Bevacizumab biosimilar LY01008 demonstrated comparative safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product Avastin when combined with paclitaxel and carboplatin in patients with non–small cell lung cancer (NSCLC).
A biosimilar bevacizumab developed by Luye Pharma (LY01008; Boyounuo) was found to have comparable safety, efficacy, immunogenicity, and pharmacokinetics profiles to the reference product in patients with advanced or recurrent nonsquamous non–small cell lung cancer (NSCLC), according to a recent study.
The phase 3 randomized double-blinded trial, published in Cancer Communications, is the largest study comparing the biosimilar with Avastin in the first-line treatment of Chinese patients with NSCLC. The study also evaluates therapy with the bevacizumab products in combination with chemotherapy.
“LY01008 combined with paclitaxel/carboplatin can be considered as a new treatment option for unresectable, metastatic, or recurrent nonsquamous NSCLC patients in the first-line setting,” wrote the investigators.
In 2020, there were 2.2 million new lung cancer cases and 1.8 million lung cancer–related deaths worldwide, of which one-third occurred in China. Approximately 80% to 85% of lung cancer cases are attributed to NSCLC.
Reference bevacizumab (Avastin; Genetech) is an antiangiogenic drug widely used with chemotherapy in several malignant NSCLC tumors and is considered the standard of care for advanced or recurrent nonsquamous NSCLC.
“In order to make bevacizumab more available, the development of [a] bevacizumab biosimilar is needed. [A] bevacizumab biosimilar can provide accessibility at low costs with similar efficacy, thus enabling more patients to obtain clinical benefits,” the investigators noted.
The investigators enrolled patients between aged 18 to 75 years with histologically or cytologically confined, unresectable, untreated, metastatic, or recurrent nonsquamous NSCLC who were recruited from 67 centers across China. The patients were randomized to receive either the biosimilar or the reference product in combination with paclitaxel and carboplatin for 4 to 6 cycles, after which they underwent maintenance monotherapy with the biosimilar. The investigators performed imaging examinations every 6 weeks until disease progression, intolerable toxicity, death, or the end of the study.
Between December 25, 2017, and May 15, 2019, 649 patients were randomized to receive the biosimilar (n = 324) or the reference product (n = 325). The data cutoff to analyze the primary end point of objective response rate (ORR) was September 25, 2019, and the cutoff date for analyzing the secondary end points of disease control rate (DCR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and safety was May 15, 2020.
Among the patients, 648 received at least 1 dose of a study drug: 323 in the biosimilar group and 325 in the Avastin group. The median age of the patients was 58 years, and 59.8% of the analysis set prior to randomization and intervention (n = 589) were male.
As of September 25, 2019, 142 (48.5%) of the patients who received the biosimilar and 157 (53.0%) who received Avastin achieve an objective response. The ORR of response-evaluable patients (n = 589) was 48.5% in the biosimilar group and 53.0% in the reference product group, indicating comparable effectiveness between the 2 bevacizumab drugs. The stratified ORR was 0.91 (95% CI, 0.80-1.04).
Up to May 15, 2020, the median follow-up period was 13.6 months. The investigators observed no notable differences between the treatment arms in regard to DCR, median DOR, median PFS, median OS, and 1-year OS rates. Additionally, there were no clinically meaningful differences in safety and immunogenicity between the groups.
Shi Y, Lei K, Jia Y, et al. Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non–small-cell lung cancer: a multicenter, randomized, double-blinded, phase III trial. Cancer Commun. 2021;41(9):889-903. doi:10.1002/cac2.12179