Researchers at the Johns Hopkins Kimmel Cancer Center, the Greenberg Bladder Cancer Institute, the Bloomberg~Kimmel Institute for Cancer Immunotherapy, the Brady Urological Institute, and the Center for Computational Genomics at Johns Hopkins have received a $3.2 million grant from the National Institutes of Health to study new treatment options for early-stage bladder cancer.
Early stage bladder cancer, formally known as non-muscle invasive bladder cancer, is identified in close to 50,000 patients each year, according to the National Cancer Institute, and typically is treated with a weakened form of bacillus Calmette-Gurin (BCG) bacteria instilled directly into the bladder. BCG is similar to the bacterium that causes tuberculosis, and is used to immunize against TB. BCG bladder cancer therapy stimulates the immune system and can be temporarily successful in preventing the cancer from growing or returning. But those undergoing this treatment have a high risk of cancer recurrence and frequently experience side effects such as increased frequency of and discomfort with urination.
The new grant will support efforts by Johns Hopkins physician-scientists to participate in a novel multidisciplinary clinical trial for this cancer, called ADAPT-BLADDER for its ability to accommodate changes during the trial that optimize and accelerate tests of promising treatments.
With initial plans to study anti-PD-L1-directed immunotherapy with the monoclonal antibody durvalumab in combination with BCG and radiation, the ADAPT-BLADDER (NCTO3317158) trial is the first systemic immunotherapy trial to involve all three modalities.
The Johns Hopkins study is also believed to be the only trial among non-muscle invasive bladder cancer trials combining BCG with a shortened, six-month course of systemic immunotherapy, according to Noah Hahn, M.D., associate professor of oncology and urology at the Johns Hopkins University School of Medicine, deputy director of the Greenberg Bladder Cancer Institute, and principal investigator of the study.
“We’re pleased and encouraged that NIH has chosen to support our work within the ADAPT-BLADDER trial,” says Hahn. “Studying the benefits of immunotherapy drugs in high-risk non-muscle invasive bladder cancer patients that have relapsed disease after standard BCG therapy is a natural next step. “Overall, the NIH-funded ADAPT-BLADDER project is designed with several arms and phases, starting with the investigation of durvalumab combination treatments, but expandable to include other drugs and combinations at a future date without having to start a new trial.
Hahn said this adds a degree of flexibility to the trial, but also brings a wider array of cancer experts than is usually the case with clinical trials for this cancer.
“If this trial is successful, it could change the care of non-muscle invasive bladder cancer to a multidisciplinary treatment model,” Hahn says.
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Claridge - (7/3/2019 2:12:07 PM)
Incentives to have a 1st cohort (UHN) 3-month data publish
TLT will have many incentives to have a first cohort (UHN) 3-month data publish:
1) 3-month is a primary measurable endpoint requested by HC/FDA
2) it will give TLT's technology instant international visibility to urologists
3) it will accelerate enrollment of US and international sites
4) it will create awareness to patients and so, accelerate enrollment of patients to clinical sites
5) it will allow to position its technology against competition, in terms of CR (complete response) rate
6) it will spark coverages in medias
7) it will spark analysts coverages
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