U.S. Food and Drug Administration (FDA)-Approved Indications

Lunsumio is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Compendial Uses

Mosunetuzumab-axgb is available as Lunsumio (Genentech, Inc.) which is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin GI (IgG1) isotype. Recombinant DNA technology is utilized to produce mosunetuzumab-axgb in Chinese Hamster Ovary (CHO) cells. Mosunetuzumab-axgb binds to the CD3 receptor expressed on the surface of lymphoma cells and certain healthy B-lineage cells. Mosunetuzumab-axgb activated T-cells, in vitro, resulted in the release of proinflammatory cytokines, and induced lysis of B-cells (Genentech, 2022).

According to the prescribing information, Lunsumio carries a black box warning for cytokine release syndrome (CRS), including serious or life-threatening reactions. Initiate treatment with the Lunsumio step-up dosing schedule to reduce the risk of CRS. Withhold Lunsumio until CRS resolves or permanently discontinue based on severity.

Per the prescribing information, Lunsumio carries the following warnings and precautions:

Per the prescribing information, Lunsumio carries the following adverse reactions:

Refer to full prescribing information for Lunsumio for use in specific populations.

On December 22, 2022, the U.S. Food and Drug Administration (FDA) granted approval to mosunetuzumab-axgb (Lunsumio), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The FDA approval for Lunsumio was based on supporting data from the GO29781 study (FDA, 2022).

The GO29781 study was an open-label, single-arm, multicenter, multi-cohort, phase 2 trial, in which Budde and colleagues (2022) evaluated the safety and efficacy of mosunetuzumab-axgb (Lunsumio) in patients with relapsed or refractory follicular lymphoma (FL) who had received at least two prior therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. Patients with active infections, history of autoimmune disease, prior allogeneic transplant, or any history of CNS lymphoma or CNS disorders were excluded from the study. Intravenous Lunsumio infusion was administered in 21-day cycles as step-up doses of 1 mg on cycle 1 day 1 and 2 mg on cycle 1 day 8, followed by 60 mg on cycle 1 day 15, and 60 mg on cycle 2 day 1, then 30 mg every 3 weeks in subsequent cycles. Lunsumio was administered for 8 cycles unless patients experienced unacceptable toxicity or disease progression. Following the 8 cycles, patients with a complete response discontinued therapy, whereas patients with a partial response or stable disease continued treatment up to 17 cycles, unless patients experienced an unacceptable toxicity or disease progression. The primary efficacy endpoint measures were objective response rate (ORR) and duration of response (DOR) assessed by an independent review facility according to standard criteria for non-Hodgkin's lymphoma (Cheson, et al., 2007). The evaluable efficacy population consisted of 90 patients with relapsed or refractory FL. The ORR was 80% (95% confidence interval [CI]: 70, 88), with 60% achieving complete responses. The median follow-up was 14.9 months among responders with the estimated median duration of response (DOR) of 22.8 months (95% CI: 10, not reached) and the estimated DOR rate at 12 months and 18 months as 62% and 57%, respectively. Of the 218 patients with hematologic malignancies who received Lunsumio at the recommended dose, cytokine release syndrome (CRS) occurred in 39% of patients, neurologic toxicity in 39% of patients (including immune effector cell-associated neurotoxicity syndrome [ICANS] in 1%), serious infections in 17%, and tumor flare in 4%. With regard to CRS, grade 2 occurred in 15%, grade 3 in 2%, and grade 4 in 0.5% (FDA, 2022; Genentech, 2022).

: Requires Precertification:

Precertification of mosunetuzumab-axgb (Lunsumio) is required of all Aetna participating providers and members in applicable plan designs. For precertification of mosunetuzumab-axgb (Lunsumio),

Criteria for Initial Approval

Follicular Lymphoma

Aetna considers all other indications as experimental and investigational.

Continuation of Therapy

Aetna considers continuation of mosunetuzumab-axgb (Lunsumio) therapy medically necessary in members requesting reauthorization for an indication listed in Section I when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Dosage and Administration

Mosunetuzumab-axgb is supplied as Lunsumio 1mg/mL solution in a single-dose vial and 30 mg/30 mL (1 mg/mL) solution in a single-dose vial injections for intravenous infusion only.

Follicular Lymphoma

The recommended dosage for Lunsumio is as follows:

The rate of administration for cycle 1 is over a minimum of 4 hours. The rate of administration for cycles 2 and cycles 3 and beyond is over 2 hours if infusions from cycle 1 were well-tolerated. Administer Lunsumio for 8 cycles, unless individuals experience unacceptable toxicity or disease progression. No further treatment beyond 8 cycles is required for individuals who achieve a complete response. In individuals who achieve a partial response or have stable disease in response to treatment with Lunsumio after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless an individual experiences unacceptable toxicity or disease progression.

Refer to full prescribing information for Lunsumio for preparation and administration instructions, step-up dosing schedule to reduce the risk of cytokine release syndrome (CRS), and dosage modifications for adverse reactions.

Source: Genentech, 2022