Merrimack Pharma (MACK) Will Present Phase 3 NAPOLI-1 Study Data at ESMO 2016

September 28, 2016 4:11 PM EDT
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Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) 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-colorectalDate/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-colorectalDate/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 researchDate/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 metastaticDate/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, metastaticDate/Time: October 8, 2016, 1:00 pm – 2:00 pm (CEST)Location: Hall E


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