Researchers Dose First Patient in Pivotal Study of Duvelisib

February 7, 2020

The study is evaluating the oral inhibitor for patients with relapsed or refractory follicular lymphoma.

A pivotal Chinese study evaluating the inhibitor duvelisib (Copiktra) in patients with relapsed or refractory follicular lymphoma dosed their first patient, according to Verastem, the agent’s developer.1

The study is being conducted by CSPC Pharmaceutical Group Limited in partnership with Verastem.

“Building on CSPC’s strong track record of successfully developing and commercializing oncology products in China, we are pleased that this CSPC trial is now underway as they work to provide a new option for patients with follicular lymphoma in China, where there are limited options for this difficult to treat disease,” Brian Stuglik, chief executive officer for Verastem Oncology, said in a press release. “The first patient dosed in this trial is a critical step in our mission to bring Copiktra to patients around the world.” 

The single-arm, open-label, multicenter study is expected to operate as a bridging study based on the efficacy and safety observed in the phase II DYNAMO study, which demonstrated clinically meaningful activity and a manageable safety profile in heavily pretreated, double-refractory indolent non-Hodgkin lymphoma.2 According to the company, results from this study are intended to form the basis of a regulatory submission for duvelisib for the treatment of relapsed or refractory follicular lymphoma in China.

Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and the first approved dual inhibitor of PI3K-delta and PI3K -gamma, 2 enzymes that have been found to help support the growth and survival of malignant B-cells in the US. It has previously been suggested that PI3K signaling might lead to the proliferation of malignant B-cells and is also thought to play a role in the formation and maintenance of the supportive tumor microenvironment. 

The most common adverse reactions observed in patients prescribed duvelisib (≥20%) have been diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. It is not yet known if duvelisib is safe and effective in children less than 18 years of age. 

The FDA approved duvelisib in September 2018 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least 2 prior therapies. The inhibitor also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least 2 prior systemic therapies. However, continued approval for the treatment of patients with follicular lymphoma may be dependent upon verification and description of clinical benefit in confirmatory trials. 

According to the National Cancer Institute SEER program, 88.4% of people survive 5 years or more after being diagnosed with follicular lymphoma. Additionally, based on 2012-2016 cases and deaths, the number of new cases of follicular lymphoma was 2.7 per 100,000 men and women per year. 

Reference:

1. Verastem Oncology Announces Dosing of First Patient in CSPC’s Chinese Study Evaluating COPIKTRA® (Duvelisib) in Patients with Relapsed or Refractory Follicular Lymphoma [news release]. Published January 29, 2020. finance.yahoo.com/news/verastem-oncology-announces-dosing-first-120600926.html. Accessed February 7, 2020. 

2. Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. Journal of Clinical Oncology. doi:10.1200/JCO.18.00915.