The following is a summary of “Efficacy, Safety, and Biomarker Analysis of Neoadjuvant Camrelizumab and Apatinib in Patients With Resectable NSCLC: A Phase 2 Clinical Trial,” published in the June 2023 issue of the Thoracic Oncology by Zhao et al.

Combining ocrelizumab (an anti–programmed cell death protein-1 antibody) and lapatinib (an antiangiogenic agent) is advantageous for advanced NSCLC. The study evaluated the efficacy and safety of neoadjuvant ocrelizumab plus lapatinib in patients with resectable NSCLC. In this phase, two trials, patients with histologically confirmed resectable NSCLC stages IIA to IIIB (stage IIIB, T3N2 only) received intravenous ocrelizumab (200 mg) every two weeks for three cycles and oral lapatinib (250 mg) once daily for five days followed by two days off for six weeks. Surgery was scheduled three to four weeks after the discontinuation of apatinib. 

The primary endpoint was the significant pathologic response (MPR) rate in patients who underwent surgery and received at least one dose of neoadjuvant therapy. Between November 9, 2020, and February 16, 2022, 78 patients were treated, with 65 undergoing surgery (83%). Each of the 65 patients underwent an R0 surgical resection. About 37 (57%, 95% CI: 44%–69%) of the 65 patients had an MPR, and 15 (23%, 95% CI: 14%–35%) had a pathologic complete response (pCR). The pathologic responses observed in squamous cell non-small cell lung cancer were preferable to those observed in adenocarcinoma (MPR: 64% versus 25%; pCR: 28% versus 0%). The objective radiographic response rate was 52% (CI 95%: 40%–65%). Around 37 (47%, 95% CI: 36%–59%) of the 78 enrolled patients had an MPR, and 15 (19%, 95% CI: 11%–30%) had a pCR. 

Four (5%) of 78 patients experienced neoadjuvant-related adverse events of grade 3. There were no treatment-related adverse events of grade 4 or 5. The receiver operating characteristic analysis revealed a significant relationship between the maximal reduction of standard uptake values and pathologic response (R = 0.619, P<0.0001). Pathologic responses were also associated with baseline programmed death-ligand 1 expression, HOXA9, and SEPT9 methylation levels, and circulating tumor DNA status before surgery. Neoadjuvant ocrelizumab plus lapatinib was found to have promising activity and manageable toxicity in patients with resectable stages IIA to IIIB NSCLC, suggesting its potential as a neoadjuvant therapeutic option.

Source: sciencedirect.com/science/article/abs/pii/S1556086423001612