HUTCHMED to Present First Data from Global Phase II SAVANNAH Study at 2022 World Conference on Lung Cancer

HUTCHMED (00013) announced that the company will present for the first time the ongoing SAVANNAH global Phase II research data at the 2022 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The conference will be held from August 6 to 9, 2022, in Vienna, Austria.

SAVANNAH Study is a global Phase II clinical trial designed to evaluate savolitinib, co-developed by HUTCHMED and AstraZeneca (LSE/STO/Nasdaq: AZN), in combination with AstraZeneca's Tagrisso.^®(Osimertinib) Combination Therapy for Patients Previously Treated with Tagrisso^®Patients with epidermal growth factor receptor ("EGFR") mutations and mesenchymal-epithelial transition factor ("MET")-driven non-small cell lung cancer whose disease progressed after treatment. In addition to continuing treatment with Tagrisso®, patients also received savolitinib at doses of 300 mg once daily, 300 mg twice daily, or 600 mg once daily. The study has recruited a total of 294 patients.

As of the data cutoff date of August 27, 2021, the abstract announced the administration of 300 mg of savolitinib once daily and 80 mg of Tagrisso once daily.^®Analysis results of 193 evaluable patients for dose treatment efficacy. Eligible MET abnormalities include MET amplification (MET copy number ≥ 5 and/or MET:CEP signal ratio ≥ 2 [FISH5+]) detected by fluorescence in situ hybridization ("FISH") or MET overexpression (≥ 50% tumor cells with 3+ staining [IHC50+]) detected by immunohistochemistry ("IHC"). Exploratory analysis results using higher MET abnormality levels as thresholds were disclosed in the abstract. The thresholds for high MET abnormality levels are MET copy number ≥ 10 (FISH10+) and/or 3+ staining in ≥ 90% of tumor cells (IHC90+). In this study, patients meeting these high MET abnormality levels accounted for 34% of the total number of enrollments tested by the central laboratory.

The results showed that, as the level of MET abnormality increased, there was a trend toward an improved disease response rate. Among all patients in this analysis, the objective response rate (“ORR”) was 32% [95% confidence interval (“CI”): 26-39%], the median duration of response (“DoR”) was 8.3 months [95% CI: 6.9-9.7 months], and the median progression-free survival (“PFS”) was 5.3 months [95% CI: 4.2-5.8 months]. These results are consistent with earlier findings from the TATTON study, a global exploratory clinical trial conducted in over 220 patients with MET amplification, EGFR mutation-positive non-small cell lung cancer who had previously received any EGFR tyrosine kinase inhibitor (“TKI”) therapy.

In SAVANNAH study patients with high MET aberration levels (n=108), ORR was 49% [95% CI: 39-59%], median DoR was 9.3 months [95% CI: 7.6-10.6 months], and median PFS was 7.1 months [95% CI: 5.3-8.0 months]. The safety profile of savolitinib in combination with Tagrisso® was consistent with the known profiles of this combination therapy and each drug.

The findings from the ongoing SAVANNAH study and the earlier submitted TATTON Ib/II study have laid the groundwork for the initiation of the SAFFRON global Phase III study. SAFFRON is a study in patients with EGFR mutations, MET-driven tumors who are receiving first-line or second-line Tagrisso.^®A study conducted in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced recent disease progression after the most recent treatment. Patients with higher levels of MET abnormalities will be prospectively selected for inclusion in the study.

SAFFRON Study to Evaluate Savolitinib and Tagrisso^®Efficacy and Safety of Combination Therapy vs. Pemetrexed Plus Platinum Doublet Chemotherapy (the Current Standard of Care for Such Patients). Approximately 324 patients are planned to be randomized. If the study results are favorable, this international multicenter clinical trial (MRCT) may potentially support Tagrisso.^®Global Marketing Authorization Applications for Savolitinib Combination Therapy.

Currently, in China, two registration studies targeting EGFR mutation-positive non-small cell lung cancer with MET abnormalities are underway: the SANOVO study in treatment-naïve patients and the SACHI study in patients who experienced disease progression after prior treatment with any EGFR TKI.

Volitinib is a potent, highly selective oral MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. Savolitinib can block the abnormal activation of the MET receptor tyrosine kinase signaling pathway caused by mutations (such as exon 14 skipping mutations or other point mutations) or gene amplification.

Savolitinib in China under the brand name Volitinib^®Launched for the treatment of non-small cell lung cancer patients with MET exon 14 skipping mutations whose disease has progressed after receiving systemic therapy or who are unable to receive chemotherapy. Currently, savolitinib is being developed as a monotherapy or in combination with other drugs for the treatment of various tumor types, including lung cancer, renal cancer, and gastric cancer.