Carvykti delays myeloma symptom worsening, per Phase 3 trial data
New findings show 'significant clinical benefits' of approved cell therapy
The cell therapy Carvykti (ciltacabtagene autoleucel) — approved earlier this year as a second-line treatment for people with multiple myeloma — was shown to delay symptom worsening and maintain life quality for myeloma patients in a Phase 3 clinical trial.
That’s according to new data presented at the American Society of Hematology (ASH) annual meeting, which showed that, at 2.5 years after the start of treatment, more than 75% of patients given Carvykti had not experienced symptom worsening, compared with fewer than 65% of those on standard of care.
The researchers say these findings, based on data from an earlier clinical trial, “support [the] significant clinical benefits” seen with Carvykti treatment in myeloma patients.
The presentation, titled “Long-Term Benefits in Patient-Reported Outcomes and Time to Next Anti-Myeloma Therapy of Ciltacabtagene Autoleucel (Cilta-cel) Versus Standard of Care for Patients with Lenalidomide-Refractory Multiple Myeloma: Results from the Phase 3 Cartitude-4 Clinical Trial,” was made at the ASH meeting, held Dec. 7-10 in San Diego.
Phase 3 trial data show Carvykti also helps maintain quality of life
Carvykti is a CAR T-cell therapy, a type of immunotherapy that uses the body’s own immune system to target cancer cells. Codeveloped by Legend Biotech and Janssen, now Johnson & Johnson Innovative Medicine, it works by collecting T-cells — a type of immune cell — from patients, engineering them with a receptor that directs them to attack myeloma cells, and then infusing the modified cells back into the patient to go after the cancer.
The therapy is authorized in the U.S. as a second-line treatment for multiple myeloma.
That authorization was based mainly on data from a Phase 3 study called CARTITUDE-4 (NCT04181827) that involved more than 400 myeloma patients. All participants had previously received one to three prior lines of therapy, including treatment with an immunomodulatory agent and a proteasome inhibitor, and their disease did not respond to Revlimid (lenalidomide).
In that study, about half of the patients received treatment with Carvykti, while the rest received standard of care myeloma treatments — specifically, either a combination of Pomalyst (pomalidomide), Velcade (bortezomib), and dexamethasone, or a combo of Darzalex (daratumumab), Pomalyst, and dexamethasone.
Previously reported study data showed that individuals given Carvykti had a significantly lower risk of death compared with patients given standard of care. To further investigate the impact of the cell therapy, the researchers now assessed how Carvykti treatment affected scores on standardized measurements of symptom severity and quality of life.
The team looked at two standardized measurements: the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q), which assesses symptom severity and the impact of myeloma on day-to-day life, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which evaluates quality of life.
Scores on the MySIm-Q showed that, after 30 months (2.5 years) of follow-up, 77% of patients given Carvykti didn’t have any worsening of symptoms. That compared with 63% of patients on standard-of-care. Similarly, 83% of patients given Carvykti showed no worsening in function, compared with 69% of patients on standard of care.
With [nearly] 3 years of follow-up, a single infusion of [Carvykti] provided patients with a longer delay in worsening of [multiple myeloma] related symptoms, functional impacts, and [life quality]. … The totality of clinical and patient-reported evidence demonstrates the significant benefit of [Carvykti].
Likewise, scores on the EORTC QLQ-C30 showed significant benefits with Carvykti versus standard of care: After 30 months, 79% of patients on the cell therapy had no worsening in life quality scores, compared with 66% of standard of care patients.
The analysis also showed that the time to the start of another myeloma treatment or death was significantly longer, by about 66%, in patients given Carvykti.
“Importantly, with [nearly] 3 years of follow-up, a single infusion of [Carvykti] provided patients with a longer delay in worsening of [multiple myeloma] related symptoms, functional impacts, and [life quality],” the researchers concluded. “The totality of clinical and patient-reported evidence demonstrates the significant benefit of [Carvykti].”
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