% increase in the sum of the diameters of the target lesions, taking as reference the smallest sum
- Not every bar that falls below the x-axis represents a CR or PR (ie, confirmed objective response), and these results should be interpreted with caution as they may reflect the natural history of the disease rather than any treatment effect
- Changes in individual patients’ target lesions data are not included in the Prescribing Information for TRODELVY
Best percent change from baseline in patient target lesion diametersa-c
aBars represent best percent change from baseline in the sum of the diameters of the target lesions (longest for non-nodal and short axis for nodal lesions) in 94 patients with at least 1 postbaseline target lesion measurement. These data include All Treated Patients, defined as all enrolled patients who had received at least 1 dose of study drug. Data exclude 19 patients due to no postbaseline radiologic assessments (n=15), or incomplete assessment of target lesions at baseline or postbaseline (n=4).
bThe dashed lines at +20% and −30% indicate thresholds of progressive disease and PR, respectively, according to RECIST 1.1 criteria.
cThe change in target lesion size may not account for new lesions.
§CR was defined as the disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in the sum of the diameters of the target lesions, taking as reference the baseline sum of diameters.
Noncomparative analysis of median PFS and OS in TROPHY (Cohort 1)2||
- The accelerated approval of TRODELVY for this indication was based on ORR and DOR. PFS and OS were secondary endpoints in Cohort 1 of the TROPHY trial and this data has not been reviewed by the FDA. Single-arm studies cannot adequately characterize time-to-event endpoints such as PFS and OS. As such, the clinical significance of these data are not known and these analyses should be interpreted with caution
- These data include All Treated Patients, defined as all enrolled patients who had received at least 1 dose of TRODELVY
- OS and PFS data are not included in the Prescribing Information for TRODELVY
(95% CI: 3.5-7.2)
(95% CI: 9.0-13.8)
TRODELVY is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
||Based on Kaplan-Meier estimate of data with a median duration of follow-up of 9.1 months with a data cutoff date of September 18, 2020.
Delve more deeply into the results of the TROPHY trial with investigator Scott T. Tagawa, MD, PhD
BICR=blinded, independent, central review; CI=confidence interval; CR=Complete Response; DOR=Duration of Response; IRA=independent review assessment; ORR=Objective Response Rate; OS=Overall Survival; PD-1=programmed death receptor-1; PD-L1=programmed death-ligand 1; PFS=Progression-Free Survival; PR=Partial Response; RECIST=Response Evaluation Criteria in Solid Tumors.
References: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; June 2022. 2. Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J Clin Oncol. 2021;39(22):2474-2485. 3. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247.