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ASCO 2021 | HER2CLIMB-04: tucatinib plus T-DXd for HER2+ breast cancer

Erika Hamilton, MD, Sarah Cannon Research Institute, Nashville, TN, shares the details of the Phase II HER2CLIMB-04 trial in progress (NCT04539938), assessing the combination of tucatinib and trastuzumab deruxtecan (T-DXd) in patients with HER2-positive locally advanced/metastatic breast cancer. Both tucatinib and T-DXd have shown to be highly efficacious in the pivotal HER2CLIMB and Destiny-Breast01 trials, respectively. HER2CLIMB-04 aims to assess if the combination of these agents may further improve the efficacy seen with either agent alone. The trial aims to enroll around 60 patients following an initial safety lead-in cohort of 10 patients. Patients with active brain metastases are eligible for trail participation. The primary endpoint will be confirmed objective response rate. This interview took place at the American Society of Clinical Oncology (ASCO) 2021 Virtual Meeting.

Transcript (edited for clarity)

So HER2CLIMB-04 was presented by Dr. Krop here at ASCO 2021 and it’s a really exciting study because it combines two of our newest approved drugs in the HER2 space together into one trial. So obviously I’m talking about to tucatinib and trastuzumab deruxtecan here. And so trastuzumab deruxtecan is approved third line and beyond for HER2 positive breast cancer, shows an incredibly exciting overall response rate, duration of response, et cetera...

So HER2CLIMB-04 was presented by Dr. Krop here at ASCO 2021 and it’s a really exciting study because it combines two of our newest approved drugs in the HER2 space together into one trial. So obviously I’m talking about to tucatinib and trastuzumab deruxtecan here. And so trastuzumab deruxtecan is approved third line and beyond for HER2 positive breast cancer, shows an incredibly exciting overall response rate, duration of response, et cetera. And then tucatinib is also approved really for second line and beyond in combination with its partner of capecitabine and trastuzumab. Interestingly, a lot of the side effects of the HER2CLIMB regimen actually comes from the capecitabine, the chemotherapy backbone partner. Hand foot syndrome, diarrhea, et cetera. And so this new trial is looking at the combination of trastuzumab deruxtecan with tucatinib. So you get both of the exciting agents in one trial and drop the traditional chemotherapy backbone of capecitabine. So we’re particularly excited to enroll to this trial. We’re hoping we’re going to see a really great activity.

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Disclosures

Dr. Hamilton discloses research funding (payable to institution only, no personal funds) 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, Shattuck Labs

Dr. Hamilton discloses consulting/advisory role payments( to institution only, no personal funds accepted) 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, Seagen

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