AbbVie’s multiple myeloma drug achieves 74% response rate, may enable outpatient treatment

AbbVie’s bispecific T-cell engager antibody etentamig improved response rates and progression-free survival in a phase 3 trial involving patients with relapsed or refractory multiple myeloma.

According to Fierce Biotech on the 3rd local time, AbbVie announced that it had confirmed positive results from the phase 3 trial of etentamig, called Cervino, that day.

The objective response rate was 74% in the etentamig group, substantially higher than the 45.7% in the standard-treatment group. Progression-free survival also improved significantly, with a 60% lower risk of disease progression or death versus standard treatment.

The analysis included 393 patients who had previously received an average of 3 lines of therapy. After a median follow-up of 11.4 months, the 12-month overall survival rate was 87.9% in the etentamig group and 72% in the standard-treatment group. However, the prespecified efficacy threshold for overall survival had not been reached at the data cutoff.

Etentamig is administered with one step-up dose followed by once-monthly dosing. AbbVie said the low rates of cytokine release syndrome (CRS) and fatal infections could enable outpatient and community-based treatment.

Grade 3 or higher infections occurred in 27.7% of patients in the etentamig group and 19.2% of those in the standard-treatment group. Grade 5 infections occurred in 1.5% and 3.1%, respectively. The CRS rate was 28.3%, most cases were grade 1, and no grade 3 or higher cases were reported.

The rate of treatment discontinuation due to treatment-related adverse events was 3.6% in the etentamig group, lower than the 9.6% in the standard-treatment group.

These results came from Cervino’s first planned interim efficacy analysis. Based on the results, the independent data monitoring committee recommended unblinding the trial.

The full results are scheduled to be presented at a plenary session of the International Myeloma Society’s annual meeting, to be held from the 23rd to the 26th in Glasgow, Scotland. AbbVie plans to discuss the results with global regulatory authorities and determine the next steps for etentamig.

Etentamig is a second-generation bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3. In addition to multiple myeloma, AbbVie is developing etentamig for AL amyloidosis, a rare disease caused by abnormal plasma cells.

Dajine Abidoye, AbbVie’s vice president of oncology, solid tumors and hematologic malignancies, told Fierce Biotech, "Our focus has become improving treatments so that patients can not only live longer but also live better."