Bladder cancer is the fourth most commonly diagnosed cancer in men in the United States and the 10th leading cause of cancer deaths. Many treatments can be used for bladder cancer, and the kind of treatment that your health care provider will suggest depends on the kind of tumor and if it has spread.
Inlexzo is used to treat adults with a type of cancer of the bladder lining called non-muscle-invasive bladder cancer (NMIBC) that has not spread to other parts of the body. It is for people whose cancer has come back or has not responded to other treatments. Inlexzo delivers the chemotherapy medicine gemcitabine directly into the bladder, where it slowly releases the medicine to help destroy cancer cells. This approach treats the cancer locally while helping to preserve the bladder.
However, it is important to recognize that delaying bladder removal surgery (cystectomy) can increase the chance that bladder cancer will spread to other parts of your body. The longer the surgery is delayed while cancer cells remain, the higher the risk. Your health care provider should discuss with you the risks of delaying surgery before starting treatment with Inlexzo.
How Do I Use Inlexzo?
Inlexzo is a small, pretzel-shaped system made of a thin, flexible silicone tube that contains a chemotherapy medicine called gemcitabine. Inlexzo is placed directly into your bladder by your health care provider using a thin tube called a catheter. The catheter is gently inserted through the urethra (where urine leaves your body) into the bladder. Before it is placed, Inlexzo is straightened so it can easily pass through the catheter and urethra. Once inside your bladder, it curls back into its pretzel shape, which helps it stay in place while slowly releasing the medicine over time.
After about three weeks, Inlexzo is removed from your bladder by your health care provider. During the first six months of treatment, Inlexzo may be placed into your bladder once every three weeks for a total of eight doses. During the next 18 months, it may be placed once every 12 weeks for a total of six doses. Your health care provider will determine how many times you will get Inlexzo based on how well your cancer responds to treatment and how you tolerate the therapy.
How Was Inlexzo Studied?
A clinical study called SunRISe-1 evaluated Inlexzo in adults with NMIBC that had not spread to other parts of the body. To take part in the study, people had to have cancer that did not respond to or came back within 12 months after completing multiple rounds of treatment with another cancer therapy called bacillus Calmette-Guérin (BCG). Additionally, all visible tumors had to be removed before starting the study.
People in the study had Inlexzo placed into their bladder once every three weeks for six months, followed by once every 12 weeks for up to 18 months. Once inserted into the bladder, Inlexzo stayed in the bladder for three weeks and was then removed.
People enrolled in the study had their bladder checked for signs of cancer every 12 weeks for up to two years and every 24 weeks after that until the end of the study. Imaging of the bladder, as well as a biopsy of the bladder, was done 24 and 48 weeks after starting treatment.
How well Inlexzo worked for bladder cancer was looked at in two groups of people. The first group had 85 adults. The median age was 71 years, meaning half of the people were younger and half were older. Most people (80%) were men; 87% were White, 10% were Asian, 2.4% were Black or African American, and 10% were Hispanic or Latino. In total, 89% of people identified as not Hispanic or Latino, and for 1.2%, ethnicity was unknown or not reported. The most common tumor stage was carcinoma in situ (67.1%). This means that the cancer was only growing in the inner lining layer of the bladder. The rest had either cancer that had grown inward toward the hollow part of the bladder but not grown deeper (22.4%) or cancer that had grown into the layer of connective tissue under the lining layer of the bladder (10.6%). The median number of prior doses of BCG was 12 (range, 7-42). Nearly all (96.5%) people chose not to undergo bladder removal surgery (cystectomy).
The second group had 52 adults with high-risk papillary bladder cancer. People had either cancer that had grown inward toward the hollow part of the bladder but not grown deeper (59.6%) or cancer that had grown into the layer of connective tissue under the lining layer of the bladder (40.4%). The median age in this group was also 71 years, and the group included mostly men (71.2%). The median number of prior doses of BCG was 12 (range, 8-45). Nearly all (82.4%) people in this group chose not to undergo cystectomy.
What Are the Main Benefits Based on the SunRISe-1 Study?
In the first group, 70 of the 85 people (82%) who received treatment with Inlexzo had a complete response at any time. Of these people, about half (53%) continued to have a complete response for at least 12 months.
Of the 52 people with high-risk papillary bladder cancer, 70.2% did not have signs of the cancer returning or spreading at 12 months. The cancer came back or got worse in 11 people, and two people died.
Your results may differ from what was seen in the clinical study.
What Do We Know About Long-Term Safety?
The most common side effects of Inlexzo are frequent need to pass urine, urinary tract infection, pain or burning sensation when passing urine, and urgent need to pass urine.
In the SunRISe-1 study, people received treatment with Inlexzo for a maximum of two years. Serious side effects related to treatment occurred in five people (5.9%). These included bladder inflammation or pain, urinary tract infection or pain, and more severe infections affecting the kidneys. About 32% of people had to pause treatment temporarily because of side effects such as urinary pain, blood in the urine, or frequent urination. Most of these pauses lasted for only one or two doses, and people were usually able to continue treatment afterward. Only three out of 85 people (about 3.5%) stopped treatment completely because of bladder or urinary problems.
What Can I Do to Manage Side Effects?
Your health care provider will monitor you closely while you are receiving treatment with Inlexzo. Go to all your medical appointments. If you miss any appointments, call your health care provider as soon as possible to schedule your appointment.
Your health care provider will give you a Magnetic Resonance Imaging (MRI) Safety Information Card. Keep this card with you and show it to any health care provider if you need an MRI while Inlexzo is in your bladder. The card helps your health care provider know how an MRI can be safely done during your treatment.
Is There Any Cost Assistance Available?
There is a cost support program from the drugmaker that may allow you to pay $5 per treatment and $0 for certain treatment administration costs. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more https://www.inlexzo.com/savings-support/ or by calling 833-742-0791.
