Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results from a single-arm, open-label Phase 2 study (Study 101-09) evaluating idelalisib (formerly GS-1101), an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of patients with indolent non-Hodgkin’s lymphoma (iNHL) that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy. Previously, this has been a largely unstudied population for which there is significant unmet medical need for effective therapy. In the study, single-agent treatment with idelalisib achieved an overall response rate of 53.6 percent, with a median duration of response at this interim analysis of 11.9 months. Detailed study results will be presented this Thursday during an oral session at the 12 th International Conference on Malignant Lymphoma in Lugano, Switzerland (Abstract #064bis).
“Despite the progress achieved in recent years, most patients suffering from indolent non-Hodgkin’s lymphoma will progressively become resistant to currently available treatments. Therefore, there is a significant unmet medical need for novel therapies,” said Gilles A. Salles, MD, PhD, Professor of Medicine, Department of Hematology, Claude Bernard University, Lyon-Sud Hospital Center, Pierre-Benite, France. “These data suggest that idelalisib has the potential to provide durable disease control to this group of patients who have few if any remaining conventional treatment options.”
The overall response rate observed in the study was 53.6 percent (n=67; 95 percent CI: 44.5, 62.6) with five complete responses (four percent), 60 partial responses (48 percent), two minor responses and 46 patients with stable disease (36.8 percent). The overall response rate was highly consistent across all subgroups analyzed. Among patients who responded, the median duration of response was 11.9 months and the median time to response was 1.9 months (1.8, 3.7). Median progression-free survival for all patients was 11.4 months. Most patients (89 percent) experienced some shrinkage in lymph node size.
The most common Grade ≥3 adverse event was diarrhea (10 percent). Grade ≥3 transaminase elevations (measure of liver function) were reported via central laboratory testing in 13 percent of patients; Grade ≥3 neutropenia occurred in 26 percent of patients. Sixteen percent of patients discontinued due to adverse events. The study is ongoing.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV