Introduction
Methods
Study design
Patients, treatment, and follow-up
Objectives
Assessments
Statistical analysis
Results
Patients, treatment, and follow-up
Cemiplimab 250 mg Q3W (n = 6) | Cemiplimab 350 mg Q3W (n = 7) | Total (N = 13) | |
---|---|---|---|
Median age, years (range) | 55.5 (33‒75) | 64.0 (45‒74) | 62.0 (33‒75) |
≥ 65 years, n (%) | 2 (33.3) | 3 (42.9) | 5 (38.5) |
Female, n (%) | 3 (50.0) | 5 (71.4) | 8 (61.5) |
ECOG performance status, n (%) | |||
0 | 5 (83.3) | 3 (42.9) | 8 (61.5) |
1 | 1 (16.7) | 4 (57.1) | 5 (38.5) |
Primary tumor site, n (%) | |||
Lung | 1 (16.7) | 1 (14.3) | 2 (15.4) |
Bladder | 1 (16.7) | 0 | 1 (7.7) |
Breast | 0 | 1 (14.3) | 1 (7.7) |
Non-melanoma skin | 1 (16.7) | 0 | 1 (7.7) |
Urethra | 0 | 1 (14.3) | 1 (7.7) |
Uterus | 1 (16.7) | 0 | 1 (7.7) |
Ovary | 1 (16.7) | 0 | 1 (7.7) |
Prostate | 0 | 1 (14.3) | 1 (7.7) |
Pancreas | 0 | 1 (14.3) | 1 (7.7) |
Other | 1 (16.7) | 2 (28.6) | 3 (23.1) |
Prior cancer-related radiation, n (%) | 3 (50.0) | 4 (57.1) | 7 (53.8) |
Median number of prior cancer-related radiation (range) | 0.5 (0‒1) | 1.0 (0‒2) | 1.0 (0‒2) |
Prior cancer-related systemic therapy, n (%) | 5 (83.3) | 7 (100) | 12 (92.3) |
Median number of prior cancer-related systemic therapy (range) | 3.0 (0‒15) | 3.0 (1‒9) | 3.0 (0‒15) |
Prior cancer-related surgery, n (%) | 4 (66.7) | 5 (71.4) | 9 (69.2) |
Median number of prior cancer-related surgeries (range) | 1.5 (0‒5) | 1.0 (0‒5) | 1.0 (0‒5) |
Safety
n (%) | Cemiplimab 250 mg Q3W (n = 6) | Cemiplimab 350 mg Q3W (n = 7) | Total (N = 13) |
---|---|---|---|
Any | 6 (100.0) | 6 (85.7) | 12 (92.3) |
Grade ≥ 3 | 2 (33.3) | 2 (28.6) | 4 (30.8) |
Serious | 1 (16.7) | 1 (14.3) | 2 (15.4) |
Led to discontinuation | 0 | 1 (14.3) | 1 (7.7) |
With an outcome of death | 0 | 0 | 0 |
Occurred in any patient enrolled | |||
Contact dermatitis | 1 (16.7) | 2 (28.6) | 3 (23.1) |
Rash | 2 (33.3) | 1 (14.3) | 3 (23.1) |
Viral upper respiratory tract infection | 2 (33.3) | 1 (14.3) | 3 (23.1) |
Increased aspartate aminotransferase | 1 (16.7) | 1 (14.3) | 2 (15.4) |
Diarrhea | 2 (33.3) | 0 | 2 (15.4) |
Fatigue | 0 | 2 (28.6) | 2 (15.4) |
Hyperthyroidism | 1 (16.7) | 1 (14.3) | 2 (15.4) |
Hypophosphatemia | 2 (33.3) | 0 | 2 (15.4) |
Insomnia | 1 (16.7) | 1 (14.3) | 2 (15.4) |
Oropharyngeal pain | 2 (33.3) | 0 | 2 (15.4) |
Pruritus | 2 (33.3) | 0 | 2 (15.4) |
Abdominal pain | 1 (16.7) | 0 | 1 (7.7) |
Increased alanine aminotransferase | 0 | 1 (14.3) | 1 (7.7) |
Arthralgia | 1 (16.7) | 0 | 1 (7.7) |
Autoimmune colitis | 1 (16.7) | 0 | 1 (7.7) |
Increased blood creatinine | 1 (16.7) | 0 | 1 (7.7) |
Increased blood thyroid stimulating hormone | 0 | 1 (14.3) | 1 (7.7) |
Constipation | 0 | 1 (14.3) | 1 (7.7) |
Contusion | 1 (16.7) | 0 | 1 (7.7) |
Cough | 1 (16.7) | 0 | 1 (7.7) |
Dehydration | 1 (16.7) | 0 | 1 (7.7) |
Bullous dermatitis | 1 (16.7) | 0 | 1 (7.7) |
Dry eye | 0 | 1 (14.3) | 1 (7.7) |
Dry mouth | 1 (16.7) | 0 | 1 (7.7) |
Dysgeusia | 1 (16.7) | 0 | 1 (7.7) |
Eye pruritus | 0 | 1 (14.3) | 1 (7.7) |
Increased gamma-glutamyltransferase | 1 (16.7) | 0 | 1 (7.7) |
Hypertension | 1 (16.7) | 0 | 1 (7.7) |
Hypoalbuminemia | 1 (16.7) | 0 | 1 (7.7) |
Hypomagnesemia | 1 (16.7) | 0 | 1 (7.7) |
Hyponatremia | 0 | 1 (14.3) | 1 (7.7) |
Hypothyroidism | 1 (16.7) | 0 | 1 (7.7) |
Inappropriate antidiuretic hormone secretion | 0 | 1 (14.3) | 1 (7.7) |
Influenza | 0 | 1 (14.3) | 1 (7.7) |
Decreased lymphocyte count | 1 (16.7) | 0 | 1 (7.7) |
Lymphopenia | 0 | 1 (14.3) | 1 (7.7) |
Muscular weakness | 0 | 1 (14.3) | 1 (7.7) |
Neutropenia | 1 (16.7) | 0 | 1 (7.7) |
Small intestinal obstruction | 1 (16.7) | 0 | 1 (7.7) |
Spinal column stenosis | 1 (16.7) | 0 | 1 (7.7) |
Tumor pain | 1 (16.7) | 0 | 1 (7.7) |
Upper respiratory tract infection | 0 | 1 (14.3) | 1 (7.7) |
Urticaria | 0 | 1 (14.3) | 1 (7.7) |
Pharmacokinetics
Immunogenicity
Clinical activity
Cemiplimab 250 mg Q3W (n = 6) | Cemiplimab 350 mg Q3W (n = 7) | Total (N = 13) | |
---|---|---|---|
Best overall tumor response, n (%) | |||
Complete response | 0 | 0 | 0 |
Partial response | 3 (50.0) | 1 (14.3) | 4 (30.8) |
Stable disease | 1 (16.7) | 1 (14.3) | 2 (15.4) |
Progressive disease | 2 (33.3) | 5 (71.4) | 7 (53.8) |
Objective response ratea (95% confidence interval) | 50.0 (11.8‒88.2) | 14.3 (0.4‒57.9) | 30.8 (9.1‒61.4) |
Disease control rateb (95% confidence interval) | 66.7 (22.3‒95.7) | 28.6 (3.7‒71.0) | 46.2 (19.2‒74.9) |