ImmunoGen, Inc. announced the initiation of a randomized Phase 1/2 clinical trial to evaluate its proprietary product candidate, IMGN901 (lorvotuzumab mertansine), for first-line treatment of small-cell lung cancer (SCLC) in patients with extensive disease.

“We believe IMGN901 has the potential to be an important treatment for SCLC, particularly as part of a combination regimen,” commented James O’Leary, MD, vice president and chief medical officer. “IMGN901 has been found to be well tolerated and to demonstrate evidence of activity when used as a single agent to treat this highly aggressive cancer. The tolerability profile of IMGN901 supports evaluating it in combination with other active agents and, in preclinical testing, it has shown highly compelling activity used together with these same therapies.”

This multi-national trial will evaluate IMGN901 used together with carboplatin plus etoposide (C/E)—standard care for first-line treatment of SCLC—versus C/E alone. In the dose escalation Phase I portion of the trial, increasing doses of IMGN901 will be administered with C/E to establish the maximum tolerated dose of the study compound with C/E. In the Phase II portion, patients will be randomized to receive C/E plus IMGN901 (60 patients) or C/E alone (30 patients). 

IMGN901 will be administered weekly for two weeks in a three-week cycle, and C/E will be dosed on the standard three-week schedule. Patients can receive up to six cycles of C/E, consistent with established usage, but those randomized to also receive IMGN901 will be allowed to remain on the study drug alone as long as they continue to benefit from it.

The primary endpoint of this trial is progression-free survival (PFS). Secondary endpoints include PFS at 6 months, overall survival at 12 months, time to progression, overall survival and overall response rate.

Date: November 30, 2010
Source: ImmunoGen, Inc.