MM-398 (Nanoliposomal Irinotecan): Emergence of a Novel Therapy for the Treatment of Advanced Pancreatic Cancer

References

• Siegel RL , MillerKD, JemalA. Cancer Statistics, 2015. CA Cancer J. Clin.65(1), 5–29 (2015).
   PubMed Web of Science ®Google Scholar
• Jemal A , BrayF, CenterMM, FerlayJ, WardE, FormanD. Global Cancer Statistics. CA Cancer J. Clin.61(2), 69–90 (2011).
   PubMed Web of Science ®Google Scholar
• Moore MJ , GoldsteinD, HammJet al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a Phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J. Clin. Oncol.25(15), 1960–1966 (2007).
   PubMed Web of Science ®Google Scholar
• Conroy T , DesseigneF, YchouMet al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N. Engl. J. Med.364(19), 1817–1825 (2011).
   PubMed Web of Science ®Google Scholar
• Von Hoff DD , ErvinT, ArenaFPet al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N. Engl. J. Med.369(18), 1691–1703 (2013).
   PubMed Web of Science ®Google Scholar
• Rahma OE , DuffyA, LiewehrDJ, SteinbergSM, GretenTF. Second-line treatment in advanced pancreatic cancer: a comprehensive analysis of published clinical trials. Ann. Oncol.24(8), 1972–1979 (2013).
   PubMed Web of Science ®Google Scholar
• Oettle H , RiessH, StielerJMet al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J. Clin. Oncol.32(23), 2423–2429 (2014).
   PubMed Web of Science ®Google Scholar
• Gill S , KoY-J, CrippsMet al. PANCREOX: a randomized Phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. J. Clin. Oncol.32(5s), Abstract 4022 (2014).
   Google Scholar
• Assaf E , Verlinde-CarvalhoM, DelbaldoCet al. 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma. Oncology80(5–6), 301–306 (2011).
   PubMed Web of Science ®Google Scholar
• Berger AK , WeberTF, JagerD, SpringfeldC. Successful treatment with nab-paclitaxel and gemcitabine after FOLFIRINOX failure in a patient with metastasized pancreatic adenocarcinoma. Onkologie36(12), 763–765 (2013).
   PubMedGoogle Scholar
• Bertocchi P , AbeniC, MeriggiFet al. Gemcitabine plus nab-paclitaxel as second-line and beyond treatment for metastatic pancreatic cancer: a single institution retrospective analysis. Rev. Recent Clin. Trials10(2), 142–145 (2015).
   PubMedGoogle Scholar
• Lee MG , LeeSH, LeeSJet al. 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) as second-line chemotherapy in patients with advanced pancreatic cancer who have progressed on gemcitabine-based therapy. Chemotherapy59(4), 273–279 (2013).
   PubMed Web of Science ®Google Scholar
• Portal A , PernotS, SiauveNet al. Sustained response with gemcitabine plus nab-paclitaxel after folfirinox failure in metastatic pancreatic cancer: report of an effective new strategy. Clin. Res. Hepatol. Gastroenterol.38(2), e23–e26 (2014).
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network . Pancreatic adenocarcinoma: NCCN clinical practice guidelines in oncology (v. 2.2015). www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf.
   Google Scholar
• Howlader N NA , KrapchoM, GarshellJet al. SEER Cancer Statistics Review, 1975–2012. National Cancer Institute. Bethesda, MD, USA. http://seer.cancer.gov/csr/1975_2012/.
   Google Scholar
• Ko AH . Progress in the treatment of metastatic pancreatic cancer and the search for next opportunities. J. Clin. Oncol.33(16), 1779–1786 (2015).
   PubMed Web of Science ®Google Scholar
• Drummond DC , NobleCO, GuoZ, HongK, ParkJW, KirpotinDB. Development of a highly active nanoliposomal irinotecan using a novel intraliposomal stabilization strategy. Cancer Res.66(6), 3271–3277 (2006).
   PubMed Web of Science ®Google Scholar
• Borad MJ , ReddySG, BaharyNet al. Randomized Phase II trial of gemcitabine plus TH-302 versus gemcitabine in patients with advanced pancreatic cancer. J. Clin. Oncol.33(13), 1475–1481 (2015).
   PubMed Web of Science ®Google Scholar
• Hingorani SR , HarrisWP, HendifarAEet al. High response rate and PFS with PEGPH20 added to nab-paclitaxel/gemcitabine in stage IV previously untreated pancreatic cancer patients with high-HA tumors: interim results of a randomized Phase II study. ASCO Meeting Abstracts33(Suppl. 15), 4006 (2015).
   Google Scholar
• Hurwitz H , UppalN, WagnerSAet al. Randomized, (mPC) double-blind, Phase II study of ruxolitinib or placebo in combination with capecitabine in patients with metastatic pancreatic cancer for whom therapy with gemcitabine has failed. J. Clin. Oncol.33(34), 4039–4047 (2015).
   PubMed Web of Science ®Google Scholar
• Isakoff SJ , SalehMN, LugovskoyAet al. First-in-human study of MM-141: a novel tetravalent monoclonal antibody targeting IGF-1R and ErbB3. ASCO Meeting Abstracts33(Suppl. 3), 384 (2015).
   Google Scholar
• Le DT , Wang-GillamA, PicozziVet al. Safety and survival with GVAX pancreas prime and Listeria Monocytogenes-expressing mesothelin (CRS-207) boost vaccines for metastatic pancreatic cancer. J. Clin. Oncol.33(12), 1325–1333 (2015).
   PubMed Web of Science ®Google Scholar
• Hsiang YH , HertzbergR, HechtS, LiuLF. Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J. Biol. Chem.260(27), 14873–14878 (1985).
   PubMed Web of Science ®Google Scholar
• Hsiang YH , LihouMG, LiuLF. Arrest of replication forks by drug-stabilized topoisomerase I-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res.49(18), 5077–5082 (1989).
   PubMed Web of Science ®Google Scholar
• Tournigand C , AndreT, AchilleEet al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J. Clin. Oncol.22(2), 229–237 (2004).
   PubMed Web of Science ®Google Scholar
• Kawato Y , AonumaM, HirotaY, KugaH, SatoK. Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res.51(16), 4187–4191 (1991).
   PubMed Web of Science ®Google Scholar
• Matsumura Y , MaedaH. A new concept for macromolecular therapeutics in cancer chemotherapy: mechanism of tumoritropic accumulation of proteins and the antitumor agent smancs. Cancer Res.46(12 Pt 1), 6387–6392 (1986).
   PubMed Web of Science ®Google Scholar
• Senior JH . Fate and behavior of liposomes in vivo: a review of controlling factors. Crit. Rev. Ther. Drug Carrier Syst.3(2), 123–193 (1987).
   PubMed Web of Science ®Google Scholar
• Chang TC , ShiahHS, YangCHet al. Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients. Cancer Chemother. Pharmacol.75(3), 579–586 (2015).
   PubMed Web of Science ®Google Scholar
• Roy AC , ParkSR, CunninghamDet al. A randomized Phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann. Oncol.24(6), 1567–1573 (2013).
   PubMed Web of Science ®Google Scholar
• Biason P , MasierS, ToffoliG. UGT1A1*28 and other UGT1A polymorphisms as determinants of irinotecan toxicity. J. Chemoth.20(2), 158–165 (2008).
   PubMed Web of Science ®Google Scholar
• Innocenti F , RatainMJ. Irinotecan treatment in cancer patients with UGT1A1 polymorphisms. Oncology (Williston Park)17(5 Suppl. 5), 52–55 (2003).
   PubMedGoogle Scholar
• Toffoli G , CecchinE, CoronaGet al. The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer. J. Clin. Oncol.24(19), 3061–3068 (2006).
   PubMed Web of Science ®Google Scholar
• Palomaki GE , BradleyLA, DouglasMP, KolorK, DotsonWD. Can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? An evidence-based review. Genet. Med.11(1), 21–34 (2009).
   PubMed Web of Science ®Google Scholar
• Ko AH , TemperoMA, ShanYSet al. A multinational Phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br. J. Cancer109(4), 920–925 (2013).
   PubMed Web of Science ®Google Scholar
• Innocenti F , SchilskyRL, RamirezJet al. Dose-finding and pharmacokinetic study to optimize the dosing of irinotecan according to the UGT1A1 genotype of patients with cancer. J. Clin. Oncol.32(22), 2328–2334 (2014).
   PubMed Web of Science ®Google Scholar
• Camptosar (irinotecan) package insert. Pfizer (NY, USA). www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf.
   Google Scholar
• Chen L , ShiahH, ChaoTet al. Phase I study of liposome irinotecan (PEP02) in combination with weekly infusion of 5-FU/LV in advanced solid tumors. ASCO Meeting Abstracts28(Suppl. 15), e13024 (2010).
   Google Scholar
• Chen L-T , ShiahH-S, LinP-Cet al. Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer failed on first-line oxaliplatin-based chemotherapy. ASCO Meeting Abstracts30(Suppl. 4), 613 (2012).
   Google Scholar
• Wang-Gillam A , LiCP, BodokyGet al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, Phase 3 trial. Lancet doi: 10.1016/S0140-6736(15)00986-1 ( Epub ahead of print) (2015).
   Google Scholar
• Chibaudel B , Maindrault-GoebelF, AndreTet al. PEPCOL: a randomized noncomparative Phase II study of PEP02 (MM-398) or irinotecan in combination with leucovorin and 5-fluorouracil as second-line therapy in patients with unresectable metastatic colorectal cancer – a GERCOR Study. ASCO Meeting Abstracts33(Suppl. 3), 751 (2015).
   Google Scholar
• Clarke JL , MolinaroAM, DesilvaAAet al. A Phase I trial of intravenous liposomal irinotecan in patients with recurrent high-grade gliomas. ASCO Meeting Abstracts33(Suppl. 15), 2029 (2015).
   Google Scholar
• Baker JH , LamJ, KyleAHet al. Irinophore C, a novel nanoformulation of irinotecan, alters tumor vascular function and enhances the distribution of 5-fluorouracil and doxorubicin. Clin. Cancer Res.14(22), 7260–7271 (2008).
   PubMed Web of Science ®Google Scholar
• Verreault M , StruttD, MasinDet al. Vascular normalization in orthotopic glioblastoma following intravenous treatment with lipid-based nanoparticulate formulations of irinotecan (Irinophore C), doxorubicin (Caelyx®) or vincristine. BMC Cancer11, 124 (2011).
   PubMed Web of Science ®Google Scholar