1991P - Safety and effectiveness of surgery or radiotherapy after PD-L1 Inhibitor (TQB-2450) and chemotherapy induction therapy in patients with limited-stage small cell lung cancer: A phase II trial

Background

PD-1/PD-L1 inhibitor and chemotherapy improved the survival of patients with extensive-stage small-cell lung cancer. Thus, we conducted a non-randomized, single-center, phase II study (LungMate-005; NCT04539977) to explore the safety and effectiveness of surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy in treating limited-stage small-cell lung cancer (LS-SCLC).

Methods

Eligible patients received four 21-day-cycles of neoadjuvant therapy: TQB2450 (1200 mg) and carboplatin (AUC5) on day1, etoposide (100 mg/m²) on day1-3. MDT to discuss surgery or radiotherapy was performed 3-4 weeks after last dose of therapy. Maintenance therapy was 2-cycles TQB2450, carboplatin, and etoposide followed by 1-year TQB2450. The primary outcome was objective response rate (ORR). Secondary outcomes included the incidence of adverse events (AEs), events-free survival (EFS), and major pathological response (MPR).

Results

Between December 2020 to January 2023, a total of 40 patients received induction therapy. Among them, 21 and 14 patients received surgery or radiotherapy, respectively. Other 5 patients quitted during induction therapy. Most (95%) patients were at stage III. The incidence of any grade and grade 3-5 AE were 100% and 47.5%, respectively. The highest incidence of TQB2450-specific AEs was rush (12.5%, grade 1-2). Three (7.5%) patients had TRAEs leading to discontinuation. ORR was 92.5% (95%CI: 79.6%-98.4%). In surgery group, 13 (61.9%) patients achieved MPR, including 9 (42.9%) patients with PCR. Seventeen (81.0%) patients achieved pathological downstage. The median followed-up was 14.8 months by April 21, 2023. The median EFS and median OS were not reached in surgery group. The median EFS and OS were 11.6 (95% CI: 8.9-14.3) and 18.6 (95% CI: 13.4-23.8) months in radiotherapy group. 1-year EFS and OS were 82.0% and 100% in surgery group, and 49.2% and 88.9% in radiotherapy group, respectively.

Conclusions

Surgery or radiotherapy after PD-L1 inhibitor (TQB-2450) and chemotherapy induction therapy followed by TQB-2450 maintenance therapy in treating LS-SCLC were safe and effective, especially surgery.

Clinical trial identification

NCT04539977.

Editorial acknowledgement

TQB2450 injections was supported by Chia Tai Tianqing Pharmaceutical Group Co.,Ltd. Shanghai. China.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.