Imjudo

Treatment must be initiated and supervised by a physician experienced in the treatment of cancer. Posology The recommended dose of IMJUDO is presented in Table 1. IMJUDO is administered as an intravenous infusion over 1 hour. When IMJUDO is administered in combination with other therapeutic agents, refer to the summary of product characteristics (SmPC) of the therapeutic agents for further information.

3 Table 1. Recommended dose of IMJUDO Indication Recommended IMJUDO dosage Duration of Therapy Advanced or unresectable HCC IMJUDO 300 mga as a single dose administered in combination with durvalumab 1500 mga at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks.

Until disease progression or unacceptable toxicity. Metastatic NSCLC During platinum chemotherapy: 75 mgb in combination with durvalumab 1500 mg and platinum-based chemotherapy every 3 weeks (21 days) for 4 cycles (12 weeks).

Post-platinum chemotherapy:

Durvalumab 1500 mg every 4 weeks and histology-based pemetrexed maintenance c therapy every 4 weeks. A fifth dose of IMJUDO 75 mgd,e should be given at week 16 alongside durvalumab dose 6. Up to a maximum of 5 doses. Patients may receive less than five doses of IMJUDO in combination with durvalumab 1500 mg and platinum-based chemotherapy if there is disease progression or unacceptable toxicity.

a For IMJUDO, HCC patients with a body weight of 40 kg or less must receive weight-based dosing, equivalent to IMJUDO 4 mg/kg until weight is greater than 40 kg. For durvalumab, patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to durvalumab 20 mg/kg until weight is greater than 30 kg.

b For IMJUDO, metastatic NSCLC patients with a body weight of 34 kg or less must receive weight-based dosing, equivalent to 1 mg/kg of IMJUDO until the weight improves to greater than 34 kg. For durvalumab, patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to durvalumab 20 mg/kg until the weight improves to greater than 30 kg.

c Consider maintenance administration of pemetrexed for patients with non-squamous tumours who received treatment with pemetrexed and carboplatin/cisplatin during the platinum-based chemotherapy stage. d In the case of dose delay(s), a fifth dose of IMJUDO can be given after Week 16, alongside durvalumab.

Summary of the safety profile IMJUDO in combination with durvalumab 12 The safety of tremelimumab 300 mg as a single dose in combination with durvalumab, is based on pooled data in 462 HCC patients (HCC pool) from the HIMALAYA Study and another study in HCC patients, Study 22.

4%) (see Table 3). 9%). 2%). 5%. 3%). IMJUDO in combination with durvalumab and chemotherapy The safety of tremelimumab given in combination with durvalumab and chemotherapy is based on data in 330 patients with metastatic NSCLC. 9%). 6%).

1%). 5% of patients. 9%). 6% of patients. 1%). Tabulated list of adverse reactions Table 3, unless otherwise stated, lists the incidence of adverse reactions (ADRs) in patients treated with tremelimumab 300 mg in combination with durvalumab in the HCC pool of 462 patients, and IMJUDO in combination with durvalumab and platinum-based chemotherapy in the POSEIDON Study, in which 330 patients received tremelimumab.

In the POSEIDON study, patients were exposed to tremelimumab during a median of 20 weeks. Adverse reactions are listed according to system organ class in MedDRA. Within each system organ class, the ADRs are presented in decreasing frequency.

The corresponding frequency category for each ADR is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from 13 available data).

Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Table 3. 2 […]

2, Table 2 for recommended treatment modifications. For suspected immune- mediated adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude alternate aetiologies. Based on the severity of the adverse reaction, IMJUDO in combination with durvalumab should be withheld and corticosteroids administered.

Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month. Consider increasing dose of corticosteroids and/or using additional systemic immunosuppressants if there is worsening or no improvement.

Traceability 8 In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. 8). Patients should be monitored for signs and symptoms of pneumonitis.

2. For Grade 2 events, an initial dose of 1-2 mg/kg/day prednisone or equivalent should be initiated followed by a taper. For Grade 3 or 4 events, an initial dose of 2-4 mg/kg/day methylprednisolone or equivalent should be initiated followed by a taper.

8). Monitor alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase levels prior to initiation of treatment and prior to each subsequent infusion. Additional monitoring is to be considered based on clinical evaluation.

2. Corticosteroids should be administered with an initial dose of 1-2 mg/kg/day prednisone or equivalent followed by taper for all grades. 8). Intestinal perforation and large intestine perforation were reported in patients receiving tremelimumab in combination with durvalumab.

2. Corticosteroids should be administered at an initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper for Grades 2-4. Consult a surgeon immediately if intestinal perforation of ANY grade is suspected. 8). Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and as indicated based on clinical evaluation.

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