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Background
Aviscumine, a recombinant plant protein, inactivates the 28S rRNA (“ribotoxic stress”)
after endocytosis. In this way cytokine release and T-cell responses are enhanced.
This phase II trial was conducted to test the efficacy and safety of aviscumine in
pts with systemically pre-treated metastatic melanoma stage IV.
Methods
32 pts with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
were enrolled onto a single-arm, multi-centre, open-label, phase II trial. Pts received
350 ng aviscumine twice weekly by subcutaneous (SC) injection until progression. Primary
end points were progression-free survival (PFS) and overall survival (OS). Safety
was assessed as adverse events (AEs). Tumor response was assessed every eight weeks
and survival of patients was followed up to one year after the end of therapy. 31
pts (ITT population) were assessed for efficacy; safety was assessed in the whole
population.
Results
One pt achieved a partial response (PR) and 10 pts showed stable disease (SD). The
median progression-free survival (mPFS) was 63 days (95% confidence interval (CI) 57–85) and median overall survival (mOS) was 335 days (95% CI 210–604). Grade 1 or 2 AEs occurred in 72% of pts and were mostly application-site
effects such as pruritus Grade 3–4 treatment-emergent drug-related adverse events
occurred in 9% of pts.
Conclusion
These results suggest that aviscumine may have a clinical impact in patients with
previously treated metastatic melanoma and provide rationale for further clinical
evaluation. In the light of effective new immune checkpoint blockers it might be a
candidate for combinations with these agents.
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