Bevacizumab Biosimilar Demonstrated Similar Efficacy, Safety as Reference Product Among Patients With Metastatic Colorectal Cancer

Bevacizumab-awwb, a bevacizumab biosimilar, was found to be effective and well-tolerated in the first-line setting among patients with metastatic colorectal cancer who either initiated on the biosimilar, or switched from the reference bevacizumab to the biosimilar.

Previously, in the MAPLE trial, this bevacizumab biosimilar demonstrated similar efficacy, safety, and immunogenicity to the reference product among patients with non-small cell lung cancer. Later, this biosimilar was granted FDA approval for the same indications as the reference product.

There were a total of 134 patients with metastatic colorectal cancer included in this study, 129 of which were treatment-naïve patients, who were initiated on biosimilar bevacizumab, and 105 who initiated on the reference bevacizumab and switched to the biosimilar. All of the naïve patients and 96.2% of the switch patients were treated with the biosimilar in combination with chemotherapies, the 2 most common regimens being fluorouracil, leucovorin, and oxaliplatin  (FOLFOX) and fluorouracil, leucovorin, and irinotecan (FOLFIRI).

The median follow-up duration of naïve patients was 10.7 months, and 15.8 months for switch patients. In naïve patients, the median duration of treatment with bevacizumab in the first line was 5.1 months. In the switch patients, the median duration of treatment with the reference product was 4.4 months, followed by a median duration of treatment with the biosimilar of 4.4 months. The median PFS and OS estimated for the naïve patients were 8.6 months and 17.3 months, respectively. The median PFS and OS estimated for the switch patients were 14.1 months and 25.9 months, respectively. The 12-month OS probability of the naïve patients was 71.4%, compared to 87.6% in the switch patients. The overall number of adverse events was 18 in the naïve patients and 4 in the switch patients. None of the adverse events recorded on study resulted in death.

The study authors concluded, “In this real-world cohort of [metastatic colorectal cancer] patients who were treated [in the first line] with a bevacizumab biosimilar (bevacizumab-awwb), the clinical effectiveness and tolerability data were as expected and consistent with previously published findings from real-world studies of the bevacizumab [reference product] in [metastatic colorectal cancer] patients.”

Source:

Jin R, Ogbomo AS, Accortt NA, et al. Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb). Ther Adv Med Oncol. Published on June 21, 2023. doi:10.1177/17588359231182386