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Posted by on Dec 15, 2018 in Non-Hodgkin lymphoma | 0 comments

In a nutshell

This study evaluated the safety and effectiveness of a new targeted therapy (INCB040093) with or without itacitinib in patients with relapsed or refractory (does not respond to treatment) lymphoma. This study concluded that this new agent was well-tolerated and showed promising effectiveness in these patients. 

Some background

Typical first-line therapy for non-Hodgkin's lymphoma (NHL) involves chemoimmunotherapy with rituximab (Rituxan). However, many patients relapse or develop refractory disease. New treatment options are needed for these patients, especially those who do not respond to multiple chemotherapy regimens. 

INCB040093 and itacitinib are targeted therapies. This type of treatment specifically targets cancer cells, blocking their growth. This leads to cancer cell death. The safety and effectiveness of INCB040093 alone or in combination with itacitinib for relapsed or refractory HL remain under investigation. 

Methods & findings

This study involved 114 patients with relapsed or refractory lymphoma. 65% of patients had NHL. Patients received either INCB040093 alone (monotherapy group) or together with itacitinib (combination group). Patients were treated for an average of 140 – 180 days. 

In the monotherapy group, 63% of patients with follicular lymphoma (FL) responded to treatment. 13% of these patients had a complete response (disappearance of all signs of cancer). 33% with mantle cell lymphoma (MCL) responded and 17% had a complete response. 50% with diffuse large B cell lymphoma (DLBCL) responded to treatment but none had a complete response.

In the combination group, 36% of patients with FL had a response, 9% a complete response. In patients with DLBCL, combination treatment led to a response in 26% and 17% had a complete response. 

The most common side effects in the monotherapy group were diarrhea (39%), fatigue (35%), cough (33%), nausea (33%), and headache (31%). The most common side effects in the combination group were nausea (46%), cough (43%), fatigue (39%), fever (36%), vomiting (35%) and diarrhea (31%).

The bottom line

This study concluded that INCB040093 with or without itacitinib was well-tolerated and showed promising effectiveness in patients with relapsed or refractory NHL. 

The fine print

This study was a Phase 1 study. Further studies are needed to determine the role of INCB040093 in the treatment of relapsed or refractory NHL. 

Published By :

Blood

Date :

Aug 09, 2018

Original Title :

Phase 1 study of the PI3Kδ inhibitor INCB040093 ± JAK1 inhibitor itacitinib in relapsed/refractory B-cell lymphoma.

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