{"id":10389,"date":"2019-08-09T12:00:00","date_gmt":"2019-08-09T12:00:00","guid":{"rendered":"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2019\/erdafitinib-advanced-bladder-cancer"},"modified":"2024-11-03T15:17:10","modified_gmt":"2024-11-03T15:17:10","slug":"targeted-drug-erdafitinib-benefits-some-patients-with-advanced-bladder-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/targeted-drug-erdafitinib-benefits-some-patients-with-advanced-bladder-cancer\/","title":{"rendered":"Targeted Drug Erdafitinib Benefits Some Patients with Advanced Bladder Cancer"},"content":{"rendered":"

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Erdafitinib has been approved to treat some people with advanced bladder cancer, including cancer that has spread to other parts of the body.<\/p>\n

Credit: National Cancer Institute<\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n

In April, the drug erdafitinib (Balversa)<\/a> became the first therapy targeting a genetic alteration<\/a> to be approved by the Food and Drug Administration (FDA) to treat patients with metastatic urothelial carcinoma, the most common type of bladder cancer<\/a>.\u00a0<\/p>\n

FDA granted an accelerated approval to the drug, which blocks the activity of a family of proteins called fibroblast growth factor receptors (FGFR), for patients with specific FGFR<\/em> gene alterations, based on preliminary data from a clinical trial.\u00a0<\/p>\n

New findings from that trial have just been published. The updated results confirm that erdafitinib can benefit patients with advanced bladder cancer<\/a> whose tumors have a genetic alteration in one of the four FGFR<\/em> genes, according to Arlene Siefker-Radtke, M.D., of the University of Texas MD Anderson Cancer Center, who led the trial.\u00a0<\/p>\n

In the study,\u00a0erdafitinib decreased the tumors of some patients whose cancers did not respond<\/a> to other treatments, the researchers reported in the New England Journal of Medicine<\/em> on July 25.\u00a0<\/p>\n

FDA\u2019s approval covers patients whose cancer has spread outside of the bladder locally or to other parts of the body during or after treatment with standard chemotherapy.\u00a0<\/p>\n

\u201cOur patients with metastatic bladder cancer have very limited treatment options, and this represents a real unmet need,\u201d Dr. Siefker-Radtke said. \u00a0<\/p>\n

\u201cNow that erdafitinib has been approved by the FDA, doctors can incorporate the drug into treatment strategies to benefit patients with FGFR<\/em>-altered urothelial cancer<\/a>,\u201d she continued. \u201cAdditional research is ongoing to learn how to combine erdafitinib with immunotherapy drugs such as immune checkpoint inhibitors.\u201d\u00a0<\/p>\n

FDA has approved several checkpoint inhibitors for advanced bladder cancer, but only approximately 20% of patients benefit from these treatments, Dr. Siefker-Radtke noted.\u00a0<\/p>\n

By comparison, 40% of the patients in the international phase 2 trial that led to the approval responded to erdafitinib, Dr. Siefker-Radtke and her colleagues reported.<\/p>\n

To confirm the study’s results, a phase 3 clinical trial is comparing erdafitinib<\/a> with standard chemotherapy and with the checkpoint inhibitor pembrolizumab (Keytruda)<\/a> in patients with advanced bladder cancer whose tumors have an FGFR<\/em> alteration.<\/p>\n

Clinical Trial Results\u00a0<\/h2>\n

Approximately 20% of patients with metastatic urothelial cancer of the bladder and 35% of patients with metastatic urothelial cancer of the renal pelvis<\/a> and ureter<\/a> have an alteration in an FGFR<\/em> gene. When FDA approved erdafitinib, which is given as a pill, the agency also approved a companion diagnostic test<\/a> that doctors can use to help identify patients whose tumors carry one of these FGFR<\/em> alterations.\u00a0<\/p>\n

Of the 99 patients in the\u00a0trial, 87 had been treated previously with chemotherapy, and 43% had received at least two prior courses of treatment. Nearly 80% had metastases beyond nearby lymph nodes<\/a>.\u00a0<\/p>\n

\u201cOverall, this group of patients typically has poor outcomes,\u201d said Dr. Siefker-Radtke.\u00a0<\/p>\n

For this reason, a 40% response rate<\/a> is \u201creally remarkable,\u201d noted Andrea Apolo, M.D., of NCI\u2019s Center for Cancer Research<\/a>, who was not involved in the trial.\u00a0<\/p>\n

\u201cErdafitinib is an important new drug for some of our patients with bladder cancer,\u201d she added.\u00a0<\/p>\n

In the trial, the median<\/a> amount of time before the disease progressed (progression-free survival<\/a>) was 5.5 months, and the median overall survival<\/a> was 13.8 months.\u00a0<\/p>\n

The most common treatment-related side effects included inflammation or irritation of the mucous membranes in the mouth, changes to nails, and hand<\/a>\u2013<\/span><\/span><\/span>foot syndrome<\/a>.\u00a0<\/p>\n

Erdafitinib can also cause eye\u00a0disorders that can lead to changes in the visual field, although these can be managed, according to Dr. Siefker-Radtke. \u00a0<\/p>\n

In the trial, 46% of patients experienced side effects that were largely managed by adjusting the dose of therapy. Thirteen percent of the patients discontinued treatment because of side effects.\u00a0<\/p>\n

Janssen Research & Development, which developed erdafitinib in collaboration with Astex Pharmaceuticals, sponsored the trial.<\/p>\n

Rapid Responses to Treatment\u00a0<\/h2>\n

For some patients in the trial, tumors started responding to erdafitinib soon after their treatments began, Dr. Siefker-Radtke noted. \u00a0<\/p>\n

\u201cI was surprised by how quickly some patients with rapidly progressing disease responded to the drug,\u201d she said. \u201cWithin a week or two of starting treatment, the health of some of these patients improved significantly.\u201d\u00a0<\/p>\n

For one group of patients\u2014those whose cancers did not respond to immunotherapy drugs\u2014the response rate was 59%, suggesting to the researchers that these patients, in particular, might benefit from erdafitinib. \u00a0\u00a0<\/p>\n

In previous bladder cancer clinical trials, Dr. Siefker-Radtke had noticed that patients with FGFR<\/em> mutations were less likely to respond to checkpoint inhibitors than patients who lacked the mutations.<\/p>\n

When erdafitinib became available, she and her colleagues developed the phase 2 trial. But the current results are not definitive, Dr. Siefker-Radtke cautioned.\u00a0<\/p>\n

The phase 3 trial, she added, will provide more information about \u201cwhether patients with FGFR<\/em>-altered urothelial cancer benefit more from erdafitinib or a checkpoint inhibitor.\u201d\u00a0
\u00a0<\/p>\n

Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"

August 9, 2019, by NCI Staff Erdafitinib has been approved to treat some people with advanced bladder cancer, including cancer that has spread to other parts of the body. Credit: National Cancer Institute In April, the drug erdafitinib (Balversa) became the first therapy targeting a genetic alteration to be approved by the Food and Drug […]<\/p>\n","protected":false},"author":2,"featured_media":10390,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-10389","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/10389","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=10389"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/10389\/revisions"}],"predecessor-version":[{"id":44459,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/10389\/revisions\/44459"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media\/10390"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=10389"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=10389"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=10389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}