Merck and Endocyte Announce Independent DSMB Recommends Vintafolide PROCEED Phase 3 Trial Be Stopped for Futility Following Interim Analysis
WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, and Endocyte, Inc. (ECYT), today announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has completed a pre-specified, interim futility analysis and the DSMB recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. The DSMB did not identify any safety concerns for the patients enrolled in the trial. Based on the DSMB recommendation and while further review of the data is conducted, the Companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended.
PROCEED is a Phase 3 randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant ovarian cancer. The primary endpoint of the trial was PFS as measured by RECIST v 1.1 (Response Evaluation Criteria In Solid Tumor) criteria in patients with all target tumor lesions positive as assessed by etarfolatide imaging agent.
About Merck
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company's SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment. For more information, visit http://www.endocyte.com.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they 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.
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 in the United States and internationally; 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; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Endocyte Forward-Looking Statement
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's expectations for seeking regulatory approval and commercial launch of its products, including any conditional marketing authorization from the EMA, initiation of future clinical trials, and expectations for the receipt of milestones, royalties or other profits from the company’s partnership with Merck. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, unavailability of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company's product candidates, the goals of its development activities, estimates of the potential markets for its product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected financial results. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company's periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Contact:
Merck
Media:
Ian McConnell, +1 908-423-3046
Claire Mulhearn, +1 908-423-7425
or
Investors:
Carol Ferguson, +1 908-423-4465
Justin Holko, +1 908-423-5088
or
Endocyte
Media:
Martina Schwarzkopf, +1 212-845-4292
Tony Russo, +1 212-845-4251
or
Investors:
Stephanie Ascher, +1 212-362-1200
On the contrary, the monotherapy arm of MM-398 did not meet the primary endpoint as compared to the control arm of 5-FU/LV (4.9 months vs. 4.2 months, p-value = 0.942, hazard ratio = 0.99), and the patients in this monotherapy arm displayed higher levels of adverse events than those in the combination arm.
“NAPOLI-1 study is the first phase 3 registration trial successfully demonstrating survival benefits of the MM-398/5-FU/LV combination in the metastatic pancreatic cancer patients in the post-gemcitabine setting. It has been my privilege to have contributed since the beginning of the clinical development of this drug in Taiwan, which I hope, offers clinically meaningful benefits to this devastating patient population around the globe,” said Prof. Li-Tzong Chen, Director of National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
“My sincere gratitude goes to Prof. Aimery de Gramont, Hôpital Saint-Antoine, Paris, France who proposed this combination regimen (known as FUPEP regimen) and provided its initial safety data in a phase 2 metastatic colorectal cancer study which allowed us adding this arm to the NAPOLI-1 study. We are grateful to so many patients, their physicians, and caregivers who were willing to partake in this important study,” said C. Grace Yeh, Ph.D., President and CEO of PharmaEngine. “We are delighted to collaborate effectively with Merrimack in completing the study in such an expeditious manner, and plan to submit a New Drug Application to Taiwan FDA before the end of this year. The successful development of this drug has opened a new page for the pharmaceutical industry in Taiwan.”
An abstract for this study has been accepted for oral presentation by the global principal investigator, Dr. Daniel D. Von Hoff, Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief for the Translational Genomics Research Institute (TGen), at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer to be held on June 25-28, 2014 in Barcelona, Spain.
About NAPOLI-1 Study
The global, randomized, open label phase 3 study, referred to as NAPOLI-1 (NAPOLI acronym: NAnoliPOsomaL Irinotecan), is being sponsored by Merrimack Pharmaceuticals, Inc. (Cambridge, MA, USA). Patients were recruited from over 100 sites in 15 countries (North America, South America, Europe, Asia and Australia). The total enrollment of 417 patients were randomized across the three arms: MM-398 (120 mg/m2, every three weeks) as a monotherapy, MM-398 (80 mg/m2, every two weeks) in combination with 5-FU/LV, and a shared control arm of 5-FU/LV. The primary endpoint of this study is overall survival. For study details, please see http://www.clinicaltrials.gov.
About MM-398 (aka PEP02)
MM-398 (irinotecan liposome injection), also known as “nal-IRI”, is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. In May 2011, PharmaEngine granted back to Merrimack the rights to develop, manufacture, and commercialize MM-398 in Asia and Europe, and retained its rights to the product in Taiwan, where it is known as PEP02. MM-398 has received orphan drug designation from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in metastatic pancreatic cancer during the same year.
About Pancreatic Cancer
Metastatic pancreatic cancer is almost uniformly fatal, with an overall survival rate of approximately 5 percent at 5 years worldwide. The first-line therapy approved for the metastatic pancreatic cancer is gemcitabine or gemcitabine-containing regimen. However, the treatment effect of gemcitabine is limited in terms of extending the survival period and improving the quality of life. The patients with metastatic pancreatic cancer, who failed gemcitabine treatment, have no standard therapy approved by any regulatory authority.
About PharmaEngine, Inc. (4162.TWO)
PharmaEngine, Inc. is a biopharmaceutical company established in Taipei, Taiwan in 2003. PharmaEngine focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases. PharmaEngine has two clinical stage projects and one in drug discovery stage. For further information, please visit the PharmaEngine’s website at http://www.pharmaengine.com.
Contact:
PharmaEngine, Inc.
Peter Wu, +886-2-2515-8228 ext. 300
Director, Corporate Development
Mobile: +886-935-154-559
peter.wu@pharmaengine.com
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