KEY TAKEAWAYS
- The phase 2 trial aimed to investigate the efficacy and safety of anlotinib combined with TQB2450, cisplatin, and paclitaxel as a 1L treatment for advanced ESCC pts.
- The primary endpoint was to determine PFS, and secondary endpoints included iPFS, ORR, DCR, DOR, and safety.
- Researchers noticed promising activity and well-tolerated toxicities with TQB2450 +anlotinib, paclitaxel, and cisplatin in ESCC pts.
Anlotinib, a multi-target TKI, has demonstrated notable efficacy and manageable toxicity in advanced esophageal squamous cell carcinoma (ESCC), particularly when used as first-line treatment in combination with TP (paclitaxel and cisplatin). Concurrently, TQB2450, a novel humanized anti-PD-L1 monoclonal antibody, holds promise as an immunotherapeutic agent.
Junsheng Wang and his team aimed to evaluate the efficacy and safety of anlotinib combined with TQB2450, cisplatin, and paclitaxel in the first-line treatment of advanced ESCC.
The team of researchers performed an inclusive analysis involving eligible patients (pts) with previously untreated unresectable locally advanced or metastatic ESCC. The treatment regimen consisted of TQB2450 (1200mg, iv, d1, q3w), anlotinib (10mg, po, d1∼14, q3w), paclitaxel (135mg/m2, iv, d1, q3w), and cisplatin (60∼75mg/m2, iv, d1∼3, q3w) administered for 4-6 cycles as initial therapy. Patients without the progressive disease (PD) continued to receive the same dose of anlotinib plus TQB2450 as maintenance therapy until PD or unacceptable toxicity.
The primary endpoint for the analysis was progression-free survival (PFS) according to RECIST version 1.1. Secondary endpoints included immune-related progression-free survival (iPFS) assessed by iRECIST, objective response rate (ORR) based on RECIST version 1.1, disease control rate (DCR), duration of response (DOR), and safety parameters.
About 50 pts were enrolled in the study as of the data cutoff date of April 15, 2023, with a median age of 64 years (range 41-74). The majority were male (38/50, 76%) and ECOG PS 1 (39/50, 78%). Among the 45 pts evaluated for tumor response, the ORR was 82.2% (95% CI: 68.3%, 91.7%), and the DCR was 100.0% (95% CI: 92.1%, 100.0%).
As of the preliminary analysis, the median PFS had not been reached. Grade 3-4 treatment emergent adverse events (AEs) occurred in 66% (33/50), with no reported grade 5 treatment-related adverse events (TRAE).
Treatment-related serious AEs were observed in 20 pts (40%, 20/50). A total of 25 pts received maintenance treatment for more than 10 cycles, with a median duration of treatment (DOT) of 12.19 months (range: 9.53-18.53 months). Only 5 pts experienced grade 3-4 AE, primarily including leukopenia, hypertension, hyponatremia, and hypokalemia.
The study concluded that the combination of TQB2450 plus anlotinib with paclitaxel and cisplatin demonstrated promising activity as a first-line treatment in patients with advanced ESCC. Notably, the maintenance treatment phase also exhibited manageable safety profiles.
The study is sponsored by Henan Cancer Hospital
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT05013697
Wang J, et al. (2023).” 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).” Presented at ESMO IO 2023 (Abstract 95P).
