Kristina N. Michael, APRN, WHNP-BC, Senior Clinical Associate
With the ongoing advancements of immunotherapy in cancer care reaching many solid tumor types, it is important to understand how this translates into the community oncology practice setting and how VieCure can support these advancements.
Dostarlimab-gxly (Jemperli) had an accelerated approval 04/22/2021 as a programmed death receptor-1 (PD-1) antibody for adult females with endometrial cancer who meet the following criteria: the tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR), and the tumor has returned, or it has spread (advanced cancer), and you have received certain types of chemotherapy that did not work or are no longer working (U.S. Food and Drug Administration, 2023). This is a significant achievement within the gynecologic oncology community to improve the quality of care provided to patients and to present new opportunities for treatment. Under the FDA’s accelerated program, patients were given access to receive this novel immunotherapy treatment while clinical trials were conducted, which include the RUBY and GARNET studies.
While endometrial cancer diagnosis rates continue to rise, over the last decade the statistics demonstrate “the incidence rate increasing by 1% per year in White women and 2% to 3% per year in women of all other racial/ethnic groups” (American Cancer Society, 2024). The rates of diagnoses and cancer deaths are reflected by risk factors, improvement in screening protocol, and improvement in treatment regimens. While no recommended screening tests are clinically indicated, the 5-year survival rate from 2013-2019 was at 81% due to earlier intervention and identification of risk factors (SEER, 2023). Dostarlimab-gxly (Jemperli) can be used in combination with existing protocols such as carboplatin and paclitaxel, and then subsequently used alone or can be used alone if existing qualifying criteria have been met. This combination of carboplatin-paclitaxel with Dostarlimab-gxly is listed in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a “Category 1 preferred treatment option for primary or adjuvant therapy for stage III-IV* dMMR/MSI-H endometrial carcinoma or as a first-line therapy option for dMMR/MSI-H recurrent disease” (NCCN Guidelines®, 2023).
Until the approval of Dostarlimab-gxly (Jemperli), there was only one FDA-approved agent, Pembrolizumab (Keytruda), for the treatment of patients with metastatic or unresectable mismatch repair deficient (dMMR) solid tumors with progression following prior treatment. Significant strides have been achieved in community oncology practices being able to offer patients personalized treatment based on comprehensive genomic profiling. Earlier intervention with ordering NGS testing improves long-term outcomes. VieCure’s patented Artificial Intelligence platform (U.S. Patent No. 11,798,689 B2) streamlines precision oncology decision support through automated (“one-click”) ordering of NGS testing through an integration with the laboratory and the platform. Having results to guide clinical decision making as well as an interpretation of those results provides increased satisfaction and improved outcomes for patients and providers. Utilization and interpretation of NGS testing has several long-term benefits and rapidly expansive diagnostic, therapeutic, and prognostic implications for patients.
Commonly reported side effects of Dostarlimab-gxly (Jemperli) parallel to alternate immunotherapies include, but are not limited to the following: fatigue, weakness, anemia, diarrhea, nausea, constipation, and vomiting (GlaxoSmithKline, 2021). The toxicities can continue through treatment and even after cessation. For toxicity management, VieCure has codified alerts (referred to as “considerations”) in the platform when a patient assessment returns a result that requires clinical intervention to support the patient and manage existing or potential toxicities. Early identification of these immune-mediated adverse reactions maintains a controlled safety and efficacy profile. VieCure uses the CTCAE graded results for toxicities, which can be actioned through the platform without leaving clinical workflow. These toxicities are tied to the patient’s treatment plan to enable active management by the clinical team.
Recent developments for endometrial cancer with Dostarlimab-gxly (Jemperli), continue to be promising within the gynecologic oncology community in guiding individualized treatment. VieCure continues to support these advancements and supports clinicians in their efforts to manage advanced malignancies.
** (For stage IIIA, IIIB, or IIIC1 with measurable disease, stage IIIC1 with carcinosarcoma, clear-cell, serous, or mixed histology regardless of the presence of measurable disease, and stage IIIC2 or stage IV regardless of the presence of measurable disease.
References:
American Cancer Society. Facts & Figures 2024. American Cancer Society. Atlanta. 2024.
GlaxoSmithKline. Jemperli [package insert]. U.S. Food and Drug Administration. Revised August 2021. Reference ID: 4842942. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761223s000lbl.pdf
Jemperli (dostarlimab-gxly) injection, for intravenous use [prescribing information]. GlaxoSmithKline; April 2021. Accessed March 7, 2024. https://www.jemperlihcp.com/dosing-and-administration/
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms. V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed March 7, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org
Phillips, C. (2023). Immunotherapy’s Role in Treating Endometrial Cancer Expected to Grow. Cancer Currents: An NCI Cancer Research Blog, 12 April 2023, https://www.cancer.gov/news-events/cancer-currents-blog/2023/immunotherapy-endometrial-cancer-pembrolizumab-dostarlimab
SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; 2023 Apr 19. [updated: 2023 Nov 16; cited 2024 Mar 11]. Available from: https://seer.cancer.gov/statistics-network/explorer/. Data source(s): SEER Incidence Data, November 2022 Submission (1975-2020), SEER 22 registries.
Kristina Michael, APRN, WHNP-BC
Senior Clinical Associate, VieCure