Legend Biotech Seeks Expanded Use for Cilta-cel in Lenalidoimide-Refractory Multiple Myeloma

Legend Biotech has submitted a supplemental biologics license application for ciltacabtagene ciloleucel (cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.¹

“This submission brings us one step closer to potentially helping more patients facing relapsed and refractory multiple myeloma, as we continue to explore the potential of CARVYKTI® in earlier lines of treatment,” Ying Huang, PhD, chief executive officer, Legend Biotech, said in a statement.¹ “The prospect of bringing this vital treatment option to more patients excites us, and we remain committed to working with the US FDA and our partner, Janssen, to help patients with multiple myeloma around the world.”

Cilta-cel, a BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy, is currently approved under the name Carvykti for the treatment of adult patients with relapsed or refractory MM, after 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

WATCH NOW: Binod Dhakal, MD, on Assessing Cilta-Cel in Lenalidomide-Refractory Multiple Myeloma

The new submission is supported by data from the CARTITUDE-4 trial (NCT04181827), a phase 3, randomized, open-label study in patients who received one to three prior lines of therapy evaluating cilta-cel compared with standard of care (SOC). The most recent data from CARTITUDE-4 were presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, held June 2-6, in Chicago, Illinois, by Binod Dhakal, MD, associate professor, Medical College of Wisconsin.²

The new data demonstrated that cilta-ce lyielded higher rates of progression-free survival (PFS) compared with SOC in patients with MM. Patients in the cilta-cel arm had a 12-month PFS rate of 76% compared with 49% in the SOC arm. In the intent-to-treat population, cilta-cel yielded an 84.6% overall response rate compared with 67.3% with SOC and an 84.7% (95% CI, 78.1-89.4) 12-month duration of response (DOR) rate compared with a 63.0% DOR rate.²

“New data from the study werecompared to SOC and cilta-cel has been shown to provide some very efficacious responses with a manageable safety profile in patients who are lenalidomide-refractory. The PFS benefit was seen in all high-risk subgroups,” Dhakal told CGTLive.“ Cilta-celled to deep and durable responses compared to SOC and use ofcilta-celin early lines improved tolerability than when used in later lines. So, all this data suggests that in patients who are lenalidomide-refractory after the first relapse, this can be a new SOC option.”

REFERENCES

1. Legend Biotech announces submission of supplemental application to the U.S. FDA for expanded use of CARVYKTI® (ciltacabtagene autoleucel). News release. Legend Biotech. June 6, 2023. https://www.businesswire.com/news/home/20230606005760/en/Legend-Biotech-Announces-Submission-of-Supplemental-Application-to-the-U.S.-FDA-for-Expanded-Use-of-CARVYKTI%C2%AE-ciltacabtagene-autoleucel
2. Dhakal B, Yong K, Harrison SJ, et al. First phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma. Presented at: ASCO 2023 Annual Meeting; June 2-6; Chicago, Illinois. Abstract #LBA106