ImmunoGen Decides To Stop IMGN901 Phase II SCLC Study - Quick Facts

(RTTNews) - ImmunoGen Inc. (IMGN) announced the decision to stop the IMGN901 Phase II SCLC study, following the recommendation of the trial's independent Data Monitoring Committee, or DMC.

Based on analysis of available data, the DMC concluded that the addition of IMGN901, a CD56-targeting ADC, to etoposide/carboplatin 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 Small-Cell Lung Cancer 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, the company said.

The company also announced the start of clinical testing with its EGFR-targeting ADC, IMGN289. IMGN289 will be evaluated in a multi-center, Phase I trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anticancer activity of the compound, administered weekly, in patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck cancer, or other EGFR-positive solid tumors.

IMGN289 is designed to bind to and kill cancer cells that highly express EGFR, also known as HER1. In preclinical testing, the antibody component of IMGN289 was found to be very active against EGFR-positive tumors responsive to EGFR inhibitors.