Experimental EGFR inhibitor added nothing but rash

Source: www.oncologypractice.com Author: Neil Osterweil, Oncology Report Digital Network The addition of the experimental targeted agent zalutumumab to primary curative chemoradiation for head and neck cancers did not improve locoregional control, disease-specific survival, or overall survival at 3 years of follow-up. The only thing that zalutumumab added to therapy was a skin rash in the large majority of patients who received it, reported Dr. Jens Overgaard, of the department of experimental clinical oncology at Aarhus University, Denmark. Response to zalutumumab, a monoclonal antibody targeted to the epidermal growth factor receptor (EGFR), was not related to tumor human papillomavirus 16 (HPV/p16) status or to chemoradiotherapy, Dr. Overgaard reported at the Multidisciplinary Head and Neck Cancer Symposium. The results of the DAHANCA 19 trial echo those of the RTOG (Radiation Oncology Therapy Group) trial 0522, which found no benefit from the addition of the EGFR inhibitor cetuximab (Erbitux) to accelerated cisplatin-based chemoradiotherapy, said Dr. Paul Harari, an invited discussant from the University of Wisconsin, Madison. "Where I think we have a lot of unanswered questions is acknowledging how little we actually understand about EGFR biology, despite now 40 years of progressive knowledge," Dr. Harari said. "We’re now seeing very clearly in molecular and clinical correlate studies that the more we suppress the EGFR, the more we see collateral overexpression of additional RTKs [receptor tyrosine kinases], including members of the HER family, such as HER-3, that enable an escape mechanism for tumors that become resistant to EGFR inhibition," he said. Dr. Overgaard and [...]

Genmab to review clinical plans for head and neck cancer candidate after mixed results from phase III trial

Source: www.genengnews.com Author: staff Genmab is reporting that Phase III results of its antibody for head and neck cancer, zalutumumab, showed that the treatment did not increase overall survival enough for it to be statistically significant but did significantly boost progression-free survival. The company says that it is evaluating its development program in this indication in light of this data. Zalutumumab is a human antibody targeting the epidermal growth factor receptor. The Phase III trial evaluated the treatment in 286 patients with recurrent or metastatic squamous cell carcinoma of the head and neck who failed standard platinum-based chemotherapy. Patients were randomized to receive either zalubumuab in combination with best supportive care (BSC) or BSC alone. Data showed that median overall survival in the zalutumumab plus BSC group was 6.7 months compared with 5.2 months for the BSC-only group. Genmab points out that although this represented a 30% improvement, the increase was not sufficient to demonstrate a statistically significant difference in survival. However, patients in the zalutumumab cohort did demonstrate a 61% increase in progression-free survival compared with those in the BSC-only arm. “The progression-free survival data indicates that zalutumumab can provide a benefit to these cancer patients, and we will review with our clinical advisors and the regulatory agencies how to best proceed with this product,” says Lisa N. Drakeman, Ph.D., Genmab CEO. Zalutumumab is also undergoing Phase I/II trials as a treatment for advanced head and neck cancer either in combination with chemo-radiation or in combination with radiotherapy in [...]

Genmab says FDA lifts hold on zalutumumab studies

Source: www.reuters.com Author: staff Danish biotechnology firm Genmab said on Thursday: - The U.S. Food and Drug Administration lifted a partial clinical hold on zalutumumab studies being conducted under a U.S. Investigational New Drug application. - Enrolment of patients can now resume in the Phase II study in patients with head and neck cancer considered incurable with standard treatment and the Phase I/II frontline study of zalutumumab in combination with chemo-radiation. Note: 1. Reporting by Copenhagen newsroom

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