Treatment with a single infusion of the novel CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) induced early and deep responses in a group of patients with relapsed/refractory multiple myeloma, according to results of a phase 2 study.

The findings, which were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated that a single-infusion of the CAR-T cell therapy resulted in an overall response rate (which includes a partial response or better) of 95% with a stringent complete response rate of 75%, and a very good partial response rate or better of 85%.

Cilta-cel, formerly JNJ-68284528, is a second-generation CAR-T cell therapy with two BCMA-targeting, single-domain antibodies designed to confer avidity. Previous data that were published from the phase 1b/2 CARTITUDE-1 trial demonstrated that single infusion of cilta-cel was associated with deep and durable response among heavily pretreated patients with relapsed/refractory disease.

Measuring minimal residual disease negativity, or the small number of cancer cells in the body after cancer treatment, was the main goal of the study. Other goals included assessing overall response rate, duration of response, as well as time and duration of minimal residual disease negativity and incidence and severity of side effects.

The study comprised 20 patients (median age, 60 years; 65% men) who were either refractory to treatment with the chemotherapy lenalidomide or relapsed after one to three prior lines of treatment. One of the patients was treated in an outpatient setting.

Twelve of the patients had received fewer than three lines of prior therapy, and the remaining individuals received three prior lines of therapy.

All the patients had been previously treated with a proteasome inhibitor, an immunomodulatory drug and the steroid dexamethasone. Almost all (95%) of the patients were exposed to alkylating agents, and 65% received treatment with Darzalex (daratumumab).

As of the data cutoff of January 2021, four evaluable patients achieved minimal residual disease negativity.

Blood-related side effects that occurred in 20% or more of the patients included neutropenia (95%), thrombocytopenia (80%), anemia (65%), lymphopenia (60%) and leukopenia (55%). Moreover, cytokine release syndrome (which involves the cytokines overstimulating the immune system so that it attacks healthy organs) occurred in 85% of patients, of which 10% were considered serious or severe.

The safety profile was manageable, including in the one patient that was treated in the outpatient setting, said study author Dr. Mounzer E. Agha, director of the Mario Lemieux Center for Blood Cancers and clinical director of Hematopoietic Stem Cell Transplantation at the UPMC Hillman Cancer Center in Pittsburgh, during a recorded presentation of the data. There were no cases of movement and neurocognitive adverse effects.

Agha noted that one death occurred 100 days after the infusion of cilta-cel due to COVID-19 infection and was assessed as treatment-related by the investigators.

Early and deep responses were observed with a single infusion of cilta-cel in lenalidomide refractory patients with multiple myeloma, who received one-to three prior lines of therapy, he concluded.

The CAR-T cell therapy is being evaluated in other cohorts of the CARTITUDE-2 in earlier line settings, as well as in the phase 3 CARTITUDE-4 study in patients with one to three prior lines of therapy.

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Novel CAR-T Cell Therapy Produces Early and Deep Responses in Certain Patients with Multiple Myeloma - Curetoday.com