KEY TAKEAWAYS
- The ongoing Beamion Lung 1 study assessed the safety, MTD, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BI 1810631 in HER2 aberration-positive solid tumors.
- The study shows that BI 1810631 is well-tolerated and effective across dose levels in pre-treated HER2-positive solid tumors.
The Beamion Lung 1 study’s phase Ia enrolled patients with HER2 aberration-positive advanced/unresectable/metastatic solid tumors refractory to standard therapy. Patients (pts) received escalating doses of BI 1810631 BID (starting dose 15 mg) or BI 1810631 QD (starting dose 60 mg). Phase Ib will include pts with advanced HER2 tyrosine kinase domain mutation-positive NSCLC. The trial’s primary endpoints were the maximum tolerated dose (MTD) (Phase Ia) and overall response rate (Phase Ib). The secondary endpoints included dose-limiting toxicities (DLTs), pharmacokinetics (Phase Ia/Ib), duration of response, disease control rate, progression-free survival (Phase Ib).
As of March 9, 2023, 43 pts from various countries were treated for NSCLC, lung cancer (unspecified), colorectal cancer, or other tumors. Most had a HER2 mutation. BI 1810631 doses ranged from 15 mg to 300 mg BID or QD, with a median of 4 cycles. Four DLTs were observed (outside MTD evaluation period), and MTD has not been determined. TRAEs occurred in 65% of pts, with diarrhea and increased ALT being common. In lung cancer pts, 46% achieved a partial response, and 50% had stable disease. Two pts with other tumor types also achieved a partial response.
Preliminary data indicated BI 1810631 is well-tolerated and showed efficacy across dose levels in pre-treated HER2 aberration-positive solid tumors. Phase Ib recruitment is ongoing, and updated Phase Ia data and emerging Phase Ib results will be presented.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/1006
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04886804
Yamamoto, N., Opdam, F., Barve, M., Tu, H-Y., Wu, Y-L., Schroeter, L., Sadrolhefazi, B., Serra, J., Yoh, K., Heymach, J. Beamion Lung 1, a Phase Ia/Ib Trial of the HER2 TKI, BI 1810631 in Patients with Advanced Solid Tumors with HER2 Aberrations.
