Thread by @VincentRK

Re Belantamab withdrawal from market. @GSKUS #Myeloma

An unfortunate casualty of:

1) Wrong dose and schedule
2) Wrong trial design for phase III — going against an active control is high risk.
3) Wrong price at launch — drained support from MDs

I don’t know why we push the dose to the max. Clinical benefit is efficacy and safety. Efficacy is not enough. Safety is critical. And anything to do with eye is not going to be treated lightly by regulators.

It is getting complicated to find the right control arm in myeloma. Building an experimental arm that can go with low risk against an active treatment is not easy.

This is FOCUS trial repeated again. Unfortunate.

The drug performed really well in the DREAMM-3 trial in efficacy. But fell short in safety. And matched but could not beat a really good drug used as control. I led first phase II of pomalidomide. This is a good drug and not easy to beat.

In real life we are not trying to decide whether to use Pomalidomide or belantamab. But rather what to do when pomalidomide based regimens stop working. A response rate and response duration seen with belantamab would be a good option to have. But we won’t. At least for a while.

Other BCMA based therapies approved now - the two CART products and teclistamab are easier said than done in reality. They are hard to secure except for the well connected.

Belantamab would have bought precious time for patients with no other option.

There are lessons to be learnt for companies. Don’t be misled into to MTD type dosing. Safety is critical. Talk to lot more investigators about the trial design. Don’t go with what you like to hear. The truth is what matters. Price your drugs reasonably.