LYMPHIR is available for use.
LYMPHIR has a manageable safety profile1
In phase III Study 302:
No cumulative toxicity was seen
12% of patients permanently discontinued LYMPHIR due to adverse reactions
Dosage interruptions of LYMPHIR due to an adverse reaction occurred in 38% of patients. Adverse reactions requiring dosage interruption of LYMPHIR included infusion-related reaction, weight increase, nausea, tachycardia, and CLS.
Adverse reactions (≥10%) in patients with relapsed or refractory Stage I-III CTCL who received LYMPHIR in Study 3021
| LYMPHIR (N=69) | ||
|---|---|---|
| Adverse Reaction | All Grades (%) | Grade 3 or 4 (%) |
| Gastrointestinal disorders | ||
| Nausea | 43 | 1.4* |
| Diarrhea | 19 | 0 |
| Vomiting | 13 | 0 |
| Constipation | 12 | 0 |
| General disorders and administration site conditions | ||
| Fatiguea | 38 | 0 |
| Edemab | 33 | 1.4 |
| Chills | 27 | 1.4 |
| Pyrexia | 16 | 1.4 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal painc | 27 | 2.9 |
| Arthralgia | 12 | 0 |
| Nervous system disorders | ||
| Headached | 25 | 0 |
| Dizziness | 13 | 0 |
| Mental status changese | 13 | 0 |
| Injury, poisoning, and procedural complications | ||
| Infusion-related reaction | 25 | 6 |
| Skin and subcutaneous tissue disorders | ||
| Rashf | 23 | 6 |
| Pruritus | 19 | 6 |
| Vascular disorders | ||
| Capillary leak syndrome | 17 | 6 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 13 | 1.4 |
| Eye disorders | ||
| Blurred vision | 13 | 0 |
| Investigations | ||
| Weight increased | 13 | 0 |
| Infections and infestations | ||
| Skin infectiong | 13 | 1.4 |
| Renal and urinary disorders | ||
| Renal insufficiencyh | 12 | 2.9 |
| Psychiatric disorders | ||
| Insomnia | 10 | 0 |
Only Grade 3 adverse reaction occurred.
aIncludes fatigue, asthenia, and lethargy.
bIncludes edema, edema peripheral, generalized edema, face edema, swelling face, and peripheral swelling.
cIncludes musculoskeletal pain, back pain, neck pain, pain in extremity, myalgia, and bone pain.
dIncludes headache and migraine.
eIncludes amnesia, confusional state, delirium, memory impairment, disturbance in attention, somnolence, and cognitive disorder.
fIncludes rash, drug eruption, erythema, rash maculo-papular, rash papular, rash pustular, rash pruritic, dermatitis exfoliative generalized, and acute generalized exanthematous pustulosis.
gIncludes skin infection, skin bacterial infection, staphylococcal skin infection, and impetigo.
hIncludes acute kidney injury, blood creatinine increase.
Select laboratory abnormalities (≥ 10%) that worsened from baseline in patients with relapsed or refractory Stage I-III CTCL who received LYMPHIR in Study 3021
| Laboratory Abnormalitya,b | ||
|---|---|---|
| Any Gradec (%)b | Grade 3 or 4c (%) | |
| Chemistry | ||
| Alanine aminotransferase increased | 66 | 13 |
| Aspartate aminotransferase increased | 60 | 4.5 |
| Albumin decreased | 43 | 1.5 |
| Creatine phosphokinase increasedd | 22 | 3 |
| Alkaline phosphatase increased | 18 | 0 |
| Hematology | ||
| Lymphocyte count decreased | 52 | 20 |
| Hemoglobin decreased | 34 | 1.5 |
aGraded according to NCI CTCAE version 5.0.
bThe denominator used to calculate the rate was 67 based on the number of patients with a baseline value and at least one post-treatment value.
cPercentage of patients with an increase of at least 1 CTCAE grade from baseline to the worst postbaseline value of any grade, or to the worst postbaseline value that is Grade 3 or 4.
dThe denominator used to calculate the rate was based on 36 patients with a baseline value and at least one post-treatment value.
LYMPHIR safety was evaluated across 3 clinical trials consisting of 119 patients1
Most common adverse reactions with LYMPHIR in the pooled patient population1:
The most common (≥20%) adverse reactions, including laboratory abnormalities, were increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and CLS.
CLS and LYMPHIR1
What is CLS?
Patients taking LYMPHIR are at risk for CLS, defined in clinical trials as the occurrence of ≥2 of the following symptoms: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as CLS.
Occurrence
In the pooled safety population, 27% of patients experienced CLS.
81% of CLS occurred in the first 2 treatment cycles
The median time to onset was 6.5 days (range: 1-77), and the median duration of CLS was 14 days (range: 2-40).
Of those who experienced CLS, 75% of patients had documented resolution.
How to manage
Withhold, reduce dose, or permanently discontinue LYMPHIR treatment based on severity of CLS. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is ≥3 g/dL.
Monitor and maintain serum albumin before each LYMPHIR cycle and as often as clinically indicated.1
CLS=capillary leak syndrome; NCI CTCAE=National Cancer Institute’s Common Terminology Criteria for Adverse Events.
Reference: 1. LYMPHIR. Prescribing information. Citius Oncology, Inc.; 2024.
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