Cetuxa (cetuximab biosimilar) / Alkem Labs, Lupin - LARVOL DELTA

Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting

Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF

RTOG 1216: Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer (clinicaltrials.gov) - P2/3 | N=613 | Suspended | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Suspended

Trial suspension • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • EGFR

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System (clinicaltrials.gov) - P2 | N=86 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting

Enrollment open • Genetic Disorders • Multiple Myeloma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • mTOR

Cetuximab in platinum-ineligible patients with locally advanced squamous cell carcinoma of the head and neck: Consensus from India. (PubMed, Indian J Cancer) - "Hence, alternative treatment strategies have been suggested for cisplatin-unfit LA-SCCHN patients and include docetaxel, carboplatin, and cetuximab-based regimens...However, with the availability of cetuximab biosimilars, it has become possible to extend the drug's benefits to cisplatin-ineligible/unfit LA-SCCHN patients in India. Hence, this Expert opinion from India was organized, and nine consensus statements were drafted to highlight the various clinical settings where cetuximab-based regimens can benefit cisplatin-ineligible/unfit LA-SCCHN patients. An attempt was also made to understand the burden and causes of cisplatin ineligibility and toxicity in Indian patients."

Journal • Review • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy and safety of ENZ-124 versus innovator cetuximab in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN) (ESMO Asia 2023) - "87 AEs in 47 patients (39.2%) were attributed to ENZ-124, while 49 AEs in 30 patients (50%) were related to the reference product safety analysis, including clinical laboratory data, anti-cetuximab antibody assessments, and other parameters, demonstrated comparable safety and immunogenicity. Conclusions This study shows ENZ-124 as a biosimilar of innovator cetuximab, the first approved biosimilar cetuximab from India."

Clinical • Combination therapy • Metastases • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Novel immunotherapy approaches in metastatic head and neck cancer (YouTube) - "Nabil Saba, MD, FACP...gives an overview of developments in utilizing immunotherapy for patients with metastatic head and neck cancer. The combination of PD-1 and VEGF inhibitors such as pembrolizumab and cabozantinib is a promising strategy, and findings from the LEAP-010 trial (NCT04199104) of pembrolizumab with lenvatinib further demonstrated the efficacy of this combination. Cetuximab with ficlatuzumab has additionally been assessed in a Phase II trial (NCT03422536) in patients with HPV-negative head and neck cancer. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL."

Interview • Video

Alkem Labs launches world’s first biosimilar of Cetuximab for head & neck cancer treatment (BioSpectrum India) - "Alkem Oncology has announced the launch of Cetuxa, the world’s first biosimilar of Cetuximab used for the treatment of head and neck cancer. Cetuxa has been researched and manufactured indigenously by Enzene Biosciences Limited, the biological arm of Alkem Laboratories....Cetuxa is administered as an intravenous infusion and is available as 100 mg (2 mg/mL) in a single-dose vial. Initial dose is 400 mg/m2, follow-up of 250 mg/m2 per week."

Biosimilar launch • Head and Neck Cancer • Oncology • Solid Tumor

Lupin Announces the Launch of Cetuximab (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited (Lupin) today announced a strategic collaboration with Enzene Biosciences to launch Cetuximab in India, the first biosimilar developed for Cetuximab. This collaboration marks a significant milestone in expanding therapeutic options and fostering innovation in the critical area of treatment of head and neck cancer. Cetuximab has received approval from the Drug Controller General of India (DCGI) for its effectiveness in treating head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN), making it a crucial solution for patients with recurrent locoregional or metastatic conditions. Cetuximab is available as a 100mg vial."

Licensing / partnership • Non-US regulatory • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck