Merrimack to Present Final Results of Phase 3 NAPOLI-1 Study at the European Society for Medical Oncology 2016 Congress
- Final results of NAPOLI-1 study will be presented in a poster discussion session
- Primary Phase 3 NAPOLI-1 data were the basis of the ONIVYDE® (irinotecan liposome injection) regimen's US and Taiwan FDA approvals and the EU CHMP positive opinion
- NAPOLI-1 safety-over-time subset analysis and new research on MM-302's potential to treat HER2-intermediate tumors will also be presented
CAMBRIDGE, Mass., Sept. 28, 2016 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced it will present six posters from its systems-biology derived antibody engineering and nanotherapeutic portfolios at the European Society for Medical Oncology (ESMO) 2016 Congress, October 7 – 11, 2016 in Copenhagen, Denmark.
Merrimack will present the final results of the Phase 3 NAPOLI-1 study in a poster discussion session and a NAPOLI-1 safety-over-time subset analysis in a separate poster session. The primary Phase 3 NAPOLI-1 data were the basis of the US Food and Drug Administration (FDA) and Taiwan FDA approvals of the ONIVYDE® (irinotecan liposome injection) combination regimen in October 2015. It is also the basis of the European Union's Committee for Medicinal Products for Human Use (CHMP) positive opinion issued in July 2016.
Additional ESMO 2016 poster presentations include an evaluation of MM-302's potential for treating HER2-intermediate tumors as well as two trials-in-progress posters, both potentially registrational, for MM-302 and seribantumab, also known as MM-121. MM-302 is an investigational HER2-targeted liposomal encapsulation of doxorubicin from Merrimack's antibody-directed nanotherapeutic platform, while seribantumab is Merrimack's investigational anti-ErbB3 monoclonal antibody that targets heregulin-positive cancer cells within solid tumors.
Poster Discussion Session:
- Final results of NAPOLI-1: A Phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract 622PD)
Session Title: Gastrointestinal tumours, non-colorectal
Date/Time: October 8, 2016, 8:40 am – 8:50 am (CEST)
Location: Copenhagen
Poster Sessions:
- Time course of selected treatment emergent adverse events (TEAEs) in NAPOLI-1: A Phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract 693)
Session Title: Gastrointestinal tumours, non-colorectal
Date/Time: October 8, 2016, 1:00 pm – 2:00 pm (CEST)
Location: Hall E
- Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumors (Abstract 1560)
Session Title: Translational research
Date/Time: October 10, 2016, 1:00 pm – 2:00 pm (CEST)
Location: Hall E
- HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and T-DM1 (Abstract 315TIP)
Session Title: Breast cancer, locally advanced and metastatic
Date/Time: October 10, 2016, 1:00 pm – 2:00 pm (CEST)
Location: Hall E
- SHERLOC: A Phase 2 study of seribantumab (MM-121) in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive (HRG+), locally advanced or metastatic non-small cell lung cancer (NSCLC) (Abstract 1296TIP)
Session Title: NSCLC, metastatic
Date/Time: October 8, 2016, 1:00 pm – 2:00 pm (CEST)
Location: Hall E
About Merrimack
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 in October 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.
Forward-Looking Statements
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.
Contacts:
Media Contact
Marianne McMorrow
774-776-1478
[email protected]
Investor Contact
Geoffrey Grande, CFA
617-441-7602
[email protected]
SOURCE Merrimack Pharmaceuticals, Inc.
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