On August 23, GlaxoSmithKline announced positive headline results for the DREAMM-2 randomized trial with two doses of GSK2857916 (belantamab mafodotin or “Bela”), an anti-BCMA monoclonal antibody drug conjugate. (View IMF video about belantamab mafodotin, filmed at ASCO 2019.) Exact responses and outcomes were not disclosed, but excellent results were previously reported. Safety and tolerability were acceptable, as noted in the earlier DREAMM-1 exploratory study.
These results mean that plans for submission to receive FDA approval for the drug are on track with filings expected later this year. This is excellent news. Bela is an off-the-shelf monoclonal antibody against the key BCMA myeloma cell target with important efficacy in the relapsed/refractory setting. This contrasts with the CAR T-cell-engineered T-cell approach against BCMA, which is much more cumbersome and expensive. It is therefore very positive to have the potential for the drug’s FDA approval early in 2020.
In other news, oral selinexor clinical trial results were reported in the New England Journal of Medicine. Selinexor was recently approved by the FDA. It was very helpful to have the full results of the phase IIb STORM trial (selinexor + dexamethasone in relapsed/refractory myeloma exposed to all major prior therapies [penta-exposed/triple-class refractory]). A partial response (50% reduction in disease) or better was observed in 26% of patients. The side effects and adverse events were clearly challenging, but enhanced guidelines are available to help manage toxicities.
Additional news released this week with implications for ongoing therapy development for myeloma patients, is the announcement that Celgene has sold Otezla (a psoriasis treatment) to Amgen for $13.4 billion. This clears the way for Bristol-Myers Squibb to fully acquire Celgene, which is expected to occur before the end of 2019. This means that the future development of the CAR T-cell program, including the lead CAR T-product bb2121 (anti-BCMA CAR T-cell-engineered product), will fall to Bristol-Myers Squibb.
Something good in the news: Red wine really can be good for you!
To end with today, it is worth noting a new report from King’s College London, which says that “in moderation” red wine can be healthful by improving the quality of microorganisms in the gastrointestinal system, or, as they say, the “gut.” This is quite important because the intestinal microorganisms can impact many things, from weight to a whole range of inflammatory diseases, diabetes, heart disease, and cancer.
I have mentioned this before in my “Real Food” blogs. However, it is excellent to see new research supporting the health benefits of red wine: as the author's comment, “a little bit now and again!” All in favor, say aye!
Dr. Brian G.M. Durie co-founded and now serves as Chairman of the International Myeloma Foundation and serves on its Scientific Advisory Board. Additionally, he is Chairman of the IMF's International Myeloma Working Group, a consortium of nearly 200 myeloma experts from around the world. Dr. Durie also leads the IMF’s Black Swan Research Initiative®.