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BCG (Bacillus Calmette-Guérin), live attenuated, strain RIVM (strain 1173-P2 derived) is a live but weakened form of the bacterium Mycobacterium bovis. In the EU trial registry it is classified under neoplasms, because its main use in this setting is as a cancer immunotherapy.[1] The product used in the trial is called BCG-MEDAC, powder and solvent for intravesical suspension.[1] BCG-MEDAC is authorised as a medicine in France, and the authorisation holder is Medac Gesellschaft für klinische Spezialpräparate mbH.[1] In the United Kingdom, BCG vaccines such as BCG AJV are also used for tuberculosis vaccination in risk groups according to the national immunisation schedule.[2] The same weakened bacterium therefore has two very different uses: preventing tuberculosis and treating certain bladder cancers.
When BCG is instilled into the bladder, it triggers a strong local immune reaction. The exact way it acts against cancer is not fully understood, but it is thought to work by stimulating the body's own immune system inside the bladder.[3] The live bacteria cause immune cells to move into the bladder lining, and this immune activation can destroy or suppress cancer cells. Because the bacteria are attenuated, they are weakened and normally do not cause tuberculosis in healthy people, but they can still cause serious infections in some situations.[3]
For bladder cancer, BCG is given as an intravesical suspension. This means a liquid containing the live bacteria is run through a tube, called a catheter, directly into the bladder.[3] The pharmaceutical form recorded in the EU registry is an intravesical suspension, and the route of administration is intravesical use.[1] The product BCG-MEDAC is supplied as a powder and solvent that are mixed before use.[1] For tuberculosis prevention, BCG is given as an injection.[2] In the trial, BCG-MEDAC was given together with an investigational antibody called PD1IL2v iMAb, also by intravesical use.[1]
One trial in the EU Clinical Trials Information System studied BCG-MEDAC in combination with an investigational antibody. The trial, identified as 2024-515410-41-00, was a Phase 1 study that has been completed.[1] It enrolled 23 participants with BCG-unresponsive high-risk non-muscle invasive bladder cancer.[1]
The trial had two parts. The Phase 1 part evaluated safety and tolerability of the combination, the nature and frequency of dose-limiting toxicities, and aimed to determine the maximum tolerated dose or the recommended dose for extension. The Phase 2 part, called Cohort A, planned to evaluate the complete response rate at 12 months, meaning the absence of high-risk non-muscle invasive bladder cancer or progressive disease as determined by cystoscopy, imaging, and central pathology review of cytology and biopsy.[1]
The registry record does not report the results of these measurements, only the outcomes that were planned. The substance BCG appears as the test substance in this trial, meaning it was one of the medicines being investigated in the combination.[1]
Because this is a single completed Phase 1 trial, the evidence is early. Phase 1 trials primarily establish safety and dosing, not whether a treatment works. The planned Phase 2 part would have begun to look at effectiveness, but the registry does not state whether that part was carried out.[1]
Serious and fatal disseminated BCG infections have occurred with intravesical administration. Disseminated means the bacteria have spread beyond the bladder to other parts of the body. These infections may not appear for months or years after treatment, because BCG can persist in the urinary tract for several months.[3]
BCG infections have also been reported in healthcare workers and in patients because of exposure to the vaccine during preparation and administration. Because BCG contains live attenuated mycobacteria, it is prepared, handled, and disposed of as a biohazard material.[3]
In older people, BCG has not been shown to cause different side effects than in younger adults. There is no specific information comparing use of BCG for cancer treatment in children with use in other age groups.[3]
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