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ESMO Breast 2021 | HER2CLIMB-04: tucatinib + trastuzumab deruxtecan in HER2+ breast cancer

Erika Hamilton, MD, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, introduces the HER2CLIMB-04 trial (NCT04539938) which is investigating tucatinib plus trastuzumab deruxtecan for patients with HER2+ breast cancer. This interview took place at the virtual European Society for Medical Oncology (ESMO) Breast Cancer Congress 2021.

Transcript (edited for clarity)

HER2CLIMB-04 is a new trial, and it’s combining our newest two agents in HER2+ disease all into one trial. And so, this is a single trial that we’ll be giving trastuzumab deruxtecan, as well as tucatinib for patients that have had at least two prior therapies in the metastatic setting. So, this is really exciting, because we’re excited about both of these compounds, and so the ability to use them together is particularly attractive for both patients and oncologists as well...

HER2CLIMB-04 is a new trial, and it’s combining our newest two agents in HER2+ disease all into one trial. And so, this is a single trial that we’ll be giving trastuzumab deruxtecan, as well as tucatinib for patients that have had at least two prior therapies in the metastatic setting. So, this is really exciting, because we’re excited about both of these compounds, and so the ability to use them together is particularly attractive for both patients and oncologists as well.

This trial is going to be very similar to HER2CLIMB, and the fact that we’re also allowing patients with brain metastases, patients without brain metastases, and that more liberal definition of brain metastases, where they can be stable and treated, treated and progressive or untreated brain metastases.

There’s initially going to be ten patients, and then once we get through those initial safety of the ten, I will be expanding up to 60 patients, again, receiving tucatinib and trastuzumab deruxtecan in the third line and beyond setting.

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Disclosures

Erika Hamilton, MD, discloses institutional research funding from OncoMed, Genentech/Roche, Zymeworks, Rgenix, ArQule, Clovis, Silverback Therapeutics, Millenium, Acerta Pharma, Sermonix Pharmaceuticals, Torque, Black Diamond, Karyopharm, Infinity Pharmaceuticals, Curis, Syndax, Novartis, Boehringer Ingelheim, Immunomedics, FujiFilm, Taiho, Deciphera, Fochon, Molecular Templates, Onconova Therapeutics, Dana Farber Cancer Hospital, Hutchinson MediPharma, MedImmune, SeaGen, Puma Biotechnology, Compugen, TapImmune, Lilly, Pfizer, H3 Biomedicine, Takeda, Merus, Regeneron, Arvinas, StemCentRx, Verastem, eFFECTOR Therapeutics, CytomX, InventisBio, Lycera, Mersana, Radius Health, Abbvie, Nucana, Leap Therapeutics, Zenith Epigenetics, Harpoon, Orinove, AstraZeneca, Tesaro, Macrogenics, EMD Serono, Daiichi Sankyo, Syros, Sutro, G1 Therapeutics, Merck, PharmaMar, Olema, Polyphor, Immunogen, Plexxicon, Amgen, Akesobio Australia and Shattuck Labs; and discloses institutional consulting/advisory role payments from Genentech/Roche, Boehringer Ingelheim, Novartis, Dantari, Lilly, Merck, Puma Biotechnology, Silverback Therapeutics, CytomX, Pfizer, Mersana, Black Diamond, H3 Biomedicine, Daiichi Sankyo, AstraZeneca, Arvinas, Deciphera Pharmaceuticals, Eisai and Seagen.