[ad_1]
SBillionaire billionaire Valley Sean Parker – founder and founder of Napster – has pledged $ 250 million in 2016 to bring together researchers from the country's leading cancer centers to accelerate the development of new ones. treatments that allow the immune system to attack cancer.
On Sunday, the Parker Institute for Cancer Immunotherapy presents the results of clinical trials for the first time. And these results, which occur just a year and a half after the first patient's enrollment in the study, show a narrowing of the tumor due to the multi-drug regimen administered to patients with breast cancer. Metastatic pancreas.
The new findings from the Phase 1 clinical trial were unveiled at the annual meeting of the American Association of Cancer Research in Atlanta.
publicity
"This is the first clinical trial entirely sponsored by the Parker Institute and we are excited about the results," said Parker Institute Medical Director Ramy Ibrahim on a phone call with STAT. "In terms of pharmaceutical standards, we are progressing rapidly."
Pancreatic cancer is the third leading cause of cancer death and is notoriously difficult to treat. The researchers funded by Parker have therefore tried a new approach. They combined standard chemotherapy with two different immunotherapies: an experimental antibody that activates immune cells and an approved PD-1 checkpoint inhibitor that slows down the immune system.
The trial included 30 patients with previously untreated metastatic pancreatic cancer. All were treated with gemcitabine and Abraxane – the chemotherapy regimen considered the treatment of choice for this type of cancer – as well as an experimental antibody called APX005M. Half of the patients also received Opdivo, the Bristol-Myers Squibb checkpoint inhibitor.
Results: 54% of the 24 evaluable patients had a partial narrowing of the tumor, with some responses lasting 10 months or longer. The best responses were observed in patients treated with the four drugs. The reported adverse effects included a reduction in white blood cells, anemia and fatigue, but all were considered manageable.
"I do not want to look too far down the road, but these results are impressive," said Dr. Robert Vonderheide, Parker Institute investigator in charge of the trial and director of the Abramson Cancer Center at the University of Pennsylvania, in an interview with STAT.
To put the results into perspective, Vonderheide noted that 23% of patients with metastatic pancreatic cancer were responding to treatment with gemcitabine and Abraxane, according to a large clinical trial that led to the treatment. treatment approval.
In recent years, checkpoint inhibitors such as Opdivo, used alone or in addition to chemotherapy, have had an increased beneficial effect for patients with a wide range of tumors solid. Not so in pancreatic cancer, though.
The idea of this new four-drug approach to treat pancreatic cancer came from mouse experiments conducted by researchers at the Vonderheide UPonder Laboratory. These data suggest that adding an antibody to stimulate a receptor called CD40 on the surface of immune cells could increase response rates seen with checkpoint inhibitors and chemotherapy.
Based on this preclinical research, the Parker Institute brought together the nonprofit Cancer Research Institute and six academic cancer centers to conduct the first human clinical trial. The group chose the CD40 APX005M experimental antibody from the private biotechnology company Apexigen to use in the new regimen, while Bristol-Myers Squibb agreed to provide Opdivo.
"With the Parker Institute model, we have the opportunity to combine the scale and scope of a pharmaceutical trial with the scientific approach of an investigator initiated trial. It's a more efficient way to test, "said Vonderheide. "I work with leading pancreatic cancer specialists in all these facilities through the Parker Institute, and I can tell you that participation in our weekly security conferences is the highest I've ever had. view."
Based on promising Sunday data on pancreatic cancer, the Parker Institute is recruiting 93 additional pancreatic patients in a randomized Phase 2 trial that will collect additional data on the efficacy and safety of treatment with four drugs. Entries will end later this spring, said Vonderheide.
Although the Parker Institute is sponsoring this early research on pancreatic cancer, it will ultimately be up to Bristol-Myers Squibb and the private biotechnology company owning the drugs used to conduct the Phase 3 trials required to obtain approvals. regulations.
"We will not do registration studies," said Ibrahim of the Parker Institute. "If the Phase 2 data we collect helps move this approach forward, we hope that the companies will do it, but we will not be able to force them. Our goal is to ensure that data quality is high and convincing enough for therapies to move to the next phase. "
[ad_2]
Source link