Genmab Presents Data from a Pivotal Trial of Zalutumumab Versus Best Supportive Care in Patients with Refractory Head and Neck Cancer
Copenhagen, Denmark; June 7, 2010 – Genmab A/S (OMX: GEN) announced today that data from the pivotal trial of zalutumumab in refractory head and neck cancer patients will be presented today at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 1-8 in Chicago, Illinois. This is the first controlled study to demonstrate that an EGFr-targeted antibody given as monotherapy induces a clinically meaningful improvement in progression free survival in patients with refractory head and neck cancer who have failed platinum-based chemotherapy.
Dr. Jean-Pascal Machiels will present data from a pivotal Phase III trial of zalutumumab in combination with best supportive care (BSC) versus BSC alone in patients with non-curable squamous cell carcinoma (SCCHN) of the head and neck who have failed standard platinum-based chemotherapy (abstract number: LBA5506) today at 3:45 PM CDT. This research will also be presented at the 2010 Best of ASCO San Francisco Meeting, July 16-17, 2010. The purpose of the Best of ASCO meeting, according to their program announcement, is to provide additional “accessibility to important scientific research presented by respected members of the oncology community.” The full abstract may be viewed at www.asco.org.
“We are pleased that the data shows zalutumumab given as monotherapy can provide a clinically meaningful improvement in progression free survival for these very sick patients,” said Lisa N. Drakeman, Chief Executive Officer of Genmab. “We will continue to review the results with our clinical advisors and the regulatory authorities to determine next steps.”
About the study
The pivotal, randomized multicenter trial compared zalutumumab in combination with BSC to BSC alone in 286 patients with recurrent or metastatic SCCHN who had previously failed at least one course of standard platinum-based chemotherapy. Patients randomized to zalutumumab in combination with BSC received an initial dose of 8 mg/kg of zalutumumab, followed by weekly administrations of individually dose adjusted maintenance therapy of up to 16 mg/kg until disease progression. Patients treated with BSC alone were also allowed to receive methotrexate at a maximum weekly dose of 50 mg/m2. Disease status was assessed by CT scan or MRI every 8 weeks and response evaluated according to RECIST criteria by an Independent endpoints Review Committee. The primary endpoint in the study was overall survival from randomization until death.
Analysis showed a 61% improvement in progression free survival (PFS) was observed for patients in the zalutumumab plus BSC arm (p=0.001). The six month PFS rate for patients in the zalutumumab plus BSC arm was 20% compared to 7.3% for patients in the BSC alone arm.
Although a median overall survival of 6.7 months was observed in the zalutumumab group compared to 5.2 in the BSC group, this was not statistically significant (p=0.065).
In addition, the objective response and disease control rates for the patients in the zalutumumab arm were 6.3% and 48% respectively, compared to 1.1% and 27% respectively for patients in the BSC alone arm.
Zalutumumab is a novel, investigational, high-affinity, human antibody that targets the Epidermal Growth Factor receptor (EGFr), a molecule over-expressed on the surface of many cancer cells and that is a well validated target. Zalutumumab is in development to treat head and neck cancer and has received Fast Track designation from the FDA for advanced, metastatic and/or unresectable SCCHN that has progressed following standard platinum-based chemotherapy.
Under the FDA Modernization Act of 1997, Fast Track designation
means that FDA will take such actions as are appropriate to
expedite the development and review of the application for approval
of such product. FDA may also evaluate for filing and commence
review of portions of an application for approval of a Fast Track
product under certain conditions.
Posted: June 2010