Results from a multicenter, open-label, single-arm phase 2 trial on the efficacy of camrelizumab plus apatinib in patients with treatment-naïve non-squamous advanced non-small cell lung cancer (NSCLC), presented at the virtual 2021 World Conference on Lung Cancer.

“Our preclinical work suggests that appropriate angiogenesis inhibition could potentiate PD-1/PD-L1 blockade, and promising anti-tumor activity was already observed with this treatment in chemotherapy-pretreated advanced NSCLC,” explained Shengxiang Ren, MD, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China, and co-researchers.

The open-label, multicenter trial selected 25 patients with non-squamous NSCLC and EGFR/ALK wild type who were eligible for enrollment. All patients received apatinib 250 mg orally once daily with camrelizumab 200 mg in the frontline setting every 2 weeks until disease progression or intolerable toxicity.

The primary endpoint was objective response rate (ORR) with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

The median follow-up time was 15.2 months which ranged between 2 to 20.1 months.

“12 patients (48%) were still on treatment at the time of analysis, including 4 who received treatment beyond disease progression. Among them, 10 (40%) had partial responses, 13 (52%) stable diseases, 1 (4%) progressive disease and 1 (4%) was not evaluable for observation,” continued Dr Ren, et al.

The ORR was 40% (95% CI, 21.1-61.3) and DCR was 92% (95% CI, 74-99). Median PFS was 11 months (95% CI, 7.3-14.8), with median DOR and OS not being reached. All patients had PD-L1 expression detection and 15 (60%) were PD-L1≥1% and subgroups showed similar rates.

The most common adverse events (AEs) of grade 3 or higher involved hypertension (6 [24%]), increased gamma-glutamyltransferase (5 [20%]) and abnormal hepatic function (4 [16%]).

“Frontline camrelizumab plus apatinib showed promising clinical activity with acceptable safety in patients with advanced NSCLC regardless of PD-L1 expression. A randomized phase 3 clinical trial is undergoing to validate the potent of this combination,” concluded Dr Ren, et al. - Alexa Stoia