August 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) ivunyiwe yi-Food and Drug Administration yokwelashwa kwe-adjuvant kweziguli ezine-urothelial carcinoma (UC) ezisengozini enkulu yokuphindeka emuva kokuvuselelwa okunamandla.
Lesi yisikhathi sokuqala ukuthi i-FDA ivume ukwelashwa okunciphisayo kweziguli ezinobungozi obukhulu be-UC. Okutholakele kuphinde kwasisekela isinqumo sokuguqula ukugunyazwa okusheshisiwe kwe-nivolumab kwe-UC esezingeni eliphakeme / ye-metastatic ekuvumweni okujwayelekile.
UNivolumab wafundwa e-CHECKMATE-274 (NCT02632409), isilingo esilawulwa ngokungahleliwe, esimpumputhe, esilawulwa nge-placebo ezigulini ezine-UC zesinye noma ipheshana elingaphezulu lomchamo (i-renal pelvis noma i-ureter) ababesengozini enkulu yokuphindeka zingakapheli izinsuku eziyi-120 ukuvuselelwa okunamandla. Iziguli zabelwa ngokungahleliwe (1: 1) ukuthola i-nivolumab 240 mg noma i-placebo ngokumfakelwa ngemithambo njalo emavikini amabili kuze kube ukuphindaphinda noma ubuthi obungabekezeleleki, isikhathi sokwelashwa esiphezulu sonyaka owodwa.
In the intent-to-treat (ITT) group and in patients with tumours expressing PD-L1 less than 1%, the primary effectiveness objective was investigator-assessed disease-free survival (DFS). Time to first recurrence (local urothelial tract, local non-urothelial tract, or distant metastatic) or death was used to determine DFS. For all primary objectives, a statistically significant improvement in DFS was reported in participants on the nivolumab arm vs. placebo at a prespecified interim analysis. In the ITT analysis, patients who got nivolumab had a median DFS of 20.8 months (95 percent CI: 16.5, 27.6) compared to 10.8 months (95 percent CI: 8.3, 13.9) in patients who received placebo (HR 0.70; 95 percent CI: 0.57, 0.86; p=0.0008). Patients who received nivolumab had a median DFS of not achieved (95 percent confidence interval: 21.2, not estimable) compared to 8.4 months (95 percent confidence interval: 5.6, 21.2) for those who got placebo (HR 0.55; 95 percent confidence interval: 0.39, 0.77; p=0.0005).
Isilinganiso esilinganiselwe sobungozi be-DFS besingu-0.83 ekuhlolweni kokuhlola kweziguli ezinamathumba angenayo i-PD-L1 (amaphesenti angama-58) (amaphesenti angama-95 we-CI: 0.64, 1.08). Ngamaphesenti angama-33 okufa kwabantu bonke abangahleliwe, idatha ye-OS isesekuqaleni. Kube nokushona kwabantu abangama-37 endaweni engaphansi kwe-UTUC (abangama-20 engalweni ye-nivolumab, abangu-17 engalweni ye-placebo).
Ukuqhuma, ukukhathala, isifo sohudo, i-pruritus, ubuhlungu be-musculoskeletal, kanye nokutheleleka komgudu womchamo kwakuyimiphumela emibi kakhulu evame kakhulu ebonwe cishe kuma-20% wabahlanganyeli abathola i-nivolumab ku-CHECKMATE-274.
I-Nivolumab inqunywe kumthamo ka-240 mg njalo emavikini amabili noma i-480 mg njalo emavikini amane ekwelashweni kwe-UC.
Izikhombo: https://www.fda.gov/
Bheka imininingwane lapha.
