Trinity Delta SANET-p trial stopped early for efficacy

SANET-p trial stopped early for efficacy

Lighthouse | 21 January 2020

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Chi-Med has announced that the China Phase III SANET-p study of surufatinib in advanced pancreatic neuroendocrine tumours (NET) has been stopped early as it has already met its primary endpoint of progression free survival (PFS) at the planned interim stage analysis.
The Independent Data Monitoring Committee (IDMC) determined that the trial has already met the pre-defined primary endpoint and so the study result is viewed as achieved. Full data will be presented at a future scientific conference.
Chi-Med intends to schedule a pre-NDA (New Drug Application) with the NMPA (China National Medical Products Administration) to discuss the process for the NDA submission. On the basis that the surufatinib NDA for extra-pancreatic NET (ep-NET) was accepted for review in November 2019, following a similar early stop of the pivotal SANET-ep study in June 2019, we expect the NDA for pancreatic NET (p-NET) to be submitted around mid-2020.
To recap, surufatinib in the Phase III SANET-ep study was also stopped early at the interim analysis, and data from the trial was presented at ESMO 2019 (see October 2019 Update). The investigator assessed PFS in SANET-ep was 9.2 months for surufatinib vs 3.8 months for placebo (p<0.0001), with encouraging broad utility across epNET subtypes.
For the second time, an impressive outcome for a surufatinib registration study means that our forecast timelines for approval and marketing will be accelerated, this time in pNET. Consequently, we will review our model, and valuation, but a rough assessment suggests a benefit of c 12 months compared to our previous expectations.

Trinity Delta view: The positive result from the SANET-p study suggests that not only could an approval for a second indication follow in close succession, but that surufatinib could be uniquely positioned as a targeted therapy that can effectively treat a broad spectrum of advanced NET types.

Acceptance of the China NDA filing for surufatinib in epNET and the grant of Priority Review status in Q419 means that it is on track for potential first approval in late-2020. Surufatinib will be the first approved and marketed product where Chi-Med holds worldwide rights, and it would be launched and commercialised through its own China Oncology commercial organisation. Chi-Med recently initiated a China Phase II trial evaluating surufatinib in combination with PD-1 inhibitor Tuoyi, and has global plans for surufatinib monotherapy with a US/Europe Phase III registration study in NET planned to initiate in H120.

We currently value Chi-Med at $5.14bn ($38.55/ADS) or £3.95bn (£5.93/share), although our assumptions for surufatinib in p-NET will be reviewed following the positive outcome of the SANET-p trial.

Lighthouse

21 January 2020


Price (US ADS) (UK share)	$29.41 444p
Market Cap	$3.92bn £2.96bn
Exchanges	NASDAQ AIM London
Sector	Healthcare
Company Codes	HCM HCM.L

Corporate client	Yes

Company description

Hutchison China MediTech is a Hong Kong headquartered biopharma focused on discovering, developing and commercializing innovative targeted therapeutics and immunotherapies for the treatment of cancer and autoimmune diseases. It has a diverse pipeline of first-in-class/best-in-class selective oral tyrosine kinase inhibitors in development for the China and global markets.

Analysts

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

Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041

Mick Cooper
mcooper@trinitydelta.org
+44 (0) 20 3637 5041

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