Oncothyreon And Array BioPharma Announce Phase 1b Trial For ONT-380 In Breast Cancer

Oncothyreon And Array BioPharma Announce Phase 1b Trial For ONT-380 In Breast Cancer

Oncothyreon Inc. and Array BioPharma Inc. announced in a press release that they have initiated a Phase 1b trial of ONT-380 (ARRY-380) in combination with Kadcyla (ado-trastuzumab emtansine or TDM-1). The oral agent for patients with metastatic HER2+ breast cancer was discovered by Array and is being developed in collaboration with Oncothyreon. Diana Hausman, M.D., Chief Medical Officer of Oncothyreon said, "The strategy of combining two agents targeting HER2 has previously proven useful in HER2+ breast cancer, and we believe the combination of ONT-380 and Kadcyla is particularly relevant to evaluate as the treatment of metastatic HER2+ breast cancer continues to evolve."

Metastatic HER2+ Breast Cancer

Breast cancer is a disease wherein malignant cells form in the breast tissue. Metastatic breast cancer develops when cancerous cells travel from the breast to other parts of the body. HER2+ breast cancer is a variant and diagnosed when cancer cells express epidermal growth factor receptor 2 (HER2), a protein that grows cancer cells. HER2+ cancer can grow in other organs and are usually more aggressive than other kinds of cancer. This type is not as responsive to hormone treatment as other types are.  

ONT-380

ONT-380 is a selective HER2 inhibitor. The agent has proved effective in inhibiting tumor growth and showed superior results to Herceptin and Tykerb (lapatinib) and to the investigational drug neratinib. ONT-380 has also shown positive results when combined with other agents like Taxotere (docetaxel). In the new study underway, ONT-380 will be combined with Kadcyla.

Phase 1b Trial for ONT-380

In the new Phase 1b trial, 48 patients previously treated with Herceptin (trastuzumab) and a taxane for metastatic breast cancer will try different doses of ONT-380. The dose-escalation trial (NCT01983501, ClinicalTrials.gov Identifier) will determine the highest dose tolerated in combination with Kadcyla.  Investigators will profile the drug’s anti-tumor activity and evaluate safety. 

About Oncothyreon and Array BioPharma

Oncothyreon specializes in innovative approaches to cancer treatment. Its goal is to develop small molecules and synthetic vaccines. Array BioPharma Inc. focuses on discovery and development of small molecules drugs for cancer. It wholly owns drugs like filanesib (ARRY-520) for multiple myeloma and co-owns drugs like selumetinib with AstraZeneca and MEK162 with Novartis.