ImmunoGen has started Phase II of a study designed to evaluate the safety and efficacy of its IMGN901 (lorvotuzumab mertansine) product candidate, used for first-line treatment of small-cell lung cancer (SCLC).
IMGN901 targets and kills CD56-expressing cancer cells, and has been granted orphan drug designation for SCLC in the US and in Europe.
The Phase II NORTH trial will assess whether the addition of IMGN901 to standard first-line care for SCLC impacts the duration of progression-free survival (PFS) in patients.
In the trial, all patients with cancer will be randomised to receive standard care for up to six cycles of carboplatin plus etoposide (C/E), and two thirds will receive IMGN901 in addition to C/E.
The primary endpoint of the study is PFS, while secondary endpoints include PFS at six months, overall survival at 12 months, time to progression, overall survival, and overall response rate.
The NORTH trial is the Phase II portion of a Phase I/II trial. The completed Phase I portion was designed to establish the dose of IMGN901 to be used in the Phase II assessment.
ImmunoGen vice president and chief medical officer James O’Leary said the company’s experience with IMGN901 to date, preclinical and clinical, supports Phase II evaluation of IMGN901 for first-line use in SCLC.
"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," O’Leary added.
ImmunoGen develops targeted anticancer therapeutics using the company’s expertise in tumour biology, monoclonal antibodies, cancer-cell killing agents and engineered linkers.
Image: Histopathologic image of small cell carcinoma of the lung. Photo: KGH.