LeukemiaNewsworthyWeb Exclusives

Quizartinib Significantly Improves Survival Over Chemotherapy in Patients with Relapsed/Refractory AML and FLT3-ITD Mutation

This is the first treatment that targets patients with AML and the FLT3-ITD mutation. In this clinical trial, patients who received quizartinib lived longer without disease progression than those receiving chemotherapy.

Web Exclusives – May 11, 2018

New results from the international, randomized, phase 3 clinical trial QuANTUM-R show that the targeted drug quizartinib, an oral, selective FLT3 inhibitor, significantly extended overall survival compared with chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) and the FLT3-ITD mutation, the most common FLT3 gene mutation, affecting approximately 25% of patients with AML. These results from QuANTUM-R make quizartinib the first FLT3 inhibitor to demonstrate such improvement over chemotherapy in this patient population.

“Single agent quizartinib is the first FLT3 inhibitor to show a significant improvement in overall survival compared to cytotoxic chemotherapy in a randomized phase 3 study of patients with relapsed/refractory AML with FLT3-ITD mutations, a very aggressive form of the disease with limited treatment options,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, in a press release from the company.

Treatment options for patients with relapsed or refractory AML and the FLT3-ITD mutation are limited, and no therapy targeting the FLT3-ITD mutation has yet been approved by the US Food and Drug Administration (FDA). Patients with AML and this mutation have a poor prognosis, characterized by increased risk for relapse and death, as well as an increased risk for relapse after hematopoietic stem-cell transplant (HSCT) compared with patients who do not have this mutation.

In QuANTUM-R, 367 patients with relapsed or refractory AML and the FLT3-ITD mutation who had received standard first-line therapy, with or without HSCT, were randomized in a 2:1 ratio to quizartinib or to salvage chemotherapy. Quizartinib met the study’s primary end point, which was whether quizartinib monotherapy extended overall survival compared with salvage chemotherapy. In addition, the study results demonstrated that the safety of quizartinib was consistent with that observed at similar doses in an ongoing comprehensive development program for the drug, which includes the QuANTUM-First trial, and a variety of combination trials.

The FDA granted quizartinib an orphan drug designation for the treatment of patients with AML, as well as a fast track status for relapsed or refractory AML. Based on these new results from QuANTUM-R, Daiichi Sankyo will start the global regulatory submissions for quizartinib in the setting of AML with FLT3-ITD mutation.

Recommended For You
MelanomaSlideshowsWeb Exclusives
Skin Cancer Awareness Month
May is Skin Cancer Awareness Month! View this slideshow to learn the latest statistics in the United States, leading causes and preventive measures, and quick facts on melanoma, one of the most common types of skin cancer. Conquer cancer with knowledge.
LeukemiaPatient Stories
Lessons in Love and Resurrection: My Journey Through Leukemia
By Shaun Willson
Shaun Willson’s story is one of daring independence and strength, as he championed through an acute myeloid leukemia diagnosis while also being the primary caregiver to his wife, Deborah, during her battle with metastatic cancer.
Breast CancerNewsworthy
Living Beyond Breast Cancer to Host 12th Annual National Metastatic Breast Cancer Conference in Philadelphia, April 20-22
Hundreds of people with metastatic breast cancer and their caregivers from across the country will attend the 2018 Conference on Metastatic Breast Cancer in Philadelphia on April 20–22, 2018, hosted by Living Beyond Breast Cancer.
Breast CancerNewsworthyWeb Exclusives
Breaking News: Sellas Announces Promising Data on NeuVax in Combination with Herceptin in HER2 1+/2+ Breast Cancer
NeuVax + Herceptin may provide a clinically meaningful benefit to breast cancer patients with low to intermediate HER2-expression.
Last modified: May 14, 2018

Subscribe to CONQUER: the patient voice® magazine

Receive timely cancer news & updates, patient stories, and more.