Trinity Delta SACHI details de-risk savolitinib potential approvals

SACHI details de-risk savolitinib potential approvals

Lighthouse | 5 June 2025

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Detailed interim data from the savolitinib Phase III SACHI study were presented at ASCO in a late-breaking oral presentation. At the data cut-off of 30 August 2024 in 211 patients, progression free survival (PFS) was significantly improved. The all-oral combination of savolitinib + osimertinib was well tolerated, no new safety signals were observed, and adverse events were manageable. The trial was stopped early for efficacy at the interim analysis, and an NDA was filed with the China NMPA in December 2024.
The SACHI trial, a randomised study conducted in China, investigated the combination of savolitinib + osimertinib vs chemotherapy for the treatment of locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification in patients who had progressed on first-line EGFR treatment. The investigator assessed PFS in the ITT (intent to treat) population ie patients who had received prior 1^st, 2^nd or 3^rd gen EGFR TKI treatment, was 8.2 months with savolitinib + osimertinib vs 4.5 months with chemotherapy, with a hazard ratio (HR) of 0.34 ie the risk of progression reduced by 66% (95% CI: 0.23-0.49, p<0.0001). On the more stringent IRC (independent review committee) assessment, PFS was 7.2 months vs 4.2 months (HR 0.40, 95% CI: 0.28-0.59, p<0.0001). The savolitinib combination also improved outcomes across key secondary endpoints (objective response rate, disease control rate, and median duration of response). Overall survival (OS) was not mature at the interim analysis, but an improvement was observed (data to be published); OS is not required for approval in China and we note the OS analysis will be confounded by the crossover element of the study.
In the predefined subgroup of patients that had received prior 3^rd gen EGFR TKI treatment ie osimertinib, the PFS benefit was consistent with the ITT population, with 6.9 months PFS vs 3.0 months (HR 0.32). This population is similar to the patients being recruited into the ongoing global Phase III SAFFRON study for ex-China regulatory approvals. Notably, this population is also representative of the real world setting as Tagrisso (osimertinib) is now the standard of care in 1L EGFRm+ NSCLC in the US and Europe. With the usual caveats of cross-trial comparisons, exacerbated by small patient numbers, the savolitinib combination of 6.9 months PFS appears numerically favourable in this population vs competitor amivantamab with 4.2 months.

Trinity Delta view: The highly positive data from the China Phase III SACHI study of savolitinib, with statistically significant PFS benefits and clinically meaningful improvements for 2L EGFRm NSCLC with MET amplification patients, reassure on the upcoming approval decision in China, and help to de-risk the ongoing Phase III SAFFRON study for global approvals, in our view. MET amplification, which is estimated to affect c 35% of 2L patients following 3rd gen EGFR treatment, leads to a poorer prognosis. However, this is underdiagnosed by liquid biopsies compared to tissue re-biopsy, highlighting that a biomarker specific treatment and a precision diagnostic is key. A companion diagnostic is part of partner AstraZeneca’s commercial plan, and this could be a key differentiator for savolitinib in patients with MET amplification. Our HUTCHMED valuation is $5.86bn/ £4.69bn/ HK$45.74bn, or $33.64/ADS or 538p/HK$52.48 per share.

Lighthouse

5 June 2025


Price (US ADS) (UK share) (SEHK share)	$15.30 218.0p HK$23.95
Market Cap	$2.67bn £1.90bn HK$20.88bn
Exchanges	NASDAQ AIM London SEHK
Sector	Healthcare
Company Codes	HCM HCM.L 0013.HK

Corporate client	Yes

Company description

HUTCHMED is a Hong Kong headquartered biopharma focused on discovering, developing and commercialising innovative targeted therapeutics and immunotherapies to treat cancer and immunological diseases for the China and global markets.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

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