GlaxoSmithKline plans to have four important new cancer drugs in final stage clinical trials to cater to patient needs for cancer prevention, treatment and supportive care.
GSK's substantial oncology and supportive care portfolio includes new chemical entities (NCEs), product line extensions (PLEs) and oncology- related vaccines. The four NCEs in phase III development in 2006 include Tykerb (lapatinib), eltrombopag, casopitant and pazopanib, informs a GSK release.
Tykerb, a targeted oral therapy has the potential to become an essential component in the treatment of breast cancer: The latest data demonstrated a promise as first-line treatment for advanced breast cancer, with 40% of patients experiencing clinical benefit including tumour reduction or stable disease for at least 24 weeks. Three new phase III trials are being initiated by January 2006, two in first-line therapy and one in refractory breast cancer
Large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005. In mid-November, the Breast International Group and GSK agreed to collaborate on a large global clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer.
Tykerb, a dual-kinase inhibitor, is an oral once-daily treatment currently being developed for breast cancer and other tumours. It works by inhibiting two well-validated targets in oncology, the kinase components of ErbB1 (EGFR) and ErbB2 receptors, which are associated with cancer-cell proliferation and tumour growth.
GSK expects to file Tykerb for US Food and Drug Administration approval at the end of 2006 or in the first half of 2007.
Paolo Paoletti, senior vice president of GSK's Oncology Medicine Development Centre, stated, "GSK is pursuing therapies targeting cancer at a molecular level in order to block biochemical pathways that transform normal, healthy human cells into cancer cells. We are particularly excited that the promising efficacy of Tykerb, our targeted dual-kinase inhibitor, has led to support among leading cancer experts for the initiation next year of a large study of Tykerb in the treatment of early stage breast cancer."
Eltrombopag, a new clinical data demonstrated the potential for eltrombopag to become the first oral platelet growth factor for patients suffering from thrombocytopenia, a condition which can lead to uncontrolled bleeding, significantly reduced life expectancy and compromised treatment for cancer or liver disease, adds the release.
Eltrombopag is an orally administered small molecule that interacts with the receptor for thrombopoietin (TPO), a protein in the body that is the primary growth factor responsible for the production of blood platelets.
Allen Oliff, senior vice president of GSK's Oncology Centre for excellence in drug discovery, said, "We are very encouraged by the recent clinical data on eltrombopag. This product clearly has the potential to be a significant advance in the treatment of thrombocytopenia, a condition which has few therapeutic options and can lead to sub-optimal treatment for patients suffering from a number of conditions including cancer and liver disease."
The release further stated that Casopitant clinical data demonstrated the potential for casopitant when combined with Zofran as a new and improved therapy for the prevention of nausea and vomiting associated with chemotherapy and after surgery. Pazopanib, latest clinical data demonstrated prevention of tumour growth. Consequently an aggressive clinical development programme is expected to begin shortly in multiple cancer types including phase III trials in renal cancer.
Other GSK oncology assets highlighted at the seminar include Arranon for T-cell acute lymphoblastic leukaemia and lymphoma, new indications for Hycamtin in relapsed cervical and relapsed small cell lung cancer , Avodart for reducing the risk of prostate cancer (phase III) and relacatib a cathepsin-K inhibitor for the prevention and treatment of bone metastases (entering phase II in 2006).
“GSK has made tremendous progress in building its oncology pipeline. From modest beginnings, we now have a pipeline which is one of the largest in our industry with seven major assets expected to be in phase III development in the coming months, including the four NCEs," said Tachi Yamada, GSK's chairman of R&D.
"Cancer remains an area of substantial unmet medical need. Our strategy is focused on meeting all aspects of a cancer patient's treatment - from control, reduction and prevention of tumours to novel medicines that will improve supportive care for patients undergoing chemotherapy," added Yamada.
World-wide, 400,000 women die each year as a result of breast cancer, and its prevalence is increasing with approximately 1.5 million new cases diagnosed every year.