ImmunoGen Inc. (IMGN) announced Tuesday that it has completed patient enrollment in the first stage of its NORTH two-stage Phase II trial. The NORTH trial is assessing the Company's IMGN901 product candidate for first-line treatment of extensive disease small-cell lung cancer or SCLC. Attaining this milestone enables the findings from the planned interim analysis of PFS at 6 months to be available in 2H2013.
According to the company, the NORTH trial is designed to assess whether IMGN901 provides a clinically meaningful benefit when used in conjunction with a standard-of-care for this cancer, etoposide plus carboplatin (E/C). Patients with newly diagnosed extensive disease SCLC enrolled in the trial are randomized, two-to-one, to treatment either with IMGN901 plus E/C or with E/C alone.
While the NORTH trial is designed to include a total of 120 patients, its two-stage design specifies that an analysis of PFS at six months is to be performed with the first 39 evaluable patients randomized to the IMGN901 plus E/C treatment arm. Patient enrollment of this cohort of patients - and the corresponding 20 patients in the E/C alone arm - has now been completed. These patients will now be followed for the interim analysis while patient enrollment continues.
The 120-patient NORTH trial is designed to evaluate the efficacy and safety of IMGN901 for first-line treatment of extensive disease SCLC. All patients enrolled are provided with up to six cycles of E/C, standard-of-care for this cancer. Two-thirds of the patients enrolled are randomized to also receive IMGN901. These patients can elect to remain on IMGN901, as monotherapy, after completion of the E/C cycles if benefiting from treatment.
The primary endpoint of the NORTH trial is progression-free survival or PFS. Secondary endpoints include PFS at 6 months, overall survival at 12 months, time to progression, overall survival, and overall response rate.
IMGN901 was developed by ImmunoGen to target and kill CD56-positive cancer cells. CD56 is expressed on virtually all cases of SCLC. It is also expressed on a variety of other cancers including Merkel cell carcinoma and many cases of multiple myeloma.
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