This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Positive Data From Phase 2 Trial Of NKTR-102 In Patients With AvastinA®-Refractory High-Grade Glioma Presented At 50th ASCO Meeting

SAN FRANCISCO, May 31, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) announced today new data from an investigator-sponsored Phase 2 study of NKTR-102 (etirinotecan pegol) in patients with Avastin-refractory high-grade glioma conducted at Stanford Cancer Institute under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigator Seema Nagpal, M.D., Clinical Assistant Professor of Neurology and Neurological Sciences, Stanford School of Medicine.

"Patients with Avastin-refractory high-grade glioma currently have little to no treatment options to help them manage their disease," said Dr. Recht. "Patients progress rapidly once resistance develops, objective responses are rarely seen. In this study we saw three patients – 15%, all with glioblastoma - with confirmed partial responses on single-agent NKTR-102 according to RANO criteria and an additional eight patients – 40% -- who had stable disease as a best response."

The trial enrolled 20 patients with high-grade glioma from August 2012 to May 2013. Patients had a median KPS of 70 and had received a median of three lines of prior therapy, including recurrence following treatment with Avastin. Avastin-refractory was defined as progression by RANO criteria within 60 days of prior Avastin (bevacizumab) treatment. Ninety percent of patients in the trial had glioblastoma. Patients received a median of three cycles (1-22) of NKTR-102 once every three weeks as monotherapy. Six-week progression-free survival in at least 25% of the patients was needed to reject the null hypothesis for the primary endpoint. 

Study ResultsThe primary endpoint was met and exceeded with fifty-five percent (95% CI: 31%-75%) of patients in the study achieving six-week progression-free survival. Response and disease progression were assessed by RANO criteria in the trial. Three patients, or 15%, achieved partial responses with NKTR-102 monotherapy with maximum percent reductions in tumor area of 86%, 72%, and 59%. An additional eight patients, or 40%, achieved stable disease as best response. Two of the three patients with RANO responses experienced a long duration of response of 14 and 20 months. Secondary endpoints include median progression-free survival (2.2 months), median survival from time of first NKTR-102 infusion (4.5 months) and median overall survival from date of pathologic diagnosis or confirmation of high-grade glioma (17.1 months). NKTR-102 monotherapy was well-tolerated in patients with Avastin-refractory high-grade glioma with low toxicity in spite of being heavily pre-treated and neurologically symptomatic. Only one patient (5%) had Grade 3 toxicity (diarrhea with dehydration) attributable to NKTR-102 as a result of not taking anti-diarrheal medication. Hematologic toxicity was mild. As of May 31, 2014, there is one patient in the study who is continuing on NKTR-102 monotherapy.

"Though participants in this trial were heavily pre-treated and more neurologically symptomatic than many clinical trial patients, we observed low toxicity with three partial responses," said Dr. Nagpal. "In addition, two of the three patients with responses experienced a long duration of response of 14 and 20 months, respectively. These results warrant further investigation of NKTR-102 in high-grade glioma, including glioblastoma as single-agent and in combination with bevacizumab, which could theoretically enhance retention of NKTR-102 in the tumor."

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

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.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,279.74 +13.75 0.08%
S&P 500 2,010.40 -0.96 -0.05%
NASDAQ 4,579.7890 -13.6380 -0.30%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs