- \n
- No reported Grade 3 or higher fatigue or peripheral neuropathy.<\/li>\n
- One study participant in the Part 1A\u2013cohort B dose exploration phase reported a DLT (febrile neutropenia).<\/li>\n
- Treatment emergent adverse events (TEAEs) Grade 3 or higher were reported by 20 of 32 study patients in the 50\/60 PP and included: neutropenia (n=9); febrile neutropenia (n=4); hypokalemia (n=4); diarrhea (n=3); nausea (n=3); anemia (n=2); vomiting (n=2).<\/li>\n
- Four study patients in the 50\/60 PP reported TEAEs leading to discontinuation (n=4\/32), with 23 study patients requiring dose adjustment due to AEs.<\/li>\n
- At data cut-off, 15\/32 study patients in the 50\/60 PP remained on treatment.<\/li>\n<\/ul>\n
Efficacy Results:<\/b><\/p>\n
- \n
- BOR (Best Overall Response) was: one complete response (CR; study participant diagnosed with locally advanced Stage III disease), 10 partial responses (PR) in 31.3% (10\/32) and 15 stable diseases (SD) in 46.9% (15\/32) (sum of CR+PR+SD = 81.3%).<\/li>\n
- 71.9% (23\/32) of study patients in the 50\/60 PP achieved disease control at 16 weeks.<\/li>\n
- Overall, 34% of study patients had a response.<\/li>\n<\/ul>\n
ABOUT ONIVYDE\u00ae (irinotecan liposome injection)<\/b><\/p>\n
ONIVYDE\u00ae is an encapsulated formulation of irinotecan available as a 43 mg\/10 mL single dose vial. This liposomal form is designed to increase length of tumor exposure to both irinotecan and its active metabolite, SN-38.
\nIpsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE\u00ae in the US. Servier is responsible for the development and commercialization of ONIVYDE\u00ae outside of the U.S. and Taiwan under an exclusive licensing agreement with Ipsen.
\nONIVYDE\u00ae is approved by the FDA and the EMA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Limitation of Use: ONIVYDE\u00ae is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.<\/p>\nIMPORTANT SAFETY INFORMATION \u2013 UNITED STATES<\/b><\/p>\n
BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA<\/b>
\nFatal neutropenic sepsis occurred in 0.8% of patients receiving ONIVYDE\u00ae. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving ONIVYDE\u00ae in combination with 5-FU and LV.<\/b>
\nWithhold ONIVYDE\u00ae for absolute neutrophil count below 1500\/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.<\/b>
\nSevere diarrhea occurred in 13% of patients receiving ONIVYDE\u00ae in combination with 5-FU\/LV. Do not administer ONIVYDE\u00ae to patients with bowel obstruction. Withhold ONIVYDE\u00ae for diarrhea of Grade 2\u20134 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.<\/b><\/p>\nCONTRAINDICATION<\/b><\/p>\n
ONIVYDE\u00ae is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE\u00ae or irinotecan HCl<\/p>\n
Warnings and Precautions<\/b><\/p>\n
Severe Neutropenia: See Boxed WARNING.<\/b> In patients receiving ONIVYDE\/5-FU\/LV, the incidence of Grade 3\/4 neutropenia was higher among Asian (18\/33 [55%]) vs White patients (13\/73 [18%]). Neutropenic fever\/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients
\nSevere Diarrhea: See Boxed WARNING<\/b>. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset \u226424 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed
\nInterstitial Lung Disease (ILD):<\/b> Irinotecan HCl can cause severe and fatal ILD. Withhold ONIVYDE in patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue ONIVYDE in patients with a confirmed diagnosis of ILD
\nSevere Hypersensitivity Reactions:<\/b> Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue ONIVYDE in patients who experience a severe hypersensitivity reaction
\nEmbryo-Fetal Toxicity:<\/b> ONIVYDE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after ONIVYDE treatment<\/p>\nAdverse Reactions<\/b><\/p>\n
- \n
- The most common adverse reactions (\u226520%) were diarrhea (59%), fatigue\/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)<\/li>\n
- The most common Grade 3\/4 adverse reactions (\u226510%) were diarrhea (13%), fatigue\/asthenia (21%), and vomiting (11%)<\/li>\n
- Adverse reactions led to permanent discontinuation of ONIVYDE in 11% of patients receiving ONIVYDE\/5- FU\/LV; The most frequent adverse reactions resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and sepsis<\/li>\n
- Dose reductions of ONIVYDE for adverse reactions occurred in 33% of patients receiving ONIVYDE\/5 FU\/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia<\/li>\n
- ONIVYDE was withheld or delayed for adverse reactions in 62% of patients receiving ONIVYDE\/5-FU\/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia<\/li>\n
- The most common laboratory abnormalities (\u226520%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)<\/li>\n<\/ul>\n
Drug Interactions<\/b><\/p>\n
- \n
- Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies \u22652 weeks prior to initiation of ONIVYDE<\/li>\n
- Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors \u22651 week prior to starting therapy<\/li>\n<\/ul>\n
Special Populations<\/b><\/p>\n
- \n
- Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after ONIVYDE treatment<\/li>\n
- Lactation: Advise nursing women not to breastfeed during and for 1 month after ONIVYDE treatment<\/li>\n<\/ul>\n
Please see full U.S. Prescribing Information for ONIVYDE\u00ae.<\/p>\n
About the Phase 1\/2 Study<\/b><\/p>\n
The Phase 1\/2, open-label, comparative trial is designed to assess the safety, tolerability and dose-limiting toxicities of irinotecan liposomal injection (ONIVYDE\u00ae) in combination with 5- fluorouracil\/leucovorin (5-FU\/LV) and oxaliplatin (OX) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma cancer patients. The study has enrolled 56 patients at 15 sites across the United States, Spain and Australia. It is being conducted in two parts:<\/p>\n
- \n
- Part 1a: a safety run-in as initial dose exploration<\/li>\n
- Part 1b: dose expansion of the nal-IRI + 5FU\/LV + oxaliplatin regimen<\/li>\n<\/ul>\n
The study\u2019s primary endpoint is safety and tolerability. Secondary assessments of clinical efficacy include overall response rate, disease control rate and best overall response. For more information visit clinicaltrials.gov and use identifier NCT02551991.<\/p>\n
About Ipsen<\/b><\/p>\n
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas \u2013 Oncology, Neuroscience and Rare Diseases. Its commitment to Oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over \u20ac2.2 billion in 2018, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen\u2019s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com<\/b><\/a>.<\/p>\n
About Servier<\/b><\/p>\n
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a turnover of 4.2 billion euros in 2018, Servier employs 22,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generics) in research and development and uses all its profits for development. Corporate growth is driven by Servier\u2019s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.
\nBecoming a key player in oncology is part of Servier\u2019s long-term strategy. Currently, there are twelve molecular entities in clinical development in this area, targeting gastro-intestinal and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune targeted therapies, to deliver life-changing medicines to patients.
\nMore information: www.servier.com<\/b><\/a><\/p>\nIpsen\u2019s Forward Looking Statement<\/b><\/p>\n
The forward-looking statements, objectives and targets contained herein are based on the Group\u2019s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group\u2019s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words \u201cbelieves\u201d, \u201canticipates\u201d and \u201cexpects\u201d and similar expressions are intended to identify forward-looking statements, including the Group\u2019s expectations regarding future events, including regulatory filings and determinations, and the outcome of this study or other studies.
\nMoreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
\nOther risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group\u2019s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group\u2019s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and\/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group\u2019s activities and financial results.
\nThe Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group\u2019s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group\u2019s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group\u2019s business is subject to the risk factors outlined in its registration documents filed with the French Autorit\u00e9 des March\u00e9s Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group\u2019s 2018 Registration Document available on its website (www.ipsen.com<\/b><\/a>).<\/p>\nFor further information:<\/b><\/p>\n
Christian Marcoux, M.Sc.
\nGlobal Corporate Communications
\n+33 (0) 1 58 33 67 94
\nchristian.marcoux@ipsen.com<\/b><\/a><\/p>\nKelly Blaney
\nGlobal Corporate Communications
\n+44 (0) 7903 402275
\nkelly.blaney@ipsen.com<\/b><\/a><\/p>\nMaryann Quinn
\nDirector, Product Communications
\n+1-857-529-1151
\nmaryann.quinn@ipsen.com<\/b><\/a><\/p>\nFinancial Community
\nEugenia Litz
\nVice President, Investor Relations
\n+44 (0) 1753 627721
\neugenia.litz@ipsen.com<\/b><\/a><\/p>\nMyriam Koutchinsky
\nInvestor Relations Manager
\n+33 (0)1 58 33 51 04
\nmyriam.koutchinsky@ipsen.com<\/b><\/a><\/p>\nServier media relations
\nSonia MARQUES: media@servier.com<\/b><\/a> \u2013 Tel.: +33 (0)1 55 72 40 21 \/ + 33 (0)7 84 28 76 13
\nJean-Cl\u00e9ment VERGEAU: media@servier.com<\/b><\/a> \u2013 Tel.: +33 (0)1 55 72 46 16 \/ +33 (0)6 79 56 75 96<\/p>\nAttachment<\/strong><\/p>\n
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