# Half of myeloma patients given one CAR-T infusion after an early relapse were progression-free five years on - Published: 2026-11-11 - Author: [Healthcare News](https://healthcarenews.io/author/healthcarenews-io.md) - Topics: [News](https://healthcarenews.io/news.md) - About: [Legend Biotech](https://legendbiotech.com/), [CARVYKTI (ciltacabtagene autoleucel)](https://www.fda.gov/vaccines-blood-biologics/carvykti) - Based on: [Legend Biotech Reports Third Quarter 2026 Results and Recent Highlights](https://www.globenewswire.com/news-release/2026/11/10/3399316/0/en/legend-biotech-reports-third-quarter-2026-results-and-recent-highlights.html), GlobeNewswire, 2026-11-10 - Based on: [Cancer Stat Facts: Myeloma](https://seer.cancer.gov/statfacts/html/mulmy.html), National Cancer Institute SEER Program - Based on: [CARVYKTI](https://www.fda.gov/vaccines-blood-biologics/carvykti), U.S. Food and Drug Administration - Based on: [CARTITUDE-2 (NCT04133636)](https://clinicaltrials.gov/study/NCT04133636), ClinicalTrials.gov - Based on: [Legend Biotech](https://legendbiotech.com/), Legend Biotech - Source: https://healthcarenews.io/news/car-t-first-relapse-myeloma-five-year-results/ - Publication: Healthcare News - Publisher: Connectively (Terkel, Inc.) - Editorial policy: https://healthcarenews.io/editorial-policy/ - AI use: Connectively's automated system wrote this article with AI from a press release issued by Legend Biotech on November 10, 2026, linked under Sources. Statements about the company and its products are the company's. The illustration was generated with AI. The article was assembled and published automatically, without an editor's review. Report errors to corrections@connectively.us. Legend Biotech said on November 10, 2026, that half of 20 multiple myeloma patients treated with one CARVYKTI infusion after one to three earlier therapies were alive and progression-free five years on. The data cover CAR-T at first relapse or soon after, the point where updated NCCN guidelines now say every patient should be referred to a T-cell therapy center. ## Key points - Legend Biotech says 10 of the 20 patients in Cohort A of the CARTITUDE-2 trial remained alive and progression-free, with no further myeloma treatment, five years or more after a single CARVYKTI infusion. - The company says median progression-free survival in that cohort was 60.5 months, and 69.2% of patients were alive at five years. - According to the release, updated NCCN Guidelines recommend referring all multiple myeloma patients to a center able to give T-cell therapy at first relapse. - About 36,000 Americans are expected to be diagnosed with myeloma in 2026, and five-year relative survival for the disease is 63.7%, according to the [National Cancer Institute's SEER program](https://seer.cancer.gov/statfacts/html/mulmy.html). ## What did the five-year CAR-T data at first relapse show? Half of the patients treated early were still free of progression five years after one infusion, Legend Biotech reports. Cohort A of [CARTITUDE-2](https://clinicaltrials.gov/study/NCT04133636), a Phase 2 study sponsored by Janssen, enrolled people whose myeloma had relapsed or stopped responding after one to three prior lines of treatment. The results, with a median follow-up of 60.7 months, were presented at the International Myeloma Society's annual meeting in September. The company says the safety profile seen over the longer follow-up matched what was already known for CARVYKTI, with no new CAR-T-related neurotoxicity. It places the result beside five-year CARTITUDE-1 data from the 2025 ASCO meeting, where 32 of 97 more heavily pretreated patients (33%) stayed progression-free for five years or more. | Trial group | Prior lines of therapy | Patients | Progression-free at 5+ years | |---|---|---|---| | CARTITUDE-2 Cohort A | 1 to 3 | 20 | 10 (50%) | | CARTITUDE-1 | More heavily pretreated | 97 | 32 (33%) | > "Five-year CARTITUDE-2 Cohort A data added to the growing body of long-term evidence supporting the curative potential of CARVYKTI, especially in earlier-line multiple myeloma, demonstrating that half of the 20 patients remained alive and progression-free after a single infusion." > > — Ingrid Zhang, Chief Executive Officer, Legend Biotech ## What do the updated NCCN guidelines say about CAR-T referral? They recommend that every multiple myeloma patient be sent to a T-cell therapy capable center at first relapse to weigh the options there, as Legend Biotech summarises them. The company says the guidelines also state that when both BCMA-directed CAR-T and T-cell engagers are viable, current data favour CAR-T, and that patients planning BCMA CAR-T should have as little prior BCMA-directed therapy as possible. Our analysis: for patients and the doctors who treat them in the community, the referral timing is the practical change. The [FDA label](https://www.fda.gov/vaccines-blood-biologics/carvykti) already covers CARVYKTI for adults who have had at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose disease is refractory to lenalidomide. A referral at first relapse puts the conversation about CAR-T at the stage where Legend's five-year early-line data sits, rather than after several more treatments. ## What is LB2501, Legend's in vivo CAR-T? LB2501 is an investigational therapy designed, Legend Biotech says, to produce CAR-T cells inside the patient's own body after one intravenous infusion. The company says the FDA cleared its investigational new drug application for relapsed or refractory B-cell cancers, including B-cell non-Hodgkin lymphoma, and that it targets two markers, CD19 and CD20. It calls LB2501 the first known dual-targeting in vivo CAR-T to receive that clearance, and says early data shown at the European Hematology Association in June 2026 support a planned Phase I/II trial in the U.S. ## Frequently asked questions ### Who can be treated with CARVYKTI in the U.S.? Under its [FDA-approved indication](https://www.fda.gov/vaccines-blood-biologics/carvykti), adults with relapsed or refractory multiple myeloma who have had at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose disease is refractory to lenalidomide. ### How many infusions of CARVYKTI does a patient receive? One. Legend Biotech describes CARVYKTI as a one-time treatment, and the five-year CARTITUDE-2 results it reports followed a single infusion. ### Where is CARVYKTI available? Legend Biotech says CARVYKTI is offered at 373 treatment sites in 20 markets worldwide. It develops and markets the therapy with Johnson & Johnson. ### How long were the CARTITUDE-2 Cohort A patients followed? Median follow-up was 60.7 months, about five years, according to Legend Biotech. The company's previous analysis of the cohort came at a median of roughly 30 months. ### Where is Legend Biotech listed? Its shares trade on the Nasdaq under the ticker LEGN. ## Sources - [Legend Biotech Reports Third Quarter 2026 Results and Recent Highlights](https://www.globenewswire.com/news-release/2026/11/10/3399316/0/en/legend-biotech-reports-third-quarter-2026-results-and-recent-highlights.html): press release from Legend Biotech via GlobeNewswire, 10 November 2026. - [Cancer Stat Facts: Myeloma](https://seer.cancer.gov/statfacts/html/mulmy.html): incidence and survival figures from the National Cancer Institute's SEER program. - [CARVYKTI](https://www.fda.gov/vaccines-blood-biologics/carvykti): the U.S. Food and Drug Administration's product page, with the approved indication. - [CARTITUDE-2 (NCT04133636)](https://clinicaltrials.gov/study/NCT04133636): the trial's record on ClinicalTrials.gov. - [Legend Biotech](https://legendbiotech.com/): the company's website.