Oncology immunotherapy options have greatly expanded recently, and it is important for oncology nurses to understand what the therapies are, how they work, and who should be receiving them. Rowena Schwartz, PharmD, BCOP, the vice president of clinical content and services at McKesson Specialty Health, discussed the latest treatment information during a session at the 41st Annual Congress in San Antonio, TX.
Elotuzumab is a humanized immunoglobulin G1 immunostimulatory monoclonal antibody that is approved in combination with lenalidomide and dexamethasone for patients with multiple myeloma (MM) who have received one to three prior therapies. The drug targets signaling lymphocytic activation molecular F7, a glycoprotein expressed on myeloma and NK cells, that directly activates NK cells and mediates antibody-dependent cellular cytotoxicity through the CD16 pathway.
Elotuzumab was approved following the results of the phase III, open-label ELOQUENT-2 trial that compared elotuzumab plus lenalidomide and dexamethasone (ELd; n = 321) to lenalidomide and dexamethasone (Ld; n = 325) alone.
The study found that those treated with ELd had a longer median progression-free survival (PFS; 19.4 months) compared with those treated with Ld (14.9 months; hazard ratio [HR] = 0.57–0.85; P<.001). The one-year PFS rate was 68% and 57%, respectively, and the two-year PFS rate was 41% and 27%, respectively. Patients receiving ELd also had a greater overall response rate (ORR; 79%) compared with the Ld cohort (66%; p < 0.001).
Elotuzumab was administered via an IV infusion over 60 minutes through separate lines. Infusion reactions occurred in 10% of patients, of which the majority were grade 1 or 2.
The most common any-grade adverse events associated with ELd and Ld treatment included lymphopenia (99% versus 98%, respectively), anemia (96% versus 95%, respectively), thrombocytopenia (84% versus 78%, respectively), neutropenia (82% versus 89%, respectively), and fatigue (47% versus 39%, respectively).
Ixazomib, a proteasome inhibitor (PI), is approved in combination with lenalidomide and dexamethasone for patients with MM who have received at least one prior therapy. The drug should be administered one hour before or two hours after food consumption. It should not be crushed, chewed, or opened. If a dose of ixazomib is missed, it should not be taken within 72 hours of the next scheduled dose. The recommended dose of ixazomib is 4 mg orally on days one, eight, and 15 of each 28-day cycle.
Ixazomib was approved based on the results of the phase III TOURMLINE-MM1 study that compared ixazomib in plus lenalidomide and dexamethasone (ILd; n = 360) to lenalidomide and dexamethasone alone (Ld; n = 360) in patients with relapsed/refractory MM.
The study found that those treated with ILd reached a PFS of 20.6 months compared with 14.7 months in the Ld cohort (HR = 0.742; p = 0.012). The ORR was 78.3% for ILd compared with 71.5 months for Ld (odds ratio = 1.44; P = 0.035). The median duration of response was 20.5 months and 15 months, respectively.
Some of the any-grade toxicities associated with the ILd and Ld cohorts included upper respiratory infection (19% versus 14%, respectively), peripheral neuropathy (28% versus 21%, respectively), diarrhea (42% versus 36%, respectively), constipation (34% versus 25%, respectively), nausea (26% versus 21%, respectively) , and vomiting (22% versus 11%, respectively).
Daratumumab is approved as a single agent for the treatment of patients with myeloma who have received more than three prior lines of therapy, including a PI and an immunomodulatory agent, or those who are double-refractory to both of these agents.
The drug has been studied in two clinical trials. An open-label trial studied daratumumab monotherapy in patients with relapsed or refractory myeloma, while an open-label, dose-escalation study examined daratumumab monotherapy in patients with relapsed or refractory myeloma who had received at least two different cytoreduction therapies.
Common any-grade adverse events include lymphopenia (72%), neutropenia (60%), thrombocytopenia (48%), infusion reaction (48%), and anemia (45%). Infusion reactions are more likely to occur in the first infusion (46%) than in subsequent infusions (5%).
See Table 1 for all of the oncology drug approvals in 2015.
Schwartz, R. (2016). Immunotherapy: Nibs and mabs. Session presented at the ONS 41st Annual Congress, San Antonio, TX, April 29, 2015.