September 4, 2019

Impact: High

  • GSK has announced that the pivotal phase 2 DREAMM-2 trial (NCT03525678) of belantamab mafodotin has met the primary endpoint of ORR.
  • 196 relapsed multiple myeloma patients who were refractory to an immunomodulatory drug, a PI and an anti-CD38 antibody were enrolled.
  • Safety and tolerability are reportedly consistent with what was observed in the DREAMM-1 trial.
  • Data will be submitted for presentation at an upcoming scientific meeting and be used to support regulatory filings later this year.

inThought Analysis

This announcement brings belantamab mafodotin one step closer to becoming the first BCMA-targeted agent to reach the market. With a filing planned by the end of this year, we are expecting an approval by 2Q20 in the U.S. and 4Q20 in the EU. Recall that belantamab mafodotin has Breakthrough Therapy and PRIME designations in the U.S. and EU, respectively, which will likely streamline the review process.

Experts have a positive outlook on efficacy data for belantamab mafodotin and this off-the-shelf approach. However, ocular toxicity remains to be an important concern and could limit the long-term potential of this treatment. GSK will continue to use a wide range of analyses to support that this adversity is manageable and reversible.

Even though GSK will likely have first-mover advantage, its footprint in multiple myeloma and oncology is small. With an aggressive clinical development program is in the works, including pivotal trials in earlier lines of therapy slated to open over the next year, the company hopes to use this approval as a way to make up ground in MM and oncology as a whole.

Source: GSK Press Release

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