Promising Lung Cancer Trial Results
BlossomHill Therapeutics Reports Positive Phase Trial Results for Resistant Lung Cancer
Anonymous
BlossomHill Therapeutics reported updated Phase 1/2 SOLARA trial results for investigational BH-30643 in patients with EGFR C797S-positive non-small cell lung cancer, a resistance setting with no approved targeted therapies. Among 40 patients, the drug produced a 45% objective response rate and an 88% disease control rate, with 63% still receiving treatment after a median follow-up of 6.9 months. Safety findings from 174 patients at expansion doses indicated generally favorable tolerability, with mostly mild wild-type EGFR-related adverse events and low rates of dose reductions or treatment discontinuation. Presented at the 2026 World Conference on Lung Cancer in Seoul, the findings support further development of the oral, brain-active, mutant-selective inhibitor, which has received FDA Fast Track designation. BlossomHill plans to begin a global Phase 2 study in EGFR C797S-positive NSCLC in 2027 while continuing to evaluate BH-30643 in additional EGFR-mutant populations and treatment combinations.
Key Points
1
The SOLARA cohort included patients with EGFR C797S resistance both with and without a concurrent T790M mutation, reflecting a molecularly heterogeneous, heavily pretreated population.
2
C797S commonly emerges after disease progression on third-generation EGFR inhibitors such as osimertinib, leaving patients with limited treatment options because no approved oral targeted therapies currently address this resistance mechanism.
3
The 174-patient safety analysis at expansion doses found that the adverse events were mainly Grade 1 and associated with wild-type EGFR, providing more specific detail on the generally mild tolerability profile.
4
Hidehito Horinouchi of Japan’s National Cancer Center Hospital said the responses support BH-30643’s potential to directly target the C797S resistance mechanism in patients who currently lack approved targeted treatment options.
5
Beyond the planned global Phase 2 study, SOLARA is continuing to evaluate BH-30643 in other EGFR-mutant subgroups, including patients without prior targeted therapy, on-target resistance mutations and combinations with chemotherapy.
Sentiment
Mostly PositiveNEGATIVENEUTRALPOSITIVE
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