Balancing Safety and Efficacy: Inotuzumab Ozogamicin Dosage Studies in B-Cell ALL

Overview of Inotuzumab Ozogamicin (InO)

Inotuzumab ozogamicin (InO), also known as BESPONSA (Pfizer), is an FDA-approved medication used to treat relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in adults. InO is an antibody-drug conjugate that works by delivering chemotherapy directly to cancer cells.

Ongoing Research

It is common for the FDA to require additional studies to gather more data on the safety and best use of a medication, even after it has been approved. This research allows the FDA to continue collecting information about a treatment and helps to further understand long-term side effects and optimal dosages for different patient groups.

Following InO's approval in 2017, the FDA required a postmarketing study to determine whether a lower dose of InO (1.2 mg/m² per cycle) would be as effective as the approved dose (1.8 mg/m² per cycle) while reducing side effects.

A Lower Dose of InO Might Be Safer, But Is It as Effective? 

In the study, researchers compared different doses of InO using a clinical utility index—a measurement that balances the benefits and risks of a treatment.  

Data from three clinical studies of InO showed that remission rates varied by dose. Overall, individuals who received higher doses of InO were more likely to achieve remission than those who received lower doses.

Additionally, the study showed that among individuals who achieved remission, the rates of minimal residual disease negativity—the absence of detectable cancer cells—were higher in those who received higher doses.

The study also examined remission rates and the occurrence of veno-occlusive disease (VOD), a serious liver complication that can develop after a hematopoietic stem cell transplantation. For individuals who underwent a stem cell transplant, a lower dose of InO was associated with a lower risk of VOD. However, the lower dose was not as effective in treating ALL as the higher dose.

The Optimal InO Dosage

The results of these studies support the current FDA-approved recommendation of 1.8 mg/m² per cycle as the optimal dose for adults with relapsed or refractory B-cell ALL. A range of factors must be considered when determining the appropriate InO dose for treatment.  Individualizing treatment is essential for ensuring the best outcomes.  The right dose of InO depends on each unique person's health status, prior therapies, and responses to treatment. Patients should work closely with their healthcare providers to monitor for potential side effects and ensure the best treatment strategy is implemented based on their individual needs.

Follow the link below to explore the latest treatment advances for ALL and other blood cancers.

Treatment Advances

Source:

• https://ash.confex.com/ash/2024/webprogram/Paper194244.html