NewLink Genetics Corporation today announced positive Phase 2 clinical trial data of its HyperAcute®-Pancreas cancer immunotherapy combined with standard adjuvant chemotherapy in patients with surgically resectable pancreatic cancer. The study results suggest a potentially longer disease-free survival and one-year overall survival in this patient group than reported in previous studies of surgery and adjuvant therapy alone. These data were presented in a poster session at the American Society of Clinical Oncology (ASCO) annual meeting.
"The reported overall one year survival rate of 96 percent (based on Kaplan Meier Analysis) in this study was substantially higher than previously observed in similar pancreatic cancer patients undergoing surgical resection followed by chemotherapy and chemoradiotherapy," said lead investigator Jeffrey M. Hardacre, M.D., University Hospitals Case Medical Center, Cleveland, Ohio.
"There are few treatment options available for patients with pancreatic cancer, resulting in poor outcomes. These data offer new hope for patients with stage 1 or 2 disease," said Nick Vahanian, M.D., chief medical and operations officer of NewLink Genetics Corporation.
In 2009, an estimated 42,470 new cases of pancreatic cancer were diagnosed and 35,240 patients died from their disease. For all stages combined, the 1- and 5-year relative survival rates are 24 percent and 5 percent, respectively. Even for patients diagnosed with local disease, 5-year survival is only 20 percent.
The cellular components of HyperAcute immunotherapy are designed to essentially trick a patient's immune system into thinking a tumor is similar to an organ transplanted from a different species while also retraining the immune system to attack the patient's cancer cells. HyperAcute immunotherapy is tumor-specific. NewLink Genetics is currently testing two other products in Phase 2 clinical trials for melanoma and non small cell lung cancer with this approach and has additional tumor specific HyperAcute immunotherapy products under various stages of development. Each product is constructed by genetically modifying a particular cell(s) representing the targeted cancer type to elicit a HyperAcute immune response when they are injected into a patient with that particular cancer type. So in each case, genetically modified lung, melanoma or pancreas cancer cells targeting the respective cancer type is mass produced and stored in freezers.
The primary objective of this open-label, non randomized, multicenter Phase 2 study of 70 patients was to assess disease-free survival at 12 months for patients with resected pancreatic cancer who received the Hyperacute-Pancreas immunotherapy in combination with Gemcitabine and 5FU-based chemoradiation. The secondary objectives were overall survival and toxicity. Prognostic indicators such as nodal status, tumor size and tumor grade were similar to or worse than those found in landmark studies of pancreatic cancer patients undergoing resection and chemotherapy or chemoradiotherapy.
Study results showed disease-free survival of 17 months and one-year overall survival of 96 percent observed which can be compared to published studies of the standard therapies that report median disease-free survival of about 11 months and one year survival rates of about 70 percent. The HyperAcute-Pancreas immunotherapy was well tolerated with no serious or life threatening adverse events directly attributed to the vaccine. Injection site pain was the most common serious adverse event reported that can be attributed to the vaccination and this side effect at the Grade 3 level was only observed occurring in 3 percent of patients.
"Based on these positive data, we have begun a pivotal Phase 3 trial of HyperAcute-Pancreas," said Dr. Charles Link, chairman and chief executive officer of NewLink Genetics Corporation. "Our HyperAcute cancer immunotherapies potentially offer a new strategy to stimulate the immune system to recognize the abnormal components found in tumor cells and to stimulate a powerful immune response that destroys or blocks cancer growth. We are excited to have entered late-stage trials with this exciting technology and we continue to make progress with our additional HyperAcute programs."
NewLink is currently enrolling patients in a Phase 3 study, which will enroll up to 722 previously untreated patients with Stage I or II surgically-resected adenocarcinoma of the pancreas who have minimum residual disease. Investigators will randomly assign patients to receive the current standard of care, either Gemcitabine alone or with 5-FU chemoradiation, with or without HyperAcute-Pancreas immunotherapy. Patients will be treated with adjuvant therapy for approximately six months and followed with imaging for five years.
In addition to HyperAcute-Pancreas, NewLink is conducting clinical trials with its HyperAcute-Lung and HyperAcute-Melanoma immunotherapies and is evaluating multiple new tumor specific HyperAcute immunotherapies. Preclinical and clinical data have shown indications of effectiveness and a well-tolerated profile for in more than 175 patients treated for five tumor types – two Phase 1 studies in prostate and breast and three Phase 2 studies in pancreas, lung and melanoma.
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