With dozens of clinical trials being carried out on the race development, testing and obtaining the approval of the first drug since 1998 for the treatment of high-risk bladder cancer that does not respond to bacillus Calmette-Guérin (BCG).
Experimental intravesical agent CG0070, developed by Cold Genesys, was presented at the plenary session here at the annual meeting of the American Urological Association (AUA) 2018.
Agent gave a total of 12-month complete response in 30% of the single-phase phase 2 study in patients with immune to BCG tau high grade, T1 or CIS-Ta / T1, non-muscle bladder cancer, said Vignesh T. Pakiam, doctor, urologist University of Chicago in Illinois.
Complete response was defined as the absence of signs of disease cystoscopy, cytology and / or random biopsies.
30% of the total reaction for 1 year is a good indicator, said Richard J.. Lee, MD, MD, a medical oncologist at the Grand Massachusetts Cancer Center in Boston, which asked for comments.
He explained that the latest drug, which must be approved by the FDA for these patients was valrubicin (Valstar, Endo Pharmaceuticals), in 1998. However valrubicin associated only with the norm of 18% complete response in 6 months. "The answer is not very strong, so we need new drugs, - said Lee.
He noted that intravenous gemcitabine (Gemzar, Lilly) is an option. But as Lee and coroner Pakyam stressed that the new intravesical agents that are administered directly into the bladder through a catheter, and systemic immunotherapy (anti-PD-1 or anti-PD-L1), may represent an important new treatments for this disease .
CG0070 is a selective oncolytic adenovirus, which leads to the selective expression of granulocyte-macrophage colony stimulating factor (GM-CSF) in cells defective retinoblastoma cells, which are found in many tumors. It stimulates the expression of GM-CSF and has a direct oncolytic action following topical treatment (i.e., intravesical), and can induce systemic immunity specific to the tumor.
Currently, the main intravesical BCG immunotherapy is the early stage of bladder cancer.
In this test, all patients (n = 67) showed disease progression while receiving BCG therapy: either they were not able to reach a state of disease-free 6 months after BCG (BCG-refractory) or they relapse after complete response to BCG -therapy (relapse-BCG).
All patients gave up the next treatment option, cystectomy, or surgical removal of the bladder, and instead decided to take part in a clinical trial.
Ultimately, 10 of 61 patients who were included in the interim analysis underwent cystectomy. Pathological evaluation showed that six patients had muscle-invasive disease, not less dangerous non-muscle-invasive cancer, as mentioned above.
These findings illustrate the need for more treatment options, Lee intervened.
Non-muscle-invasive disease is usually controlled by urologists, medical oncologists, and that, like himself, become involved only after the disease progresses to the point of muscle invasive.
Treatment-related side effects during 12 months included flu (7%), fatigue (4%) and chills (1%). Five deaths occurred secondary to advanced urothelial carcinoma, esophageal carcinoma, carcinoma of the lung and heart disease.