1265P - Toripalimab plus chemotherapy as neoadjuvant treatment for resectable stage IIB-IIIB NSCLC (RENAISSANCE study): A single-arm, phase II trial

Background

Immunotherapy has changed the treatment paradigm for patients with NSCLC. Now considerable effort is focused on how to best use immunotherapy for resectable early-stage NSCLC. This study aimed to investigate the efficacy and safety of neoadjuvant toripalimab plus chemotherapy for resectable stage IIB-IIIB NSCLC.

Methods

Pts with resectable stage IIB-IIIB, wildtype EGFR/ALK NSCLC were eligible. All pts received 2-4 cycles of toripalimab (240mg, q3w) plus double platinum-based chemotherapy. Surgery was planned to occur within 4-10 weeks after the completion of neoadjuvant treatment. Primary endpoint was major pathological response (MPR). Secondary endpoints were complete pathological response (pCR), objective response rate (ORR), event-free survival (EFS), R0 resection rate and safety.

Results

From Dec 2020 to Apr 2023, a total of 100 pts (median age: 63, range: 45-76; male: 89, 89%, smoking history: 87, 87%; squamous cell carcinoma: 76, 76%) were enrolled. Disease distribution in stage IIB, IIIA and IIIB consisted of 33, 48 and 19 pts, respectively. Among the 98 pts completed the neoadjuvant treatment and received the radiological assessment, ORR was 63.3% (62/98). 1 pts (1/98, 1.0%) achieved complete response, 61 pts (61/98, 62.3%) had partial response. 83 pts underwent resection (median interval between neoadjuvant treatment and surgery: 89 days, range: 60-153). R0 resection was achieved for 81 pts (97.6%). 52 pts (52/83, 62.7%) achieved MPR, including 37 pts (37/83, 44.6%) with pCR. 40 pts underwent surgery with cN2/N1 at baseline (40/72, 55.6%) achieved nodal downstaging. 4 pts were preparing for surgery. Surgery was cancelled for 13.0% (13/100) of pts, reasons for cancellation included poor performance status (5%), adverse events (3%), unresectability (2%), disease progression (1%), patient refusal (1%), another primary tumor (1%). TRAEs of any grade occurred in 96% (96/100) of patients. The incidence of grade 3-4 TRAEs was 37% (37/100). The most common grade 3-4 TRAEs was neutropenia (32/100, 32%).

Conclusions

Neoadjuvant toripalimab plus chemotherapy resulted in promising MPR rate and manageable toxicity for patients with resectable stage IIB-IIIB NSCLC.

Clinical trial identification

NCT04606303.

Editorial acknowledgement

N/A

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.