Abstract 93P
Background
For medically inoperable patients (pts) with early-stage non-small-cell lung cancer (NSCLC), stereotactic body radiation therapy is recommended, but long-term outcomes are not satisfactory for this population. At present, chemoimmunotherapy has become the standard of care for untreated advanced NSCLC; however, its benefit in medically inoperable early-stage NSCLC is unclear. Herein, we explored the efficacy and safety of camrelizumab (an anti-PD-1 antibody) plus chemotherapy in pts with medically inoperable stage I–IIA NSCLC.
Methods
In this single-arm, single-center, phase II study, treatment-naïve pts with pathologically confirmed medically inoperable stage I–IIA NSCLC and an ECOG PS of 0 or 1 received camrelizumab (200 mg) plus chemotherapy (pemetrexed [500 mg/m2] for non-squamous NSCLC or nab-paclitaxel [260 mg/m2] for squamous NSCLC) intravenously on day 1 of a 21-day cycle. After 4–6 cycles, pts received up to 1 year of camrelizumab (200 mg, day 1, every 21 days) monotherapy as maintenance treatment. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) as per RECIST 1.1, disease control rate (DCR), overall survival (OS), PFS and OS rates at 1, 2 and 5 years, and safety.
Results
From October 19, 2020 to July 4, 2022, 18 pts were enrolled. The median age was 75 years (IQR 71–78). Ten pts (55.6%) were male and 11 pts (61.1%) had adenocarcinoma. As of December 15, 2022, the median PFS was not reached (95% CI 11.1-not reached). Of the 18 pts, six pts (33.3%) achieved partial response, 11 pts (61.1%) had stable disease and one pt (5.6%) was not evaluable. The ORR and DCR were 33.3% (95% CI 13.3%-59.0%) and 94.4% (95% CI 72.7%-99.9%), respectively. The median treatment cycle of camrelizumab was 17 (IQR 11–17). Treatment-related adverse events (TRAEs) occurred in 14 pts (77.8%). Four pts (22.2%) had grade 3 TRAEs, with one each of anemia, platelet count decreased, white blood cell count decreased, and pneumonia. No grade 4 or 5 TRAEs were reported.
Conclusions
Camrelizumab plus single-agent chemotherapy showed promising activity with a manageable safety profile in pts with medically inoperable stage I-IIA NSCLC.
Clinical trial identification
NCT04530227.
Legal entity responsible for the study
C. Wang.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.