(BPT) - Sponsored by GSK - An estimated 948,000 women will be diagnosed with cancer this year.[i] While breast and cervical cancer may come to mind, a lesser-known, but equally important disease is endometrial cancer, which affects the lining of the uterus. Endometrial cancer is the most common gynecologic malignancy in the US.[ii] Approximately 1 out of 4 people with endometrial cancer have either advanced or recurrent cancer.[iii]
Until recently, people with advanced or recurrent endometrial cancer had limited options.[iv] Unlike breast or cervical cancer, there are no standardized screening tests or exams to detect endometrial cancer early.[v] In addition, advancements in treatment have been slower, especially for recurrent or advanced forms of the disease and for those with specific biomarkers.[vi] A biomarker is a biological marker found in blood, tissue, or cells in the body.[vii] Biomarkers can help your doctor diagnose cancer and may help decide which treatment options may be right for you.[viii] For approximately 25% of people with endometrial cancer, one particular biomarker is mismatch repair deficiency, or dMMR.[ix]
In normal cells, mismatch repair (MMR) is a process that ensures DNA is copied without errors during natural cell growth and replication.[ix] When a repair mechanism is defective, it is known as mismatch repair deficient (dMMR). A dMMR system results in the accumulation of errors, which may lead to an increased risk of cancer.[ix]
To date, there have been limited Food and Drug Administration (FDA)-approved treatment options for those with dMMR recurrent or advanced endometrial cancer whose disease progresses on or after initial treatment with platinum-based chemotherapy; and the prognosis for these patients is poor.[ix] However, with new cases rising and increased attention given to awareness and research, progress is being made for patients.[x]
In 2021, the FDA approved a treatment option, known as JEMPERLI (dostarlimab-gxly for injection 500 mg), for this population of patients with high unmet need, as well as for those with dMMR recurrent or advanced solid tumors.
JEMPERLI is a prescription medicine used to treat adults with certain cancers that have been shown by a laboratory test to be dMMR, and your cancer has returned, or it has spread (advanced cancer). JEMPERLI may be used when:
- you have a kind of uterine cancer called endometrial cancer, and you have received chemotherapy that contains platinum and it did not work or is no longer working and your cancer cannot be treated by surgery or radiation.
- you have a solid tumor that progressed during treatment or after treatment, and you have no satisfactory treatment options. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to confirm the clinical benefit of JEMPERLI for this use.
JEMPERLI is a medicine that may treat certain cancers by working with your immune system. JEMPERLI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Please see below for additional Important Safety Information and full Prescribing Information.
Endometrial cancer has the highest rate of dMMR across all types of tumors.[xi] Tumors with dMMR have certain properties that may make them more likely to respond to an immunotherapy like JEMPERLI.[xii]
For those with dMMR recurrent or advanced endometrial cancer, this treatment may give them, as well as their providers, more tools in their arsenal to face this disease.
As research continues to progress, awareness of the disease and the patients it affects remains important.
JEMPERLI is being studied in other types of cancers. JEMPERLI was studied in 209 patients with dMMR recurrent or advanced solid tumors who had progressed on or following systemic therapy and had no satisfactory alternative treatment options. Some of the dMMR tumor types studied included the following: colorectal cancer, small intestinal cancer, gastric cancers, pancreatic carcinoma, biliary neoplasm, liver cancer, ovarian cancer, adrenal cortical cancer, breast cancer, esophageal cancer, malignant neoplasm of the female genitals, pleural cancer and renal cell carcinoma. It is a positive step forward to see treatments being developed for eligible patients who need them.
Those impacted by dMMR recurrent or advanced solid tumors, including endometrial cancer, should talk to their doctors about potentially available treatment options, such as JEMPERLI and visit jemperli.com to learn more.
Approved Uses
JEMPERLI is a prescription medicine used to treat adults with certain cancers that have been shown by a laboratory test to be mismatch repair deficient (dMMR), and your cancer has returned, or it has spread (advanced cancer).
JEMPERLI may be used when:
- you have a kind of uterine cancer called endometrial cancer, and you have received chemotherapy that contains platinum and it did not work or is no longer working and your cancer cannot be treated by surgery or radiation.
- you have a solid tumor that progressed during treatment or after treatment, and you have no satisfactory treatment options. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to confirm the clinical benefit of JEMPERLI for this use.
It is not known if JEMPERLI is safe and effective in children.
Important Safety Information
JEMPERLI is a medicine that may treat certain cancers by working with your immune system. JEMPERLI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Call or see your healthcare provider (HCP) right away if you develop any new or worsening signs or symptoms, including:
Lung problems. Signs and symptoms may include cough, shortness of breath, or chest pain.
Intestinal problems. Signs and symptoms may include diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.
Liver problems. Signs and symptoms may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than usual.
Hormone gland problems. Signs and symptoms may include headaches that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness.
Kidney problems. Signs and symptoms may include change in the amount or color of your urine, blood in your urine, swelling in your ankles, or loss of appetite.
Skin problems. Signs and symptoms may include rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; or swollen lymph nodes.
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with JEMPERLI. Call or see your HCP right away for any new or worse signs or symptoms. Signs and symptoms may include chest pain, irregular heartbeat, shortness of breath, swelling of ankles; confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs; double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight; persistent or severe muscle pain or weakness, muscle cramps; low red blood cells, bruising.
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.
Rejection of a transplanted organ. Your HCP should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with JEMPERLI. Your HCP will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your HCP will check you for these problems during treatment with JEMPERLI and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your HCP may also need to delay or completely stop treatment with JEMPERLI.
Before receiving JEMPERLI, tell your HCP about all of your medical conditions, including immune system problems such as Crohn's disease, ulcerative colitis, or lupus; received an organ transplant; have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic); have received radiation treatment to your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.
If you are pregnant or plan to become pregnant, tell your HCP. JEMPERLI can harm your unborn baby. If you are able to become pregnant, your HCP will give you a pregnancy test before you start treatment. Use an effective birth control method during treatment and for 4 months after your last dose of JEMPERLI. Tell your HCP right away if you become pregnant or think you may be pregnant during treatment with JEMPERLI.
If you are breastfeeding or plan to breastfeed, tell your HCP. It is not known if JEMPERLI passes into your breast milk. Do not breastfeed during treatment with JEMPERLI and for 4 months after your last dose.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of JEMPERLI include tiredness and weakness, low red blood cell count (anemia), diarrhea, nausea, decreased number of certain white blood cells, decreased albumin in the blood, increase in certain liver blood tests, decreased salt (sodium) in the blood.
These are not all of the possible side effects of JEMPERLI. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.Trademarks are property of their respective owners.
©2023 GSK or licensor. DSTCOCO230004 March 2023 Produced in USA.
[i] American Cancer Society. Cancer facts & figures 2023. Accessed February 22, 2023. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2023-cancer-facts-figures.html.
[ii] Mahdy H, Casey MJ, Crotzer D. Endometrial Cancer. StatPearls [Internet]. January 2022. [Updated September 26, 2022]. Accessed February 22, 2023. https://www.ncbi.nlm.nih.gov/books/NBK525981/
[iii] CancerMPact® Patient Metric, Cerner Enviza. Accessed February 22, 2023. https://cancermpact.khapps.com/
[iv] Halla K. J Adv Pract Oncol. 2022;13(1):45­59.
[v] National Cancer Institute (NCI). NCI Endometrial Cancer Screening. Bethesda, MD: U.S. National Institutes of Health (NIH); 2021. Accessed February 22, 2023. https://www.cancer.gov/types/uterine/patient/endometrial-screening-pdq
[vi] Brooks RA, et al. CA Cancer J Clin. 2019;69(4):258­279.
[vii] National Cancer Institute (NCI). NCI Dictionary of Cancer Terms. Bethesda, MD: U.S. National Institutes of Health (NIH); 2021. Accessed February 22, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/biomarker
[viii] National Cancer Institute (NCI). Biomarker Testing for Cancer Treatment. Bethesda, MD: U.S. National Institutes of Health (NIH); 2021. Accessed February 22, 2023. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment
[ix] Lorenzi M, et al. J Oncol. 2020;2020:1­17.
[x] Ferriss JS, et al. Int J Gynecol Cancer. 2021;31:1165­1174.
[xi] Le DT, et al. Science. 2017;357(6349):409­413.
[xii] Le DT, et al. N Engl J Med. 2015;372(26):2509­2520.
