Amgen and Allergan’s Phase III trial of ABP 215 meets primary and secondary endpoints

23rd September 2015 (Last Updated September 23rd, 2015 18:30)

Amgen and Allergan have reported positive results from a Phase III trial that evaluated the efficacy and safety of ABP 215 compared with Avastin (bevacizumab) in adults with advanced non-squamous, non-small cell lung cancer (NSCLC).

Amgen and Allergan have reported positive results from a Phase III trial that evaluated the efficacy and safety of ABP 215 compared with Avastin (bevacizumab) in adults with advanced non-squamous, non-small cell lung cancer (NSCLC).

The results show that the trial of biosimilar candidate ABP 215 met its primary and secondary endpoints.

The data showed that the primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared to bevacizumab, showing clinical equivalence.

The company said that the safety and immunogenicity of ABP 215 were comparable to bevacizumab.

The trial's secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).

A total of 642 NSCLC patients who had received first-line chemotherapy with carboplatin and paclitaxel were included in this randomised, double-blind, active-controlled Phase III trial.

They were randomised to receive investigational product (ABP 215 or bevacizumab) at a dose of 15mg / kg administered as an IV infusion every three weeks (Q3W) for up to six cycles.

"Amgen is committed to bringing high-quality, reliably supplied medicines to patients."

Of the total subjects, 328 patients were randomised to the ABP 215 group and 314 patients to the bevacizumab group.

Amgen Research and Development executive vice-president Sean Harper said: "Amgen is committed to bringing high-quality, reliably supplied medicines to patients and we're excited to leverage our development and manufacturing capabilities in oncology for our biosimilars.

"The positive Phase III results from ABP 215 study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab.

"Non-small cell lung cancer is the leading cause of cancer death in both men and women in the US and the EU. ABP 215 holds the potential to advance access to treatment options for oncology patients."

ABP 215 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, preventing establishment of new blood vessels necessary for the maintenance and growth of solid tumours.

Allergan Global Research and Development president and executive vice-president David Nicholson said: "The positive Phase III clinical results of ABP 215 mark an important step forward in the development of biosimilar treatment options for patients with advanced non-small cell lung cancer.

"Allergan is committed to developing biosimilars that provide safe, high-quality and effective therapies in key disease areas for patients."

Both the firms are collaborating on the development and commercialisation of four oncology biosimilars.

Currently, Amgen has a total of nine biosimilars in development, while Allergan is also independently developing biosimilars.

In December 2011, the companies collaborated to develop and commercialise, on a worldwide basis, four oncology antibody biosimilar medicines.