Polaris-02 study

STUDY DESIGN

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

Patients received ZYTORVI ^® 3 mg/kg intravenously every 2 weeks until disease progression according to RECIST v1.1 or unacceptable toxicity. The main efficacy outcomes were confirmed ORR and DOR assessed by BIRC.
 

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Eligibility Criteria⁷

• Histologically or cytologically documented R/M NPC, refractory to prior standard chemotherapy.

• Disease progression within 6 months after adjuvant chemotherapy or chemoradiotherapy.

• Age 18 or over.

• Measurable disease.

• ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

• Adequate organic function.

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Exclusion Criteria⁷

• Anticancer monoclonal antibody therapy within 4 weeks prior to starting treatment.

• Any anticancer therapy within 2 weeks before starting treatment.

• Previous treatment with ICI (Immune Checkpoint Inhibitors).

• Systemic corticosteroid therapy within 7 days prior to initiation of treatment.

• Known additional malignancies and active CNS metastases.

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EFFECTIVENESS

Response was achieved in 21% of patients with ZYTORVI^®1

Patients were heavily pretreated, with a median of 2 prior systemic therapies for disease R/M^1.2*

Main outcomes of POLARIS-02: Confirmed ORR and DOR, as assessed by BIRC using RECIST v1.1.¹

* Range: 1–13.1

† ORR confirmed and evaluated by BIRC.¹

‡ Based on observed PAIN.¹

BIRC = blinded independent review committee; CI = confidence interval; DOR = duration of response; NE = not estimable; R/M = recurrent/metastatic; ORR = overall response rate; RECIST = response evaluation criteria in solid tumors.

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SECURITY

Adverse Reactions (≥10%) in Patients with Previously Treated Unresectable or Metastatic NPC Who Received ZYTORVI^® in POLARIS-02



 

Serious and fatal adverse reactions

• Serious adverse reactions occurred in 24% of patients receiving ZYTORVI^®

  • Serious adverse drug reactions in ≥2% were pneumonia (4.7%), abnormal liver function (2.6%), and hyperbilirubinemia (2.1%)

• Fatal adverse reactions occurred in 3.7% of patients receiving ZYTORVI^®, including unspecified death (1.6%), tumor hemorrhage (0.5%), hepatic failure and thrombocytopenia (0.5%), hyponatremia (0.5%), and sudden death (0.5%).

Dosage discontinuations and interruptions

• Permanent discontinuation of ZYTORVI^® due to an adverse reaction occurred in 9% of patients

  • Adverse reactions resulting in permanent discontinuation of ZYTORVI^® in ≥1% of patients were pneumonia (1.1%), abnormal liver function (1.1%), and hyperbilirubinemia (1.1%).

• Dosage interruptions due to an adverse reaction occurred in 23% of patients

  • Adverse reactions requiring dose interruption in ≥1% were pneumonia (2.1%), thrombocytopenia (2.1%), fatigue (1.6%), hyperbilirubinemia (1.6%), anemia (1.1%), decreased appetite (1.1%), abnormal liver function (1.1%), hypothyroidism (1.1%), and pneumonitis (1.1%)

*Toxicity was graded according to NCI CTCAE^v4.03.1

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

‡Includes fatigue and asthenia.¹

§Includes cough and productive cough.¹

‖ Includes musculoskeletal pain and myalgia.¹

¶Includes allergic dermatitis, eczema, and rash.¹*The POLARIS-02 study was conducted at 17 sites in China.²
† Tumor response assessments were performed every 8 weeks for the first year and every 12 weeks thereafter.¹

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Abbreviations

• BIRC: Independent Blind Review Committee

• PAIN: Duration of response

• ORR: Overall Response Rate

• R/M NPC: Recurrent locally advanced/metastatic nasopharyngeal cancer

• RECIST: Response evaluation criteria in solid tumors

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References

1. ZYTORVI^® (toripalimab-tpzi) Prescribing Information.

2. ClinicalTrialsgov. 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

3. Mai HQ, Chen QY, Chen D, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 study. Nat Med. 2021;27(9):1536-1543. doi:10.1038/s41591-021-01444-0

4. Data on file. Coherus BioSciences, Inc. 2023

5. Mai HQ, Chen QY, Chen D, et al. Toripalimab + chemotherapy in advanced nasopharyngeal carcinoma: a JUPITER-02 randomized clinical trial. JAMA 2023; 330(20):1961-1970.

6. Chen QY, Mai HQ, 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.

7. Wang FH, Wei XL, 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