Bevacizumab Biosimilar Shows Clinical Equivalence in Advanced NSCLC

HD204 (Vasforda), a biosimilar for bevacizumab (Avastin), demonstrated clinical equivalence with the reference agent regarding overall response rate (ORR) among patients with advanced nonsquamous non–small cell lung cancer (NSCLC), according to a press release on data from the phase 3 SAMSON-II trial (NCT03390686).¹

At 18 weeks, the ORR was 48.7% with HD204 and 46.5% with reference bevacizumab, fulfilling the trial’s prespecified equivalence margin (risk ratio [RR], 1.047; 95% CI, 0.86-1.27). The estimated risk difference was 0.022 (95% CI, –0.07 to 0.11).

Data showed comparable ORRs between the treatment arms at 12 weeks. Additionally, progression-free survival (PFS) and overall survival (OS) outcomes were comparable between treatment arms, as investigators reported no statistically significant differences.

The safety profile of HD204 was comparable with prior reports of bevacizumab. Investigators noted treatment-related adverse effects (TRAEs) in 33.9% of patients who received HD204 and 34.4% of those who received reference bevacizumab. Furthermore, 5.2% and 8.3% of patients experienced treatment-related serious AEs. Overall, there were no new or unexpected safety signals in the trial.

“These results illustrate the increasing precision with which biosimilarity can be established through advanced analytical and clinical [pharmacokinetic] studies. Our experience with HD204 supports the view that well-designed development programs can reliably anticipate clinical performance, enabling more focused and efficient biosimilar development,” Lisa Park, PhD, chief executive officer at Prestige Biopharma, the developer of HD204, stated in the press release.¹ “By reducing unnecessary clinical burden, such advances can accelerate patient access to high-quality biologic medicines and support more sustainable healthcare systems worldwide.”

According to the press release, outcomes from the SAMSON-II trial are similar to previous analytical and pharmacokinetic equivalence observed between HD204 and reference bevacizumab. Developers plan to advance regulatory pathways for HD204 based on their analytical and pharmacokinetic programs for HD204. Additionally, they look to share detailed findings from SAMSON-II to contribute to a global scientific experience in evaluating biosimilars.

Investigators of the double-blind SAMSON-II trial compared the efficacy, safety, pharmacokinetics, and immunogenicity of HD204 with reference bevacizumab to establish equivalence between the therapies.² Patients were randomly assigned to receive HD204 or reference bevacizumab at 15 mg/kg intravenously every 3 weeks on day 1 in combination with chemotherapy. All patients received carboplatin area under the curve 6 intravenously every 3 weeks on day 1 for 4 to 6 cycles plus paclitaxel at 200 mg/m² intravenously every 3 weeks on day 1 for 4 to 6 cycles.

The trial’s primary end point was ORR at 18 weeks per RECIST v1.1 criteria as assessed by central independent review. Secondary end points included duration of response, PFS, OS, change in tumor burden from baseline, incidence of TRAEs per CTCAE v5.0 guidelines, immunogenicity, and pharmacokinetics.

Investigators conducted the study at 18 locations, which included sites in Belarus, Bulgaria, Croatia, Georgia, Greece, Hungary, and India.

Patients 18 years and older with histologically confirmed metastatic or recurrent nonsquamous NSCLC, at least 1 measurable lesion per RECIST v1.1 guidelines, and adequate laboratory and clinical parameters were eligible for enrollment on the trial. An ECOG performance status of 0 or 1 was an additional requirement for study entry.

Those with small cell carcinoma of the lung or squamous cell carcinoma, sensitizing EGFR mutations or ALK rearrangements, or an increased risk of bleeding based on radiographic or clinical observations were ineligible for study entry. Having a history of systemic frontline chemotherapy for metastatic or recurrent NSCLC was also grounds for exclusion from the trial.

References

1. Prestige Biopharma announces positive topline results from comparative SAMSON-II study for HD204, a potential biosimilar to Avastin (bevacizumab). News release. Prestige Biopharma. March 24, 2026. Accessed March 25, 2026. https://tinyurl.com/483y2vjw
2. A trial to compare the efficacy, safety, pharmacokinetics and immunogenicity of HD204 to Avastin® in advanced non-squamous non-small cell lung cancer patients. ClinicalTrials.gov. Updated May 31, 2025. Accessed March 25, 2026. https://tinyurl.com/39uszvax