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  5. Drug Trials Snapshot: LUNSUMIO
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Drug Trials Snapshot: LUNSUMIO

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

Follicular lymphoma is a type of blood cancer.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the LUNSUMIO Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

LUNSUMIO (mosunetuzumab-axgb)
(lun-SUM-mee-oh)
Genentech, Inc.
Original Approval date
: December 22, 2022


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

LUNSUMIO is a drug used to treat adult patients with follicular lymphoma (FL) who have received at least two prior treatments that did not work or are no longer working.

Follicular lymphoma is a type of blood cancer.

How is this drug used?

LUNSUMIO is given through a vein weekly during the first cycle up to a dose of 60 mg (i.e., 1 mg, 2 mg, then 60 mg). The same dose, 60 mg, is repeated on the first day of the second cycle, then patients receive 30 mg during cycle 3 and during subsequent cycles every 21 days. LUNSUMIO is administered for a total of 8 cycles unless patients develop progressive lymphoma or unacceptable toxicity. After 8 cycles, patients with a complete response in whom all signs of cancer disappear can discontinue therapy. Patients with a partial response or stable disease in whom there is residual lymphoma can continue treatment up to 17 cycles as long as they have no evidence of progressive lymphoma or unacceptable toxicity.

Who participated in the clinical trials?

The FDA approved LUNSUMIO based on evidence from a clinical trial (Study GO29781) that included 90 adults with relapsed or refractory follicular lymphoma who received at least two prior treatments for follicular lymphoma that did not work or was no longer working.

Trials were conducted at 40 sites in 7 countries that included Australia, Canada, Germany, South Korea, Spain, United Kingdom, and the United States.

How were the trials designed?

The benefit and side effects of LUNSUMIO were evaluated in Study GO29781, a clinical trial which enrolled 90 patients with follicular lymphoma who had received at least two prior therapies that did not work or were no longer working. Patients received increasing doses of LUNSUMIO through a vein weekly during the first cycle up to a dose of 60 mg. Patients received a single 60 mg dose of LUNSUMIO in Cycle 2, and a single 30 mg dose of LUNSUMIO 21 days later in Cycle 3 and during subsequent cycles every 21 days (i.e., 1 mg, 2 mg, 60 mg, then 30 mg dose schedule). For patients whose lymphoma disappeared by Cycle 8, treatment was stopped as long as they did not develop an unacceptable side effect. For patients with residual lymphoma whose disease did not disappear, patients continued treatment through Cycle 17 as long as they had no evidence of growing disease or unacceptable toxicity. The benefit of LUNSUMIO was evaluated by measuring how many patients had complete or partial tumor shrinkage (response) and by how long that response lasted.

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were enrolled in the clinical trial used to evaluate the safety and efficacy of LUNSUMIO.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 55 (61%) male patients and 35 (39%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the safety and efficacy of LUNSUMIO.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, American Indian or Alaska Native, and unknown patients were in the clinical trial. In total, 74 (82%) White patients, 4 (5%) Black or African American patients, 8 (9%) Asian patients, 1 (1%) American Indian or Alaska Native patient, and 3 (3%) patients with unknown race participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the safety and efficacy of LUNSUMIO.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 60 (67%) patients younger than 65 years of age and 30 (33%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In a clinical trial with 90 patients with follicular lymphoma, 80% of patients had a complete or partial shrinkage of their tumors (response).

LUNSUMIO was approved under the FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: LUNSUMIO worked similarly in males and females.
  • Race: The number of patients of races other than White was small; therefore, differences in how well the drug worked among races could not be determined because of the small number of patients in other races.
  • Age: LUNSUMIO worked similarly among patients younger and older than 65 years of age.

What are the possible side effects?

LUNSUMIO may cause serious side effects including an acute systemic inflammatory syndrome called cytokine release syndrome (characterized by fever, nausea, headache, rash, rapid heartbeat, low blood pressure, low oxygen levels, and trouble breathing), neurologic problems, serious infections, low blood cell counts, and growth in your tumor or worsening of tumor-related problems (tumor flare).

The most common side effects of LUNSUMIO include cytokine release syndrome, fatigue, rash, fever, and headache.

Were there any differences in side effects among sex, race, and age?

  • Sex: The occurrence of side effects was generally similar in males and females. However, cytokine release syndrome was reported more frequently in males whereas fatigue, rash, and headache were reported more frequently in females.
  • Race: The number of patients of races other than White was small; Therefore, differences in the occurrence of side effects among races could not be determined.
  • Age: The occurrence of side effects was generally similar in patients younger than 65 years of age and 65 years of age and older. However, cytokine release syndrome was reported more frequently in patients younger than 65 years of age as compared to patients 65 years of age and older.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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