(NASDAQ: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced 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 (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.
“Achieving timely enrollment of patients with small-cell lung cancer is known to be challenging, and we believe our attainment of this milestone on schedule speaks to both the clinical need for new therapies for SCLC and our increasing strength as a development company,” commented James O’Leary, MD, Vice President and Chief Medical Officer. “When available, we intend to use the findings from the interim analysis to make decisions related to the development of IMGN901. We also plan to submit them for presentation at a medical conference.”
ImmunoGen’s NORTH Trial
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.