Adnkronos (Adnkronos) – New long-term data on Johnson & Johnson's CAR-T therapy ciltacabtagene-autoleucel, or cilta-cel, from the initial subgroup of cohort A of the phase 2 Cartitude-2 study (N=20) were presented at the International Myeloma Society (IMS) Congress. Follow-up results, according to a company statement, show that 50 percent of patients (10 out of 20) with relapsed or refractory multiple myeloma treated with a single infusion of CAR-T remained alive without disease progression for at least five years without any maintenance therapy. “Until five years ago, treatment-free remissions of this duration were difficult to imagine for patients with relapsed or refractory multiple myeloma,” said Niels van de Donk, MD, PhD, Professor of Hematology, University Medical Center, Amsterdam.
These new results for cilta-cel provide further evidence that when therapies best suited to a patient's characteristics are used early in the disease, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance therapy."
These results – it is stated – increase the evidence observed in the previous Cartitude-1 study, which evaluated patients in more advanced therapeutic lines, in terms of durable and treatment-free remission, and confirm, albeit in a limited number of patients, that early treatment with cilta-cel can increase long-term remission and disease control.
“These results strengthen the evidence supporting the efficacy of cilta-cel and demonstrate the importance of bringing these therapies to patients just starting their treatment journey,” continued Yusri Elsayed, MD, MHSc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “As we continue to develop a portfolio of complementary and combinable therapies, these results reinforce our commitment to redefining what patients can expect from the treatment of multiple myeloma.”
“Although outcomes for patients with multiple myeloma have improved significantly in recent years, achieving durable remission is more challenging in relapsed or refractory forms of the disease, where the disease can become more difficult to control,” comments Ester in 't Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson.
Cohort A of the Cartitude-2 study (N=20) – the note details – enrolled patients with relapsed or refractory multiple myeloma (RRMM) who had received one to three prior lines of therapy, had been exposed to a proteasome inhibitor, and were refractory to lenalidomide.
The primary endpoint was minimal residual disease (MRD) negativity. Patients in the initial cohort A were followed for five years in the follow-up study to evaluate long-term outcomes after a single infusion of cilta-cel without maintenance therapy. At a median follow-up of 60,7 months, half of the patients (n=10, 50%) who received a single infusion of cilta-cel without maintenance therapy remained alive and free of disease progression at five years. The five-year overall survival rate was 69,2%, while the median progression-free survival was 60,5 months.
At five years, “MRD was assessed by bone marrow analysis in three patients without being required by the protocol. All three patients were MRD-negative at the deepest level tested (10-6), indicating the absence of detectable disease even with the use of highly sensitive tests. Furthermore, long-term remissions were observed even among patients with high-risk disease features. Of the 10 patients who were progression-free at five years, five had at least one high-risk cytogenetic abnormality, including four patients with two or more high-risk features.”
The safety profile observed with longer follow-up – the statement concludes – was consistent with the known safety profile of cilta-cel, with no new CAR-T cell-related neurotoxicities reported. Since the previous follow-up, one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to disease progression and a new tumor.
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