FDA Grants Fast Track Designation to PEGPH20 Program for Metastatic Pancreatic Cancer

Editor’s note: The U.S. Food and Drug Administration (FDA) has granted a “Fast-Track” designation to a new treatment for people with advanced pancreatic cancer. The treatment combines the drugs PEGPH20, gemcitabine, and nab-paclitazel. The Fast-Track designation means that the FDA will facilitate a faster approval process so that the treatment can soon be prescribed by oncologists in the U.S.

“The FDA granted fast track designation today to Halozyme Therapeutics for its PEGPH20 program in treating patients with pancreatic cancer, according to a company press release.

The program seeks to demonstrate improved overall survival in metastatic pancreatic cancer patients by studying the use of pegylated recombinant human hyaluronidase in combination with gemcitabine and nab-paclitaxel.

“The FDA’s fast track designation for our PEGPH20 program in pancreatic cancer underscores the significant need for new treatment options for pancreatic cancer patients with advanced disease,” Helen Torley, MD, Halozyme president and CEO, said in the release. “We look forward to continuing to work with the FDA on this program to explore whether patients with metastatic pancreatic cancer can benefit from this therapy.”

Investigational Pancreatic Cancer Drug Trial Resumes Patient Enrollment, Dosing

Editor’s note: Researchers are conducting a clinical trial with volunteer patients to test a new pancreatic cancer treatment called PEGPH20. The trial is currently enrolling people with stage IV metastatic pancreatic cancer. Some patients in the trial will be treated with PEGPH20 plus the drugs gemcitabine and nab-paclitaxel, and for comparison, the others will receive gemcitabine and nab-paclitaxel alone.

“Halozyme Therapeutics recently announced that it has resumed enrollment and dosing of patients in its Study 202 trial, evaluating its investigational pegylated formulation of recombinant human hyaluronidase in pancreatic cancer, under a revised clinical protocol agreement with the FDA.

“Study 202 is a phase 2 multicenter, randomized clinical trial evaluating Haolzyme’s PEGPH20 as a first-line therapy for treatment of patients with stage IV metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in PFS in patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel vs. gemcitabine and nab-paclitaxel alone.

“Following the protocol amendment, a second primary endpoint has been added to assess the thromboembolic event rate in the PEGPH20 treatment group. Secondary endpoints include objective response rate and OS. The protocol amendments to the study include the exclusion of patients who may be at higher risk of thromboembolic events. Additionally, low-molecular weight heparin will be used as a prophylaxis to prevent thromboembolic events.”

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Comparison of Gemcitabine Combined with Targeted Agent Therapy Versus Gemcitabine Monotherapy in the Management of Advanced Pancreatic Cancer

“This systematic evaluation compared the efficacy and safety profiles of gemcitabine combined with targeted agents (GEM + TA) versus gemcitabine administered as monotherapy or combined with placebo (GEM ± PLC) in locally advanced/metastatic pancreatic cancer (LA/MPC) patients. Based on the results from this analysis, the addition of targeted agents to a regimen of gemcitabine treatment does not bring survival benefits except 1–year survival rate to patients with LA/MPC.”

The gist: Researchers analyzed data from ten different clinical trials that tested whether the chemotherapy drug gemcitabine worked better for pancreatic cancer patients when combined with targeted therapy drugs. (Targeted therapies are drugs developed to fight tumors that have specific genetic mutations, as detected by molecular testing.) Not many benefits were found for the combination treatments, except that patients who took gemcitabine combined with targeted therapy were more likely be alive one year later than patients who only took gemcitabine.

Immunotherapy Duo Improves Survival in Metastatic Pancreatic Cancer

Overall survival was improved in metastatic pancreatic cancer patients through an innovative immunotherapy strategy in a multicenter study reported at the 2014 Gastrointestinal Cancers Symposium.

“ ‘This is the first time a randomized study has shown that immunotherapy is effective in pancreatic cancer,’ said Dung T. Le, MD, Assistant Professor of Medicine at the Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore. ‘This is just a first step, and we believe we’ll be able to take this approach further.’ ”

“The novel treatment, which may be better tolerated than standard chemotherapy, involves two different anticancer vaccines: GVAX Pancreas followed by CRS-207. GVAX is composed of pancreatic cancer cells that have been genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), which stimulates the immune system. GVAX is given with low-dose cyclophosphamide to inhibit regulatory T cells and boost the vaccine’s efficacy. The second vaccine, CRS-207, is live-attenuated Listeria monocytogenes (Lm), which has been genetically modified to be safe for human use while retaining its ability to stimulate an immune response against the protein mesothelin on pancreatic tumor cells.

“The combination essentially trains the body to recognize and attack pancreatic tumors. In mouse tumor models, Lm/GVAX vaccines are synergistic, and in a phase I study of CRS-207, patients with pancreatic ductal adenocarcinoma who had received prior GVAX lived more than 15 months, Dr. Le explained.”

Editor’s note: Immunotherapy treatments work by boosting a patient’s own immune system to fight cancer. This story describes such a treatment, which combines two “cancer vaccines” called GVAX Pancreas and CRS-207. Scientists found promising results for the treatment in pancreatic cancer patients.