Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Interesting JAMA article on the Evomela/melphalan-ASCT front.

From the JAMA article

Key Points
Question - What is the role of autologous stem cell transplantation in patients with multiple myeloma in the context of use of novel agents?

Findings - In this systematic review and meta-analysis, this modality (including tandem transplantation or single-transplant followed by consolidation with bortezomib, lenalidomide, and dexamethasone) when compared with standard-dose therapy was associated with superior progression-free survival. None of the transplant-based approaches were associated with improved overall survival.

Meaning - Autologous stem cell transplantation remains the preferred therapy in transplant-eligible patients with multiple myeloma.
(https://jamanetwork.com/journals/jamaoncology/article-abstract/2667738?redirect=true)

A review by Medpage Today summarizes it as follows

• Note that this meta-analysis of four phase III randomized trials found good evidence that high-dose melphalan plus autologous bone marrow transplant is superior to conventional dosing in terms of progression-free survival.
• The survival benefit seemed to increase over time, suggesting that some initial toxicity may mask the true benefit of this approach.

This paper was authored by the Medical College of Wisconsin and includes Dr Hari who presented the Evomela data back on Analysts Day in March 2015. Dr. Hari finished a high dose PK study last year (200 mg/m2 dosed once vs 100 mg/m2 on 2 consecutive days as per the label). I thought they’d release the results at ASH but they never did. Not a biggie as far as studies go (but they do call it a Phase 2 even though it’s just PK endponts) but that would help in marketing the drug since it’s dosed both ways in practice (i.e 200 once vs 100 on 2 consecutive days).