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BCC 2021 | HER2CLIMB: tucatinib efficacious against brain metastases in patients with HER2+ breast cancer

Nancy Lin, MD, Dana-Farber Cancer Institute, Boston, MA, shares the latest intracranial efficacy and survival findings of the Phase II randomized, international HER2CLIMB trial (NCT02614794) of tucatinib versus placebo in combination with capecitabine and trastuzumab, in patients with advanced HER2-positive breast cancer. Capecitabine plus trastuzumab is an effective combination frequently used in pretreated metastatic populations. To investigate if the addition of tucatinib improved outcomes in patients with stable or active brain metastases, an exploratory analysis of this subgroup was conducted. Almost 50% of the overall population had brain metastases at baseline and the trial results showed substantial improvements in progression-free survival (PFS), overall survival, central nervous system (CNS)-PFS, and CNS objective response compared to the control arm. This interview took place during the 17th St. Gallen International Breast Cancer Conference.

Transcript (edited for clarity)

The HER2CLIMB trial was a randomized study that tested the triplet combination of tucatinib, capecitabine and trastuzumab, versus placebo in combination with trastuzumab-capecitabine, in patients who have HER2-positive, pretreated, metastatic breast cancer. Importantly, the trial, unlike really all other registration trials in breast cancer, until quite recently, included patients, not only with stable treated brain metastases, but also those with progressive or active brain metastases...

The HER2CLIMB trial was a randomized study that tested the triplet combination of tucatinib, capecitabine and trastuzumab, versus placebo in combination with trastuzumab-capecitabine, in patients who have HER2-positive, pretreated, metastatic breast cancer. Importantly, the trial, unlike really all other registration trials in breast cancer, until quite recently, included patients, not only with stable treated brain metastases, but also those with progressive or active brain metastases. And almost half of the patients included in HER2CLIMB had brain metastases at baseline.

The study showed that for the overall study population of all patients combined, there was an improvement in progression-free survival and overall survival, but in addition showed that for the subset of patients with brain metastases, there were substantial improvements in progression-free survival, overall survival, CNS progression-free survival and CNS objective response. And these improvements extended to the group of patients who had active brain metastases at baseline.

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Disclosures

Clinical trial/grant funding (to institution): Genentech, Seattle Genetics, Merck, Pfizer
Consulting/advisory board: AstraZeneca, Daichii Sankyo, Puma, Prelude Therapeutics, Seattle Genetics, Denali Therapeutics, California Institute for Regenerative Medicine

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