US biotech firm ImmunoGen (Nasdaq: IMGN) will stop the IMGN901 Phase II small cell lung cancer (SCLC) study, following the recommendation of the trial's independent Data Monitoring Committee (DMC). Shares of Immunogen dropped $3.50, or 21%, to $13.05 in morning trading after the news.
Based on analysis of available data, the DMC concluded that the addition of IMGN901 to etoposide/carboplatin (E/C) was unlikely to demonstrate a sufficient improvement in progression-free survival compared to E/C alone to justify continuation of the trial. As an imbalance in the rate of infection and infection-related deaths was noted between the arms, the DMC recommended that all patients discontinue IMGN901 treatment. Infection-related death is a recognized risk in SCLC trials, including trials with E/C. Among the 198 patients receiving IMGN901 as a single agent in early trials, there was one incidence of infection-related death; it was deemed “possibly drug related.”
Charles Morris, ImmunoGen executive vice president and chief development officer, said: “This is clearly a disappointing outcome, as there is a tremendous need for new treatment options for SCLC. We will be analyzing the findings to date in this trial as part of assessing potential next steps for IMGN901.”
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