CAMBRIDGE, Mass., Jan. 11, 2016 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced that an additional overall survival analysis from the Phase 3 NAPOLI-1 study of ONIVYDE™ (irinotecan liposome injection), also known as "nal-IRI," in post-gemcitabine metastatic pancreatic cancer will be presented at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium (ASCO GI), January 21-23, 2016, at the Moscone West Building in San Francisco.
Merrimack will also present under the "Trials in Progress" category posters on two ongoing front-line metastatic pancreatic cancer studies: ONIVYDE in combination with fluorouracil (5-FU) and leucovorin (LV), with or without the addition of oxaliplatin, versus nab-paclitaxel and gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma, and MM-141, also known as istiratumab, in combination with gemcitabine and nab-paclitaxel in front-line metastatic pancreatic cancer.
Session Title: General Poster Session B and Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Friday, January 22, 2016: 12:30 PM–2:00 PM and 5:30 PM–7:00 PM (PT)
- Updated overall survival analysis of NAPOLI-1: Phase 3 study of nanoliposomal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy. (Abstract #417, Board L11)
- Effect of baseline carbohydrate antigen 19-9 (CA19-9) level on overall survival (OS) in NAPOLI-1 trial: A Phase 3 study of MM-398 (nal-IRI), with or without 5-fluorouracil and leucovorin (5-FU/LV), versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy. (Abstract #425, Board L19)
- A randomized, open-label Phase 2 study of nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (mPAC). (Abstract #TPS482, Board O10)
- A multicenter Phase 2 study of istiratumab (MM-141) plus nab-paclitaxel (A) and gemcitabine (G) in metastatic pancreatic cancer (MPC). (Abstract #TPS481, Board O9)
About ONIVYDE™ [pronounced \ 'on - ih - vide \]
ONIVYDE™ (irinotecan liposome injection), also known as MM-398 or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal formulation. 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. ONIVYDE was recently approved by the U.S. Food and Drug Administration (FDA) in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.
About MM-141 (Istiratumab)
MM-141 is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). IGF-1R and ErbB3 complexes both activate a major signaling pathway that allows tumor cells to grow and develop resistance to chemotherapy. MM-141 is currently being tested in a Phase 2 study in combination with gemcitabine and nab-paclitaxel in front-line metastatic pancreatic cancer. The U.S. FDA has granted orphan drug designation for MM-141 for the treatment of pancreatic cancer. This orphan drug designation could provide Merrimack with seven-year marketing exclusivity and other benefits for MM-141 when approved by the U.S. FDA.
Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.
Any statements in this press release about future expectations, plans and prospects for Merrimack constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended. Actual results may differ materially from those indicated by such forward-looking statements. Merrimack anticipates that subsequent events and developments will cause its views to change. However, while Merrimack may elect to update these forward-looking statements at some point in the future, Merrimack specifically disclaims any obligation to do so.
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