Biotech Values

[DewDiligence]

GSK reports 31% ORR for anti-BCMA ADC in MM—BLA has been submitted:

https://www.prnewswire.com/news-releases/pivotal-dreamm-2-study-demonstrated-a-clinically-meaningful-overall-response-rate-with-belantamab-mafodotin-gsk2857916-for-patients-with-relapsedrefractory-multiple-myeloma-300975664.html

GlaxoSmithKline…today announced treatment with the investigational single-agent belantamab mafodotin… Full results from the DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study of belantamab mafodotin were published today in The Lancet Oncology. GSK also confirmed submission of a Biologics License Application to the US Food and Drug Administration (FDA) seeking approval of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

…Thirty of the 97 patients (31%) in the 2.5 mg/kg cohort achieved an overall response. Of these responders, 18 patients achieved a very good partial response or better, including three patients with stringent complete or complete responses [i.e. CR=3%]. …overall survival in patients achieving a response was not reached in the six month follow-up period.

…The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin. The three most commonly reported Grade 3 or 4 adverse events in the 2.5 mg/kg arm were keratopathy (27%), thrombocytopenia (20%) and anaemia (20%).

So, GSK’s belantamab mafodotin will likely be the first anti-BCMA drug to reach the US market, but we can’t say it will necessarily become the preferred agent with this MoA.