Dangerous Side Effects Prompts FDA to Suspend Unum Therapeutics’ Cancer Drug Trial

Shares of Unum Therapeutics were on a downward turn this week after the Food and Drug Administration suspended a trial of one of the company’s cancer drugs on Tuesday.

The FDA suspended the trial of cancer drug ACTR087, after a patient had experienced serious side effects which included Grade 3 neurotoxicity and cytomegalovirus (CMV) infection, and Grade 4 respiratory distress. The Phase 1 trial now has a “clinical hold” on it.

ACTR087 is being tested in patients with a form of non-Hodgkin lymphoma, and had been at the front of Unum’s pipeline. The Phase 1 trial is evaluating ACTR087 in combination with rituximab following lymphodepleting chemotherapy with fludarabine and cyclophosphamide in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL).

The biotech company only went public last year and has no products in the market yet.

Shares of the stock dropped as much as 23% on the news.

Phase I trial (ATTCK-20-2) is evaluating Unum’s ACTR087 in combination with rituximab following lymphodepleting chemotherapy with fludarabine and cyclophosphamide in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL).

The FDA has agreed that patients who previously received ACTR087 and have ongoing clinical responses may continue to receive rituximab infusions, with continued monitoring for adverse events.

Unum has plans to report data from the ATTCK-20-2 trial at the end of the year.

Disclaimer: We have no position in Unum Therapeutics Inc. (NASDAQ: UMRX) and have not been compensated for this article.