2016.05.11 (수)

  • -동두천 11.1℃
  • -강릉 10.2℃
  • 구름조금서울 11.4℃
  • 대전 12.6℃
  • 흐림대구 12.9℃
  • 흐림울산 12.6℃
  • 흐림광주 13.5℃
  • 흐림부산 13.8℃
  • -고창 13.5℃
  • 흐림제주 13.5℃
  • -강화 12.5℃
  • -보은 11.6℃
  • -금산 11.5℃
  • -강진군 14.3℃
  • -경주시 12.4℃
  • -거제 13.2℃

건강

Merrimack Pharmaceuticals Announces MM-398 Achieves Primary Endpoint of Overall Survival in Phase 3 Trial in Post-Gemcitabine Metastatic Pancreatic Cancer

[By NBC-1TV H. J Yook]Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced that the combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone. The NAPOLI-1 Phase 3 study was conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. The primary log-rank analysis of overall survival was statistically significant (p=0.012) with a corresponding hazard ratio of 0.67. A statistically significant advantage for progression free survival was also observed in the combination arm.

The most common Grade 3 or higher adverse events in the combination arm were neutropenia (14.5%), fatigue (13.7%), diarrhea (12.8%) and vomiting (11.1%). Sepsis (3.4%) was the only serious life threatening event that occurred with a more than 2% difference between the combination arm and the control arm.

“We are excited by the results of the NAPOLI-1 study because of the critical need to help patients with this devastating illness and are moving forward as quickly as possible to get MM-398 to patients,” said Robert Mulroy, President and CEO of Merrimack. “Given that there have only been a handful of successful Phase 3 trials in pancreatic cancer in the past 25 years, it is gratifying to have the first positive Phase 3 trial in the post-gemcitabine setting. The results reinforce our confidence in our entire nanoliposomal pipeline. We are grateful for the dedication of the investigators, the research community and, most importantly, the patients and their families who bravely participated in this study.”

The Phase 3 study also examined MM-398 in a monotherapy regimen. MM-398 had a 4.9 month median overall survival as a monotherapy, but did not achieve a statistically significant survival advantage compared to the 4.2 months in the control arm. The hazard ratio for overall survival was 0.99 with a corresponding p-value of 0.942. In general, patients experienced a higher level of adverse events with the MM-398 monotherapy dose and treatment schedule compared to patients who received the combination of MM-398 with 5-FU and leucovorin.

“This demonstration of a survival benefit from the MM-398 plus 5-FU and leucovorin combination is particularly important given that we have very few treatment options for patients in this tough clinical setting,” said Daniel D. Von Hoff, M.D., F.A.C.P., global principal investigator of the NAPOLI-1 study, Chief Scientific Officer for Scottsdale Healthcare's Virginia G. Piper Cancer Center and Distinguished Professor at Translational Genomics Research Institute (TGen).

“The Pancreatic Cancer Action Network‘s goal is to double pancreatic cancer survival by 2020. The positive results of this trial demonstrate progress toward that goal in a disease for which additional treatment options are urgently needed to improve patient outcomes,” stated Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network. “These results also underscore the important role clinical trials play when patients are exploring their treatment options. We applaud Merrimack’s dedication to improving the treatment landscape for this patient population, and helping us charge forward in the fight against pancreatic cancer.”


관련기사

NEWS BEYOND CLICHE-BiG NEWS-100



배너
배너
배너
배너