Allos Therapeutics Inc presented positive response rate and survival results from its Phase II trial of RSR13 combined with radiation therapy in patients with non-small cell lung cancer. The latest findings were presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
The poster presentation entitled "Positive Phase II Results of RSR13 and Concurrent Radiation Therapy After Induction Chemotherapy with Paclitaxel and Carboplatin for Locally Advanced Inoperable Non-Small Cell Lung Cancer" was presented by Hak Choy, Clinical Director, Center for Radiation Oncology, Vanderbilt University Medical Center.
Dr. Choy presented updated response and survival data from a 52-patient, open-label, multi-center, Phase II clinical trial of induction chemotherapy followed by chest radiation therapy in combination with RSR13 for stage IIIA/IIIB non-small lung cancer.
Based upon the positive results of the trial, the Company is evaluating its best path for continued development in this indication.
The Company also announced plans to increase the number of patients enrolled in its ongoing Phase III randomized study of RSR13 combined with standard whole brain radiation therapy versus standard whole brain radiation therapy alone for the treatment of patients with brain metastases.
The purpose of increasing the number of patients in this pivotal study is to conduct an appropriately powered subgroup analysis of patients with brain metastases from only breast cancer and non-small cell lung cancer. As a result of this change, the Company expects to increase the study size from 408 patients to 501 patients. With this change, the trial is designed to demonstrate a 35 per cent increase in median survival in the subgroup of patients as well as all patients enrolled in the study.
The Company has concurrence from the FDA that the subgroup survival analysis, if positive, would support a NDA submission and labeling claim for this subset of patients. At projected enrollment rates, the Company anticipates completing enrollment of the trial during the second half of 2002. Patient enrollment will be facilitated through the current investigative sites in North America and at least an additional 30 investigative sites in Europe and other countries.