GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Tr...(reating this complex form of breast canc...),Health

Despite receiving multiple prior lines of anti-cancer therapy, patients who received TYKERB plus trastuzumab in this study experienced:

-- A statistically significant increase in median progression-free survival

versus TYKERB alone (12 weeks vs. 8.1 weeks) (1)

-- A 27 percent reduction in the risk of disease progression [Hazard Ratio:

0.73; p=0.008] (1)

-- A response rate of 10.3 percent versus 6.9 percent. Response rate is a

clinical term that is calculated by complete and partial disappearance

of the tumor.

-- Double the overall clinical benefit rate versus TYKERB alone (24.7

percent vs. 12.4 percent; p=0.01) (1). Clinical benefit rate is

calculated by the response rate and the rate of durable stable disease

(greater than or equal to 6 months).

-- A trend in improved overall survival [Hazard Ratio: 0.75; p=0.106] (1)

The study also demonstrated the activity of TYKERB as a single agent in this patient population, with patients on this arm achieving a median progression free survival of 8.1 weeks and an overall clinical benefit rate of 12.4 percent (1).

The clinical synergy of TYKERB and trastuzumab confirms previous observational findings in preclinical studies and previously reported data from a Phase I study. These latest findings confirm the rationale for further research of this combination in earlier lines of therapy in the metastatic setting and in early stage disease. Additional analysis is underway to explore the benefit that TYKERB plus trastuzumab can offer to less heavily pre-treated patients (1).

Study Background

In this study, 296 patients with HER2 positive breast cancer who had documented progression on trastuzumab treatment in the metastatic setting were eligible to be randomized to receive TYKERB (1000 mg QD) plus trastuzumab (2 mg/kg weekly after 4 mg/kg lo
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