An analysis of Benmelstobart's R&D progress and its clinical results presented at the 2023 AACR Annual Meeting

On 15 Apr 2023, the updated PFS & OS from the interim analysis (data cutoff Oct 14, 2021) of the study (NCT03910127) was reported at the AACR Congress, illustrating its potential clinical benefits and setting the stage for further exploration.

Benmelstobart's R&D Progress

Benmelstobart is a monoclonal antibody drug that targets PDL1. It has a wide range of therapeutic areas, including neoplasms, infectious diseases, digestive system disorders, endocrinology and metabolic disease, urogenital diseases, respiratory diseases, immune system diseases, hemic and lymphatic diseases, mouth and tooth diseases, skin and musculoskeletal diseases, and otorhinolaryngologic diseases. 

According to the Patsnap Synapse, Benmelstobart has reached the highest phase of development, NDA/BLA globally. And the clinical trial areas for Benmelstobart are primarily in the China. The key indication is Advanced Lung Non-Small Cell Carcinoma.

Detailed Clinical Result of Benmelstobart

The randomized, parallel assignment, quadruple masking clinical trial (NCT03910127) was aimed to evaluate the efficacy and safety of TQB2450 alone/with Anlotinib in previously treated advanced non-small cell lung cancer. 

In this study, adult patients with histologically or cytologically-confirmed stage IIIB or IV NSCLC who had wild-type EGFR/ALK and at least one line of prior systemic therapy or being intolerable of chemotherapy were randomized 1:1:1 to receive TQB2450 1200 mg plus placebo, or anlotinib 10 or 12 mg. The primary end point was PFS and secondary endpoints included safety and OS. 

The result showed that Between July. 2019 and March. 2021, 101 pts were enrolled. 33 patients were randomly assigned to TQB2450 plus placebo and 68 patients to TQB2450 plus anlotinib. As of 19 September 2022, The median follow-up was 26.3 months. The median PFS (7.3 months, 95% CI 5.3-11.0) for TQB2450 plus anlotinib was significantly longer than that for TQB2450 plus placebo group (2.8 months, 95% CI 1.4-4.7) (HR 0.39, 95% CI 0.23-0.64; P=0.0001). In patients with PD-L1 ≥ 1%, the mPFS was 17.9 months (95% CI 5.8-31.1) in TQB2450 plus anlotinib 12 mg, which was numerically higher than that in TQB2450 plus anlotinib 10 mg. The median OS of patients with PD-L1 ≥ 1% for TQB2450 plus anlotinib 12 mg was numerically higher than that in TQB2450 plus anlotinib 10 mg (32.2 months vs 21.8 months). Grade 3 or higher TRAEs occurred in 50.0% of the patients in TQB2450 plus anlotinb and in 12.1% of those in TQB2450 plus placebo.

It can be concluded that in this updated analysis with longer follow-up, TQB2450 combined with anlotinib continues to demonstrate overall efficacy and manageable safety profiles in chemotherapy treated patients with advanced NSCLC without driver gene mutations.

How to Easily View the Clinical Results Using Synapse Database?

If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. 

Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. 

A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. 

If you would like to view more information about this result, you can go to the result detail page by clicking on the title. 

Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. 

In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. 

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