On August 3, 2017 Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, reported the publication of the first large-scale multi-institutional analysis of outcomes of patients with refractory aggressive non-Hodgkin lymphoma (NHL) in the latest electronic edition of BLOOD (Press release, Kite Pharma, AUG 3, 2017, View Source [SID1234520014]). The study, SCHOLAR-1 (Retrospective Non-Hodgkin Lymphoma Research), showed outcomes in patients with refractory aggressive NHL subtypes including diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) or primary mediastinal B-cell lymphoma (PMBCL) following treatment with currently available therapies:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Objective response rate of 26 percent
Complete response rate of 7 percent
Median overall survival of 6.3 months
These findings highlight the unmet medical need and provide an important benchmark for studies that address this refractory patient population.
"SCHOLAR-1 demonstrates the uniformly poor treatment outcomes for patients with aggressive non-Hodgkin lymphoma and emphasizes the need for breakthrough therapies for these refractory patients," said Christian Gisselbrecht, MD, Professor of Hematology, Saint Louis Hospital at Diderot University Paris 7, and corresponding author of the study. "Although 60 to 70 percent of non-Hodgkin lymphoma patients survive five years after rituximab-based chemotherapy and autologous stem cell transplant, nearly half of them either do not respond or relapse shortly after transplant. SCHOLAR-1 provides a rigorous measure of outcomes for these patients who do not benefit from currently available therapies, and this landmark study will serve as an important historical control for evaluating new therapeutic candidates in the field of non-Hodgkin lymphoma."
Key points and findings:
SCHOLAR-1 uses pooled, patient-level data from two of the largest randomized controlled studies in NHL, the Canadian Cancer Trials Group study Ly.12 and the Lymphoma Academic Research Organization (LYSARC) Collaborative Trial in Relapsed Aggressive Lymphoma (CORAL) study, and from two observational cohorts from MD Anderson Cancer Center and the Molecular Epidemiology Resource of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (IA/MC).
The analysis includes 636 patients who met criteria for refractory DLBCL, TFL and PMBCL. Refractory status was defined as progressive disease or stable disease as best response to last chemotherapy, or relapse ≤12 months post-ASCT.
While patients with relapsed/refractory NHL, a more broadly defined patient population studied in Ly.12 and CORAL, have heterogeneous outcomes to subsequent therapy, the subgroup of patients with strictly refractory NHL, as studied in SCHOLAR-1, have uniformly poor outcomes and greater unmet need.
In the refractory NHL patient pool studied in SCHOLAR-1, objective response rate was 26 percent, complete response rate was 7 percent, and median overall survival was 6.3 months.
Outcomes for the refractory NHL patient pool studied in SCHOLAR-1 were consistently poor across patient subgroups.
SCHOLAR-1 was funded through an unrestricted grant from Kite.