KEY TAKEAWAYS
- The phase 2 trial aimed to evaluate ivo’s efficacy and safety when combined with chemotherapy for first-line Sq-NSCLC treatment.
- The primary endpoint was ORR per RECISTv1.1.
- Ivonescimab combined with chemotherapy showed promising anti-tumor activity and safety in advanced NSCLC, including Sq histology.
Ivonescimab (ivo), a bispecific antibody, exhibits enhanced binding to PD-1 and VEGF, potentially driving synergistic anti-tumor effects, with a T1/2 of 6-7 days.
Zhang Li and the team aimed to evaluate the efficacy and safety of combining ivo with chemotherapy as the initial treatment for advanced squamous (Sq) non-small cell lung cancer (NSCLC).
In an updated analysis from an open-label, multi-center phase II trial presented at ASCO 2023, researchers evaluated the effectiveness and safety of combining ivo with chemotherapy in patients undergoing first-line treatment for advanced Sq-NSCLC.
Patients received either 10 mg/kg (n=10) or 20 mg/kg (n=53) of ivo every three weeks alongside carboplatin and pemetrexed (for non-Sq) or carboplatin and paclitaxel (for Sq). Patients were excluded if they exhibited tumor-encircling blood vessels, necrosis, cavitation, central, cavitary Sq NSCLC, or were at risk of hemorrhage. The primary endpoint was the overall response rate (ORR) according to RECISTv1.1 criteria, assessed by investigators.
In a cohort of 63 patients with advanced Sq-NSCLC, a combination of ivo and chemotherapy was administered. The median age of participants was 59 years. Of these, 3% had an ECOG PS of 0, while 97% had a PS of 1. Patients (8%) presented with baseline brain metastasis.
The median follow-up duration was 21.0 months. Among patients with Sq-NSCLC, a 71.4% ORR was observed, with a median duration of response (DOR) of 12.7 months. Additionally, a disease control rate (DCR) of 90.5%, a median PFS of 11.1 months, and a 21-month overall survival (OS) rate of 69.5% were recorded.
The treatment-related adverse events (TRAEs) with an incidence of ≥10%. Grade ≥3 TRAEs occurred in 44.4% of patients, while TRAEs leading to discontinuation were noted in 11.1% of cases. The overall incidence of bleeding events was 46%, with one grade ≥3 events (hemoptysis) reported at the 10 mg/kg dose.
The results demonstrated that ivonescimab combined with chemotherapy showed encouraging anti-tumor efficacy in patients with advanced NSCLC while maintaining safety, especially in Sq histology patients.
The trial was sponsored by the Akeso.
Clinical Trial: https://clinicaltrials.gov/study/NCT04736823
Li Z, Fang WF, Zhao Y, et al. (2024) “Phase II results of ivonescimab (ivo) a novel PD-1/VEGF bispecific in combination with chemotherapy for first-line treatment of patients (pts) with advanced/metastatic squamous (Sq) non-small cell lung cancer (NSCLC).” Annals of Oncology (2024) 9 (suppl_3): 1-53. 10.1016/esmoop/esmoop102569. Presented at ELCC 2024 (68P)
