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GSK’s Phase III trial of breast cancer combination treatment fails to meet primary endpoint

UK-based drug maker GlaxoSmithKline (GSK) has reported results from its Phase III trial of two anti-HER2 agents, lapatinib (Tykerb/Tyverb) and trastuzumab, as an adjuvant treatment for patients with HER2 positive primary breast cancer.

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The trial failed to meet the primary endpoint of improved disease free survival (DFS) compared to single agent therapy with trastuzumab.

The company said that the safety profile was consistent with the established safety profile of the study drugs, with no new safety signals observed.

ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation trial; NCT00490139) is a randomized, multi-center, open-label, Phase III trial of lapatinib and trastuzumab combination to treat breast cancer patients.

GSK senior vice president of Oncology R&D Rafael Amado said that while it is disappointing that ALTTO did not meet its primary endpoint, the company now has a tremendous amount of information that will help to further its knowledge of the biology of this disease and inform future studies in HER2 positive breast cancer in the adjuvant setting.

"Further analysis of these data will continue over the coming months," Amado said.

"We are most grateful to the more than 8,000 patients across the world who participated in ALTTO — their generous contribution to the scientific community will facilitate a greater understanding of this aggressive disease."

Primary analysis of the trial tested for superiority between the combination arm and trastuzumab alone with respect to DFS, while the trastuzumab followed by lapatinib arm was tested for non-inferiority.

The results showed that at four years, 88% of women lived without their disease returning (4-year DFS) in the lapatinib plus trastuzumab arm and 86% in the trastuzumab arm.

The 4-year DFS rate for the trastuzumab followed by lapatinib arm was 87% compared to 86% in the trastuzumab arm.


Image: GlaxoSmithKline headquarters in London, UK. Photo: Courtesy of Maxwell Hamilton