BEIJING (dpa-AFX) - HUTCHMED (China) Limited (HCM) announced that results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy.
The findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease.
As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival (PFS) assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy. The independent review committee (IRC) assessed median PFS was 7.2 months vs 4.2 months, respectively.
The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively.
The company said overall survival was not mature at the time of the interim analysis. Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor (TKI) treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI nave populations. In the third generation EGFR-TKI treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months.
The company noted that the safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile.
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