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2014-05-01

Merrimack Pharmaceuticals: Merrimack Pharmaceuticals Announces MM-398 Achieves Primary Endpoint of Overall Survival in Phase 3 Trial in Post-Gemcitabine Metast

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|MM-398 in combination with 5-fluorouracil and leucovorin demonstrates |
|statistically significant advantage compared to control arm |
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|Plan to submit New Drug Application in 2014 |
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|Conference Call Scheduled for 8:30 a.m. ET Today |
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|CAMBRIDGE, Mass., May 1, 2014 (GLOBE NEWSWIRE) -- 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. |
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|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. |
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|"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." |
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|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. |
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|"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). |
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|"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." |
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|This study has been accepted for oral presentation at the European Society for |
|Medical Oncology World Conference on Gastrointestinal Cancer being held in |
|Barcelona, Spain on June 25-28, 2014. Merrimack expects to submit a New Drug |
|Application to the U.S. Food and Drug Administration for the MM-398 |
|combination regimen in 2014. |
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|NAPOLI-1 Trial Design |
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|NAPOLI-1 (NAnoliPOsomaL Irinotecan) is a randomized, open label Phase 3 study |
|in patients with metastatic pancreatic cancer who received prior |
|gemcitabine-based therapy. The study evaluated two MM-398 regimens, 80 |
|mg/m2combined with 5-FU and leucovorin every two weeks, and 120 mg/m2as a |
|monotherapy every three weeks. Each arm was compared to a control arm of 5-FU |
|and leucovorin. A total of 417 patients were randomized across the three |
|arms. Each MM-398 regimen was compared against the control arm on the primary |
|endpoint of overall survival. Patients were enrolled at over 100 sites in |
|North America, South America, Europe, Asia and Australia. |
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|Merrimack to Host Conference Call |
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|Merrimack will conduct a live conference call and webcast today, Thursday, May |
|1 at 8:30 a.m., Eastern Time, to discuss these top line results and provide a |
|summary of first quarter 2014 financial results. Investors and the general |
|public are invited to listen to the call by dialing (877) 564-1301 (domestic) |
|or (224) 357-2394 (international) five minutes prior to the start of the call |
|and providing the passcode 37032608. A listen-only webcast of the call can be |
|accessed in the Investors section of Merrimack's |
|website,http://investors.merrimackpharma.com, and a replay of the call will |
|be archived there for six weeks following the call. |
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|About MM-398 |
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|MM-398 (irinotecan liposome injection), also known as "nal-IRI," is a |
|nanoliposomal encapsulation of the chemotherapeutic irinotecan. MM-398 has |
|demonstrated extended circulation in comparison to free irinotecan in the |
|clinical setting. The activated form of irinotecan is SN-38, which functions |
|by inhibiting topoisomerase I (an essential enzyme involved in DNA |
|transcription and replication) and promoting cell death. |
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|MM-398 is an investigational agent which is also currently being evaluated in |
|an ongoing Phase 2 study in patients with metastatic colorectal cancer and |
|Phase 1 studies in Ewing's sarcoma and glioma. An additional Phase 1 clinical |
|trial is assessing a potential companion diagnostic for MM-398 in patients |
|with multiple cancer types to determine which patients are most likely to |
|benefit from treatment with the drug. |
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|Under a 2011 agreement with PharmaEngine, Inc. (Taipei, Taiwan), Merrimack |
|consolidated the worldwide development and commercialization rights to |
|MM-398, with PharmaEngine, Inc. retaining commercialization rights in Taiwan. |
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|MM-398 is not approved for any indication by the U.S. Food and Drug |
|Administration (FDA) or any other regulatory agency. Both the FDA and the |
|European Medicines Agency have granted MM-398 orphan drug designation in |
|metastatic pancreatic cancer. |
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|About Pancreatic Cancer |
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