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More evidence that immunotherapy with programmed cell death (PD) inhibitors is effective in bladder cancer was presented here today at the 2016 European Society for Medical Oncology (ESMO) Congress.

The results come from two new phase 2 trials. The CheckMate-275 study showed nivolumab (Opdivo, Bristol-Myers Squibb) was active in patients with metastatic bladder cancer who progressed despite first-line platinum-based chemotherapy, while the KEYNOTE-052 study showed pembrolizumab (Keytruda, Merck) was active as first-line therapy in cisplatin-ineligible patients with metastatic or locally advanced bladder cancer.

The companies are expected to use data from these trials to obtain approval for bladder cancer as a new indication for the agents, which are already approved for melanoma and lung cancer.

The first immunotherapy for bladder cancer, atezolizumab (Tecentriq, Genentech), was approved by the US Food and Drug Administration earlier this year. The decision was based on the IMvigor 210 trial for use in patients with locally advanced or metastatic disease that has progressed during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy.

It seems that every company is conducting a phase 2 study with its own immunotherapy to get a bladder cancer indication, commented session cochair Bernard Escudier, MD, from the Institut Gustave Roussy, Villejuif, France, but “we need phase 3 trials,” he told Medscape Medical News in an interview.

“Everything that we have seen in the past few years shows that immunotherapy is active in bladder cancer — probably more active than chemotherapy, at least overall,” he said. All the evidence suggests that immunotherapy is important in bladder cancer, he added, “but it is still important to know which patients will benefit more from one than the other, because we have some patients who benefit a lot from chemotherapy.”

In the first instance, he feels a randomized clinical trial of standard chemotherapy vs immunotherapy as first-line treatment in bladder cancer is needed — and is being planned. The next step would be to look at combinations of these therapies.

So far, the PD-L1 biomarker has not proven to be very useful in selecting patients who may respond to immunotherapy, he said, as patients who are PD-L1-negative sometimes respond. There is some suggestion that, for patients who are PD-L1-negative, it would be best to start with a combination of therapies, while in those who are PD-L1-positive, it may be reasonable to begin with immunotherapy as monotherapy, Dr Escudier commented. But he agreed with some of the other speakers that the question of which drugs to use is mainly a clinical decision. For example, in a patient with a high burden of disease, it is probably better to start with chemotherapy to try to shrink the tumor and then add immunotherapy. “This is what we do,” Dr Escudier noted.



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