FOR RESPONSE TO INQUIRIES
Tuesday, May 5, 1998
NCI Press Office
Questions and Answers
About NCI's Role in the Development of Herceptin®
- Solid tumors: This is a phase I/pilot study of low-dose interleukin-2 plus Herceptin® in solid tumors — most cancers with the exception of leukemias and lymphomas. Phase I studies involve a small number of patients, usually with advanced cancers, and test the safety of a new drug at various doses. This trial is being conducted through one of the NCI cooperative trial groups, called the Cancer and Leukemia Group B (Protocol ID: CALGB-9661).
- Ovarian or peritoneal cancer: This is a Phase II study of Herceptin® in recurrent or refractory ovarian or primary peritoneal carcinoma. Phase II studies test the effectiveness of a drug in particular kinds of cancer. It is being conducted through the Gynecologic Oncology Group (Protocol ID: GOG-160).
6. Will NCI launch more studies of Herceptin® in other kinds of cancer?
Yes. Once there is an adequate drug supply, NCI and Genentech hope to explore the use of Herceptin® in a variety of malignancies, including gastric, endometrial, salivary gland, non-small cell lung, pancreatic, prostate, and colorectal cancers. Not all patients with these types of cancer have high levels of HER2. But as many as 30 percent to 40 percent of patients with some of these tumor types may overexpress the protein and therefore be candidates for clinical trials with Herceptin®.
7. Is NCI supporting studies of other anti-HER2 antibodies?
Yes. NCI currently is involved in early trials of other monoclonal antibodies directed against the HER2 protein. For example, several phase I studies sponsored by NCI are testing a HER2 antibody, designated 520C9xH22, produced by the Medarex Corporation in Annandale, N.J. Other early, NCI-sponsored studies are evaluating a different HER2 antibody, 2B1, from Chiron Corporation in Emeryville, Calif.
Studies with other monoclonal antibodies targeted against different proteins on cancer cells are also under way. For more information, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). You can also search the NCI's clinical trial database, called PDQ, on the Internet at http://cancernet.nci.nih.gov/prot/protsrch.shtml.
For more information about cancer visit NCI's Website for patients, public and the mass media at http://rex.nci.nih.gov or NCI's main website at http://www.nci.nih.gov.