Abstract 146P
Background
This is a prospective, open-label, phase 1b study to evaluate the safety and feasibility of stereotactic body radiotherapy (SBRT) and anlotinib ± toripalimab in untreated oligometastatic brain metastases (BMs) NSCLC patients (pts).
Methods
Ten pts were randomized into 2 groups. Induction therapy: SBRT (35 Gy/5 F) plus anlotinib (12 mg, d1∼14, q3w) with (group A) or without (group B) toripalimab (240 mg, d1, q3w). Then will continue toripalimab and anlotinib on d22 for 1 year until disease progression or intolerable toxicity. Key inclusion criteria: ≥ 18 years old, ECOG ≤ 1, driver mutation-negative, untreated NSCLC BMs (1∼5 lesions). Primary endpoints: intracranial response rate (iORR) and treatment-related adverse events (TRAEs). Secondary endpoints: intracranial progression-free survival, intracranial disease control rate (iDCR), and overall survival.
Results
As of Sep 15, 2022, 8 males (group A: 5, group B: 3) were included. The median age of A was 67 (range 59-71) years. The median age of B was 63 (range 61-68) years, with 1 squamous cell carcinoma in each group. The median follow-up time was 147 days. Intracranial efficacy: after the induction therapy cycle, all pts in group A had SD, 2 in group B had SD and 1 had PR. During 3∼4 months of treatment, the iORR and iDCR were 60% and 80% in group A (3 PR, 1 SD, and 1 PD: investigator error, missing brain radiotherapy, later stage salvage SBRT). Group B had 1 PR and 2 SD. In terms of systemic efficacy, group A: ORR was 40% and DCR was 80%; group B: ORR was 33.3% and DCR was 100%. 80% of group A pts developed any grade (G) TRAEs, mainly hypertension (3/5), including 1 G 3 hypertension; 1 concurrent had hypothyroidism, hypertension, elevated myocardial enzymes, and hand-foot syndrome, causing suspension of one cycle of toripalimab therapy, anlotinib was reduced to 8 mg. 66.7% (2/3) in group B experienced any grade TRAEs, 1 had G 3 hand-foot syndrome led to anlotinib dose reduction.
Conclusions
SBRT plus anlotinib ± toripalimab showed good short-term efficacy in untreated BMs NSCLC. The induction part combined immunotherapy increases manageable TRAEs incidence. Further efficacy and safety data require follow-up confirmation after enrollment.
Clinical trial identification
NCT05021328.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.