Favrille says combining FavId, Rituxan improves non-Hodgkin's lymphoma treatment

By Ted A. Knutson

Washington, Dec. 13 - Favrille, Inc. reported positive long-term follow-up data from its phase 2 clinical trial of FavId following Rituxan treatment in patients with follicular B-cell non-Hodgkin's lymphoma.

Administration of FavId following Rituxan appears to improve response over Rituxan alone and extend time to disease progression compared to historical data, according to Omer Koc, a study principal investigator and staff physician for hematology/oncology at the Cleveland Clinic Foundation.

The data also compares favorably with previous immunotherapy studies in patients with B-cell non-Hodgkin's lymphoma that have used chemotherapy to induce remissions, Koc reported to the American Society of Hematology Annual Meeting in Atlanta.

A total of 103 patients were enrolled in the multi-center, open-label phase 2 trial, of which 89 had stable disease or a better response to Rituxan and received FavId, including 55 who were relapsed from or refractory to prior treatments and 34 who were treatment-naïve.

"The data indicate that this sequential regimen is very well tolerated and has the potential to improve the course of disease in a wide variety of patients with follicular B-cell NHL [non-Hodgkin's lymphoma]," Koc said.

In particular, treatment-naïve patients who responded to an initial course of Rituxan have demonstrated the longest time to disease progression, with only 17% of the patients in this subpopulation (4 of 23) having progressed to date. At a median observation period of about 22 months, only 19% of the total treatment-naïve population (10 of 35) and 13% Rituxan-responder population (10 of 44) have progressed. The median time to disease progression of the 23 patients in the chemotherapy relapse population is projected at 24.2 months, compared to published historical data of 10.2 months in a similar population.

The overall clinical response rate in the phase 2 trial increased from 49% at month 3 following Rituxan alone to 65% following the initiation of FavId. In addition, 29% of patients improved their condition from stable disease to partial response after the initiation of FavId (12 of 42), 5% improved from stable disease to complete response (2 of 42) and 21% improved from partial response to complete response (9 of 43) for an overall Response Improvement of 27% (23 of 85) in the trial.

"We believe these data support the design of our ongoing phase 3 registration trial of FavId following Rituxan, which has enrolled a high proportion of treatment-naïve patients and is nearing completion of enrollment," said John C. Gutheil, Favrille's vice president of medical research, in the news release.

Favrille is a San Diego-based biopharmaceutical company focused on targeted immunotherapies for the treatment of cancer and other diseases of the immune system.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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