Zie ook dit artikel: https://kanker-actueel.nl/chirurgie-pdt-foto-dynamische-therapie-met-bremachlorin-geeft-veel-betere-overall-overleving-op-5-jaar-dan-alleen-chirurgie-van-melanomen-vanuit-moedervlekken-ontstaan.html

Zie ook dit artikel: https://kanker-actueel.nl/immuuntherapie-met-nivolumab-plus-ipilimumab-geeft-veel-betere-overall-ziektevrije-overleving-plus-28-en-38-procent-in-vergelijking-met-alleen-nivolumab-of-placebo-bij-patienten-met-operabele-stadium-iv-melanoom-zonder-bewijs-van-ziekte-na-operatie.html


4 juni 2021: ASCO 2021

Patiënten met inoperabel stadium III of IV melanoom die werden behandeld met een combinatie van de anti-PD medicijnen nivolumab plus ipilimumab blijken veel langer te leven dan wanneer zij werden behandeld met alleen nivolumab of alleen met ipilimumab. Mediane overall overleving was 72,1 maanden voor de combinatie vs 36,9 maanden voor alleen nivolumab en 19,9 maanden voor alleen ipilimumab.
Ook werd een langere mediane behandelingsvrije tijd gezien voor de combinatiebehandeling (27,6 maanden vs. 2,3 maanden en 1,9 maanden).
Bovendien bleek een lager percentage patiënten dat daaropvolgende systemische therapie kreeg (36% vs. 49% en 66%) en een hoger percentage patiënten dat geen behandeling meer kreeg en nooit vervolgtherapie kreeg (81% vs. 74% en 43%).
Er werden wel meer graad 3/4 behandelingsgerelateerde bijwerkingen gemeld voor de combinatiebehandeling (59%) dan de andere twee groepen (24% voor alleen nivolumab en 28% voor alleen ipilimumab).

Dit zijn de resultaten van 6,5 jaar follow-up van de fase III Checkmate 067 studie.


NIVO + IPI
(N = 314)
NIVO
(N = 316)
IPI
(N = 315)
Median OS: all pts, mo (95% CI) 72.1
(38.2–NR)
36.9
(28.2–NR)
19.9
(16.8–24.6)
6.5-y OS rate: all pts, % (95% CI) 49
(44–55)
42
(37–42)
23
(19–28)
BRAF mutant 57
(47–66)
43
(33–53)
25
(17–34)
Median PFS: all pts, mo (95% CI) 11.5
(8.7–19.3)
6.9
(5.1–10.2)
2.9
(2.8–3.2)
6.5-y PFS rate: all pts, % (95% CI) 34
(29–40)
29
(23–34)
7
(4–11)
Investigator-assessed ORR, % (95% CI) 58.3
(52.6–63.8)
44.9
(39.4–50.6)
19.0
(14.9–23.8)
Duration of response, mo (95% CI) NR
(61.9–NR)
NR
(45.7–NR)
19.3
(8.8–47.4)




Hier het abstract zoals geprenteerd op ASCO 2021:

CheckMate 067: 6.5-year outcomes in patients (pts) with advanced melanoma.

Authors:

Jedd D. Wolchok, Vanna Chiarion-Sileni, Rene Gonzalez, Jean-Jacques Grob, Piotr Rutkowski, Christopher D. Lao, Charles Lance Cowey, Dirk Schadendorf, John Wagstaff, Reinhard Dummer, Pier Francesco Ferrucci, Michael Smylie, Marcus O. Butler, Andrew Graham Hill, Ivan Marquez-Rodas, John B. A. G. Haanen, Tuba Bas, Wim van Dijck, James Larkin, F. Stephen Hodi; Medical Oncology, Memorial Sloan...

Research Funding:

Bristol Myers Squibb

Background:In the phase 3 CheckMate 067 trial, a durable and sustained clinical benefit was achieved with nivolumab (NIVO) + ipilimumab (IPI) and NIVO alone vs IPI at 5-y of follow-up (overall survival and progression-free survival rates: 52%, 44%, 26% and 36%, 29%, 8%, respectively). Here we report 6.5-y efficacy and safety outcomes.Methods:Eligible pts with previously untreated unresectable stage III or IV melanoma were randomly assigned in a 1:1:1 ratio and stratified by PD-L1 status, BRAF mutation status, and metastasis stage. Pts received NIVO 1 mg/kg + IPI 3 mg/kg for 4 doses Q3W followed by NIVO 3 mg/kg Q2W (n = 314), NIVO 3 mg/kg Q2W + placebo (n = 316), or IPI 3 mg/kg Q3W for 4 doses + placebo (n = 315) until progression or unacceptable toxicity. Co-primary endpoints were PFS and OS with NIVO + IPI or NIVO vs IPI. Secondary endpoints included objective response rate (ORR), descriptive efficacy assessments of NIVO + IPI vs NIVO alone, and safety.Results:With a minimum follow-up of 6.5 y, median OS was 72.1 mo with NIVO + IPI, 36.9 mo with NIVO, and 19.9 mo with IPI (table). Median time from randomization to subsequent systemic therapy was not reached (NR; 95% CI, 59.6–NR) with NIVO + IPI, 25.2 mo (95% CI, 16.0–43.2) with NIVO, and 8.0 mo (95% CI, 6.5–8.7) with IPI; 36%, 49%, and 66% of pts, respectively, received any subsequent systemic therapy. Median treatment-free interval (which excluded pts who discontinued follow-up prior to initiation of subsequent systemic therapy) was 27.6 mo (range, 0–83.0), 2.3 mo (range, 0.2–81.6), and 1.9 mo (range, 0.1–81.9) with NIVO + IPI, NIVO, and IPI, respectively. Of the pts alive and in follow-up, 112/138 (81%; NIVO + IPI), 84/114 (74%; NIVO), and 27/63 (43%; IPI) were off treatment and never received subsequent systemic therapy; 7, 8, and 0 pts, respectively, were still on treatment. Grade 3/4 treatment-related adverse events were reported in 59% of NIVO + IPI-treated pts, 24% of NIVO-treated pts, and 28% of IPI-treated pts. Since the 5-y analysis, no new safety signals were observed and no additional treatment-related deaths occurred.Conclusions:This 6.5-y analysis represents the longest follow-up from a phase 3 melanoma trial in the modern checkpoint inhibitor combination therapy and targeted therapy era. The results show durable improved outcomes with NIVO + IPI and NIVO vs IPI in pts with advanced melanoma. We observed improvement in OS, PFS, and ORR with NIVO + IPI over NIVO alone. Clinical trial information: NCT01844505


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