ESMO Congress 2023 | OncologyPRO

Abstract 1296P

Background

Our phase 2 trial was the first to report the efficacy and safety of neoadjuvant chemo-free regimen with camrelizumab and apatinib in patients with resectable non-small-cell lung cancer (NSCLC), showing promising pathologic responses and manageable toxicity. Here, we aimed to report 1-year event-free survival (EFS) and updated safety data from the above trial.

Methods

Treatment-naïve patients with histologically confirmed resectable stage IIA-IIIB NSCLC (stage IIIB, T3N2 only) and ECOG performance status of 0 or 1 received three cycles of camrelizumab (200 mg, i.v., q2w) and apatinib (250 mg, orally, qd, for 5 days followed by 2 days off), followed by surgery after 3-4 weeks. This analysis including EFS (a prespecified secondary endpoint) and updated safety was performed after an extended follow-up from the preliminary analysis.

Results

Between November 9, 2020 and February 16, 2022, 78 patients were enrolled and treated. With a median follow-up of 19.4 months (95% CI 18.0-20.5), the median EFS was not reached (95% CI 23.2-not reached). The 6- and 12-month EFS rates were 89.4% (95% CI 79.8-94.5) and 82.3% (95% CI 71.4-89.3), respectively. The EFS rates at 6 months and 12 months in the subgroups are presented in the Table. Seventy-one (91.0%) of the 78 patients experienced at least one treatment-related adverse event (TRAE) of any grade, of which grade 3 or above TRAEs were observed in six (7.7%) patients. No new safety signal was observed. Table: 1296P

Subgroup	Patients (n = 78), n (%)	6-month EFS rate, % (95% CI)	12-month EFS rate, % (95% CI)
Overall	78 (100)	89.4 (79.8-94.5)	82.3 (71.4-89.3)
Disease stage
II	38 (48.7)	94.5 (79.8-98.6)	86.2 (69.9-94.0)
III	40 (51.3)	84.5 (68.7-92.8)	78.7 (61.8-88.8)
PD-L1 expression
<1%	35 (55.6)	85.3 (68.2-93.6)	76.2 (57.9-87.3)
≥1%	28 (44.4)	92.9 (74.3-98.2)	85.4 (65.7-94.3)
Histologic type
Squamous cell carcinoma	59 (75.6)	91.2 (80.2-96.2)	84.1 (71.6-91.4)
Adenocarcinoma	19 (24.4)	83.9 (57.9-94.5)	76.9 (49.0-90.8)

Conclusions

The extended follow-up data shows continued benefits and a manageable safety profile with neoadjuvant camrelizumab and apatinib in patients with resectable non-small-cell lung cancer.