390P - SARELIFE: An Italian, multicentric real-world study of sacituzumab govitecan (SG) in pretreated metastatic triple-negative breast cancer (mTNBC)

Background

Based on the results of ASCENT study, SG was approved in Italy since August 2022 for mTNBC patients (pts). To date, very fragmentary real-world data are available.

Methods

SARELIFE is an observational, retro-prospective study, aimed to evaluate the safety of SG in a real-life population. The secondary objectives were: treatment adherence, safety of concomitant radiotherapy (RT) and drug-drug interactions (DDI). Treatment-related adverse events (AEs) were categorized and graded according to the NCI-CTCAEv5.0. Data were analysed for safety, activity and survival outcomes and reported using descriptive statistics.

Results

Between August 2023 and April 2024, 94 pts were enrolled from 24 Italian centers. Median age: 55.6y (30-86); PS(ECOG) 0-1: 90%, 2: 9.6%; gBRCAmut carriers: 16.4%. 21.2 % had de novo metastatic disease. Median number of prior lines of treatment: 2 (0-8); 29.7% had >2 prior lines; 24.7% had previously received immunotherapy, 8.6% PARP-inhibitors. Metastatic sites: visceral 78 (83%), CNS 9 (9.6%), bone: 32 (34%). 91 pts were considered for the safety analysis. The most frequent AEs were: neutropenia 38 (41.7% - G3/G4:17.5%), nausea 31 (34%), fatigue 27 (29.6% - G3:4.4%), diarrhea 23 (25.2% - G3:3.3%), anemia 21 (23% - G3:5.5%), febrile neutropenia 4 (4.4% - G4: 3.3%). 1 pneumonitis G3 was recorded. 37 pts had dose reduction (mean time to first reduction: 41 (7-147) days). None discontinued SG for toxicities. UGT1A1 status was evaluated only in 14 pts: 3 were (*28/*28) and 4 (*1/*28) but no serious AEs were reported. Best response was evaluable in 58 pts: 15 (25.8%) PR, 0 CR, 21 (36.2%) SD, 22 (38%) PD. 52 pts and 15 pts were alive at 6 and 12 months, respectively. Interestingly, 9 pts received RT during SG (+/- 30 days), of whom 6 concomitants, without no additional AEs. Data analyses on DDI are still ongoing.

Conclusions

This is the first large multicentric Italian study that investigated safety and activity of SG in an unselected real-world population of mTNBC pts. No new safety signals were reported. Even if in a small group, concomitant RT seems to be safe. These are preliminary results: with a longer follow-up, we trust to provide more robust data.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

M.S. Cona: Other, Personal, Funding: gilead. N.M. La Verde: Financial Interests, Personal, Invited Speaker: gilead, Daiichi Sankyo, Techdow, Gentili, Lilly, pfizer; Financial Interests, Personal, Advisory Board: Novartis, pfizer, roche, MSD, Astrazeneca, EISAI; Financial Interests, Institutional, Funding: Gilead. All other authors have declared no conflicts of interest.