2023 Targeted Therapies of Lung Cancer Meeting (Poster)-P1.11. A Phase 1 Trial of BI 1810631, a HER2 Tyrosine Kinase Inhibitor (TKI), as Monotherapy in Patients with Advanced/Metastatic Solid Tumors with HER2 Aberrations

P1.11. A Phase 1 Trial of BI 1810631, a HER2 Tyrosine Kinase Inhibitor (TKI), as Monotherapy in Patients with Advanced/Metastatic Solid Tumors with HER2 Aberrations

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A phase 1 clinical trial of BI 1810631, a tyrosine kinase inhibitor (TKI) targeting the human epidermal growth factor receptor 2 (HER2), was conducted to evaluate its safety and efficacy in patients with advanced/metastatic solid tumors with HER2 aberrations. HER2 mutations are found in a variety of solid tumors, including lung, colorectal, and breast cancer. The study enrolled patients with HER2-positive tumors refractory to or unsuitable for standard therapy. The maximum tolerated dose (MTD) of BI 1810631 has not been reached, and three dose-limiting toxicities (edema, anemia, and elevated alanine aminotransferase) have been observed thus far. Treatment-related adverse events were reported in 68% of patients, with diarrhea being the most common side effect.<br /><br />Preliminary data from the trial showed promising antitumor activity of BI 1810631, especially in patients with HER2-mutated non-small cell lung cancer (NSCLC). Objective response rates and disease control rates were high in these patients. The median number of treatment cycles was four, and ongoing treatment was observed in 65% of patients. The trial is still recruiting patients for phase 1a, while phase 1b will focus on early efficacy in patients with previously treated NSCLC harboring a HER2 mutation.<br /><br />BI 1810631 is a HER2-selective TKI that specifically targets both wild-type and mutated HER2 receptors, including those with exon 20 insertions, without affecting epidermal growth factor receptor (EGFR) signaling. The drug has shown good tolerability and efficacy in preclinical studies. Currently, there are limited treatment options available for patients with HER2 mutation-positive tumors.<br /><br />Overall, the phase 1 trial demonstrated promising results of BI 1810631 in patients with advanced/metastatic solid tumors with HER2 aberrations, particularly in HER2-mutated NSCLC. The drug exhibited a favorable safety profile, and further research is ongoing to establish the recommended phase 2 dose and to evaluate its efficacy in larger patient populations.

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Hibiki Udagawa, The University of Texas MD Anderson Cancer Center, United States

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Speaker Hibiki Udagawa, The University of Texas MD Anderson Cancer Center, United States

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Keywords

BI 1810631

tyrosine kinase inhibitor

HER2

phase 1 clinical trial

solid tumors

HER2 aberrations

HER2 mutations

lung cancer

colorectal cancer

breast cancer