CLINICAL TRIALS PROFILE FOR JEMPERLI

All Clinical Trials for JEMPERLI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04926324 ↗	A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers	Not yet recruiting	GlaxoSmithKline	Phase 1/Phase 2	2021-12-31	This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer. Once this is determined, this dose will be tested to identify what impact it has on the tumor as well as patient reported outcome measures.
NCT04926324 ↗	A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers	Not yet recruiting	Joseph Caster, Ph.D., M.D.	Phase 1/Phase 2	2021-12-31	This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer. Once this is determined, this dose will be tested to identify what impact it has on the tumor as well as patient reported outcome measures.
NCT05526989 ↗	Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma	Not yet recruiting	GlaxoSmithKline	Phase 2	2022-09-15	The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
NCT05526989 ↗	Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma	Not yet recruiting	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2022-09-15	The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
NCT05870761 ↗	Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma	Not yet recruiting	Casey Cosgrove	Phase 2	2023-06-30	This phase II trial tests how well niraparib and dostarlimab work in treating patients with uterine serous carcinoma that has come back (after a period of improvement) (recurrent) and remains despite treatment (persistent). Niraparib belongs to a class of drugs called PARP inhibitors that prevent cancer cells from growing. Dostarlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Dostarlimab belongs to a class of drugs called PD-1 inhibitors that uses the patient's own immune system to treat cancer (immuno-therapy). Giving niraparib and dostarlimab may work better in treating patients with uterine serous carcinoma.
NCT06023862 ↗	A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)	Recruiting	Yonsei University	Phase 2	2024-01-22	Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. 1. Group A: Dostarlimab monotherapy - First 3 cycles: Dostalimab 500mg every 3 weeks, IV - 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV 2. Group B: Dostarlimab + Bevacizumab combination therapy - First 3 cycles: Dostalimab 500mg every 3 weeks, IV - 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV - Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity 3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)
NCT06059495 ↗	Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study	Recruiting	GERCOR - Multidisciplinary Oncology Cooperative Group	Phase 2	2023-12-18	This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)/microsatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma. The goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.

Clinical Trial Conditions for JEMPERLI

Condition Name

Condition Name for JEMPERLI
Intervention	Trials
Endometrial Neoplasms	1
Gastric Adenocarcinoma	1
Ovarian Neoplasms	1
Penile Carcinoma	1

Condition MeSH

Condition MeSH for JEMPERLI
Intervention	Trials
Carcinoma	2
Neoplasms	2
Recurrence	1
Vaginal Neoplasms	1

Clinical Trial Locations for JEMPERLI

Trials by Country

Trials by Country for JEMPERLI
Location	Trials
United States	2
France	1
Korea, Republic of	1

Trials by US State

Trials by US State for JEMPERLI
Location	Trials
Ohio	1
Florida	1

Clinical Trial Progress for JEMPERLI

Clinical Trial Phase

Clinical Trial Phase for JEMPERLI
Clinical Trial Phase	Trials
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for JEMPERLI
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for JEMPERLI

Sponsor Name

Sponsor Name for JEMPERLI
Sponsor	Trials
GlaxoSmithKline	2
H. Lee Moffitt Cancer Center and Research Institute	1
Casey Cosgrove	1

Sponsor Type

Sponsor Type for JEMPERLI
Sponsor	Trials
Other	5
Industry	2

Clinical Trials Update, Market Analysis, and Projection for JEMPERLI (Dostarlimab)

Last updated: October 28, 2025

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Overview of JEMPERLI (Dostarlimab)

JEMPERLI (dostarlimab-gxly) is a monoclonal antibody developed by GlaxoSmithKline (GSK) targeting PD-1, a key immune checkpoint regulator. Designed to enhance the immune response against cancer cells, JEMPERLI has gained approval primarily for the treatment of mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer and other solid tumors.

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Clinical Trials Update

Current Trial Portfolio:
JEMPERLI is under extensive clinical evaluation, with pivotal trials focusing on multiple indications beyond its initial approvals. As of 2023, over 20 clinical trials are active, exploring its efficacy across various solid tumors, including ovarian, colorectal, and gastric cancers, as well as rare tumors like glioblastoma.

Key Phase III Trials:

• GARNET (NCT02997228): This pivotal trial demonstrated substantial antitumor activity in dMMR/MSI-H endometrial and other solid tumors. It achieved its primary endpoints with durable response rates and manageable safety profiles, leading to accelerated approval in several regions.

Recent Updates and Regulatory Filings:

• FDA and EMA Approvals: In early 2021, the U.S. FDA approved JEMPERLI for adult patients with unresectable or metastatic MSI-H or dMMR recurrent or advanced endometrial cancer. The European Medicines Agency (EMA) granted Conditional Marketing Authorization shortly thereafter, based on this data.

• Ongoing Trials: GSK continues to explore broader indications through phase II/III trials. Notably, trials evaluating combination therapies with chemotherapy, radiotherapy, and other immuno-oncology agents are in progress, aiming to enhance efficacy and reduce resistance.

Emerging Data Insights:
Recent interim analyses suggest promising activity in colorectal cancers with MSI-H phenotype, supporting expanded clinical trials. Furthermore, biomarker studies are underway to refine patient stratification, identifying those most likely to benefit from JEMPERLI therapy.

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Market Analysis of JEMPERLI

Market Size and Potential:
The global oncology immunotherapy market, valued at approximately USD CAD 180 billion in 2022, is projected to grow at a CAGR of 9% over the next decade. JEMPERLI, as a PD-1 inhibitor, directly competes within this lucrative space, particularly targeting subpopulations with dMMR/MSI-H tumors.

Key Indications and Revenue Drivers:

• Endometrial Cancer: As the first approved indication, this represents a significant revenue stream given the rising incidence of endometrial carcinoma globally, notably in developed nations with aging populations.
• Colorectal and Other Solid Tumors: The expanding label through ongoing trials offers upside, especially considering the high prevalence of MSI-H status in colorectal cancers (~4-5%) and other high-mortality solid tumors.
• Combination Therapies: GSK’s strategic focus on combining JEMPERLI with other agents could unlock additional market segments. For example, early-phase data indicate synergy with chemotherapy, potentially broadening indications.

Competitive Landscape:
JEMPERLI faces direct competition from pembrolizumab (Keytruda, Merck) and nivolumab (Opdivo, Bristol-Myers Squibb), both of which hold extensive approvals across multiple tumor types. However, GSK’s focus on MSI-H/dMMR cancers, coupled with early promising data, positions JEMPERLI as a targeted, potentially first-line therapy for specific niches.

Pricing and Reimbursement Trends:
GSK has leveraged the high unmet need and biomarker-driven approach to justify premium pricing in markets like the U.S. and Europe. Reimbursement decisions increasingly favor durable responses and biomarker-based patient selection, bolstering commercial viability.

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Market Projection Analysis

Short-term Outlook (Next 1-2 Years):

• Anticipated growth driven by current approvals in endometrial cancer and regulatory submissions for additional indications.
• Commercial expansion into Europe and Asia, where biomarker screening is increasing, will augment sales.
• Launch of combination regimens, particularly with chemotherapy and other immunotherapies, could lead to rapid adoption, especially in refractory settings.

Medium- to Long-term Outlook (3-10 Years):

• Market dominance may hinge upon successful demonstration of activity in broader tumor types, especially MSS (microsatellite stable) tumors, where current PD-1 inhibitors underperform. GSK’s ongoing trials targeting combination strategies aim to address this unmet need.
• Personalized medicine approaches, including biomarker refinement, could optimize patient selection, improving outcomes and market penetration.

Key Risks and Opportunities:

• Risks: Competition from established PD-1/PD-L1 inhibitors, potential safety concerns, regulatory hurdles in new indications, and payer restrictions.
• Opportunities: Potential approval in frontline settings, expansion into pediatric and rare cancers, and integration into combination regimens to improve efficacy.

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Conclusion

JEMPERLI positions itself as a focused immunotherapy option targeting MSI-H/dMMR tumors, demonstrating strong clinical activity and promising growth potential. Its expanding clinical trial portfolio and strategic combination studies could substantially increase its market share. However, competition and market dynamics necessitate ongoing innovation and evidence generation.

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Key Takeaways

• Clinical validation: JEMPERLI’s pivotal trials have confirmed its efficacy in endometrial cancer, with ongoing studies targeting broader indications.
• Regulatory momentum: Approval in key markets like the U.S. and Europe provides a strong foundation for commercial growth.
• Market opportunity: The immuno-oncology sector presents a substantial and expanding market, with niche dominance achievable through biomarker-driven strategies.
• Competitive landscape: Facing stiff competition from multi-indication PD-1 inhibitors, JEMPERLI’s success will depend on its ability to demonstrate superior efficacy in targeted populations.
• Future strategies: Focus on combination therapies, expanded indications, and personalized medicine will be critical to capturing additional market share.

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FAQs

1. What are the primary approved indications for JEMPERLI?
   JEMPERLI is approved for adult patients with unresectable or metastatic MSI-H or dMMR recurrent or advanced endometrial cancer who have progressed on prior platinum-based chemotherapy.

2. How does JEMPERLI differ from other PD-1 inhibitors?
   While sharing the same target, JEMPERLI specifically targets MSI-H/dMMR tumors, and its clinical development emphasizes biomarker-driven patient selection, potentially offering efficacy advantages in these niche populations.

3. What ongoing trials could expand JEMPERLI’s indications?
   GSK is investigating JEMPERLI in colorectal, gastric, ovarian, and other solid tumors, often in combination with chemotherapy or other immunotherapies, aiming for broader regulatory approvals.

4. What are the key challenges facing JEMPERLI’s market growth?
   Challenges include competition from well-established PD-1/PD-L1 drugs, variability in biomarker testing, regulatory hurdles for new indications, and reimbursement policies.

5. What is the long-term market outlook for JEMPERLI?
   With ongoing clinical development and potential approval in additional tumor types, JEMPERLI could become a key player in personalized immuno-oncology, especially if it can demonstrate superior efficacy with combination strategies.

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References

1. [1] U.S. Food and Drug Administration (FDA). JEMPERLI (dostarlimab-gxly) prescribing information. 2021.
2. [2] European Medicines Agency (EMA). JEMPERLI Summary of Product Characteristics. 2021.
3. [3] GSK Corporate Reports and Clinical Trial Registries. 2023.
4. [4] GlobalData. Oncology Immunotherapy Market Analysis, 2022.
5. [5] ClinicalTrials.gov. JEMPERLI Trials Database.

Note: These references synthesize publicly available data and industry reports to inform the analysis.