95P - A single-arm, multicenter phase ? trial evaluating TQB2450 plus anlotinib combined with paclitaxel and cisplatin in first-line treatment of advanced esophageal squamous cell carcinoma (ESCC)

Background

Anlotinib is a multi-target TKI that has been proved to have good efficacy and tolerable toxicity whether as first-line treatment when combined with TP in advanced ESCC. TQB2450 is a novel humanized anti-PD-L1 monoclonal antibody. We conducted a phase II trial to evaluate the efficacy and safety of alotinib combined with TQB2450, cisplatin, and paclitaxel as first-line treatment for advanced ESCC. Here is the update results.

Methods

Eligible patients (pts) with previously untreated unresectable locally advanced or metastatic ESCC received TQB2450 (1200mg, iv, d1, q3w) plus anlotinib (10mg, po, d1∼14, q3w) combined with paclitaxel (135mg/m2 , iv, d1, q3w) and cisplatin (60∼75mg/m2 , iv, d1∼3, q3w) for 4 - 6 cycles as initial therapy. Patients without progressive disease (PD) continued to receive same dose of anlotinib plus TQB2450 as maintenance therapy until PD or unacceptable toxicity. The primary endpoint was PFS (RECIST version 1.1). Secondary endpoints included iPFS (iRECIST), ORR (RECIST version 1.1), DCR, DOR and safety.

Results

At the data cutoff date of April 15, 2023, 50 pts were enrolled with a median age of 64 years (range 41-74), male (38/50, 76%) and ECOG PS 1 (39/50, 78%). Among 45 tumor response evaluable pts, the ORR was 82.2% (95% CI: 68.3%, 91.7%) and the DCR was 100.0% (95% CI: 92.1%, 100.0%). The preliminary median PFS was not reached. The incidence of grade 3-4 treatment emergent adverse events was 66% (33/50), there was no grade 5 TRAE. 20 pts (40%, 20/50) occurred treatment related serious AEs. 25 patients received maintenance treatment for more than 10 cycles, the median DOT was 12.19m(9.53m-18.53m). Only 5 patients experienced grade 3-4 AE, mainly include leukopenia, hypertension, hyponatremia and hypokalemia.

Conclusions

TQB2450 plus anlotinib with paclitaxel and cisplatin showed promising activity with well-tolerated toxicities in pts with advanced ESCC as first-line treatment and the maintenance treatment also showed manageable safety.

Clinical trial identification

NCT05013697.

Legal entity responsible for the study

The authors.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.