Elotuzumab/pomalidomide combination elicits responses in relapsed/refractory MM

Elotuzumab was compared with Pomalidomide(Pomalidomide, according to published data from a prospective Phase 2 trial (NCT02718833). ), bortezomib (Velcade), and dexamethasone (elo-PVd) demonstrated efficacy and tolerability in patients with relapsed/refractory multiple myeloma who had progressed on at least one prior therapy.

Efficacy data show that in48 patients who received elo Among patients treated with PVd, the overall response rate (ORR) was 56.3% (95% CI, 42.3%-69.3%), while for those who had received only one prior therapy, the ORR was 73.7% (95% CI, 51.2%-88.2%), and for those who had received two or more therapies, the ORR was 44.8% (95% CI-28.4%-62.3%). In addition, among patients who had received anti-CD38 antibody treatment, the ORR was 35.7% (95% CI, 16.3%-61.3%).

In the overall population, median progression-free survival (PFS) was 10.0 months (95% CI, 7.75-2.1), with a median follow-up of 36.8 months; among those who had received only one prior line of therapy, the median Progression survival was 23.4 months (95% CI, 10.0 - not reached [NR]) compared with 7.75 months (95% CI, 6.54-13.1) for patients who had received two or more lines of therapy. In addition, the median progression-free survival was 5.82 months (95% CI, 2.8-27.9) among patients who had received previous anti-CD38 antibody therapy and 7.69 months (95% CI, 2.83-NR) if they were on the last line of therapy. For high-risk fluorescence in situ hybridization patients, the median PFS was 8.89 months (95% CI, 6.54-NR). The median OS for the entire population was 25.2 months (95% CI, 18.4-NR).

In this phase 2 trial of patients with relapsed/refractory [disease], the elo-PVd combination was found to produce an ORR of 56.3% and a median PFS of 10.0 months. These response rates are noteworthy given the extensive prior treatment history: [33% had previous exposure to pomalidomide, 29% to carfilzomib, and 29% to anti-CD38 antibodies]; 13% of patients were exposed to five drugs (i.e., to these 3 drugs plus lenalidomide and bortezomib). The safety profile of elo-PVd demonstrates that the drugs used in this regimen will produce expected adverse effects.

The trial enrolled patients with relapsed/refractory multiple myeloma who received at least2 cycles of lenalidomide and 2 cycles of a proteasome inhibitor to receive elo-PVd. Patients with prior treatment with pomalidomide or bortezomib were allowed to enroll; prior treatment with elotuzumab was not allowed.

Treated patients received intravenous elotuzumab at 10 mg/kg once weekly for one to two 28-day cycles; every two weeks for cycles 3 to 9, and then 20 mg/kg on day 1 of each cycle thereafter. Patients received additional oral pomalidomide 4 mg on days 1 to 21; and bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15 for cycles 1 to 8; and days 1 and 15 as injections for each cycle thereafter. Administer 28 mg of dexamethasone orally 3 to 24 hours before the elotuzumab infusion, then 8 mg of dexamethasone orally 45 to 90 minutes before the infusion; during weeks without elotuzumab, give 40 mg of dexamethasone weekly.

The study's co-primary endpoints areORR and treatment-related adverse effects (TRAE), assessed according to the Common Terminology Criteria for Adverse Events (CTCAE). The 2 secondary endpoint is PFS.

The most common hematologic adverse events included decreased neutrophil count, anemia, leukopenia, and decreased platelet count. The most common non-hematologic adverse events included fatigue, infection, upper respiratory tract infection, hyperglycemia, diarrhea, and musculoskeletal pain.

A total of2 deaths were attributable to infections during disease progression, namely E. coli bacteremia and pneumonia. No infusion-related reactions were observed with elotuzumab. Three cases of grade 3 rash due to rash occurred but resolved with supportive measures. In addition, three patients experienced treatment-related interruptions, including stroke, pulmonary embolism leading to death, and infection.

Reference materials:https://www.oncnursingnews.com/view/elotuzumab-pvd-combo-elicits-response-in-relapsed-refractory-mm