1846 Ibrutinib Eviq Shine a bad study of upfront ibrutinib br is optimal in mantle cell | asco2022 | i explain why. vinay prasad, md mph; physician & associate professor google scholar:. The shine study met its primary endpoint of progression free survival (pfs). key findings from the phase 3 shine study include: with a median follow up of 84.7 months, the imbruvica ® plus br and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3 year improvement in median pfs. [1].
Ibrutinib Plus Bendamustine And Rituximab In Untreated Mantle Cell Primary results from the double blind, placebo controlled, phase iii shine study of ibrutinib in combination with bendamustine rituximab (br) and r maintenance as a first line treatment for older patients with mantle cell lymphoma (mcl). In this issue of blood, smith et al show that bendamustine rituximab (br) followed by rituximab maintenance (r) represents an effective induction regimen for patients with mantle cell lymphoma (mcl). 1 the authors conclude that this combination is viable standard initial therapy, at least for older patients, and can be considered the preferable. The shine trial compared br with rituximab maintenance plus ibrutinib vs placebo in patients ≥65 years old and showed that the ibrutinib arm had significantly improved progression free survival (pfs; median 80.6 vs 52.9 months) but similar overall survival (os; 57% vs 55% at 7 years) compared to the placebo arm. Shine, the designated confirmatory trial for the accelerated approval of ibrutinib in mcl, was a randomized, placebo controlled phase iii trial comparing time limited bendamustine and rituximab.
Pdf Efficacy And Safety Of Ibrutinib In Mantle Cell Lymphoma A The shine trial compared br with rituximab maintenance plus ibrutinib vs placebo in patients ≥65 years old and showed that the ibrutinib arm had significantly improved progression free survival (pfs; median 80.6 vs 52.9 months) but similar overall survival (os; 57% vs 55% at 7 years) compared to the placebo arm. Shine, the designated confirmatory trial for the accelerated approval of ibrutinib in mcl, was a randomized, placebo controlled phase iii trial comparing time limited bendamustine and rituximab. Now, data from the phase iii shine trial indicate that combining first line br with the btk inhibitor ibrutinib, which has notable single agent efficacy in later lines of treatment,. Results from the phase 3 shine trial show that adding ibrutinib to standard therapy delays progression by 50% in older patients with mantle cell lymphoma. • ibrutinib is an oral bruton tyrosine kinase (btk) inhibitor that demonstrated durable activity in relapsed refractory mcl and demonstrated anti tumor activity in early phase trials incorporating ibrutinib with br in the first line (1l) setting. • the shine trial is a phase iii clinical trial (nct01776840) evaluating the combination of. Single agent ibrutinib (ibr), a first in class, oral bruton’s tyrosine kinase inhibitor (btki), has transformed the care of pts with relapsed or refractory mcl with durable activity. we conducted a phase iii trial (shine; nct01776840) to evaluate combining ibr with a standard chemoimmunotherapy (br) and r maintenance in older pts with.
Comments are closed.