Abstract 80P
Background
Savolitinib (Savo) is a potent and highly selective oral MET inhibitor. We previously reported robust and durable activity of savo from a phase IIIb confirmatory study (data cut: Oct 20, 2023; Shun L, et al. ELCC 2024), with ORR of 62.1% and 39.2%, median PFS (mPFS) of 13.7 mo and 11.0 mo, median OS (mOS) of not mature, in treatment-naïve and previously treated patients (pts), respectively. Here we report the final OS and long-term safety outcomes of this 3b study (data cut: Nov 30, 2024).
Methods
Treatment-naïve (1 L) or previously treated (≥2 L) pts with advanced or metastatic METex14 NSCLC were enrolled. Eligible pts received savo QD at 600 mg (body weight ≥50 kg) or 400 mg (
Results
Among the 166 pts who received savo, the median follow-ups for 87 treatment-naïve pts and 79 previously treated pts were 34.5 and 25.1 mo, respectively. 48.8% of pts (48.3% of treatment-naïve and 49.4% of previously treated) received subsequent anti-tumor therapies, with chemotherapy (27.7%) and targeted therapy (23.5%) being most frequent. In 87 treatment-naïve pts, mOS (95%CI) was 28.3 mo (17.5, NE), and 36-mo OS rate was 44.7% (33.7%, 55.0%). In 79 previously treated pts, mOS was 25.3 mo (20.5, 30.5), and 24-mo OS rate was 51.7% (39.1%, 62.9%). Post-hoc OS subgroup suggested that pts with baseline brain metastasis (BM) might also gain survival benefit; mOS was 15.3 mo and 25.3 mo in treatment-naïve pts with BM (10/87 pts) and previously treated pts with BM (21/79 pts), respectively. Treatment-related Grade ≥3 treatment-emergent adverse events occurred in 103 out of 166 pts (62.0%), and the common events were hepatic function abnormal (17.5%), alanine aminotransferase increased (15.1%), and aspartate aminotransferase increased (12.0%).
Conclusions
The final OS results of this 3b study further demonstrate survival benefits of savo in advanced or metastatic METex14 NSCLC, particularly in treatment-naïve pts. No new safety signal was observed.
Clinical trial identification
NCT04923945.
Editorial acknowledgement
Writing and editing assistance was provided by Dr. Haoyun Shi of HUTCHMED Limited.
Legal entity responsible for the study
HUTCHMED Limited.
Funding
HUTCHMED Limited and AstraZeneca.
Disclosure
Q. Song, S. Fan: Financial Interests, Personal, Full or part-time Employment: HUTCHMED Limited. M. Shi: Financial Interests, Personal, Full or part-time Employment: HUTCHMED Limited; Financial Interests, Personal, Member of Board of Directors: HUTCHMED Limited; Financial Interests, Personal, Officer: HUTCHMED Limited. W. Su: Financial Interests, Personal, Full or part-time Employment: HUTCHMED Limited; Financial Interests, Personal, Member of Board of Directors: HUTCHMED Limited; Financial Interests, Personal, Officer: HUTCHMED Limited. All other authors have declared no conflicts of interest.