BEIJING (dpa-AFX) - HUTCHMED (China) Limited (HCM) announced positive results from the SAVANNAH Phase II trial, which showed high and durable response rates with the combination of savolitinib and TAGRISSO in MET-high lung cancer. This highlights a promising chemo-free oral treatment strategy to address resistance mechanisms in advanced settings. Additionally, long-term survival benefits and safety were observed in the savolitinib Phase IIIb study for METex14 non-small cell lung cancer.
The company announced that new and updated data from several studies of compounds discovered by the company, savolitinib and surufatinib, will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place on March 26-29, 2025 in Paris, France.
According to the company, results from the SAVANNAH Phase II trial showed savolitinib (300mg BID1) plus TAGRISSO demonstrated a clinically meaningful and durable objective response rate or 'ORR' in patients with epidermal growth factor receptor mutated or 'EGFRm' non-small cell lung cancer or 'NSCLC' with high levels of MET overexpression and/or amplification whose disease progressed on treatment with first line TAGRISSO.
Savolitinib plus TAGRISSO demonstrated confirmed ORR of 56% and 55% , median duration of response or 'DoR' of 7.1 and 9.9 months, and median progression-free survival or 'PFS' of 7.4 and 7.5 months by investigator and blinded independent central review (BICR) assessment, respectively.
The company noted that safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine and no new safety concerns were reported. In all patients treated with savolitinib (300mg BID) plus TAGRISSO, Grade 3 or higher adverse events (AEs) occurred in 57% and Grade 3 or higher treatment related adverse events (TRAEs) occurred in 32% of the patients.
Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor ('TKI') being jointly developed and commercialized by AstraZeneca and HUTCHMED. In 2023, savolitinib and TAGRISSO received Fast Track Designation from the US Food and Drug Administration (FDA) in this setting.
HUTCHMED noted that updated results from the savolitinib Phase IIIb study in China demonstrated survival benefits and long-term safety in MET exon 14 skipping alteration NSCLC, particularly in treatment-naïve patients. Among the 166 patients who received savolitinib treatment, the median follow-ups for 87 treatment-naïve patients and 79 previously treated patients were 34.5 and 25.1 months, respectively. In 87 treatment-naïve patients, median overall survival or 'OS' was 28.3 months, and the 36-month OS rate was 44.7%. In 79 previously treated patients, median OS was 25.3 months , and the 24-month OS rate was 51.7%.
Post-hoc OS subgroup analysis suggested that patients with baseline brain metastasis also gain survival benefit with median OS of 15.3 months and 25.3 months in treatment-naïve patients (10/87 patients) and previously treated (21/79 patients) with brain metastasis, respectively. No new safety signal was observed.
Savolitinib is approved in China under the brand name ORPATHYS for this patient population.
Results from the exploratory study suggested surufatinib plus immunotherapy as maintenance therapy following first line chemo-immunotherapy demonstrated durable survival benefit for patients with extensive-stage small cell lung cancer patients. At data cut-off on July 31, 2024, a total of 21 patients were enrolled in this single arm Phase IIa part of the study and received at least one dose of surufatinib plus PD-1/PD-L1 antibodies treatment. The median follow-up duration was 17.1 months for maintenance and 22.5 months for first line (induction + maintenance) therapy. The 12-month and 18-month OS rates were both 57.1% for maintenance therapy; and 85.7% and 57.1% for first line therapy.
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