LIBTAYO is approved for patients with metastatic basal cell carcinoma (mBCC)
previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.
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This indication is
approved under accelerated approval based on tumor response rate and durability of response. Continued approval for
mBCC may be contingent upon verification and description of clinical benefit1
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Efficacy results for LIBTAYO in patients with mBCC (n=28)
previously treated with an HHI1*
Confirmed objective response rate (ORR)
Duration of response (DOR)
Adverse reactions in ≥10% of patients receiving LIBTAYO in Study 16201†
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Serious ARs occurred in 32% of patients. Serious ARs that occurred in >1.5% (at least 2 patients) were
urinary tract infection, colitis, acute kidney injury, adrenal insufficiency, anemia, infected neoplasm, and
somnolence1
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Fatal ARs occurred in 1.5% of patients who received LIBTAYO, including acute kidney
injury and cachexia1
- Permanent discontinuation of LIBTAYO due to an AR occurred in 13% of patients1
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ARs resulting in permanent discontinuation of LIBTAYO in >1.5% (at least 2 patients) were colitis and
general physical health deterioration1
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Dosage delays of LIBTAYO due to an AR occurred in 34% of patients. ARs which required dosage delay in >2% of patients (at least 3 patients) included blood creatinine
increased, diarrhea, colitis, fatigue, headache, pneumonitis, and urinary tract infection1
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The most common ARs reported in at least 15% of patients were fatigue, musculoskeletal pain, diarrhea, rash,
pruritus, and upper respiratory tract infection1
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The most common Grade 3 or 4 ARs (>2%) were hypertension, colitis, fatigue, urinary tract infection,
pneumonia, increased blood pressure, hypokalemia, and visual impairment1
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The most common (>3%) laboratory abnormality worsening from baseline to Grade 3 or 4 was
hyponatremia1
LIBTAYO was studied in a prospective clinical trial that included patients with mBCC previously treated
with an HHI1
Study 1620 was an open-label, multicenter, phase 2, nonrandomized study that included 132 patients,
of which 48 patients had metastatic BCC that had progressed on HHI therapy, had not had an objective response after
9 months on HHI therapy, or were intolerant of prior HHI therapy. Patients received 350 mg every 3 weeks for 5
cycles of 9 weeks followed by 4 cycles of 12 weeks up to 93 weeks. Treatment continued until progression of disease,
unacceptable toxicity, or completion of planned treatment. Tumor response assessments were conducted every 9 weeks
(during cycles 1 to 5) and then every 12 weeks (during cycles 6 to 9).1,2
The primary efficacy endpoint was confirmed ORR by ICR. Secondary endpoints included complete response rate, DOR, and
safety and tolerability.1,2
The study excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents
within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1 therapy or other immune
checkpoint inhibitor therapy; infection with HIV, hepatitis B or hepatitis C; or Eastern Cooperative Oncology Group
Performance Status ≥2.1