ImmunoGen (IMGN) Completes Enrollment in NORTH Phase II
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ImmunoGen, Inc. (Nasdaq: IMGN) 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 (SCLC). Attaining this milestone enables the findings from the planned interim analysis of PFS at 6 months to be available in 2H2013.
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.
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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.
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