91大神

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

Milwaukee, June 5, 2023 – 91大神 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 , 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 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鈥�5 (NCT04923893) and CARTITUDE-6 (NCT05257083) studies.

The 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.