Kimmtrak Drug Information

Generic name: TEBENTAFUSP

Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager [EPC]

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Uses of Kimmtrak

is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Dosage & Administration of Kimmtrak

^a Based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (NCI CTCAEv4.03).
Adverse Reaction	Severity
Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1)]	Moderate defined as temperature ≥ 38°C with Hypotension that responds to fluids (does not require vasopressors) or Hypoxia requiring low flow nasal canula (≤ 6 L/min) or blow-by oxygen
Severe defined as temperature ≥ 38°C with Hemodynamic instability requiring a vasopressor (with or without vasopressin) or Worsening hypoxia or respiratory distress requiring high flow nasal canula (> 6 L/min oxygen) or face mask	Withhold KIMMTRAK until CRS and sequelae have resolved Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent) Resume KIMMTRAK at same dose level (i.e., do not escalate if severe CRS occurred during initial dose escalation; resume escalation once dosage is tolerated) For severe CRS, administer corticosteroid premedication (e.g. dexamethasone 4 mg or equivalent) at least 30 minutes prior to next dose
Life threatening defined as temperature ≥ 38°C with Hemodynamic instability requiring multiple vasopressors (excluding vasopressin) Worsening hypoxia or respiratory distress despite oxygen administration requiring positive pressure	Permanently discontinue KIMMTRAK Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent)
Skin Reactions [see Warnings and Precautions (5.2)]	Grade 2 or 3^a
Grade 4^a	Permanently discontinue KIMMTRAK Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent)
Elevated Liver Enzymes [see Warnings and Precautions (5.3)]	Grade 3 or 4^a
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 3^a
Grade 4^a	Permanently discontinue KIMMTRAK

Side Effects of Kimmtrak

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. First line metastatic uveal melanoma The safety of KIMMTRAK was evaluated in study IMCgp100-202, a randomized (2:1), open-label, active-controlled trial in patients who had not received prior systemic therapy for metastatic or advanced uveal melanoma . Patients received either KIMMTRAK administered at 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter (N=245) or investigator’s choice treatment (N=111). The median duration of exposure was 5.3 months (range: 0.3 to 33 months) in patients treated with KIMMTRAK. Serious adverse reactions occurred in 28% of patients who received KIMMTRAK. Serious adverse reactions occurring in ≥ 2% of patients were cytokine release syndrome (10%), rashes (4.5%), pyrexia (2.4%), and hypotension (2%). One patient (0.4%) experienced a fatal adverse reaction (pulmonary embolism). Adverse reactions led to permanent discontinuation in 3.3% of patients who received KIMMTRAK. Adverse reactions that led to permanent discontinuation of KIMMTRAK were anaphylactic reaction, brain edema, cytokine release syndrome, fatigue, hepatotoxicity, hypotension, and nausea (each 0.4%). Adverse reactions resulting in dosage interruption occurred in 25% of patients who received KIMMTRAK. Adverse reactions which required dosage interruption in ≥ 2% of patients included fatigue (3.7%), lipase increased (2.9%), pyrexia (2.4%), alanine aminotransferase increase (2%), and aspartate aminotransferase increase (2%). Adverse reactions leading to dose reduction occurred in 5% of patients who received KIMMTRAK. Adverse reactions which required dosage reduction in ≥ 2% of patients were cytokine release syndrome (2.4%), and rashes (2%). The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities in patient who received KIMMTRAK were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

Table 4 summarizes the adverse reactions observed in study IMCgp100-202. Table 4: Adverse Reactions (≥20%) in Patients with Metastatic Uveal Melanoma Who Received KIMMTRAK in Study IMCgp100-202 a Represents algorithmic identification of CRS cases based on ASTCT grading criteria (Lee et al. 2019). b Represents a composite of multiple related terms. Adverse Reactions KIMMTRAK (N=245) Investigator’s Choice (pembrolizumab, or ipilimumab, or dacarbazine) (N=111) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (% ) Immune system disorders Cytokine release syndrome a 89 0.8 2.7 0 Skin and subcutaneous tissue disorders Rash b 83 18 28 0 Pruritus 69 4.5 23 0 Dry skin 31 0 3.6 0 Skin Hypopigmentation b 28 NA 5 NA Erythema 24 0 0.9 0 Hair color changes b 20 NA 0 NA General disorders and administration site conditions Pyrexia 76 3.7 7

Fatigue b 64 6 42 0.9 Chills 48 0.4 3.6 0 Edema

b 45 0 10 0 Gastrointestinal disorders Nausea 49 2 26

Abdominal pain b 45 2.9 33 3.6 Vomiting 30 1.2 9 0

Diarrhea 25 1.2 20

Vascular disorders Hypotension 39 3.3 2.7 0 Nervous system disorders Headache 31

0.4 10

Musculoskeletal and connective tissue disorders Arthralgia 22 0.8 16 0 Clinically relevant

adverse reactions occurring in < 20% of patients who received KIMMTRAK included back pain, decreased appetite, constipation, hypertension, tachycardia or sinus tachycardia, dyspnea, paresthesia, dizziness, flushing, muscle spasms, myalgia, pain in extremity, alopecia, skin hyperpigmentation, influenza-like illness, oropharyngeal pain and night sweats. Table 5 summarizes the selected laboratory abnormalities observed in study IMCgp100-202. Table 5: Selected Laboratory Abnormalities (≥ 10%) worsening from baseline in patients who received KIMMTRAK versus Investigator’s Choice Alk Phos = Alkaline Phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase a The denominator used to calculate the rate varied from 242 to 245 for KIMMTRAK and 105 to 109 for IC based on the number of patients with a baseline value and at least one post-treatment value for the laboratory assessment. KIMMTRAK a (N=245) Investigator’s Choice a (pembrolizumab, or ipilimumab, or dacarbazine) (N=111) Grades 1-4 (%) Grades 3-4 (%) Grades 1-4 (%) Grades 3-4 (% ) HEMATOLOGY Lymphocyte count decreased 91 56 26

Neutrophil count decreased 14 2 8 1.8

CHEMISTRY Creatinine increased 87 0.4 73 0 Glucose increased 66 3.3 39

AST increased 55 13 39 1.9

ALT increased 52 9 29

Phosphate decreased 51 11 20 2 Albumin decreased 47 2.1 14 0.9

Calcium decreased 45 1.6 15

Lipase increased 37 15 28 6 Magnesium decreased 34 0 8 0

Alk phos increased 34 2.9 36

Sodium decreased 30 2.9 15 0.9 Potassium increased 29 1.6 15 0.9

Bilirubin increased 27 4.1 14 7 Amylase increased 23 4.1 18 1 Glucose decreased 18 0.4 4.6 0 Potassium decreased 17 0.8 8

Warnings & Cautions for Kimmtrak

Cytokine Release Syndrome Cytokine release syndrome (CRS), which may be life threatening

occurred in patients receiving KIMMTRAK. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS (≥ Grade 2) occurred in 77% of patients in Study IMCgp100-202 who received KIMMTRAK . Among patients who received KIMMTRAK, 23% received systemic corticosteroids for at least 1 infusion, 8% received supplemental oxygen during at least 1 infusion, and 0.8% received a vasopressor for at least 1 infusion. CRS led to permanent discontinuation in 1.2% of patients.

In Study IMCgp100-202, 60% of patients experienced ≥ Grade 2 CRS with more than 1 infusion, with the median number of events being 2 (range 1 - 12). The majority (84%) of episodes of CRS started the day of infusion. Among cases that resolved, the median time to resolution of CRS was 2 days. Ensure that healthcare providers administering KIMMTRAK have immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions.

Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK . Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS .

Skin Reactions Skin reactions, including rash, pruritus, and cutaneous edema occurred in

patients treated with KIMMTRAK. In study IMCgp100-202, skin reactions occurred in 91% of patients treated with KIMMTRAK, including Grade 2 (44%) and Grade 3 (21%) events. Skin reactions included rash (83%), pruritus (69%), erythema (25%), and cutaneous edema (27%) . The median time to onset of skin reactions was 1 day (range: 1 – 55 days). The median time to improvement to ≤ Grade 1 was approximately 6 days. Monitor patients for skin reactions.

If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions .

Elevated Liver Enzymes

In Study IMCgp100-202, increases in alanine aminotransferase or aspartate aminotransferase were observed in 65% of patients treated with KIMMTRAK. In patients experiencing ALT/AST elevations, 73% initially occurred within the first 3 infusions with KIMMTRAK. Most patients experiencing Grade 3 or 4 ALT/AST elevations had improvement to ≤ Grade 1 within 7 days. For events that were observed outside the setting of CRS, the median time to onset was 129 days. Grade 3 or greater elevations in liver enzymes outside the setting of CRS occurred in approximately 8% of patients.

Elevations in liver enzymes led to permanent discontinuation in 0.4% of patients receiving KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity .

Embryo-Fetal Toxicity

Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KIMMTRAK and for 1 week after the last dose .

Pregnancy Safety for Kimmtrak

Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK. Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Pediatric Use of Kimmtrak

Pediatric Use Safety and efficacy of KIMMTRAK have not been established in pediatric patients.

Clinical Studies of Kimmtrak

HR (95% CI) 2 0.73 p-value 3, 6 0.0139 Objective Response Rate

(95% CI) 7 9.1% 4.8% Complete Response 1 (0.4%) 0 Partial Response 22 (8.7%) 6 (4.8%) Figure 1: Kaplan-Meier Curves of Overall Survival in Study IMCgp100-202 Figure 1

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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