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GSK reveals positive combination Tykerb data

GSK has revealed positive data from three key studies on its first-in-class, oral small molecule HER2 kinase inhibitor for breast cancer, Tykerb

GlaxoSmithKline (GSK) has revealed positive data from three key studies on its first-in-class, oral small molecule HER2 kinase inhibitor for breast cancer, Tykerb (lapatinib).

Results of these and other Tykerb studies were presented at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois.

Dr Paolo Paoletti, senior vice-president of the Oncology Medicine Development Centre at GSK, said: "The robust clinical data presented for Tykerb at ASCO further demonstrate the great potential of this drug as an essential component of treatment regimens for women with HER2-positive breast cancer. GSK is dedicated to an ongoing Tykerb clinical programme to identify additional treatment regimens, as well as patient populations that may respond to the drug."

Credit Suisse analysts said that Tykerb had produced "two disappointing studies". However, Citigroup analysts disagreed and described the data as "good".

While the combination therapy did not demonstrate an incremental benefit for patients with HER2-negative disease, an analysis of patients retrospectively identified as having HER2-positive disease showed that Tykerb plus paclitaxel increased progression-free survival in patients with HER2-positive breast cancer not previously treated with trastuzumab.

Results for the combination of Tykerb plus paclitaxel versus paclitaxel alone respectively, in patients with HER2-positive disease were as follows:

  • Median progression-free survival was 7.9 months, compared with 5.2 months
  • Median duration of response was 7.4 months, compared with 5.5 months
  • Complete or partial response occurred in 60 per cent of patients, compared with 36 per cent

According to GSK, the data from Tykerb plus paclitaxel, compared with paclitaxel alone as first-line treatment in patients with newly diagnosed metastatic breast cancer, have provided the first evidence of activity in the HER2-positive subgroup that the combination significantly improves progression-free survival of the disease, compared with the chemotherapy alone. Several additional phase III trials combining Tykerb with taxanes are being conducted in patients with HER2-positive disease.

Results from an ongoing, multi-centre phase II study suggest that Tykerb has clinical activity in heavily pre-treated patients with CNS metastases from HER2-positive breast cancer. An additional 42 per cent of patients achieved stable disease for at least eight weeks based on a protocol defined composite response criteria. Twenty-two per cent of all patients had no disease progression within the first six months on Tykerb monotherapy.

Ongoing trials
GSKís clinical trial programme is studying Tykerb in other breast cancer settings and other cancers to identify patient populations which may respond to therapy. The phase III study TEACH (Tykerb Evaluation After CHemotherapy), trial has reached a key milestone, enrolling more than 1,000 patients.

TEACH is designed to investigate whether adjuvant treatment with Tykerb will improve disease-free survival in women with early-stage HER2-positive breast cancer, including those with positive and negative node involvement.

Bank of America analysts project that annual Tykerb sales will reach nearly USD 1bn by 2011, while Sanford C Bernstein analysts believe that sales will peak at USD 1.5 bn in 2012.

7th June 2007

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