66P - Utidelone-based therapy in metastatic solid tumors after failure of standard therapies: A prospective, multicenter, single-arm trial

Background

Treatment options are limited for patients with advanced or metastatic solid tumors after failure of standard therapies. Utidelone, a genetically engineered epothilone analogue, has demonstrated high activity in clinical studies against a broad range of tumors using regimen of 30mg/m², iv, d1-5 every 21 day. This study aimed to evaluate the efficacy and safety for solid tumors using 120h continuous intravenous infusion of utidelone.

Methods

This is a prospective, multicenter, single-arm trial. We included patients aged 18 years or older with metastatic solid tumor after failure of standard therapies. Utidelone was administrated at 150 mg/m² via 120h continuous intravenous infusion, alone or in combination with other anticancer agents every 21 days until disease progression or intolerable toxicity. The primary endpoints were ORR and safety. Secondary endpoints included mPFS, DCR and QoL.

Results

As data cut-off on June 30, 2023, a total of 50 patients were enrolled and analyzed. There were 20 patients with breast cancers,11 with gynecological cancers, 8 with gastrointestinal cancers, 6 with lung cancer and 5 with other solid tumors. The median number of previous systemic therapies was three. 38 (76%) patients had taxane-refractory diseases. The overall ORR and DCR was 20% and 66%, respectively, the mPFS was 4 months. For breast cancer patients, the ORR and DCR was 40% and 75%, respectively, and the mPFS was 6 months. For gynecological cancers, the ORR and DCR was 9% and 64%, respectively. Most of the AEs were grade 1 or 2 and were manageable and reversible. The rate of grade ≥3 AEs including peripheral neuropathy was 4% (2/50). No treatment-related discontinuation or deaths occurred.

Conclusions

This study demonstrated a promising anti-tumor activity of utidelone in patients with metastatic solid tumors after failure of the standard therapies, especially in patients with breast cand gynecological cancers. Moreover, 120h continuous intravenous infusion is a more tolerable administration method than 5 days intermittent infusion, worthy further study.

Clinical trial identification

ChiCTR2300074299.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.