Imfinzi

Durvalumab

Treatment of adults w/ unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy & radiation therapy. In combination w/ platinum-containing chemotherapy as neoadjuvant treatment, followed by Imfinzi continued as a single agent as adjuvant treatment after surgery, for the treatment of adults w/ resectable (tumors ≥4 cm &/or node +ve) NSCLC & no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In combination w/ tremelimumab & platinum-based chemotherapy for the treatment of adults w/ metastatic NSCLC w/ no sensitizing EGFR mutations or ALK genomic tumor aberrations. In combination w/ etoposide & either carboplatin or cisplatin, as 1st line treatment of adults w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ gemcitabine & cisplatin for the treatment of adults w/ locally advanced or metastatic biliary tract cancer (BTC). In combination w/ tremelimumab for the treatment of adults w/ unresectable hepatocellular carcinoma (uHCC). In combination w/ carboplatin & paclitaxel followed by Imfinzi as a single agent for the treatment of adults w/ primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

Administer as IV infusion over 60 min. Neoadjuvant & adjuvant treatment of resectable NSCLC Patient weighing ≥30 kg Neoadjuvant: 1,500 mg in combination w/ chemotherapy every 3 wk for up to 4 cycles prior to surgery. Adjuvant: 1,500 mg as single agent every 4 wk for up to 12 cycles after surgery until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a max of 12 cycles after surgery. Patient weighing <30 kg Neoadjuvant: 20 mg/kg every 3 wk in combination w/ chemotherapy for up to 4 cycles prior to surgery. Adjuvant: 20 mg/kg every 4 wk for up to 12 cycles as single agent after surgery until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a max of 12 cycles after surgery. Unresectable stage III NSCLC Patient weighing ≥30 kg 10 mg/kg every 2 wk or 1,500 mg every 4 wk until disease progression, unacceptable toxicity, or max of 12 mth. Patient weighing <30 kg 10 mg/kg every 2 wk until disease progression, unacceptable toxicity, or max of 12 mth. ES-SCLC Patient weighing ≥30 kg 1,500 mg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 1,500 mg every 4 wk as single agent until disease progression or unacceptable toxicity. Patient weighing <30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 20 mg/kg every 4 wk as single agent until disease progression or unacceptable toxicity. BTC Patient weighing ≥30 kg 1,500 mg in combination w/ chemotherapy every 3 wk (21 days) up to 8 cycles, followed by 1,500 mg every 4 wk as single agent until disease progression or unacceptable toxicity. Patient weighing <30 kg 20 mg/kg in combination w/ chemotherapy every 3 wk (21 days) up to 8 cycles, followed by 20 mg/kg every 4 wk as single agent until disease progression or unacceptable toxicity. uHCC Patient weighing ≥30 kg 1,500 mg following a single dose of tremelimumab 300 mg at day 1 of cycle 1; continue Imfinzi 1,500 mg as single agent every 4 wk. Patient weighing <30 kg 20 mg/kg following a single dose of tremelimumab 4 mg/kg at day 1 of cycle 1; continue Imfinzi 20 mg/kg as single agent every 4 wk. After cycle 1 of combination therapy, administer Imfinzi as single agent every 4 wk until disease progression or unacceptable toxicity. dMMR endometrial cancer Patient weighing ≥30 kg 1,120 mg in combination w/ carboplatin & paclitaxel every 3 wk (21 days) for 6 cycles, followed by 1,500 mg every 4 wk as single agent until disease progression or unacceptable toxicity. Patient weighing <30 kg 15 mg/kg in combination w/ carboplatin & paclitaxel every 3 wk (21 days) for 6 cycles, followed by 20 mg/kg every 4 wk as single agent until disease progression or unacceptable toxicity.

Permanently discontinue treatment in life-threatening (Grade 4) immune-mediated adverse reactions & recurrent severe (Grade 3) immune-mediated reactions. Withhold treatment in severe (Grade 3) immune-mediated adverse reactions. Closely monitor patient for symptoms & signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, & thyroid function at baseline & periodically during treatment. Interrupt or slow infusion rate in mild or moderate, & permanently discontinue for severe or life-threatening infusion-related reactions. Fatal & other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated w/ a PD-1/L-1 blocking antibody. Can cause fetal harm. Females of reproductive potential should use effective contraception. Do not breastfeed during treatment & for at least 3 mth after the last dose. Safety & effectiveness have not been established in ped patient.

Most common (≥20%) in unresectable stage III NSCLC: Cough, fatigue, pneumonitis/radiation pneumonitis, URTI, dyspnea, rash. Most common (≥20%) in resectable stage II/III NSCLC (neoadjuvant/adjuvant): Anemia, nausea, constipation, fatigue, musculoskeletal pain, rash. Most common (≥20%) in metastatic NSCLC: Nausea, fatigue, musculoskeletal pain, decreased appetite, rash, diarrhea. Most common (≥20%) in ES-SCLC: Nausea, fatigue/asthenia, alopecia. Most common (≥20%) in BTC: Fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, pyrexia. Most common (≥20%) in uHCC: Rash, diarrhea, fatigue, pruritis, musculoskeletal pain, abdominal pain. Most common (≥20%) in endometrial cancer: Peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, decreased Mg, increased ALT/AST, diarrhea, vomiting, cough, decreased K, dyspnea, headache, increased alkaline phosphatase, decreased appetite.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF03 - durvalumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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