Aumolertinib is a tolerable third-generation EGFR-TKI that has CNS efficacy in patients with EGFR-mutant NSCLC. Stereotactic radiotherapy (SRT) is highly effective and less toxic for limited intracranial metastases. We aim to investigate the efficacy and safety of aumolertinib followed by SRT in patients with intracranial oligometastatic NSCLC.
Intracranial oligometastatic patients with EGFR sensitive mutations (EGFR-TKIs naive) were enrolled and received aumolertinib 110 mg daily until intracranial disease progression. Then SRT (32–40Gy total, 8Gy/f) was given to intracranial oligo-progression disease. After SRT the patients received continued aumolertinib if extracranial lesions were stable controlled. The primary endpoint was intracranial objective response rate (iORR). Secondary endpoints included intracranial progression-free survival (iPFS), intracranial duration of response (iDOR) according to RECIST 1.1, cerebral radiation necrosis rate (CRNR) and overall survival (OS). Safety was evaluated according to CTCAE v5.0.
To January 6, 2023, a total of 35 patients were enrolled and 32 patients were assessed, and followed for 3 months to 16 months. All patients received 110 mg aumolertinib daily and received at least one independent imaging evaluation by a radiologist. After administration of aumolertinib, the best response of all patients in intracranial and extracranial lesions was partial response (PR), with an iORR of 100%. At data cut-off, one patient developed intracranial primary lesion progression at 12 months after aumolertinib treatment but stable in extracranial lesions. SRT treatment was given to this patient. No grade ≥3 adverse events occurred after continued aumolertinib. The most common adverse reactions were rash and abnormal liver enzymes.
This report showed pronounced intracranial objective response benefit with aumolertinib in patients with intracranial oligometastatic disease followed by SRT after intracranial oligo-progression and no new safety signals. Aumolertinib has promising efficacy and good tolerability in intracranial oligometastatic EGFR mutated NSCLC.
NCT04519983.
The authors.
Hansoh Pharmaceutical Group Company Limited.
H. Zhang: Financial Interests, Personal, Sponsor/Funding: Hansoh Pharma. All other authors have declared no conflicts of interest.