Roche added to the hold group by FDA for combo immunotherapy trials

The FDA has been working to ensure that all immunotherapy trials studying PD-1/L1 agents, together with immunomodulatory medicines in certain blood cancers have been placed on full or partial hold.

The FDA works to lock down certain immunotherapy trials being placed on full or partial hold.

Roche’s Tecentriq lately joined this group, with a partial hold being placed on its trials examining the drug in combination with Celgene’s Revlimid or Pomalyst for multiple myeloma and follicular lymphoma.

The move by the FDA fits the pattern, as it signalled a strong stance after analysts noted a higher rate of deaths in MSD’s Keytruda trial into multiple myeloma. Since then, partial holds have been placed on MSD’s drug that began the lockdown, followed by BMS’s Opdivo, AstraZeneca’s Imfinzi and now Roche’s Tecentriq.

"It is our understanding that the FDA is evaluating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in combination with an immunomodulatory medicine to determine if it is a class-wide (anti-PD1/PDL1) concern in multiple myeloma/blood cancers or a specific concern with certain combinations with immunomodulatory medicines", Roche released in a statement.

The two trials effected are Phase 1b and a Phase 1b/2 study into relapsed/refractory multiple myeloma and relapsed refractory follicular lymphoma, respectively. The trials are still on-going but will not be able to enrol further patients whilst the partial hold is in place.

The holds across the immunotherapy board is the first real sign of cause for concern in the wider area of PD-1/L1, as the science behind the therapies’ success is not yet fully understood. No data has yet been revealed to fully explain why the higher rate of death was noted or whether it has been experienced in other trials placed on hold.

The FDA explained that it has decided to broaden the holds across the board: "The FDA will take appropriate action as warranted to ensure patients enrolled in these trials are protected and that doctors and clinical trial researchers understand the risks associated with this investigational use".