BlossomHill's BH-30643 Hits 45% Response Rate in C797S-Positive NSCLC, Pivotal Phase 2 Planned for Early 2027
核心洞察
BlossomHill Therapeutics (搜索) reported a 45% objective response rate and 88% disease control rate from the SOLARA trial of BH-30643 in EGFR C797S (搜索)-positive advanced or metastatic NSCLC.
All 40 patients in the cohort carried EGFR C797S (搜索) resistance mutations and 98% had previously received osimertinib, leaving few remaining treatment options.
The FDA granted Fast Track designation to BH-30643, with an end-of-Phase 1 meeting expected in the fourth quarter of 2026 and first pivotal Phase 2 patient dosing targeted for early 2027.
BlossomHill Therapeutics (搜索) has reported preliminary results from the SOLARA trial showing that BH-30643 produced a 45% objective response rate and an 88% disease-control rate in patients with advanced or metastatic EGFR C797S (搜索)-positive non-small cell lung cancer (搜索). The data were disclosed in a Regulation FD filing tied to a mini-oral presentation at the International Association for the Study of Lung Cancer annual meeting.
The cohort comprised 40 patients, all of whom had EGFR C797S (搜索) mutations, the resistance mechanism that emerges after osimertinib failure. Ninety-eight percent had received prior osimertinib. The disease control rate represented 35 of 40 patients.
Durability Signal at 6.9 Months
As of an August 10 efficacy follow-up, 63% of the cohort remained on treatment at a median follow-up of 6.9 months. The trial, NCT06706076, is still enrolling, and the follow-up period is short enough that median duration of response has not matured. The key measure to watch is how many of the 25 patients still on treatment maintain response at the 12-month mark, which is where regulators and payers are expected to scrutinize whether a single-arm Phase 1/2 objective response rate can support an accelerated approval submission.
Mechanism and Subgroup Breadth
BH-30643 is a macrocyclic OMNI-EGFR (搜索) tyrosine kinase inhibitor, a structural class designed to accommodate the conformational change that C797S forces on the EGFR binding pocket. Most earlier-generation TKIs could not bridge C797S and T790M simultaneously. The SOLARA cohort included patients with and without concurrent T790M, and the 45% objective response rate held across both subgroups. That breadth, if it survives dose-expansion scrutiny, addresses a practical clinical problem: oncologists treating post-osimertinib patients often cannot wait for molecular subtyping before deciding on next therapy.
Regulatory Path and Company Resources
The FDA granted Fast Track designation to BH-30643, which may provide a more streamlined development and regulatory review pathway. BlossomHill expects to hold an end-of-Phase 1 meeting with the FDA in the fourth quarter of 2026, then targets dosing of the first patient in a pivotal Phase 2 trial during the first quarter of 2027.
The company reported second-quarter 2026 results alongside the clinical update. R&D expenses rose to $21.4 million from $12.5 million, driven by clinical-development activity for the SOLARA trial, IND-enabling work for BH-501284 (搜索) and additional personnel and facility costs. General and administrative expenses increased to $3.3 million from $1.6 million. Net loss for the quarter was $23.8 million, or $8.75 per basic and diluted share, compared with a net loss of $13.2 million, or $5.51 per share, a year earlier.
BlossomHill completed an upsized initial public offering after the quarter, selling 10,516,240 shares for $168.3 million in gross proceeds. Combined with $95.4 million in cash and cash equivalents held as of June 30, 2026, the company expects its available resources to fund operations into the second quarter of 2028.
"With a strong balance sheet following our successful initial public offering in August, we believe we are well positioned to deliver important clinical and regulatory milestones over the coming quarters as we continue advancing our intentionally designed medicines that address significant unmet medical needs in cancer treatment," the company stated.