First and only FDA-approved treatment for patients with recurrent locally advanced/metastatic nasopharyngeal carcinoma (R/M NPC)1
Proven
efficacy
for more
of
life’s
moments
LOQTORZI®, in
combination with
cisplatin and gemcitabine as first-line treatment,
delivered significantly
improved progression-free
survival (PFS) vs placebo plus cisplatin and gemcitabine1*
combination with
cisplatin and gemcitabine as first-line treatment,
delivered significantly
improved progression-free
survival (PFS) vs placebo plus cisplatin and gemcitabine1*
- 11.7 months BIRC-assessed median PFS vs 8 months,
respectively (HR=0.52 [95% CI, 0.36-0.74]; P=0.0003)
*Patients were treated for up to 6 cycles, followed by LOQTORZI® alone.1
BIRC=blinded independent review committee;CI=confidence interval; HR=hazard ratio; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma.
BIRC=blinded independent review committee;CI=confidence interval; HR=hazard ratio; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma.
![Bottle couple dancing](/static/bottle-couple-2c0b6f281bac287cbca0a5f84cadbbe6.png)
JUPITER-02 trial designPINCH TO ENLARGE
The efficacy of LOQTORZI® in combination with cisplatin and gemcitabine was investigated in JUPITER-02, a randomized, multicenter, single-region,* double-blind, placebo-controlled trial in 289 adult patients with metastatic or recurrent locally advanced NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease.1†
Treatment with LOQTORZI® or placebo continued until disease progression per RECIST v1.1, unacceptable toxicity, or a maximum of 2 years. The primary end point was BIRC-assessed PFS per RECIST v1.1 criteria. The secondary end points were BIRC-assessed ORR, BIRC-assessed DOR, and OS.1,2
LOQTORZI®: first and only treatment with a successful registrational trial in R/M NPC that has led to FDA approval2
JUPITER-02 is the first and only successful FDA registrational trial out of 6 phase 3 trials studying a PD-1/PD-L1 inhibitor in R/M NPC
*The JUPITER-02 trial was conducted across 35 sites in mainland China, Taiwan, and Singapore.3
†Patients with recurrent NPC after treatment with curative intent were required to have an interval of at least 6 months between the last dose of radiotherapy or chemotherapy and recurrence. Patients with autoimmune disease, other than stable hypothyroidism or type 1 diabetes, and patients who required systemic immunosuppression were ineligible.1
BIRC=blinded independent review committee; DOR=duration of response; IV=intravenous; ORR=overall response rate; OS=overall survival; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; PFS=progression-free survival; Q3W=every 3 weeks; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma; RECIST=Response Evaluation Criteria in Solid Tumors.
BIRC=blinded independent review committee; DOR=duration of response; IV=intravenous; ORR=overall response rate; OS=overall survival; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; PFS=progression-free survival; Q3W=every 3 weeks; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma; RECIST=Response Evaluation Criteria in Solid Tumors.
JUPITER-02 trial design
PRIMARY END POINT1
- BIRC-assessed progression-free survival
per RECIST v1.1 criteria
SELECT SECONDARY END POINTS1
- Overall survival
- BIRC-assessed overall response rate
- BIRC-assessed duration of response
Key eligibility criteria3
- Primary metastatic or recurrent locally advanced NPC
after curative-intent therapy - Treatment naïve for R/M NPC
- ECOG PS 0-1
- 18-75 years of age
- Measurable disease per RECIST v1.1
Key exclusion criteria3
- History of severe hypersensitivity reactions to any monoclonal antibody, cisplatin or gemcitabine, or any ingredient of toripalimab
- Active or untreated central nervous system metastases
- Previous monoclonal antibody treatment targeting PD-1/PD-L1/CTLA4
- History of bone marrow or solid organ transplantation
- History of protocol-specified autoimmune disease
Key demographics1
- Median age was 48 years (range: 19 to 72); 4.8% were ≥65 years
- 83% male
- 100% Asian
- 57% ECOG PS of 0
- 86% had metastatic disease
- Histological subtypes:
- 98% nonkeratinizing
- 1% keratinizing squamous
cell carcinoma - 1% not identified
- Previous therapy:
- Approximately 59% received ≥1 prior systemic therapy for locally advanced disease, and 60% received prior radiation therapy
BIRC=blinded independent review committee; CTLA4=cytotoxic T-lymphocyte–associated protein 4; ECOG PS=Eastern Cooperative Oncology Group performance status; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma; RECIST=Response Evaluation Criteria in Solid Tumors.
JUPITER-02 efficacy: interim analysis (primary end point)
LOQTORZI® + CHEMO SIGNIFICANTLY
REDUCED THE RISK OF PROGRESSION1
REDUCED THE RISK OF PROGRESSION1
LOQTORZI® + chemo delivered a BIRC-assessed mPFS of 11.7 months vs 8 months with placebo + chemo1,3*
*Cutoff date for interim analysis was May 30, 2020.1
†Based on the stratified Cox proportional-hazards model using the stratification factors at randomization, ECOG performance status, and disease stage.1
‡Two-sided P value, based on the stratified log-rank test, as compared with an alpha boundary of 0.010.1
BIRC=blinded independent review committee; CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; HR=hazard ratio; mPFS=median progression-free survival; NE=not estimable.
JUPITER-02 efficacy: final analysis
LOQTORZI® + CHEMO OFFERED DURABLE PROTECTION FROM PROGRESSION4,5*
Final PFS by BIRC per RECIST v1.14
*Cutoff date for final analysis was June 8, 2021.4,5
†Patients were treated with LOQTORZI® + cisplatin and gemcitabine for up to six 21-day cycles followed by LOQTORZI® monotherapy.1
‡Patients were treated with placebo + cisplatin and gemcitabine for up to six 21-day cycles followed by placebo monotherapy.1
BIRC=blinded independent review committee; CI=confidence interval; mPFS=median progression-free survival; NE=not estimable; RECIST=Response Evaluation Criteria in Solid Tumors.
JUPITER-02 efficacy: final analysis (secondary end point)*
FINAL OVERALL SURVIVAL ANALYSIS SHOWED REDUCED
RISK OF DEATH BY 37%1,4
RISK OF DEATH BY 37%1,4
Median OS was not reached in the LOQTORZI® + chemo arm compared with 33.7 months in the placebo + chemo arm1,4
- A significant improvement in OS was observed in patients treated with LOQTORZI® + chemo vs placebo + chemo1
- Median survival follow-up of 36 months4
*OS results are based on the final analysis with a data cutoff of November 18, 2022.1
†Two-sided P value, based on the stratified log-rank test, as compared with an alpha boundary of 0.049995.1
‡Patients were treated with LOQTORZI® + cisplatin and gemcitabine for up to six 21-day cycles followed by LOQTORZI® monotherapy.1
§Patients were treated with placebo + cisplatin and gemcitabine for up to six 21-day cycles followed by placebo monotherapy.1
CI=confidence interval; HR=hazard ratio; NE=not estimable; NR=not reached; PD-L1=programmed death-ligand 1.
JUPITER-02 efficacy: final analysis (secondary end points)
77% OF PATIENTS TREATED WITH LOQTORZI® + CHEMO ACHIEVED A RESPONSE1
BIRC-assessed ORR and DOR
Nearly 1 in 5 patients experienced a complete response rate with LOQTORZI® + chemo1
*Patients were treated with LOQTORZI® + cisplatin and gemcitabine for up to six 21-day cycles followed by LOQTORZI® monotherapy.1
†Patients were treated with placebo + cisplatin and gemcitabine for up to six 21-day cycles followed by placebo monotherapy.1
‡ORR results are based on the prespecified interim analysis with data cutoff of May 30, 2020.1
§
Two-sided P value based upon Cochran-Mantel-Haenszel test.1
BIRC=blinded independent review committee; CI=confidence interval; DOR=duration of response; NE=not estimable; ORR=overall response rate.
BIRC=blinded independent review committee; CI=confidence interval; DOR=duration of response; NE=not estimable; ORR=overall response rate.
JUPITER-02 safety
LOQTORZI® ADVERSE REACTIONS1
Adverse reactions (≥10%) in patients with R/M NPC who received LOQTORZI® + chemotherapy in JUPITER-02