Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial
PURPOSESquamous cell carcinoma of the head and neck (SCCHN) is the sixth most common cancer, with approximately 225,419 new cases with over 125,000 deaths annually in India. This trial compared the efficacy and safety of biosimilar cetuximab versus innovator cetuximab (IC) in combination with platin...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
American Society of Clinical Oncology
2024-11-01
|
| Series: | JCO Global Oncology |
| Online Access: | https://ascopubs.org/doi/10.1200/GO.24.00059 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846167318196912128 |
|---|---|
| author | Kumar Prabhash Chetan Deshmukh Hemant Malhotra Atul Sharma Minish Jain Nilesh Dhamne Rajnish Nagarakar Prasantha Ganesan Vijay K. Mahobia Chandan K. Das Rejnish Kumar Prakash S. Shivanna Manu P. Avaronnan Puligundla K. Chaithanya Vaibhav Chaudhary Kartar Singh Suhas Aagre Bellala Ravishankar Dhruv Mehta Kandipalli Shilpa Vashishth Maniar Koushik Chatterjee Saroj D. Majumdar Rohitashwa Dana Vanita Noronha Nandini Menon Akhilesh Sharma Roshan Pawar Vinayaka Shahavi Rajiv Yadav Amol Aiwale |
| author_facet | Kumar Prabhash Chetan Deshmukh Hemant Malhotra Atul Sharma Minish Jain Nilesh Dhamne Rajnish Nagarakar Prasantha Ganesan Vijay K. Mahobia Chandan K. Das Rejnish Kumar Prakash S. Shivanna Manu P. Avaronnan Puligundla K. Chaithanya Vaibhav Chaudhary Kartar Singh Suhas Aagre Bellala Ravishankar Dhruv Mehta Kandipalli Shilpa Vashishth Maniar Koushik Chatterjee Saroj D. Majumdar Rohitashwa Dana Vanita Noronha Nandini Menon Akhilesh Sharma Roshan Pawar Vinayaka Shahavi Rajiv Yadav Amol Aiwale |
| author_sort | Kumar Prabhash |
| collection | DOAJ |
| description | PURPOSESquamous cell carcinoma of the head and neck (SCCHN) is the sixth most common cancer, with approximately 225,419 new cases with over 125,000 deaths annually in India. This trial compared the efficacy and safety of biosimilar cetuximab versus innovator cetuximab (IC) in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic SCCHN.METHODSThis phase III trial is a multicenter, randomized, double-blind and parallel group study performed in Indian patients with recurrent locoregional or metastatic SCCHN. Patients were randomly assigned in 2:1 ratio to receive biosimilar cetuximab and IC in combination with cisplatin and fluorouracil via intravenous infusions. The primary end points were disease control rate (DCR) and overall response rate (ORR) as per response evaluation criteria in solid tumors version 1.1. The secondary end points included pharmacokinetics (PK), immunogenicity, safety, and tolerability.RESULTSOf 180 patients enrolled, 120 patients received biosimilar cetuximab and 60 patients received IC treatment. No significant statistical difference was observed in the primary outcomes between two groups. Treatment difference in DCR and ORR response was found to be –5.21 (90% CI, –8.94 to –1.48) and –4.79 (90% CI, –19.42 to 9.84), respectively, indicating noninferiority to reference product. The incidence of treatment-emergent adverse events (AEs; biosimilar cetuximab: 89.2% v IC: 91.7%; P = .8364) and serious AEs (biosimilar cetuximab: 23.3% v IC: 13.3%; P = .0603) and PK parameters were comparable between treatment groups. The immunogenicity findings showed higher incidence of anticetuximab antibodies in the biosimilar cetuximab group compared with the IC group at the end of Study.CONCLUSIONThe findings of this study demonstrated noninferiority along with comparable PK, safety, and immunogenicity of biosimilar cetuximab and IC in patients with recurrent or metastatic SCCHN. |
| format | Article |
| id | doaj-art-385a92650781405e9c9b773eb08cd044 |
| institution | Kabale University |
| issn | 2687-8941 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | American Society of Clinical Oncology |
| record_format | Article |
| series | JCO Global Oncology |
| spelling | doaj-art-385a92650781405e9c9b773eb08cd0442024-11-14T20:59:04ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412024-11-011010.1200/GO.24.00059Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III TrialKumar Prabhash0Chetan Deshmukh1Hemant Malhotra2Atul Sharma3Minish Jain4Nilesh Dhamne5Rajnish Nagarakar6Prasantha Ganesan7Vijay K. Mahobia8Chandan K. Das9Rejnish Kumar10Prakash S. Shivanna11Manu P. Avaronnan12Puligundla K. Chaithanya13Vaibhav Chaudhary14Kartar Singh15Suhas Aagre16Bellala Ravishankar17Dhruv Mehta18Kandipalli Shilpa19Vashishth Maniar20Koushik Chatterjee21Saroj D. Majumdar22Rohitashwa Dana23Vanita Noronha24Nandini Menon25Akhilesh Sharma26Roshan Pawar27Vinayaka Shahavi28Rajiv Yadav29Amol Aiwale30Medical Oncology, Tata Memorial Hospital, Mumbai, IndiaDeenanath Mangeshkar Hospital & Research Center, Pune, IndiaMedical Oncology, Sriram Cancer Center, Mahatma Gandhi Medical College Hospital, Jaipur, IndiaMedical Oncology, All India Institute of Medical Sciences, New Delhi, IndiaKEM Hospital and Research Center, Pune, IndiaKolhapur Cancer Center, Kolhapur, IndiaHCG Manavata Cancer Center, Nashik, IndiaDepartment of Oncology, Jawaharlal Institute of Postgraduate Medical Education, Puducherry, IndiaGovernment Medical College, Nagpur, IndiaDepartment of Radiotherapy and Oncology, Regional Cancer Center, PGIMER, Chandigarh, IndiaDepartment of Radiation Oncology, Regional Cancer Center, Trivandrum, IndiaMysore Medical College and Research Institute and K.R. Hospital, Mysore, IndiaMalabar Cancer Center, Kannur, IndiaMNJ Institute of Oncology and Regional Cancer Center, Hyderabad, IndiaMedical Oncology, RST Regional Cancer Hospital and Research Center, Nagpur, IndiaMedical Oncology, RST Regional Cancer Hospital and Research Center, Nagpur, IndiaAyush Hospital, Mumbai, IndiaOmega Hospital Chinna Gadhili, Visakhapatnam, IndiaNirmal Hospital, Surat, IndiaDepartment of Medical Oncology, Andhra Medical College/King George Hospital, Visakhapatnam, IndiaMOC Vile Parle, Mumbai, IndiaHealth Point Hospital, Kolkata, IndiaHead of Department, Radiotherapy, All India Institute of Medical Sciences, Bhubaneshwar, IndiaHead of Department, Radiotherapy, SMS Medical College and Hospital, Jaipur, IndiaTata Memorial Hospital, Mumbai, IndiaMedical Oncology, Tata Memorial Hospital, Mumbai, IndiaMedical Department, Alkem Laboratories Limited, Mumbai, IndiaMedical Department, Alkem Laboratories Limited, Mumbai, IndiaMedical Department, Alkem Laboratories Limited, Mumbai, IndiaMedical Department, Alkem Laboratories Limited, Mumbai, IndiaMedical Department, Alkem Laboratories Limited, Mumbai, IndiaPURPOSESquamous cell carcinoma of the head and neck (SCCHN) is the sixth most common cancer, with approximately 225,419 new cases with over 125,000 deaths annually in India. This trial compared the efficacy and safety of biosimilar cetuximab versus innovator cetuximab (IC) in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic SCCHN.METHODSThis phase III trial is a multicenter, randomized, double-blind and parallel group study performed in Indian patients with recurrent locoregional or metastatic SCCHN. Patients were randomly assigned in 2:1 ratio to receive biosimilar cetuximab and IC in combination with cisplatin and fluorouracil via intravenous infusions. The primary end points were disease control rate (DCR) and overall response rate (ORR) as per response evaluation criteria in solid tumors version 1.1. The secondary end points included pharmacokinetics (PK), immunogenicity, safety, and tolerability.RESULTSOf 180 patients enrolled, 120 patients received biosimilar cetuximab and 60 patients received IC treatment. No significant statistical difference was observed in the primary outcomes between two groups. Treatment difference in DCR and ORR response was found to be –5.21 (90% CI, –8.94 to –1.48) and –4.79 (90% CI, –19.42 to 9.84), respectively, indicating noninferiority to reference product. The incidence of treatment-emergent adverse events (AEs; biosimilar cetuximab: 89.2% v IC: 91.7%; P = .8364) and serious AEs (biosimilar cetuximab: 23.3% v IC: 13.3%; P = .0603) and PK parameters were comparable between treatment groups. The immunogenicity findings showed higher incidence of anticetuximab antibodies in the biosimilar cetuximab group compared with the IC group at the end of Study.CONCLUSIONThe findings of this study demonstrated noninferiority along with comparable PK, safety, and immunogenicity of biosimilar cetuximab and IC in patients with recurrent or metastatic SCCHN.https://ascopubs.org/doi/10.1200/GO.24.00059 |
| spellingShingle | Kumar Prabhash Chetan Deshmukh Hemant Malhotra Atul Sharma Minish Jain Nilesh Dhamne Rajnish Nagarakar Prasantha Ganesan Vijay K. Mahobia Chandan K. Das Rejnish Kumar Prakash S. Shivanna Manu P. Avaronnan Puligundla K. Chaithanya Vaibhav Chaudhary Kartar Singh Suhas Aagre Bellala Ravishankar Dhruv Mehta Kandipalli Shilpa Vashishth Maniar Koushik Chatterjee Saroj D. Majumdar Rohitashwa Dana Vanita Noronha Nandini Menon Akhilesh Sharma Roshan Pawar Vinayaka Shahavi Rajiv Yadav Amol Aiwale Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial JCO Global Oncology |
| title | Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial |
| title_full | Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial |
| title_fullStr | Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial |
| title_full_unstemmed | Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial |
| title_short | Efficacy and Safety of Biosimilar Cetuximab Versus Innovator Cetuximab in Indian Patients With Head and Neck Cancer: A Multicenter, Randomized, Double-Blind, Phase III Trial |
| title_sort | efficacy and safety of biosimilar cetuximab versus innovator cetuximab in indian patients with head and neck cancer a multicenter randomized double blind phase iii trial |
| url | https://ascopubs.org/doi/10.1200/GO.24.00059 |
| work_keys_str_mv | AT kumarprabhash efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT chetandeshmukh efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT hemantmalhotra efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT atulsharma efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT minishjain efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT nileshdhamne efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT rajnishnagarakar efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT prasanthaganesan efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT vijaykmahobia efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT chandankdas efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT rejnishkumar efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT prakashsshivanna efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT manupavaronnan efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT puligundlakchaithanya efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT vaibhavchaudhary efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT kartarsingh efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT suhasaagre efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT bellalaravishankar efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT dhruvmehta efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT kandipallishilpa efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT vashishthmaniar efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT koushikchatterjee efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT sarojdmajumdar efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT rohitashwadana efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT vanitanoronha efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT nandinimenon efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT akhileshsharma efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT roshanpawar efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT vinayakashahavi efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT rajivyadav efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial AT amolaiwale efficacyandsafetyofbiosimilarcetuximabversusinnovatorcetuximabinindianpatientswithheadandneckcanceramulticenterrandomizeddoubleblindphaseiiitrial |