See RUBY trial patient characteristics | See RUBY trial efficacy outcomes

See RUBY trial patient characteristics |
See RUBY trial efficacy outcomes

In the dMMR/MSI-H Endometrial Cancer Subgroup

The RUBY trial had a major efficacy outcome of PFS* with additional efficacy outcomes of OS, ORR, and DOR¹^,²

Randomization was stratified by MMR/MSI status, prior external pelvic radiotherapy, and disease status (recurrent, primary Stage III, or primary Stage IV)

*Assessed by the investigator according to RECIST v1.1.²

^†In RUBY, 494 patients underwent randomization to each treatment arm. The safety profile was evaluated in the 241 patients who were randomized to JEMPERLI + CP with primary advanced or recurrent endometrial cancer (EC). The safety data presented on the safety page reflects exposure to JEMPERLI in 52 patients with dMMR/MSI-H primary advanced or recurrent EC.¹^,²

^‡JEMPERLI was administered prior to chemotherapy on Day 1 of each 21-Day cycle. Treatment with JEMPERLI continued until disease progression, unacceptable toxicity, or a maximum of 3 years.¹^,²

AUC=area under the curve; CP=carboplatin-paclitaxel; DOR=duration of response; IV=intravenous; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; Q3W=every 3 weeks; Q6W=every 6 weeks; RECIST=Response Evaluation Criteria in Solid Tumors.

The RUBY trial included patients with broad disease characteristics including those with aggressive histologies^2-⁴

The RUBY trial included patients with broad disease characteristics^1,²

Primary FIGO Stage III or Stage IV disease, including patients with more aggressive histologies²^-⁴

First recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, including those²:

Naïve to systemic anticancer therapy
Who had received prior neoadjuvant/adjuvant systemic anticancer therapy and who had a recurrence or disease progression ≥6 months after completing treatment (first recurrent)

All patients in the RUBY trial were anti-PD-1/L1/L2 naïve.⁵

^§Measurable or evaluable by RECIST v1.1.

FIGO=International Federation of Gynaecology and Obstetrics; PD-1=programmed cell death receptor 1; PD-L1/2=programmed cell death receptor ligand 1/2.

The RUBY trial included dMMR/MSI-H endometrial cancer patients with diverse disease characteristics (n=122)¹^,²^,⁶

RUBY patient baseline characteristics infographic

In the dMMR/MSI-H Endometrial Cancer JEMPERLI + CP Arm

Groundbreaking 71% reduction in the risk of progression or death vs CP alone²

Superior PFS With JEMPERLI + CP vs CP Alone in the dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer Patient Population (n=122)²

Progression-free survival in dMMR/MSI-H RUBY population line graph

See the JEMPERLI difference

Hazard ratio for risk of progression or death with JEMPERLI + CP vs CP alone (HR=0.29, 95% CI: 0.17, 0.50^¶; P<0.0001^#)²

30.3 months median PFS^# (95% CI: 11.8, NR) with JEMPERLI + CP compared with 7.7 months (95% CI: 5.6, 9.7) with CP alone²

Overall survival data in the dMMR/MSI-H subgroup were immature with 27% deaths^2**

HR=0.29 (95% Cl: 0.13, 0.64)^6¶
OS was a prespecified exploratory analysis in the dMMR/MSI-H subgroup with no planned hypothesis testing, and no conclusions can be drawn from this analysis²
OS continues to be evaluated in the dMMR/MSI-H subgroup²

^¶Based on stratified Cox regression model.

^#One-sided p-value based on stratified log-rank test was statistically significant.

^**OS in the dMMR/MSI-H subgroup was not powered to demonstrate statistically significant differences.²^,⁶

Median follow-up time was 25 months.¹

CI=confidence interval; CP=carboplatin-paclitaxel; HR=hazard ratio; NR=not reached

In the dMMR/MSI-H Endometrial Cancer JEMPERLI + CP Arm

73.8% objective response rate with JEMPERLI + CP after >2 years of follow-up¹^,²

CP alone:

Patients on CP alone achieved a 62.2% ORR (n=28/45, 95% CI: 46.5, 76.2) with 11.1% CR (n=5/45) and 51.1% PR (n=23/45).²

^††Confirmed responses as assessed by investigator according to RECIST v1.1.¹

Median follow-up time was 25 months.¹

CP=carboplatin-paclitaxel; CR=complete response; PR=partial response.

~1 out of 3 patients who responded achieved a complete response with JEMPERLI + CP (n=11/31)²

In the dMMR/MSI-H Endometrial Cancer JEMPERLI + CP Arm

Duration of response with JEMPERLI + CP after >2 years of follow-up¹^,²^‡‡§§

61.3% (n=19/31) of responders had a DOR >1 year¹^,²

Over half of responders on JEMPERLI + CP had a DOR greater than 1 year compared with 14.3% (n=4/28) of patients on CP alone; 25 months median follow-up time¹^,²

^‡‡Confirmed responses as assessed by investigator according to RECIST v1.1.
^§§For patients with a partial or complete response.

Median DOR was not reached at 2 years (95% CI: 3.4, 28.3+) after 25 months median follow-up with JEMPERLI + CP compared with median DOR of 5.4 months (95% CI: 2.7, 27.2+) with CP alone¹^,²

Estimated probability of remaining in response at 2 years for patients in the dMMR/MSI-H endometrial cancer subgroup^6¶¶

^¶¶Probability of response estimated from Kaplan-Meier curves with a median follow-up of 25 months.¹^,⁶

DOR=duration of response; NR=not reached.

See the appropriate patient types who may benefit from JEMPERLI + CP

Learn about the safety profile
from the RUBY trial

See Safety Profile

Learn about JEMPERLI Dosing

See Dosing & Administration

Learn about support for
JEMPERLI at every step

See Access & Support

Indications & Important Safety Information

Indications

JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
JEMPERLI, as a single agent, is indicated for the treatment of adult patients with dMMR recurrent or advanced:
- EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation, or
- solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

Indications

JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.
Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. For suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Based on the severity of the adverse reaction, withhold or permanently discontinue JEMPERLI. In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.

Immune-Mediated Pneumonitis

JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Pneumonitis occurred in 2.3% (14/605) of patients, including Grade 2 (1.3%), Grade 3 (0.8%), and Grade 4 (0.2%) pneumonitis.

Immune-Mediated Colitis

Colitis occurred in 1.3% (8/605) of patients, including Grade 2 (0.7%) and Grade 3 (0.7%) adverse reactions. Cytomegalovirus infection/reactivation have occurred in patients with corticosteroid-refractory immune-mediated colitis. In such cases, consider repeating infectious workup to exclude alternative etiologies.

Immune-Mediated Hepatitis

JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Grade 3 hepatitis occurred in 0.5% (3/605) of patients.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency
- Adrenal insufficiency occurred in 1.2% (7/605) of patients, including Grade 2 (0.5%) and Grade 3 (0.7%). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
Hypophysitis
- JEMPERLI can cause immune-mediated hypophysitis. Grade 3 hypophysitis occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2 hypophysitis occurred in 0.2% (1/605) of patients receiving JEMPERLI as a single agent. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
Thyroid Disorders
- Grade 2 thyroiditis occurred in 0.5% (3/605) of patients. Grade 2 hypothyroidism occurred in 12% (28/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2 hypothyroidism occurred in 8% (46/605) of patients receiving JEMPERLI as a single agent. Hyperthyroidism occurred in 3.3% (8/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel, including Grade 2 (2.9%) and Grade 3 (0.4%). Hyperthyroidism occurred in 2.3% (14/605) of patients receiving JEMPERLI as a single agent, including Grade 2 (2.1%) and Grade 3 (0.2%). Initiate thyroid hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis
- JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Grade 3 type 1 diabetes mellitus occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 3 type 1 diabetes mellitus occurred in 0.2% (1/605) of patients receiving JEMPERLI as a single agent. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.

Immune-Mediated Nephritis with Renal Dysfunction

JEMPERLI can cause immune-mediated nephritis, which can be fatal. Grade 2 nephritis, including tubulointerstitial nephritis, occurred in 0.5% (3/605) of patients.

Immune-Mediated Dermatologic Adverse Reactions

JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI depending on severity.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred in <1% of the 605 patients treated with JEMPERLI or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
- Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
- Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
- Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur
- Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis
- Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
- Endocrine: Hypoparathyroidism
- Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection

Infusion-Related Reactions

Severe or life-threatening infusion-related reactions have been reported with PD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3) occurred in 0.2% (1/605) of patients receiving JEMPERLI. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue JEMPERLI based on severity of reaction.

Complications of Allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1–blocking antibody, which may occur despite intervening therapy. Monitor patients closely for transplant-related complications and intervene promptly.

Embryo-Fetal Toxicity and Lactation

Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after their last dose. Because of the potential for serious adverse reactions from JEMPERLI in a breastfed child, advise women not to breastfeed during treatment with JEMPERLI and for 4 months after their last dose.

Common Adverse Reactions

The most common adverse reactions (≥20%) in patients with dMMR/MSI-H EC who received JEMPERLI in combination with carboplatin and paclitaxel were rash, diarrhea, hypothyroidism, and hypertension. The most common Grade 3 or 4 laboratory abnormalities (≥10%) were decreased neutrophils, decreased hemoglobin, decreased white blood cell count, decreased lymphocytes, increased glucose, decreased sodium, and decreased platelets.

The most common adverse reactions (≥20%) in patients with dMMR EC who received JEMPERLI as a single agent were fatigue/asthenia, anemia, nausea, diarrhea, constipation, vomiting, and rash. The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased lymphocytes, decreased sodium, increased alanine aminotransferase, increased creatinine, decreased neutrophils, decreased albumin, and increased alkaline phosphatase.

The most common adverse reactions (≥20%) in patients with dMMR solid tumors who received JEMPERLI as a single agent were fatigue/asthenia, anemia, diarrhea, and nausea. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased sodium, increased alkaline phosphatase, and decreased albumin.

Please see full Prescribing Information, including Medication Guide.
.

The RUBY trial had a major efficacy outcome of PFS* with additional efficacy outcomes of OS, ORR, and DOR1,2

The RUBY trial included patients with broad disease characteristics1,2

Primary FIGO Stage III or Stage IV disease, including patients with more aggressive histologies2-4

First recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, including those2:

The RUBY trial included dMMR/MSI-H endometrial cancer patients with diverse disease characteristics (n=122)1,2,6

Groundbreaking 71% reduction in the risk of progression or death vs CP alone2

See the JEMPERLI difference

Overall survival data in the dMMR/MSI-H subgroup were immature with 27% deaths2**

73.8% objective response rate with JEMPERLI + CP after >2 years of follow-up1,2

CP alone:

Duration of response with JEMPERLI + CP after >2 years of follow-up1,2‡‡§§

61.3% (n=19/31) of responders had a DOR >1 year1,2

Estimated probability of remaining in response at 2 years for patients in the dMMR/MSI-H endometrial cancer subgroup6¶¶

The RUBY trial had a major efficacy outcome of PFS* with additional efficacy outcomes of OS, ORR, and DOR¹^,²

The RUBY trial included patients with broad disease characteristics^1,²

Primary FIGO Stage III or Stage IV disease, including patients with more aggressive histologies²^-⁴

First recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, including those²:

The RUBY trial included dMMR/MSI-H endometrial cancer patients with diverse disease characteristics (n=122)¹^,²^,⁶

Groundbreaking 71% reduction in the risk of progression or death vs CP alone²

Overall survival data in the dMMR/MSI-H subgroup were immature with 27% deaths^2**

73.8% objective response rate with JEMPERLI + CP after >2 years of follow-up¹^,²

Duration of response with JEMPERLI + CP after >2 years of follow-up¹^,²^‡‡§§

61.3% (n=19/31) of responders had a DOR >1 year¹^,²

Estimated probability of remaining in response at 2 years for patients in the dMMR/MSI-H endometrial cancer subgroup^6¶¶