72P - Camrelizumab plus apatinib after chemoradiotherapy in unresectable stage III non-small-cell lung cancer?A multi-center, single-arm, phase 2 study

Background

The PACIFIC trial established consolidation therapy with durvalumab as the standard of care for patients (pts) with unresectable stage III non-small cell lung cancer (NSCLC) without progression after chemoradiotherapy (CRT), however, additional studies are still needed to further explore the optimal therapeutic strategies. Here, we reported the preliminary results of the phase 2 study of camrelizumab (an anti-PD-1 antibody) plus apatinib (an anti-angiogenic inhibitor targeting VEGFR2) as consolidation therapy after CRT in unresectable stage III NSCLC.

Methods

This was a multi-center, single-arm, phase 2 study done at seven sites in China. Adult pts with pathologically confirmed unresectable stage III NSCLC, an ECOG PS of 0 or 1, and no disease progression following platinum-based concurrent or sequential CRT received camrelizumab (200 mg, i.v., q3w) and apatinib (250 mg, orally, qd) until disease progression, unacceptable toxicity or for up to 12 months. The primary endpoint was progression-free survival (PFS).

Results

Between March 17, 2021 to July 17, 2023, 42 pts were enrolled. The median age was 61 years (range 26-78), with 39 pts (92.9%) being male and 31 (73.8%) having squamous NSCLC. According to RECIST 1.1, three (7.1%) of the 42 pts had a complete response and eight (19.0%) had a partial response, with the confirmed objective response rate of 26.2% (95% CI 13.9-42.0). Twenty-three pts (54.8%) had stable disease, with the disease control rate of 81.0 % (95% CI 65.9-91.4). As of August 28, 2023, the median follow-up was 11.4 months (95% CI 5.8-15.6). The median PFS was not reached (NR; 95% CI 11.4-NR), with the 6- and 12-month PFS rates of 88.8% (95% CI 72.8-95.7) and 68.6% (95% CI 47.4-82.7), respectively. The median overall survival was immature, with six deaths at data cutoff. Treatment-related adverse events (TRAEs) of grade 3-4 occurred in 18 pts (42.8%), with the most common being hypertension (21.4%), AST increased (7.1%) and hand-foot syndrome (4.8%). No grade 5 TRAEs occurred.

Conclusions

Camrelizumab plus apatinib as consolidation therapy showed preliminary activity in unresectable stage III NSCLC pts without disease progression after CRT, with no new safety signals.

Clinical trial identification

NCT04749394; February 11, 2021.

Legal entity responsible for the study

Cancer Hospital Chinese Academy of Medical Sciences.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.