Drug Trials Snapshot: UNLOXCYT
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.
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 UNLOXCYT 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).
UNLOXCYT (cosibelimab-ipdl)
(un-LOX-sit)
Checkpoint Therapeutics, Inc.
Approval date: December 13, 2024
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
UNLOXCYT is a monoclonal antibody for the treatment of one type of skin cancer called cutaneous squamous cell carcinoma (CSCC). It is approved to treat patients whose cancer has spread through the body (metastatic) or is locally advanced and who cannot have radiation or surgery to remove all the cancer.
How is this drug used?
UNLOXCYT is an injection. It is given by a healthcare professional directly into the vein (an intravenous infusion) over 60 minutes every 3 weeks.
Who participated in the clinical trials?
The FDA approved UNLOXCYT based on the safety and efficacy from one clinical trial that enrolled 78 patients with metastatic CSCC and 31 patients with locally advanced CSCC who were available to evaluate tumor response to treatment and 141 patients who received at least one dose of UNLOXCYT in the safety population. The trial was conducted at 34 clinical trial sites in Australia/New Zealand, Europe, South Africa, and Asia.
How were the trials designed?
The benefits and side effects of UNLOXCYT were evaluated in one clinical trial in patients with locally advanced or metastatic CSCC.
Patients received UNLOXCYT intravenously at doses of 800 mg every 2 weeks (n=174), 1,200 mg every 3 weeks (n=35), or other doses (n=14). Patients were treated until the disease worsened, unacceptable side effects, or completion of planned treatment.
The trial measured the proportion of patients who experienced partial shrinkage or complete disappearance (overall response rate [ORR]) of their tumors while receiving UNLOXCYT.
How were the trials designed?
The benefit of UNLOXCYT was evaluated in 109 patients in one open-label, single-arm clinical trial, including 78 patients with metastatic CSCC and 31 patients with locally advanced CSCC. The safety of UNLOXCYT was evaluated in the 141 patients with advanced CSCC including patients with metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation.
The benefit of UNLOXCYT was determined by measuring the amount of tumor shrinkage or disappearance (overall response rate [ORR]) as well as how long the tumor response lasted (duration of response [DOR]) as determined by blinded central review according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with locally advanced CSCC whose tumors were not visible through radiologic imaging, digital photography was used to assess response based on World Health Organization criteria.
The efficacy population (n=109) consisted of enrolled patients with CSCC who had received ≥ 1 dose of UNLOXCYT and had ≥ 1 on-study tumor response imaging assessment. The safety population (n=141) was consisted of all enrolled patients who received ≥ 1 dose of UNLOXCYT.
Refer to UNLOXCYT Prescribing Information.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes the percentage of patients by sex in the safety population.
Figure 1. Baseline Demographics by Sex, Safety Population
Source: Adapted from FDA Review
Figure 2 summarizes the percentage of patients by race in the safety population.
Figure 2. Baseline Demographics by Race, Safety Population
Source: Adapted from FDA Review
Figure 3 summarizes the percentage of patients by age in the safety population.
Figure 3. Baseline Demographics by Age, Safety Population
Source: Adapted from FDA Review
Figure 4 summarizes the percentage of patients by ethnicity in the safety population.
Figure 4. Baseline Demographics by Ethnicity, Safety Population
Source: Adapted from FDA Review
Who participated in the trials?
TABLE 1. Baseline Demographics of by Age, Race, Sex, and Ethnicity, Safety Population
| Parameter | Metastatic CSCC (N=104) | Locally Advanced CSCC (N=37) | All Advanced CSCC (N=141) |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 71.5 (12.5) | 77.0 (8.3) | 72.9 (11.7) |
| Median | 72.4 | 76.1 | 74.6 |
| Min, Max | 37, 94 | 51, 95 | 37, 95 |
| Age Group, n (%) | |||
| < 65 years | 27 (26.0) | 2 (5.4) | 29 (20.6) |
| ≥ 65 years | 77 (74.0) | 35 (94.6) | 112 (79.4) |
| Sex, n (%) | |||
| Female | 23 (22.1) | 13 (35.1) | 36 (25.5) |
| Male | 81 (77.9) | 24 (64.9) | 105 (74.5) |
| Race, n (%) | |||
| White | 88 (84.6) | 27 (73.0) | 115 (81.6) |
| Asian | 6 (5.8) | 0 | 6 (4.3) |
| Black or African American | 1 (1.0) | 0 | 1 (0.7) |
| Other | 1 (1.0) | 1 (2.7) | 2 (1.4) |
| Missing* | 8 (7.7) | 9 (24.3) | 17 (12.1) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 3 (2.9) | 5 (13.5) | 8 (5.7) |
| Not Hispanic or Latino | 93 (89.4) | 22 (59.5) | 115 (81.6) |
| Unknown | 0 | 1 (2.7) | 1 (0.7) |
| Missing | 8 (7.7) | 9 (24.3) | 17 (12.1) |
Source: Adapted from FDA Review
CSCC = cutaneous squamous cell carcinoma; Max =maximum; Min = minimum; SD = standard deviation.
* Where applicable. Some sites in Europe did not report race due to privacy laws.
TABLE 2. Baseline Demographics of by Age, Race, Sex, and Ethnicity, Efficacy Population
| Parameter | Metastatic CSCC (N=78) | Locally Advanced CSCC (N=31) | All Advanced CSCC (N=109) |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 71.2 (12.9) | 76.5 (8.2) | 72.7 (11.9) |
| Median | 72 | 76 | 75 |
| Min, Max | 37, 91 | 51, 95 | 37, 95 |
| Age Group, n (%) | |||
| < 65 years | 22 (28.2) | 2 (6.5) | 24 (22.0) |
| ≥ 65 years | 56 (71.8) | 29 (93.5) | 85 (78.0) |
| Sex, n (%) | |||
| Female | 19 (24.4) | 12 (38.7) | 31 (28.4) |
| Male | 59 (75.6) | 19 (61.3) | 78 (71.6) |
| Race, n (%) | |||
| White | 69 (88.5) | 24 (77.4) | 93 (85.3) |
| Asian | 6 (7.7) | 0 | 6 (5.5) |
| Black or African American | 1 (1.3) | 0 | 1 (0.9) |
| Other | 0 | 1 (3.2) | 1 (0.9) |
| Missing* | 2 (2.6) | 6 (19.4) | 8 (7.3) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 3 (3.8) | 5 (16.1) | 8 (7.3) |
| Not Hispanic or Latino | 73 (93.6) | 19 (61.3) | 92 (84.4) |
| Unknown | 0 | 1 (3.2) | 1 (0.9) |
| Missing | 2 (2.6) | 6 (19.4) | 8 (6.4) |
Source: Adapted from FDA Review
CSCC = cutaneous squamous cell carcinoma; Max =maximum; Min = minimum; SD = standard deviation.
* Where applicable. Some sites in Europe did not report race due to privacy laws.
What are the benefits of this drug?
UNLOXCYT treatment led to tumor shrinkage or tumor disappearance (ORR) in 47% of patients with metastatic CSCC and 48% of patients with locally advanced CSCC.
Refer to the UNLOXCYT Prescribing Information.
What are the benefits of this drug (results of trials used to assess efficacy)?
The benefit of the clinical trial results was based on the amount tumor shrinkage or complete disappearance and how long the tumor responded (duration of response [DOR]), are presented below.
TABLE 3. Efficacy Results (Efficacy population)
| Efficacy Endpoints* | Metastatic CSCC N = 78 | Locally Advanced CSCC N = 31 |
|---|---|---|
| Objective Response Rate (95% CI) | ||
| Duration of Response (DOR) | ||
| ORR, n(%) (95% CI) | 37 (47) (36, 59) | 15 (48) (30, 67) |
| Complete response (CR) rate n(%) | 6 (8) | 3 (10) |
| Partial response (PR) rate n(%) | 31 (40) | 12 (39) |
| Range in months (Range) | 1.4+, 34.1+ | 3.7+, 17.7 |
| Patients with DOR ≥ 6 months, n (%) | 31 (84%) | 13 (87%) |
| Patients with observed DOR ≥ 12 months, n (%) | 20 (54%) | 3 (20%) |
Source: Adapted from UNLOXCYT Prescribing Information
CI: confidence interval; CSCC: cutaneous squamous cell carcinoma; +: Denotes ongoing at last assessment.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: The observed effect of UNLOXCYT was larger for males than females. Because of limited data, this difference may be due to chance.
- Age: The observed effect of UNLOXCYT was similar for patients below and above 65 years of age.
- Race: The number of patients of races other than White was small; therefore, differences in how UNLOXCYT worked among races could not be determined.
- Ethnicity: The number of patients of Hispanic or Latino was small; therefore, differences in how UNLOXCYT worked among ethnicity groups could not be determined.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 4. Efficacy Results by Sex, Age, Race, and Ethnicity (Efficacy population)
| Demographic Characteristic | Objective Response Rate (95% CI) | ||
|---|---|---|---|
| Metastatic CSCC (N = 78) | Locally Advanced CSCC (N = 31) | ||
| Sex | Male | 54.2% (40.8 – 67.3) | 57.9% (33.5 – 79.7) |
| Female | 26.3% (9.1 – 51.2) | 33.3% (9.9 – 65.1) | |
| Age | <65 years | 45.5% (24.4 – 67.8) | 50.0% (1.3 – 98.7) |
| ≥65 years | 48.2% (34.7 – 62.0) | 48.3% (29.4 – 67.5) | |
| Race | White | 50.7% (38.4 – 62.9) | 45.8% (25.6 – 67.2) |
| All other* | 22.2% (0.3 – 60.0) | 57.1% (18.4 – 90.1) | |
| Ethnicity | Hispanic or Latino | 0.0% (0.0 –70.8) | 40.0% (5.3 – 85.3) |
| Not Hispanic or Latino | 49.3% (37.4 – 61.3) | 47.4% (24.4 – 71.1) | |
Source: Adapted from FDA Review
CI: confidence interval; CSCC: cutaneous squamous cell carcinoma.
* Includes Asian, African American, other race, and patients with missing race.
What are the possible side effects?
UNLOXCYT can cause serious immune reactions including inflammation of the lungs, gut, liver, hormonal glands, kidneys, and skin as well as infusion reactions.
The most common adverse reactions are fatigue, muscle pain, rash, diarrhea, thyroid problems, constipation, nausea, headache, itchy skin, swelling, and infections.
Refer to UNLOXCYT Prescribing Information.
What are the possible side effects (results of trials used to assess safety)?
The table below summarizes the most common side effects that occurred in CSCC patients.
Table 5. Safety Results for Adverse Reactions in ≥10% of Patients with Metastatic or Locally Advanced CSCC (Safety population)
| UNLOXCYT N = 141 | ||
|---|---|---|
| Adverse Reactions | All Grades % | Grade 3 or 4 % |
| General and administrative site | ||
| Fatigue* Edema* | 33 11 | 3 0 |
| Musculoskeletal and connective tissue | ||
| Musculoskeletal pain* | 25 | 3 |
| Skin and subcutaneous tissue | ||
| Rash* Pruritus* | 23 12 | 1 0 |
| Endocrine disorder | ||
| Hypothyroidism* | 14 | 0 |
| Gastrointestinal disorders | ||
| Diarrhea | 14 | 0 |
| Nausea | 13 | 0 |
| Constipation | 13 | 0 |
| Nervous system disorders | ||
| Headache* | 12 | 0 |
| Infections and infestations | ||
| Localized infection Urinary tract infection* | 10 10 | 0.7 0 |
Source: Adapted from FDA Review
*Represents a group of multiple related terms.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: The number of patients of races other than White was small; therefore, differences between races in how well UNLOXCYT works among races could not be determined.
- Age: The occurrence of side effects was similar in patients below and above 65 years of age.
Refer to UNLOXCYT Prescribing Information.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
The subgroup safety analyses among sex, race, and age subgroups are presented below. No meaningful differences were found in the side effects of UNLOXCYT across these subgroups. Because most participants were White and ≥65, differences in how well UNLOXCYT works among races and age could not be determined.
Table 6. Side Effects by Sex (Safety population)
| Patients with at least one: | CSCC at All Doses (N=141) | |
|---|---|---|
| Male (N=105) n (%) | Female (N=36) n (%) | |
| Treatment-emergent AE | 98 (93.3) | 34 (94.4) |
| TEAE Grade ≥ 3 | 46 (43.8) | 18 (50.0) |
| Serious TEAE | 32 (30.5) | 12 (33.3) |
Source: Adapted from FDA Review
CSCC: cutaneous squamous cell carcinoma; TEAE = treatment-emergent adverse event
Table 7. Side Effects by Race (Safety population)
| Patients with at least one: | White (N=115) n (%) | Other* (N=9) n (%) |
|---|---|---|
| TEAE | 111 (96.5) | 8 (88.9) |
| TEAE Grade ≥ 3 | 53 (46.1) | 5 (55.6) |
| Serious TEAE | 38 (33.0) | 2 (22.2) |
Source: Adapted from FDA Review
CSCC: cutaneous squamous cell carcinoma; TEAE = treatment-emergent adverse event
*Note 17 patients had race indicated as “Missing”, as some sites in Europe did not report race due to privacy laws.
Table 8. Side Effects by Age (Safety population)
| Patients with at least one: | CSCC at All Doses (N=141) | ||
|---|---|---|---|
| < 65 years (N=29) n (%) | ≥ 65 to < 75 years (N=44) n (%) | ≥ 75 years (N=68) n (%) | |
| TEAE | 28 (96.6) | 42 (95.5) | 62 (91.2) |
| TEAE Grade ≥ 3 | 16 (55.2) | 20 (45.5) | 28 (41.2) |
| Serious TEAE | 6 (20.7) | 15 (34.1) | 23 (33.8) |
Source: Adapted from FDA Review
CSCC: cutaneous squamous cell carcinoma; TEAE = treatment-emergent adverse event
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 used in clinical trials 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.