Imfinzi

Treatment must be initiated and supervised by a physician experienced in the treatment of cancer. 1). 1). Posology The recommended dose for IMFINZI monotherapy and IMFINZI combination therapy is presented in Table 1. IMFINZI is administered as an intravenous infusion over 1 hour.

When IMFINZI is administered in combination with other therapeutic agents, refer to the summary of product characteristics (SmPC) of the therapeutic agents for further information. Table 1. Recommended dose of IMFINZI monotherapy and combination therapy Indication Recommended IMFINZI dose Duration of therapy Monotherapy Locally Advanced NSCLC 10 mg/kg every 2 weeks or 1 500 mg every 4 weeksa Until disease progression, unacceptable toxicity, or a maximum of 12 monthsb LS-SCLC 1 500 mg every 4 weeksa Until disease progression, unacceptable toxicity, or a maximum of 24 months HCC 1 500 mg every 4 weeksa Until disease progression or until unacceptable toxicity 4 Indication Recommended IMFINZI dose Duration of therapy Combination therapy Resectable NSCLC 1 500 mgc in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by 1 500 mg monotherapy every 4 weeks for up to 12 cycles after surgery.

Neoadjuvant phase: until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant phase: until recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery. Metastatic NSCLC During platinum chemotherapy: 1 500 mgd in combination with tremelimumab 75 mgd and platinum-based chemotherapy every 3 weeks (21 days) for 4 cycles (12 weeks) Post-platinum chemotherapy: 1 500 mg every 4 weeks as monotherapy and histology-based pemetrexed maintenancee therapy every 4 weeks A fifth dose of tremelimumab 75 mgf,g should be given at week 16 alongside IMFINZI Until disease progression or unacceptable toxicity ES-SCLC 1 500 mgh in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 1 500 mg every 4 weeks as monotherapy Until disease progression or unacceptable toxicity BTC 1 500 mgi in combination with chemotherapy every 3 weeks (21 days) up to 8 cycles, followed by 1 500 mg every 4 weeks as monotherapy Until disease progression or until unacceptable toxicity HCC IMFINZI 1 500 mgj administered in combination with 300 mgj tremelimumab as a single dose at Cycle 1/Day 1, followed by IMFINZI as monotherapy every 4 weeks Until disease progression or unacceptable toxicity Endometrial Cancer 1 120 mg in combination with carboplatin and paclitaxel every 3 weeks (21 days) for a minimum of 4 and up to 6 cycles, followed by IMFINZI 1 500 mgk every 4 weeks as monotherapy (dMMR patients) or in combination with olaparib Until disease progression or unacceptable toxicity 5 Indication Recommended IMFINZI dose Duration of therapy 300 mg twice daily (pMMR patients) MIBC 1 500 mgl in combination with chemotherapy every 3 weeks for 4 cycles prior to surgery, followed by 1 500 mgl every 4 weeks as monotherapy for up to 8 cycles after surgery Neoadjuvant phase: until disease progression that precludes definitive surgery or unacceptable toxicity Adjuvant phase: until recurrence, unacceptable toxicity, or a maximum of 8 cycles after surgery GC/GEJC 1 500 mgm in combination with FLOT chemotherapy every 4 weeks for up to 2 cycles prior to surgery, followed by 1 500 mgm, with FLOT chemotherapy, every 4 weeks for up to 2 cycles and then as 1 500 mg monotherapy every 4 weeks for up to 10 cycles, for a total of up to 12 cycles after surgery Neoadjuvant phase: until disease progression that precludes definitive surgery or unacceptable toxicity Adjuvant phase: until progression or recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery a Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg.

Summary of the safety profile IMFINZI as monotherapy The safety of IMFINZI as monotherapy is based on pooled data in 4 642 patients across multiple tumour types. IMFINZI was administered at a dose of 10 mg/kg every 2 weeks, 20 mg/kg every 4 weeks or 1 500 mg every 4 weeks.

6%). 5%). 9% of patients. 8%). 1% of patients. 0%). The safety of IMFINZI as monotherapy in patients treated for HCC is based on data in 492 patients and was consistent with the overall safety profile in the IMFINZI monotherapy pool (N=4 642).

2%). 2%). 7% of patients. 6%). 6% of patients. 9%). IMFINZI in combination with chemotherapy 16 The safety of IMFINZI in combination with chemotherapy is based on pooled data in 2 244 patients from 6 studies (TOPAZ-1, CASPIAN, DUO-E, AEGEAN, NIAGARA and MATTERHORN).

5%). 3%). 2% of patients. 5%). 4% of patients. 0%). IMFINZI in combination with tremelimumab 75 mg and platinum-based chemotherapy The safety of IMFINZI given in combination with tremelimumab 75 mg and chemotherapy is based on data in 330 patients with metastatic NSCLC.

5%). 1%). 5% of patients. 2%). 4% of patients. 3%). IMFINZI in combination with tremelimumab 300 mg The safety of IMFINZI given in combination with a single dose of tremelimumab 300 mg is based on pooled data (HCC pool) in 462 HCC patients from the HIMALAYA Study and another study in HCC patients, Study 22.

0%) (see Table 4). 9%). 7%). 5%. 5%) and aspartate […]

2, Table 2 for recommended treatment modifications. For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies. Based on the severity of the adverse reaction, IMFINZI or IMFINZI in combination with tremelimumab should be withheld or permanently 11 discontinued.

Treatment with corticosteroids or endocrine therapy should be initiated. For events requiring corticosteroid therapy, and 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 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). 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. Pneumonitis and radiation pneumonitis Radiation pneumonitis is frequently observed in patients receiving radiation therapy to the lung and the clinical presentation of pneumonitis and radiation pneumonitis is very similar.

4% vs. 1% vs. 7%). 7%) in the IMFINZI-treated group. 1% vs. 4% vs. 0). Patients should be monitored for signs and symptoms of pneumonitis or radiation pneumonitis. 2. 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). Adverse drug reactions of intestinal perforation and large intestine perforation were reported in patients receiving IMFINZI in combination with tremelimumab.

1.