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Nivolumab in all diseases



Contents

Bladder cancer

Source: Nivolumab (Opdivo) for unresectable or metastatic bladder cancer

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Regimen

Study Evidence Efficacy Pt Population
Sharma et al. 2017 (CheckMate 275) Phase II (RT) 19.6% overall
PD-L1 expression ≥5%: 28.4%
PD-L1 expression ≥1%: 23.8%
PD-L1 expression <1%: 16.1%
Prior treatment with least one platinum-based therapy

Immunotherapy

  • Nivolumab (Opdivo) 3 mg/kg IV once on day 1
    • The FDA-approved dose which is listed in the package insert is 240 mg IV over 60 minutes once on day 1

14-day cycles

References

  1. CheckMate 275: Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JÁ, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):312-322. Epub 2017 Jan 25. link to original article contains protocol PubMed

Melanoma

Source: Nivolumab (Opdivo) for melanoma, adjuvant

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Regimen

Study Evidence Comparator Efficacy 12-month recurrence-free survival (RFS) Comparator RFS
Weber et al. 2017 (Checkmate 238) Phase III (E-RT-switch-ic) Ipilimumab Superior RFS 70.5% overall
Stage IIIB or IIIC: 72.3% (95% CI, 67.4 to 76.7)
Stage IV: 63.0% (95% CI, 51.6 to 72.5)
60.8% overall
Stage IIIB or IIIC: 61.6% (95% CI, 56.3 to 66.5)
Stage IV: 57.5% (95% CI, 46.0 to 67.4)

Preceding treatment

  • Complete resection of stage IIIB, IIIC, or IV melanoma

Immunotherapy

14-day cycle for up to 26 cycles (1 year)

References

  1. CheckMate 238: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbé C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA1; CheckMate 238 Collaborators. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. Epub 2017 Sep 10. link to original article contains verified protocol PubMed