GSK ramps up cancer pipeline

GlaxoSmithKline (GSK) expects to launch up to five new oncology-related treatments in the next three years, the pharma giant has announced.

The new drugs will target breast cancer, cervical cancer, renal cell carcinoma, invasive soft tissue sarcoma (STS), ovarian cancer, lung cancer, non-Hodgkin's lymphoma and adult leukaemia. GSK is also developing a drug for chemotherapy patients targeting decreased platelet count and nausea.

"We are actively developing late-stage medicines in over twelve different cancer types, from pioneering treatments such as Tykerb to vaccines that can treat as well as prevent cancer," GSK's chairman of research and development, Moncef Slaoui, said.

"Moving deeper into the pipeline we believe that this productivity in oncology can be sustained as we have a significant number of promising new compounds in early-stage discovery."

The drugs include Tykerb (lapatinib), an oral, targeted, dual kinase inhibitor therapy that is being developed for use in breast cancer and other tumour types.

Tykerb was approved by the US FDA in March for use in metastatic breast cancer patients who have received prior therapy.

It has also been approved for treatment in combination with capecitabine (Xeloda) for patients with advanced or metastatic HER2-positive breast cancer who have received prior therapy including an anthracycline, a taxane and trastuzumab. Approximately 3,000 patients have been treated since the product was launched.

Tykerb has been filed for approval in Europe and international markets and GSK anticipates launching the product in Europe in the second half of 2007, where it will be known as Tyverb. It is also being used an adjuvant with paclitaxel (Taxol).

GSK said the latest Tykerb data show that it is a possible prevention against brain metastases and has low cardiotoxicity.

It is also developing its own cervical cancer vaccine, Cervarix, but did not present further data.

Another drug is Pazopanib, an oral, once-daily multi-kinase inhibitor targeting vascular endothelial growth factor (VEGF), platelet derived growth factor and c-kit receptors. Pazopanib inhibits angiogenesis, a process that plays a critical role in the growth and spread of many tumours.

The company said trials had revealed promising data for treating three cancer types. Pazopanib has shown high clinical response rates in advanced or metastatic renal cell carcinoma (RCC) and clear clinical activity in invasive soft tissue sarcoma (STS) and aggressive ovarian cancer, it said.

The majority of patients with ovarian cancer have advanced disease at the time of initial diagnosis. Although most respond initially to first-line therapy, recurrent disease remains a significant burden. Promising data from an ongoing phase II study has shown activity with pazopanib in nine (41%) of 22 evaluable patients with relapsed disease, GSK data shows.

GSK is also developing Promacta (eltombopag), the first oral novel compound for thrombocytopenic (decreased platelet count) patients who are at significant risk of uncontrolled bleeding. GSK is currently investigating Promacta for the treatment of idiopathic thrombocytopenic purpura (ITP), Hepatitis C-associated thrombocytopenia and chemotherapy-induced thrombocytopenia (CIT).

In addition, it is developing Rezonic (casopitant), an anti-emetic medicine to prevent both post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV).

New phase III data presented showed that Rezonic, when used in combination with Zofran (ondansetron) for treatment of PONV, delivers enhanced benefit over ondansetron alone. Importantly, these data were seen in both intravenous (IV) and oral formulations of Rezonic, supporting use of the product in both the hospital and outpatient setting.

GSK also presented data for ofatumumab (HuMax-CD20) - a fully human high-affinity antibody which is currently in late stage development for the treatment of follicular non-Hodgkin's lymphoma (FL) and chronic lymphocytic leukaemia (CLL), the most common form of adult leukaemia.

Results from very early phase studies look promising, the company said. It is also being trialled in patients with rheumatoid arthritis, with phase III trails to begin by the end of the year.

The company also announced progress in immunotherapy through its Antigen-Specific Cancer Immunotherapeutic (ASCI) programs. One is using MAGE-A3, a tumour-specific antigen for use in non-small cell lung cancer.

Final results of a phase II proof-of-concept clinical trial in MAGE-A3 positive patients with stage IB or II lung cancer showed a 27 per cent reduction in the relative risk of cancer recurrence following surgery in patients treated with the MAGE-A3 ASCI, compared to placebo, the company said.

Following these results, MAGE-A3 ASCI is entering a phase III registration trial in 2007 involving over 2200 patients. This will be the largest clinical trial ever conducted in lung cancer treatment, it said.