Physicians Hall Front

Medical College of Wisconsin Cancer Center Researcher Presents First Results from Phase 3 CARTITUDE-4 Study at ASCO

Findings suggest cilta-cel may be key therapeutic option for patients with multiple myeloma after first relapse

Milwaukee, June 5, 2023 – Medical College of Wisconsin (MCW) cancer researcher Binod Dhakal, MD, presented the first results from the Phase 3 CARTITUDE-4 study today at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting. He compared results of providing standard of care treatment in patients with multiple myeloma who had 1-3 prior lines of therapy and were lenalidomide refractory with results of cilta-cel – a CAR-T therapy, like ide-cel, that binds to B-cell maturation antigen (BCMA) on the surface of myeloma cells.

The findings presented at ASCO were also published today in the New England Journal of Medicine, where Dr. Dhakal serves as co-first author.

“The marked difference between ide-cel and cilta-cel is cilta-cel’s ability to bind to two BCMA sites, as opposed to just one,” said Dr. Dhakal. “This could make the difference for patients who require a second form of therapy.”

The CARTITUDE-4 study is one of only two phase 3 clinical trials of CAR-T therapy for multiple myeloma in early lines of therapy. It’s also the only study, to date, to evaluate CAR-T therapy in patients after one prior line of therapy.

Prognosis for patients with lenalidomide-refractory disease is generally worse than those with lenalidomide-sensitive disease or those who have never previously received lenalidomide (a prescription medicine extensively used as a frontline therapy in adults with multiple myeloma), with median progression-free survival as poor as 12 months.

Alternatively, the findings presented at ASCO show that in a heavily pre-treated, relapsed/refractory population, median progression-free survival with cilta-cel is almost 3 years. The results make cilta-cel the first CAR-T therapy to achieve a significant response for specific subgroups of patients, including those with high-risk disease after the first relapse.

“Since lenalidomide is extensively used as a frontline therapy in myeloma patients, lenalidomide refractoriness early in patient disease course is becoming increasingly common. This rules out the use of lenalidomide-based regimens in subsequent lines. This study is the first of its kind to effectively assess the use of CAR-T therapy as a second line of treatment in patients with progressive disease,” said Dr. Dhakal.

Highlights from study findings:

  • Patients saw significant benefit with CAR-T and a reduced risk of progression or death by approximately 74%.
  • Cilta-cel led to higher rates of overall response (84.6% vs. 67.3% of patients), complete response or better (73.1% vs. 21.8%), and minimal residual disease negativity (60.6% vs. 15.6%) vs. standard of care.
  • The CAR-T related adverse events were manageable with appropriate supportive care.
  • Cilta-cel showed potential to become a key therapeutic option in lenalidomide-refractory myeloma patients after the first relapse.

As with other multiple myeloma treatments, further translation of these clinical trial results will be impacted by factors such as patient selection/fitness, patient heterogeneity, treatment accessibility and treatment setting, and patient or physician preference. However, early results show a strong progression-free survival benefit and rapid and deep response with cilta-cel.

Researchers and oncologists continue following the patients in this study to determine the long-term effects of treatment with cilta-cel in this patient population. Deeper analyses of the CARTITUDE-4 data are ongoing, such as health-related quality of life and biomarker analyses. Subsequent data will be published or presented in due course. Cilta-cel is also being investigated as frontline therapies in the CARTITUDE‑5 (NCT04923893) and CARTITUDE-6 (NCT05257083) studies.

The study is sponsored by Janssen Research & Development, LLC, Legend Biotech USA Inc.

Sixteen countries across the United States, Europe, Asia, and Australia are involved in this clinical trial.

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