Nivolumab received Food and Drug Administration (FDA) approval on 10 June 2020 for managing patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior use of fluoropyrimidine and platinum-based chemotherapy.
A randomized (1:1), multicenter, active-controlled, open-label trial (ATTRACTION-3) was conducted to determine the efficacy of nivolumab in 419 patients with unresectable advanced, recurrent, or metastatic ESCC.
Patients who were intolerant or refractory to at least one platinum and fluoropyrimidine-based regimen were given investigator’s choice of taxane chemotherapy (n=209). It consists of docetaxel (75 mg/m2 IV(intravenous) every three weeks) or paclitaxel (100 mg/m2 IV once a week for six weeks followed by one week off), or IV infusion of 240 mg nivolumab (n=210) over 30 minutes every two weeks.
Overall survival (OS) was the primary efficacy endpoint. Progression-free survival (PFS), overall response rate (ORR), and response duration were the additional efficacy outcome measures, assessed using Response evaluation criteria in solid tumors (RECIST 1.1).
A substantial improvement in OS was observed in the trial. Median OS for patients receiving nivolumab was more compared with patients receiving the investigator’s choice of taxane chemotherapy as shown in the following table:
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Patients receiving nivolumab |
Patients receiving investigator’s choice of taxane chemotherapy |
|
| Median OS |
10.9 months |
8.4 months |
The ORR and median response duration in the nivolumab group and the taxane chemotherapy group is shown in the following table:
|
Nivolumab Group |
Taxane chemotherapy Group |
|
| ORR |
19.30% |
21.50% |
| Median response duration |
6.9 months |
3.9 months |
The trial did not illustrate an improvement in PFS. Decreased appetite, rash, diarrhea, musculoskeletal pain, constipation, upper respiratory tract infection, pyrexia, cough pneumonia, fatigue, anemia, pruritus, hypothyroidism, and nausea were the most common adverse reactions in >10% patients receiving nivolumab.
For managing patients with ESCC, the effective dose of nivolumab is suggested to be 240 mg every two weeks or 480 mg every four weeks. Treatment with nivolumab is an effective approach for treatment of patients with ESCC.
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Source |
US-FDA |
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Link: |
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-esophageal-squamous-cell-carcinoma#:~:text=On%20June%2010%2C%202020%2C%20the,%2D%20and%20platinum%2Dbased%20chemotherapy. [Last accessed on: 21 July, 2020] |
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Original title of the article |
FDA approves nivolumab for esophageal squamous cell carcinoma |