GlaxoSmithKline targets regulatory filings by year end for anti-BCMA drug GSK2857916 in multiple myeloma

GlaxoSmithKline on Thursday unveiled updated results from the DREAMM-1 study confirming that the anti-BCMA antibody-drug conjugate GSK2857916 was associated with an overall response rate (ORR) of 60 percent in patients with relapsed or refractory multiple myeloma. Results from the study were initially released in 2017, with the new data showing that the median progression-free survival (PFS) was 12 months, an increase from the previously reported 7.9 months. GlaxoSmithKline's chief scientific officer Hal Barron stated "we are aggressively advancing this potential new medicine and plan to have pivotal data to support its filing by the end of this year."  

In Part 2 of the DREAMM-1 study, the results of which were also published in the Blood Cancer Journal, 35 patients with relapsed or refractory multiple myeloma were enrolled independent of their BCMA expression levels. The primary endpoint was safety, while secondary endpoints included response rates, pharmacokinetics and immunogenicity. 

GlaxoSmithKline noted that the median duration of response in the final analysis was 14.3 months, adding that among heavily pre-treated patients who were not previously treated with Johnson & Johnson's Darzalex (daratumumab), the ORR was 71 percent, while the median PFS was 15.7 months.  

Meanwhile, among Darzalex-experienced patients, the drugmaker said the ORR and median PFS were 38.5 percent and 7.9 months, respectively. GlaxoSmithKline noted that no new safety signals were observed in the study.  

In 2017, GSK2857916 was granted breakthrough therapy status by the FDA for the treatment of multiple myeloma in patients who received at least three prior lines of therapy. The treatment was also awarded PRIME designation by the European Medicines Agency for the same indication. 

For related analysis, see ViewPoints: Bristol-Myers Squibb, GlaxoSmithKline primed for potential multiple myeloma show down. See also, Key takeaways from GlaxoSmithKline's Q4 earnings and investor call, as well as ViewPoints: AbbVie enters bi-specific BCMA race.





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