Opdivo®

PD-1 Inhibitor

3 mg/kg IV every 2 weeks, 4.5 mg/kg IV every 3 weeks, OR 6 mg/kg IV every 4 weeks

• Canadian funding supports 3 mg/kg IV every 2 weeks up to a maximum of 240 mg, 4.5 mg/kg IV every 3 weeks up to a maximum of 360 mg, and 6 mg/kg IV every 4 weeks up to a maximum of 480mg.

4.5 mg/kg (360 mg) IV every 3 weeks OR 6 mg/kg (480 mg) IV every 4 weeks

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240 mg, 360 mg, and 480mg

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• 1L metastatic NSCLC with ipilimumab and chemotherapy - 2 years (35 doses at every 3 weeks) or until PD / unacceptable toxicity.

• 1L metastatic esophageal, GEJ or gastric cancer with chemotherapy - 2 years (52 doses at every 2 weeks OR 35 doses at every 3 weeks OR 26 doses at every 4 weeks) or until PD / unacceptable toxicity.

• 1L metastatic renal cell carcinoma with cabozantinib - 2 years (52 doses at every 2 weeks OR 26 doses at every 4 weeks) or until PD / unacceptable toxicity.

• 1L malignant pleural mesothelioma with ipilimumab - 2 years (35 doses at every 3 weeks) or until PD / unacceptable toxicity.

• Neoadjuvant NSCLC with chemotherapy - 9 weeks (3 doses at every 3 weeks) or until PD / unacceptable toxicity.

• Adjuvant esophageal cancer - 1 year (26 doses at every 2 weeks OR 13 doses at every 4 weeks) or until PD / unacceptable toxicity.

• Adjuvant urothelial cancer - 1 year (26 doses at every 2 weeks OR 13 doses at every 4 weeks) or until PD / unacceptable toxicity.

• Adjuvant melanoma - 1 year (26 doses at every 2 weeks OR 13 doses at every 4 weeks) or until PD / unacceptable toxicity.

• Other indications (2L renal cell carcinoma, classical Hodgkin’s Lymphoma, combination with relatlimab, etc.) - Until PD or unacceptable toxicity.

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• Ipilimumab (1L Metastatic melanoma) - 1 mg/kg IV every 3 weeks x 4 doses, then 3 mg/kg (240 mg) IV every 2 weeks OR 6 mg/kg (480 mg) IV every 4 weeks.

• Ipilimumab (1L Intermediate / high risk metastatic renal cell carcinoma) - 3 mg/kg IV (no dose cap) every 3 weeks x 4 doses, then 3 mg/kg (240 mg) IV every 2 weeks OR 6 mg/kg (480 mg) IV every 4 weeks.

• Chemotherapy (Neoadjuvant NSCLC) - 4.5 mg/kg (360 mg) IV every 3 weeks.

• Cabozantinib (1L metastatic renal cell carcinoma) - 3 mg/kg (240 mg) IV every 2 weeks OR 6 mg/kg (480 mg) IV every 4 weeks.

• Ipilimumab and chemotherapy (1L metastatic NSCLC) - 4.5 mg/kg (max 360 mg) IV every 3 weeks.

• Chemotherapy (1L metastatic esophageal, GEJ or gastric cancer) - 3 mg/kg (max 240 mg) IV every 2 weeks (FOLFOX) OR 4.5 mg/kg (max 360 mg) IV every 3 weeks (CapOx, Cisplatin + 5FU, etc.).

• Relatlimab (1L Metastatic Melanoma) - 480 mg IV every 4 weeks.

All doses administered IV over 30 minutes.

40 mg and 100 mg (10 mg/mL)

Flat dose-response and dose-toxicity relationship.

26.7 days (133.5 days)

None.