Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat

 Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Istodax, a Celgene drug first approved way back in 2009, earned its accelerated approval in PTCL, a form of non-Hodgkin lymphoma, in 2011, but it took nearly a decade for the confirmatory results to gestate. At ASH 2020, Bristol Myers rolled out data showing Istodax couldn’t benefit clinical outcomes when added to a regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

So late in its life, Istodax is a micro-earner for Bristol Myers so pulling one of its two indications won’t make much of a difference in terms of the drugmaker’s topline. But the results are notable as part of an industrywide reckoning for cancer drugs that earn the FDA’s accelerated nod and eventually flop confirmatory studies.

Just last week, Bristol Myers pulled its US indication for checkpoint inhibitor Opdivo as a monotherapy for hepatocellular carcinoma in patients previously treated with sorafenib after an FDA Oncologic Drugs Advisory Committee recommended pulling the nod.

Opdivo won an accelerated approval as a second-line treatment for HCC back in 2017, becoming the first immunotherapy to get OK’d for this indication. But two years later, a confirmatory study didn’t meet statistical significance in its primary endpoint of overall survival. Last March, the drug landed another, separate accelerated approval in combination with Yervoy for the same setting.

Opdivo in monotherapy HCC was one of two indications ODAC voted against out of a six-indication review. The other indication receiving a no-vote was Merck’s Keytruda as a third-line treatment for stomach cancer, which Merck opted to withdraw earlier in July.

https://endpts.com/bristol-myers-pulls-lymphoma-indication-for-istodax-after-confirmatory-trial-falls-flat/