ImmunoGen has stopped the IMGN901 Phase II SCLC study. The decision is based on the recommendation of the trial’s independent Data Monitoring Committee (DMC). Following the discontinuation of the trial, ImmunoGen is in the process of updating study investigators and regulatory authorities. IMGN901 is a CD56-targeting ADC.
Based on analysis of available data, an independent Data Monitoring Committee (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.
In the past 18 months, ImmunoGen has initiated clinical testing with three wholly owned ADC compounds including IMGN853 for ovarian, endometrial, and other cancers that highly express folate receptor α such as IMGN529 for non-Hodgkin lymphoma; and IMGN289 for lung, head and neck, and other cancers that highly express EGFR. Seven other ADCs with ImmunoGen technology are in the clinic through partnerships, the most advanced of which is the marketed product (ado-trastuzumab emtansine (Kadcyla®; Genentech/Roche).