Horizon One Clinical Trial Beats Enrollment Goals, Plans New Treatment Arm

How the Horizon One trial is already delivering on its promise to drive faster progress for relapsed/refractory myeloma patients.

The Multiple Myeloma Research Foundation® (MMRF®) is proud to share that the Horizon One clinical trial has fully enrolled its first treatment arm six months ahead of schedule.

Horizon One is a groundbreaking trial conducted across the MMRF’s Multiple Myeloma Research Consortium® (MMRC®), a network of leading cancer centers conducting early-stage clinical trials and translational studies, to identify the best treatment combinations, sequences, and durations for relapsed and refractory multiple myeloma—with the fewest side effects for patients.

“Patients with relapsed and refractory myeloma have more treatment options than ever before, but determining the right combination, sequence, and duration remains a critical challenge,” said MMRF President and CEO Michael Andreini. “Reaching full enrollment six months ahead of schedule reflects both the urgency of the need and the power of trials designed to move faster and deliver answers to patients and their physicians sooner.”

The trial’s first treatment arm is investigating dosing approaches with Tecvayli® (teclistamab), a bispecific antibody treatment manufactured by Johnson & Johnson. Investigators are studying whether patients can receive Tecvayli less frequently but still have durable responses—or even stop treatment altogether. Less frequent and fixed dosing approaches could not only reduce common and potentially serious side effects such as frequent infections but also the time and financial burdens of weekly injections.

Horizon One uses an innovative adaptive platform design, which allows investigators to test several treatments and generate data and insights faster than they could in a traditional clinical trial. Like other landmark MMRF studies, Horizon investigators are collecting critical data on patients’ tumor biology, immune profiles, and microbiomes.

In addition to enrolling at unprecedented speed, MMRC investigators have worked to enroll a patient population that is far more representative of the disease by race, age, and geography compared with other myeloma trials.

More than 30 percent of patients enrolled in the Horizon One trial so far are Black. About 20 percent of myeloma patients in the U.S. are Black, but historically, this group has only made up about four percent of patients in myeloma trials. Fifty-nine percent of patients enrolled in Horizon One are 71 or older to reflect the fact that the average age of a myeloma diagnosis is 69. This is a stark contrast to most other myeloma trials, which overwhelmingly enroll patients under the age of 65.

Looking ahead, the Horizon One team is working to open a new investigational arm testing a novel bispecific combination by the end of the year.

“This is just the beginning,” said the MMRF’s Chief Medical Officer Hearn Jay Cho, MD, PhD. “As we continue opening new treatment arms, Horizon One will generate the data patients and clinicians need to better understand how to use these therapies—and ultimately improve outcomes.”