GSK highlights new oncology drugs
pharmafile | June 20, 2007 | News story | Research and Development |Â Â Â
GlaxoSmithKline has provided investors with details of a number of new oncology drugs it aims to launch over the next three to four years.
Until recently, GSK has had little presence in the field of oncology, but the company is now looking to establish itself in the industry's fastest growing therapeutic sector, currently worth more than £20 billion and growing at 20% annually.
In March this year, the company launched Tykerb, its new targeted treatment for advanced breast cancer, which could eventually prove to be a rival to Roche's blockbuster Herceptin.
GSK says Tykerb has got off to a strong start, with 3,000 patients already treated.
Meanwhile, Cervarix, GSK's vaccine for cervical cancer is also nearing approval in the US and Europe, but has fallen behind its rival, Merck's Gardasil, which has been available in the US since mid-2006.
European approval of Tykerb is expected shortly, and the company hopes it will signal the start of a string of cancer product launches.
But competition will be tough in all of the specialist cancer markets GSK is entering, in many cases its new drugs having to compete with groundbreaking products, such as Roche's MabThera in non-Hodgkin's lymphoma and Sutent in kidney cancer.
GSK is looking for small but significant advantages of its products over rivals – such as ease of use and tolerability – to give them the edge in the absence of long-term data.
Moncef Slaoui, chairman of R&D at the company commented: "We are actively developing late-stage medicines in over 12 different cancer types, from pioneering treatments such as Tykerb, to vaccines that can treat as well as prevent cancer.
"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."
Like its rivals such as Pfizer, which also has no long-term heritage in oncology, GSK is investing heavily in the field, including hiring 30 oncology specialists to work in its research and development programmes.
GSK's oncology pipeline – highlights
Pazopanib for renal cell carcinoma
A once-daily pill which has shown high clinical responses in patients with renal cell carcinoma, as well as early signs of efficacy in phase II trials treating invasive soft tissue sarcoma and aggressive ovarian cancer.
Pazopanib is an anti-VEGF drug, working to cut off the blood supply to tumours in the same way as Bayer's Nexavar and Pfizer's Sutent..
Pfizer's drug was first launched in March 2006, with Bayer's following in December, giving them both a considerable head start on pazopanib.
But GSK says what marks pazopanib out from the other drugs is its high tolerability factor, enabling patients to remain on therapy for longer and in combination with other treatments.
Promacta (eltombopag) for uncontrolled bleeding
Promacta is the first in a new kind of oral treatments for thrombocytopenia, or decreased blood platelet count in patients, which can be caused by chemotherapy or other conditions.
If left untreated, the condition can cause potentially fatal uncontrolled bleeding. GSK is developing the drug to treat three types of thrombocytopenia: idiopathic thrombocytopenic purpura (ITP), hepatitis C-associated thrombocytopenia and chemotherapy-induced thrombocytopenia (CIT).
Phase III trial data of the drug in ITP patients is encouraging, and GSK plans to submit the product to regulators in late 2007/early 2008.
Rezonic (casopitant) for nausea and vomiting
Rezonic is currently in phase III trials to treat post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV).
GSK says 40-50% of surgical patients still experience nausea and vomiting despite the use of existing anti-emetic medicines. Trials suggest its new drug, when combined with established treatment Zofran (ondansetron) provide better relief than Zofran alone.
The company plans to file the drug in the first half of 2008.
Ofatumumab for follicular non-Hodgkins lymphoma
The final drug, ofatumumab, is still in the early stages of development, having completed two phase I/II studies, one in follicular non-Hodgkin's lymphoma (FL) and another in chronic lymphocytic leukaemia (CLL).
Data from the lymphoma trial showed most patients responded to the drug, including nine out of 14 patients who had received prior treatment with Roche's MabThera, one the most successful products in the therapy area.
Ofatumumab (also known as HuMax-CD20) is also in more advanced studies to treat rheumatoid arthritis, and will begin phase III studies by the end of 2007.
MAGE-A3 ASCI
One area in which GSK says its oncology research is unique is in the field of immunotherapeutic products which work by enhancing the human body's immune response to cancer.
MAGE-A3 is an antigen present in 35-50% of patients with non-small cell lung cancer which can be stimulated to fight the cancer more vigorously than it would otherwise.
Phase II trials of GSK's Antigen-Specific Cancer Immunotherapeutic (ASCI) show patients with the lung cancer had a 27% reduced risk of their cancer returning compared to placebo.
The treatment is now entering phase III trials in more than 2,200 patients, the largest ever trial in lung cancer treatment.
