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Madrid, October 7 2019:- After confirming good results in melanoma, breast cancer and even lung cancer, it now seems that immunotherapy may also be effective in bladder cancer. This follows the results of IMvigor130, a clinical trial co-directed by Dr. Enrique Grande, head of the Medical Oncology Service at MD Anderson Cancer Center Madrid, which has for the first time demonstrated that the addition of immunotherapy to the standard treatment with chemotherapy of metastatic bladder cancer is better than treatment with chemotherapy alone.

The results, which have just been presented at the presidential session of the Congress of the European Society of Medical Oncology (ESMO), recently held in Barcelona, show that the combination of immunotherapeutic agent atezolizumab and chemotherapeutic agents gemcitabine/cisplatin or gemcitabine/carboplatin achieves a progression-free survival (PFS) rate of 8.2 months, compared to 6.3 months for patients treated with chemotherapy alone. Thus, this combination can reduce the probability of tumor progression by 18%.

"It is the first time in 40 years that a combination of drugs has been successful in surpassing the effectiveness of platinum-based chemotherapy in the treatment of metastatic bladder cancer," notes Dr. Grande, who also points to the solidity of data from a multicenter, prospective and randomized clinical trial already in phase 3.

"Today, bladder cancer has no cure when there is metastases already," said the specialist, who highlights this new combination as a milestone because, after decades, the door is open to new therapy options in these patients. In addition, says Dr. Grande, "Spain, with between 23,000 and 25,000 people diagnosed each year, is, together with Italy and Egypt, one of the countries with the highest incidence of bladder cancer in the world."

In fact, up to 25% of the 1,213 patients taking part in the IMvigor130 study were recruited in Spain. A very considerable contribution considering that a total of 221 centers from 35 different countries have participated in the study. "This study is the largest ever reported in bladder cancer, which gives even more value to the Spanish contribution".

PDL-1 is emerging as an essential biomarker in immunotherapy

Although it is still too early to know the definitive data on global survival, Dr. Grande points out that "the results seem to show a positive, very promising trend." Specifically, one of these positive trends that correspond to the subgroup of patients who overexpress the PDL-1 protein, where even better results have been observed than in patients who were only given immunotherapy, compared to those who were given a combination of immunotherapy and chemotherapy.

Data that, as Dr. Grande emphasizes, would translate into that "in a percentage of patients, we might even avoid chemotherapy". The detection of the presence or absence of the PDL-1 biomarker is already mandatory before starting any treatment with an anti-PDL-1 immunotherapeutic agent, in accordance with the technical data sheet, since its presence is can predict a positive response to treatment.

More than half of cancer patients cannot take cisplatin

Treatment with cisplatin-based chemotherapy has been the standard treatment for metastatic disease since the 1980s, but approximately half of the population is not eligible for cisplatin - that is, they cannot take this drug for different reasons related to age, heart or renal function, among others. In these cases, the patient is given carboplatin, another chemotherapeutic agent that is not as effective.

Aware of this problem, the IMvigor130 clinical trial was a pioneer in front line treatment that recruited both patients eligible for treatment with cisplatin (in the gemcitabine/cisplatin branch) as well as patients not eligible for cisplatin (in the gemcitabine/carboplatin branch). Immunotherapy therapy has been evaluated in both treatment branches in order to verify whether this combination is effective or not in both cases.