Targeted immunotherapy combination offers hope to older adults with leukemia

Researchers from the Alliance for Clinical Trials in Oncology have found that two targeted immunotherapy drugs lead to high remission rates and long survival with reasonable side effects for older patients with a tough-to-treat form of leukemia.

The results of Alliance A041703 Cohort 1, published in the Journal of Clinical Oncology, focused on treating patients aged 60 years and older with newly diagnosed B-cell acute lymphoblastic leukemia (ALL) with immunotherapy medications inotuzumab ozogamicin and blinatumomab. Historically, this group has faced poor outcomes with traditional chemotherapy due to high rates of treatment-related death and relapse.

“Our study shows that targeted immunotherapy is an excellent treatment option for older patients with acute lymphoblastic leukemia,” said Alliance study chair and lead author Matthew Wieduwilt, MD, PhD, Professor of Cancer Medicine at Wake Forest University School of Medicine. “This is a major step forward as we were able to effectively treat the leukemia without conventional chemotherapy, which is often too toxic for older adults.”

What the Study Found

• Who was treated: 33 patients, ages 60 to 84 years, with a specific type of leukemia (CD22-positive, Philadelphia chromosome-negative B-cell ALL).
• How they were treated: Patients received up to two cycles of inotuzumab ozogamicin, followed by four or five cycles of blinatumomab. Inotuzumab ozogamicin and blinatumomab are targeted immunotherapy cancer drugs. They work by finding leukemia cells in the body and targeting certain proteins on them, leading to the death of those cells, sparing healthy cells.
• Results:
  • 97% of patients went into remission.
  • 75% were alive and free of relapse one year after treatment.
  • 85% were still alive at one-year follow-up.

These results are significantly better than historical outcomes for this population. The treatment was generally well tolerated by participants, and more than half of them completed the full course of therapy.

The study also included patients who had previously been treated for other cancers, such as multiple myeloma or breast cancer. These individuals responded just as well to the new regimen, suggesting it could be a good option even for those with complex medical histories.

“Conventional systemic chemotherapy has long been the only option for treating Ph-negative ALL, but it can often be too toxic for older adults. This new approach of targeted immunotherapy may be a more effective approach while simultaneously being less toxic and taxing on the patient,” said Dr. Wieduwilt. “While more research in larger studies is needed to confirm these results, our study showcases how targeted therapies based on a patient’s specific cancer markers can effectively treat leukemia.”

Alliance A041703 study is being conducted by the Alliance for Clinical Trials in Oncology and supported by the National Cancer Institute (NCI) through the National Clinical Trials Network. This study is also supported by research grants from Pfizer and Amgen.

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References: Alliance A041703/NCT03739814: Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

Journal of Clinical Oncology: Inotuzumab Ozogamicin Then Blinatumomab for Older Adults With Newly Diagnosed B-Cell ALL: Alliance Study A041703 Cohort 1 Results

The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 25,000 cancer specialists at 115 main institutions and 1,400 affiliates across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Our work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and our growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years. Learn more at www.AllianceforClinicalTrialsinOncology.org.