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GARNET Trial Overview and Results

Learn more about the efficacy results of JEMPERLI monotherapy, an immunotherapy for recurrent/advanced dMMR/MSI-H endometrial cancer after platinum-based chemotherapy.

The Largest Dedicated Single-Agent Immunotherapy Trial in EC Has a Median Follow-up of Over 2 Years1,2

GARNET: a global, multicentre, uncontrolled, multiple parallel cohort, open-label study1

Primary endpoints: ORR and DOR*

Safety in Analysis

605 patients with EC or other solid tumours

Safety in Analysis Safety in Analysis

Safety and OS in Analysis

153 patients with
dMMR/MSI-H EC

Safety and OS in Analysis Safety and OS in Analysis

Efficacy in Analysis

143 patients with dMMR/MSI-H EC who had measurable disease at baseline and at least 24 weeks of follow-up

Patients received: JEMPERLI 500 mg every 3 weeks for 4 doses, followed by 1000 mg every 6 weeks1†

*As assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.1
Treatment continued until disease progression or unacceptable toxicity.1

Key Inclusion Criteria1,2 Key Exclusion Criteria1,2
  • Recurrent or advanced endometrial cancer
  • Prior treatment with PD-1/PD-L1 inhibitors or other immune checkpoint inhibitor therapy
  • dMMR endometrial cancer as determined by IHC testing
  • Autoimmune disease that required systemic treatment within 2 years
  • Progression on or after platinum-containing regimen
  • A diagnosis of immunodeficiency, including a history of infection with HIV, hepatitis B, or hepatitis C
  • ≤2 lines of prior anticancer treatment for recurrent or advanced disease
 
Patient Population1,2
  • Patients age ≥18 years
  • Recurrent or advanced endometrial cancer that had progressed on or following treatment with a platinum-containing regimen
  • dMMR/MSI-H tumour status prospectively determined by local testing

 

dMMR=mismatch repair deficient; EC=endometrial cancer; HIV=human immunodeficiency virus; IHC=immunohistochemistry;
MSI-H=microsatellite instability-high; PD-1=programmed death receptor 1; PD-L1=programmed death ligand 1.

GARNET Cohort A1: Patient Baseline Characteristics (n=143)1,3

Patient Baseline Characteristics
Years Median Age

Years Median Age

63% of patients had one prior therapy

63% of patients had one prior therapy

Histology

64.3%  Endometrioid Carcinoma Type

64.3%

Endometrioid
Carcinoma Type 1

34.3%  Endometrioid Carcinoma Type 2

34.3%

Endometrioid
Carcinoma Type 2

1.4%  Unknown

1.4%

Unknown

ECOG Performance Score

39% ECOG 0

ECOG 0

61% ECOG 1

ECOG 1

FIGO Stage

FIGO Stage

56.6%
Stage III or IV
at time of diagnosis

56.6%
Stage III or IV

at time of diagnosis

ECOG=Eastern Cooperative Oncology Group; FIGO=International Federation of Gynaecology and Obstetrics.

Overall Response Rate

JEMPERLI Demonstrated Meaningful and Lasting Efficacy Over Long-term Follow-up of More Than 2 Years1,3,4

JEMPERLI demonstrated clinically meaningful efficacy over time with nearly half of patients achieving a response1

PRIMARY ENDPOINT

Objective Response Rate (ORR)

Objective Response Rate (ORR) 45.5% NA

Over one-third of those who responded to JEMPERLI achieved a complete response (n=23/65)1

  • More than half of patients (60.1% disease control rate) [95% Cl: 51.6, 68.2] did not see their disease worsen when treated with JEMPERLI1
  • ORR benefit of JEMPERLI was observed across histologic subtypes and number of lines of therapy4*

ESMO Guidelines recommend JEMPERLI as a second-line dMMR/MSI-H endometrial cancer treatment5

*Subgroup analyses were not powered and should be interpreted with caution.4

CI=confidence interval; CR=complete response; PR=partial response.

Duration of Response

Benefit Estimated to Be Sustained for >2 Years for Most Responders3

PRIMARY ENDPOINT

93.3% Probability of Patients

93.3% Probability of Patients

still responding at 12 months

83.7% Probability of Patients

83.7% Probability of Patients

still responding at 24 months

The median DOR was not reached (1.2+ to 47.2+) with a median follow-up of 27.6 months.

JEMPERLI demonstrated a durable response1,3

54 out of 65 responders continued to respond as of data cutoff 54 out of 65 responders continued to respond as of data cutoff

54 out of 65 responders continued to respond as of data cutoff3

Find Out More

GARNET Safety Profile

JEMPERLI Dosing and Administration

JEMPERLI Support and Resources

JEMPERLI Is Indicated6

  • in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
  • as monotherapy for the treatment of adult patients with dMMR/ MSI‑H recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.

Jemperli Safety Information6

Contraindications: 
Hypersensitivity to the active substance or to any of the excipients

Adverse reactions:

Dostarlimab monotherapy:
Very common: Anaemia, Hypothyroidism, Diarrhoea, nausea, vomiting, Rash, pruritus, Arthralgia, Pyrexia and Transaminases increased

Common:
Hyperthyroidism, adrenal insufficiency, Pneumonitis, Colitis , pancreatitis, gastritis, Hepatitis, Myalgia, Chills and Infusion-related reaction

Dostarlimab in combination therapy:
Very common:
Hypothyroidism, Rash, dry skin, Pyrexia, Alanine aminotransferase increased and aspartate aminotransferase increased

Common:
Hyperthyroidism, adrenal insufficiency, Pneumonitis and Colitis

▼ This medicine is subjected to additional monitoring. This will allow quick identification of new safety information. You may help by reporting any side effects you may get.

References

  1. JEMPERLI Summary of Product Characteristics. GSK. 2023.
  2. Oaknin A, et al. J Immunother Cancer. 2022;10:e003777:1-10.
  3. Oaknin A, et al. Presented at 2022 ASCO Annual Meeting: June 3-7, 2022; Chicago.
  4. Data on file. GSK.
  5. Oaknin A, et al. Ann Oncol. 2022;33(9):860-877.
  6. Jemperli Local PI

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: www.moh.gov.om

دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
www.moh.gov.om : الموقع االكتروني

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February 2025 | PM-AE-DST-WCNT-250001