January 2015, Vol. 2, No. 1
Update on Vaccines
Immunotherapy Vaccine for Patients with Newly Diagnosed Glioblastoma Continues to Show Promising Results
ImmunoCellular Therapeutics, Ltd, a company focused on the development of immune-based therapies for the treatment of a variety of cancers, presented positive results for its leading vaccine, ICT-107, an intradermally administered autologous vaccine made of the patient’s own dendritic cells pulsed with 6 synthetic tumor-associated antigens. The ICT-107 vaccine is targeting patients with glioblastoma multiforme. The updated results from a randomized, placebo-controlled phase 2 clinical trial were presented in November at the annual meeting of the Society for Neuro-Oncology.
The results from the phase 2 ICT-107 trial demonstrate a significant progression-free survival benefit and a numeric overall survival (OS) benefit in patients receiving ICT-107 compared with placebo: the median OS was 23.9 months in the control group but has not been reached in the vaccine group. At the time of the analysis, 65% of ICT-107–treated patients and 50% of the control group patients were alive. No differences were found in adverse effects.
“ICT-107 continues to hold promise for patients with newly diagnosed glioblastoma, as no other immunotherapy has shown statistical benefit for a clinical outcome in a controlled trial in this patient population,” said Patrick Y. Wen, MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, professor of neurology at Harvard Medical School, and principal investigator on the trial. This vaccine will soon move to phase 3 testing.
ImmunoCellular Therapeutics, Ltd; November 14, 2014.
Oral Vaccine for Pancreatic Cancer Shows Positive Data in a Phase 1 Extension Trial
VAXIMM AG, a Swiss-German biotech company, released new data from an extension of the VXM01-01-DE randomized, placebo-controlled, double-blind phase 1 dose-escalation trial of its investigational oral T-cell vaccine VXM01 that is directed against the tumor vascular endothelial growth factor 2 (VEGFR2). The new data come from an extension of the trial that enrolled 27 additional patients with inoperable pancreatic cancer. Previously, 45 patients were randomized to 4 doses of VXM01 within 1 week or to placebo, in addition to standard-of-care treatment. In the extension trial, patients in the treatment arm received monthly boosting vaccinations for up to 6 months in addition to the 4 vaccinations.
Overall, 66% of the patients showed a strong T-cell–mediated immune response against the target VEGFR2 after the initial vaccination with VXM01 or after boosting. The main adverse event was a decrease in platelet count. In an interim analysis, median OS was 10.3 months in the treatment arm, and the effect was higher in patients with a target-specific T-cell response after VXM01 treatment (12.3 months for responders vs 5.4 months for nonresponders).
“We are enthusiastic about the high immunological response rate and the improved survival of patients
responding to VXM01 treatment,” said Hubertus Schmitz-Winnenthal, MD, a principal investigator. “This is especially exciting given the patients’ life expectancy and the observed safety profile, even under continued treatment.”
VAXIMM AG, Basel, Switzerland/Mannheim, Germany; December 4, 2014.
MD Anderson Cancer Center Launches New Programs After FDA Approval of Novel HPV Vaccine
Researchers at MD Anderson Cancer Center applauded the FDA for its recent approval of the new vaccine against 5 new strains of the human papillomavirus (HPV) that were not covered by the original Gardasil vaccine. The new vaccine, Gardasil 9, provides protection against 5 additional strains of HPV that can cause the vast majority of cervical, vulvar, vaginal, and anal cancers.
“This is an incredible step forward in our fight to end cancer,” said Ronald A. DePinho, MD, president of MD Anderson Cancer Center. “Up to 80% of the world will be infected with HPV at some point, according to estimates. MD Anderson hopes the vaccine approval will change the conversation about HPV vaccination from sex to saving lives,” he said.
Researchers and clinicians at this cancer center are launching new programs to address HPV-related cancers in their institution and across the country. “We are developing a national partnership with peer institutions in 18 states to increase HPV vaccination
rates,” DePinho said. “One initiative funded for $1.5 million will result in an unparalleled effort to accelerate the conversion of scientific discoveries into clinical advances.”
It is believed that this new vaccine will cover close to 90% of cervical cancers and will have the power to save many lives.
MD Anderson Cancer Center press release; December 10, 2014.
FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Cancer Immunotherapy MPDL3280A (Anti–PD-L1) in Non–Small Cell Lung Cancer
Second FDA Breakthrough Therapy Designation for MPDL3280A Following Bladder Cancer in 2014 Genentech, a member of the Roche Group, announced today that it has received a second Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A (anti–PD-L1). The designation was granted for [ Read More ]
The oncology community is abuzz with the promise of immunotherapy, sparked by the success of immunotherapeutic approaches in advanced melanoma. There is major interest in studying immunotherapy in other cancers, including breast and lung cancer. At the 2014 Chemotherapy Foundation Symposium, Heather L. McArthur, MD, MPH, a medical oncologist in [ Read More ]