ESMO 2021: Bevacizumab Versus the Biosimilar MIL60 in Nonsquamous NSCLC
Posted: Tuesday, October 5, 2021
During the European Society for Medical Oncology (ESMO) Congress 2021, Jie Wang, MD, PhD, of the Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, and colleagues presented data from their phase III study on the safety and efficacy of the bevacizumab biosimilar MIL60 in patients with non–small cell lung cancer (NSCLC; Abstract 1339P). These investigators ultimately discovered that the safety, efficacy, population pharmacokinetics, and immunogenicity of MIL60 were similar to those of bevacizumab.
The investigators focused on 517 patients with untreated, advanced or recurrent nonsquamous NSCLC. Participants were randomly assigned 1:1 to receive either 15 mg/kg of MIL60 (n = 257) or bevacizumab (n = 260) every 3 weeks, in combination with carboplatin and paclitaxel. Maintenance treatment with 7.5 mg/kg of single-agent MIL60 was administered until intolerable toxicity or disease progression.
The objective response rates in the MIL60 (48.6%) and bevacizumab (43.1%) groups were similar, yielding an objective response rate ratio of 1.14. The median duration of response in the MIL60 group was 5.7 months, and the bevacizumab group had a median duration of 5.6 months. Although there was a difference in progression-free survival between participants given MIL60 (7.2 months) and bevacizumab (8.1 months), it was not considered to be statistically significant; overall survival differences were also not significant (19.3 vs. 16.3 months).
Tolerability and safety appeared to be similar among both groups. Treatment-emergent adverse events of grade 3 or higher affected 70.3% and 72.6% of patients given MIL60 and bevacizumab, respectively. The frequency of serious adverse events was also observed to be similar, affecting 28.1% of individuals treated with MIL60 and 28.6% of those treated with bevacizumab. Of note, antidrug antibody was not detectable in either group.
Disclosure: The study authors reported no conflicts of interest.
