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*

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.

JUPITER-02 trial design

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†

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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

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.

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

LOQTORZI^® + chemo delivered a BIRC-assessed mPFS of 11.7 months vs 8 months with placebo + chemo^1,3*

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*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 PROGRESSION^4,5*

Final PFS by BIRC per RECIST v1.1⁴

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*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) and 4-year post hoc analysis

OS observed with LOQTORZI^® + chemo vs chemo alone^1,4,6*

Final analysis (secondary end point): LOQTORZI + chemo significantly reduced the risk of progression^1,4†

Median OS not reached with LOQTORZI + chemo (95% CI, 38.7-NE) vs 33.7 months with placebo + chemo (95% CI, 27.0-44.2);
HR=0.63 (95% CI, 0.45-0.89); P=0.0083^‡
- 37% reduced risk of death
Number of events was 57/146 (39%) with LOQTORZI + chemo vs 76/143 (53%) with placebo + chemo

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4-year post hoc analysis^6§

This 4-year post hoc analysis was exploratory in nature and occurred after the protocol-specified final analysis.⁶

Median OS not reached with LOQTORZI + chemo (95% CI, 38.8-NE) vs 33.7 months with placebo + chemo
(95% CI, 26.7-44.2); HR=0.61 (95% CI, 0.44-0.85); median follow-up was 36.8 months (range: 0.2-61.1 months)⁶
- 39% reduced risk of death

*Patients were treated with LOQTORZI + cisplatin and gemcitabine or placebo + cisplatin and gemcitabine for up to 6 cycles, followed by LOQTORZI alone or placebo alone.¹

^†Cutoff date for final analysis was November 18, 2022; median follow-up was 36 months.¹

^‡Two-sided P value, based on the stratified log-rank test, as compared with an alpha boundary of 0.049995.¹

^§After the final OS analysis was conducted, as specified by the study protocol, surviving patients were re-consented for long-term survival follow-up. Cutoff date for 4-year follow-up analysis was January 9, 2024, 50 months after the last patient was enrolled.⁶

NE=not estimable.

JUPITER-02 efficacy: final analysis (secondary end points)

77% OF PATIENTS TREATED WITH LOQTORZI^® + CHEMO ACHIEVED A RESPONSE¹

BIRC-assessed ORR and DOR

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*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.

JUPITER-02 safety

LOQTORZI^® ADVERSE REACTIONS¹

Adverse reactions (≥10%) in patients with R/M NPC who received LOQTORZI^® + chemotherapy in JUPITER-02

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Serious and fatal adverse reactions

Serious adverse reactions occurred in 43% of patients receiving LOQTORZI^® in combination with cisplatin and gemcitabine
- Serious adverse reactions in ≥2% were thrombocytopenia (14%), neutrophil count decreased (10%), pneumonia (10%), anemia (9%), abnormal hepatic function (2.7%), and rash (2.1%)
Of the patients who received LOQTORZI^® in combination with cisplatin and gemcitabine, there were 3 fatal adverse reactions (2.1%): 1 due to epistaxis; 1 due to intracranial hemorrhage associated with immune-related thrombocytopenia and coagulopathy; and 1 due to pneumonia

Discontinuations and dosage interruptions

Permanent discontinuation of LOQTORZI^®, when given in combination with cisplatin and gemcitabine, due to an adverse reaction occurred in 12% of patients
- Adverse reactions resulting in permanent discontinuation of LOQTORZI^® in ≥1% of patients were pneumonia (2.1%), pulmonary tuberculosis (1.4%), rash (1.4%), and vomiting (1.4%)
Dosage interruptions of LOQTORZI^® due to an adverse reaction occurred in 50% of patients
- Adverse reactions which required dosage interruption in ≥2% were anemia (17%), decreased neutrophils (12%), thrombocytopenia (12%), acute kidney injury (4.1%), pneumonia (6%), fatigue (2.7%), upper respiratory infection (2.7%), and hypothyroidism (2.1%)

*National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.¹

^†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

^§Includes mouth ulceration, stomatitis, and radiation stomatitis.¹

^‖Includes hypothyroidism, triiodothyronine decreased, triiodothyronine free decreased, and thyroiditis.¹

^¶Includes acneiform dermatitis, allergic dermatitis, catheter-site rash, dermatitis, drug eruption, eczema, erythema, macule, maculopapular rash, palmar-plantar erythrodysesthesia syndrome, papule, pruritic rash, rash, and urticaria.¹

^#Includes asthenia and fatigue.¹

**Includes hypoesthesia, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy.¹

^††Includes cough and productive cough.¹

^‡‡Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, pain in extremity, pain in jaw.¹

^§§Includes acute sinusitis, bronchitis, laryngitis, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, and upper respiratory tract infection.¹

^‖‖Includes aspiration pneumonia and pneumonia.¹

^¶¶

Includes blood pressure increased, blood pressure systolic increased, hypertension, and hypertensive crisis.¹
R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma.

POLARIS-02: Trial design

The efficacy of LOQTORZI^® was studied in POLARIS-02, an open-label, multicenter, multicohort trial conducted in a single country.* The trial included a total of 172 adult patients with unresectable or metastatic NPC who had received prior platinum-based chemotherapy for treatment of recurrent metastatic NPC or who had disease progression within 6 months of completion of platinum-based chemotherapy administered as neoadjuvant, adjuvant, or definitive chemoradiation treatment for locally advanced disease.¹

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Patients received LOQTORZI^® 3 mg/kg intravenously every 2 weeks until disease progression per RECIST v1.1 or unacceptable toxicity. The primary efficacy outcomes were confirmed BIRC-assessed ORR and DOR.¹

Key eligibility criteria⁷

Histologically or cytologically documented R/M NPC
refractory to prior standard chemotherapy
Disease progression within 6 months after adjuvant
chemotherapy or chemoradiotherapy
Aged 18 years or older
Measurable disease
Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate organ function

Key exclusion criteria⁷

Anticancer monoclonal antibody therapy within 4 weeks
before treatment initiation
Any anticancer therapy within 2 weeks before treatment initiation
Prior ICI treatment
Systemic corticosteroid therapy within 7 days before treatment initiation
Known additional malignancies
Active CNS metastases

The POLARIS-02 trial was conducted across 17 sites in China.⁷

^†

Tumor response assessments were performed every 8 weeks for the first year and every 12 weeks thereafter.¹

BIRC=blinded independent review committee; CNS=central nervous system; DOR=duration of response; ICI=immune checkpoint inhibitors; ORR=overall response rate; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma; RECIST=Response Evaluation Criteria in Solid Tumors.

POLARIS-02 efficacy

RESPONSE WAS ACHIEVED IN 21% OF PATIENTS WITH LOQTORZI^®¹

Patients were heavily pretreated, with a median of 2 prior systemic therapies for R/M disease^1,2*

POLARIS-02 efficacy end points:
confirmed ORR and DOR as assessed by BIRC using RECIST v1.1¹

BIRC-assessed ORR^†

N=172
(95% CI, 15%-28%)

Complete response rate: 2.3%
Partial response rate: 19%

BIRC-assessed DOR

n=36
(95% CI, 10.3%-NE)

Patients with DOR ≥6 months^‡: 83%
Patients with DOR ≥12 months^‡: 39%

*Range: 1-13.

^†

Confirmed ORR assessed by BIRC.¹

^‡

Based on observed DOR.¹

BIRC=blinded independent review committee; CI=confidence interval;
DOR=duration of response; NE=not estimable; ORR=overall response rate; R/M=recurrent/metastatic; RECIST=Response Evaluation Criteria in Solid Tumors.

POLARIS-02 safety

LOQTORZI^® ADVERSE EVENTS¹

Adverse reactions (≥10%) in patients with previously treated unresectable or metastatic NPC who received LOQTORZI^® in POLARIS-02

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Serious and fatal adverse reactions

Serious adverse reactions occurred in 24% of patients who received LOQTORZI^®
- Serious adverse drug reactions in ≥2% were pneumonia (4.7%), abnormal hepatic function (2.6%), and hyperbilirubinemia (2.1%)
Fatal adverse reactions occurred in 3.7% of patients who received LOQTORZI^®, including death not otherwise specified (1.6%), tumor hemorrhage (0.5%), hepatic failure and thrombocytopenia (0.5), hyponatremia (0.5%), and sudden death (0.5%)

Discontinuations and dosage interruptions

Permanent discontinuation of LOQTORZI^® due to an adverse reaction occurred in 9% of patients
- Adverse reactions resulting in permanent discontinuation of LOQTORZI^® in ≥1% of patients were pneumonia (1.1%), abnormal hepatic function (1.1%), and hyperbilirubinemia (1.1%)
Dosage interruptions due to an adverse reaction occurred in 23% of patients
- Adverse reactions which required dosage interruptions in ≥1% were pneumonia (2.1%), thrombocytopenia (2.1%), fatigue (1.6%), hyperbilirubinemia (1.6%), anemia (1.1%), decreased appetite (1.1%), abnormal hepatic function (1.1%), hypothyroidism (1.1%), and pneumonitis (1.1%)

*Toxicity was graded per NCI CTCAE v4.03.¹

^†Includes hypothyroidism, thyroiditis, triiodothyronine decreased, and triiodothyronine free decreased.¹

^‡Includes fatigue and asthenia.¹

^§Includes cough and productive cough.¹

^||Includes musculoskeletal pain and myalgia.¹

^¶Includes dermatitis allergic, eczema, and rash.¹

Dosing and administration for first-line TREATMENT¹

Recommended dosage

*LOQTORZI^® is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced NPC. Refer to the Prescribing Information for cisplatin and gemcitabine for recommended dosing information.

In JUPITER-02, LOQTORZI^® was administered:

Administration

LOQTORZI^® IV infusion details:
- Administer diluted solution intravenously via infusion pump using an in-line aseptic filter (0.2 or 0.22 micron)
- First infusion: Infuse over at least 60 minutes
- Subsequent infusions: If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes
- Do not co-administer other drugs through the same IV line
- When administered on the same day as chemotherapy, LOQTORZI^® should be administered prior to chemotherapy
- Refer to the Prescribing Information for cisplatin and gemcitabine for recommended dosing information

IV=intravenous; NPC=nasopharyngeal carcinoma.

Dosing and administration for subsequent treatment¹

Dosing

Patients should receive LOQTORZI^® until disease progression or unacceptable toxicity.

Administration

First infusion: Infuse over at least 60 minutes
Subsequent infusions: If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes
Do not co-administer other drugs through the same IV line

IV=intravenous.

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 moments¹*

Significantly improved
progression-free survival (PFS) and overall survival (OS) vs
placebo + chemo^1†
Manageable safety profile¹
The first successful
registrational trial in R/M
NPC that led to FDA
approval²

*In combination with cisplatin and gemcitabine for up to 6 cycles followed by LOQTORZI^® alone.¹

^†LOQTORZI^® improved PFS (HR=0.52 [95% CI, 0.36-0.74]; P=0.0003) and OS (HR=0.63 [95% CI, 0.45-0.89]; P=0.0083) when used in combination with cisplatin and gemcitabine for up to 6 cycles followed by LOQTORZI^® alone.¹

CI=confidence interval; HR=hazard ratio; R/M NPC=recurrent locally advanced/metastatic nasopharyngeal carcinoma.

References

LOQTORZI^® (toripalimab-tpzi) Prescribing Information. Redwood City, CA: Coherus BioSciences, Inc.
ClinicalTrials.gov. 55 studies found for: recurrent, metastatic | nasopharyngeal carcinoma. Accessed September 28, 2023. https://clinicaltrials.gov/ct2/results?term=Recurrent%2C+Metastatic&cond=Nasopharyngeal+Carcinoma&age_v=&gndr=&type=&rslt=&phase=2&Search=Apply
Mai H-Q, Chen Q-Y, Chen D, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021;27(9):1536-1543. doi:10.1038/s41591-021-01444-0
Data on file. Coherus BioSciences, Inc.; 2023.
Mai H-Q, Chen Q-Y, Chen D, et al. Toripalimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: the JUPITER-02 randomized clinical trial. JAMA. 2023;330(20):1961-1970. doi:10.1001/jama.2023.20181
Chen Q-Y, Mai H-Q, Chen D, et al. Four-year overall survival follow-up and dynamic EBV titer analysis of toripalimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (r/m NPC). Abstract presented at: 2024 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024; Chicago, IL.
Wang F-H, Wei X-L, Feng J, et al. Efficacy, safety, and correlative biomarkers of toripalimab in previously treated recurrent or metastatic nasopharyngeal carcinoma: a phase II clinical trial (POLARIS-02). J Clin Oncol. 2021;39(7):704-712. doi:10.1200/JCO.20.02712

Proven efficacy for more of life’s moments

Proven
efficacy
for more
of
life’s
moments