Ewing's Sarcoma

The Ewing's family of tumors (EFT) includes primary tumors of bone (classic Ewing's sarcoma, primitive neuroectodermal tumor and Askin tumor) and extrosseous primary tumors.  The estimated incidence of Ewing's sarcoma in the US is approximately 300 new cases per year.  More than 50 percent of patients are adolescents with a slight predominance in males.  Patients who present with metastatic disease at initial diagnosis have a survival rate of approximately 25 to 30 percent.

Ongoing Clinical Studies

Phase II Study
Roche and SARC (Sarcoma Alliance for Research through Collaboration) is conducting a Phase II study of R1507 for the treatment of recurrent or refractory sarcoma.  The approximately 305 patients to be enrolled in the study will receive weekly doses of R1507.  The primary endpoints of the study are objective response rate and progression free survival (PFS).

Previous Clinical Studies

Phase I Results
Results from a Phase I study of R1507 in patients with solid tumors conducted by Genmab's partner Roche were announced in October 2007.  Nine of 34 patients with solid tumors experienced disease stabilization when treated with R1507.  Four of the seven heavily pretreated patients with Ewing's sarcoma demonstrated clinical benefit with two of these patients achieving durable, objective partial responses.

Once a week administration of R1507 was well tolerated with few side effects.  The most frequently observed side effects were fatigue, anorexia and weight loss, symptoms that are commonly observed in patients with advanced cancer.  A similar side effect profile was seen in 26 patients who were treated with R1507 on a three week schedule.

Based on these initial results, Roche plans to conduct additional trials and work with a global consortium of sarcoma experts, including SARC.

Non Small Cell Lung Cancer (NSCLC) 

NSCLC is the leading cause of cancer deaths in both men and women, with approximately 172,000 patients being diagnosed annually in the US. Almost 25% of newly diagnosed patients will have advanced (stage IIIA or IIIB) disease for which effective treatment options are few.

Ongoing Clinical Studies

Phase II Studies
Roche is conducting two Phase II studies of R1507 for the treatment of NSCLC.  The first study will include approximately 150 patients with advanced stage NSCLC who have failed at least one standard chemotherapy regimen.  Patients will be randomized to one of four treatment arms to receive R1507 (9 mg/kg) or placebo weekly or R1507 (16 mg/kg) or placebo every 3 weeks. All patients in the study will also receive treatment with Tarceva.  The primary endpoint of the study is the proportion of patients with PFS.

The second Phase II study will include approximately 43 patients with advanced NSCLC who have progressive disease after achieving clinical benefit from second or third line Tarceva monotherapy.  Patients will receive R1507 (9 mg/kg) weekly in combination with Tarceva for a maximum of 24 months.  The primary endpoint of the study is the proportion of patients with PFS.

Breast Cancer

Ongoing Clinical Studies

Phase II Study
Roche is conducting a Phase II study of R1507 for the treatment of advanced breast cancer.  The study will include approximately 43 postmenopausal female patients.  In the first part of the study, patients will receive letrozole daily in combination with R1507 (16 mg/kg) every 3 weeks.  In the second part of the study patients who have either progressed or plateaued on letrozole treatment will receive 3 weekly cycles of combination treatment with letrozole and R1507.  The primary endpoints of the study are safety and objective tumor response. 

Solid Tumors  

Ongoing Clinical Studies

Phase I Study
Roche is conducting a Phase I study of R1507 in combination with 12 different chemotherapy regimens for the treatment of advanced solid tumors.  Approximately 240 patients will be enrolled in the trial.  Three subsets of patients will be eligible to participate in the study: untreated, treated and requiring further treatment or treated and failed for whom adding R1507 represents a suitable treatment for their disease.  Patients will receive escalating doses of R1507 in combination with chemotherapy.  The primary endpoint of the study is safety.

Phase I Study in Children
A Phase I study of R1507 for the treatment of advanced solid tumors in children and adolescents is also being conducted.  Approximately 39 patients will be enrolled in the study.  Patients will be sequentially enrolled in one of up to 3 dose levels of R1507 to determine the maximum tolerated dose.  An expanded cohort of patients will be enrolled at the optimal dose.  The primary objective of the study is to determine what dose of R1507 in children and adolescents will be equivalent to adults.

Pre-clinical Studies