ImmunoGen Inc. has initiated Phase 2 testing of its IMGN901 product candidate for first-line treatment of small cell lung cancer (SCLC). The assessment, known as the NORTH trial, is designed to evaluate whether the addition of IMGN901 to standard first-line care for SCLC meaningfully impacts duration of progression-free survival (PFS). With SCLC, the efficacy of first-line treatment is considered to be particularly important due to the low likelihood of obtaining a marked, sustained response with any subsequent treatment.
“Our experience with IMGN901 to date—preclinical and clinical—supports Phase 2 evaluation of IMGN901 for first-line use in SCLC,” commented James O’Leary, MD, vice president and chief medical officer. “SCLC almost universally expresses the CD56 antigen targeted by IMGN901, and there is a clear need for more effective treatments for this cancer. We have a number of clinical sites already open for patient enrollment, with many additional sites on track to open over the next month.”
The trial is designed to include 120 patients (80 in the IMGN901 plus C/E arm and 40 in the C/E alone arm). It utilizes a Simon Two-Stage Design. Once the specified number of patients has been enrolled (39 in the IMGN901 plus C/E arm; 20 in the C/E alone arm), these patient cohorts will be followed to establish whether the treatment arm that includes IMGN901 met the pre-defined hurdle for success, which is based on PFS at 6 months compared to historic controls. Success on this interim analysis will serve as a basis for certain development decisions by the company.
The primary endpoint of the trial is PFS. Secondary endpoints include PFS at 6 months, overall survival at 12 months, time to progression, overall survival, and overall response rate. The trial is designed to compare these findings to historic controls, with its control arm serving to verify consistency with historical results.
IMGN901 is designed to target and kill CD56-expressing cancer cells. It is wholly owned by ImmunoGen and consists of the Company’s CD56-targeting antibody with its proprietary DM1 cancer-cell killing agent attached using one of its engineered linkers. IMGN901 has been granted orphan drug designation for SCLC in the United States and in Europe.
Release date: March 30, 2012
Source: ImmunoGen, Inc.
Filed Under: Drug Discovery