New England Journal of Medicine publishes outcomes from practice-changing ALC4 clinical trial.

ALC4 (ECOG-ACRIN E1910) final statistical analysis of overall and relapse-free survival is now available in the New England Journal of Medicine. The trial results show a significant survival advantage with blinatumomab immunotherapy for minimal residual disease (MRD)-negative acute lymphoblastic leukemia in adults and contributed to its recent FDA approval for these patients. 

“This randomized phase III study demonstrates a major benefit in terms of survival attributable to the addition of Blinatumomab to standard chemotherapy in this population,” says Dr. Julie Bergeron, ALC4 Canadian study lead and CHUM Head of the hematology laboratory. “With a three-year overall survival in the Blinatumomab group at 85%, this likely represents a new standard of care that we hope to be able to propose to our patients in the near future.” 

B-cell precursor acute lymphoblastic leukemia is an aggressive (fast-growing) type of blood cancer in which too many B-cell lymphoblasts (immature white blood cells) are in the bone marrow and blood. It is a subtype of acute lymphoblastic leukemia, itself a rare disease in adults (American Cancer Society).

Many adults with this type of cancer relapse despite having no MRD detected by sensitive techniques after initial treatment. An MRD test uses tissue collected during a bone marrow biopsy. It looks for any cancer cells that were not killed by the cancer treatment.

After a median follow-up of 43 months, the study found a significant improvement in overall survival for BCR::ABL1-negative B-cell precursor acute lymphoblastic leukemia patients between the ages of 30 and 70 who had achieved an MRD-negative remission and received blinatumomab plus chemotherapy in consolidation compared to chemotherapy alone. Median overall survival was not reached in either treatment arm. The 3-year overall survival rate among patients in the blinatumomab + chemotherapy arm was 85% versus 68% in the chemotherapy-only arm.

Thank you to the six Canadian centres and their patients who participated in the trial: QEII Health Sciences Centre, CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont, Kingston Health Sciences Centre, Allan Blair Cancer Centre, Tom Baker Cancer Centre, Vancouver Coastal Health who was the top accruing site.