HUTCHMED

ASH 2024: long-term data show sovleplenib benefit

Lighthouse | 9 December 2024

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  • HUTCHMED presented long-term safety and efficacy data on sovleplenib therapy in adult China patients with primary immune thrombocytopenia (ITP) at the American Society of Hematology (ASH) 2024 congress. These data, from a follow-on open label sub-study of the extension stage of the Phase III ESLIM-01 trial, demonstrated that long-term sovleplenib therapy effectively increased and maintained platelet count in the study population, and was well-tolerated with a consistent safety profile and no new safety signals.
  • 3% (99/179) of patients treated with at least one sovleplenib dose were still on study at the 31 January 2024 data cut off, with a median duration of exposure of 56.6 weeks. Median cumulative duration of platelet count ≥50×10⁹/L was 38.9 weeks. The ORR (overall response rate) in these patients was 81% (145/179), with a DRR (durable response rate) of 51.4%, and a long-term DRR of 59.8%. As reference, in the ESLIM-01 study the ORR was 70.6% and DRR was 48.4% at week 24.
  • Sovleplenib is currently under regulatory review by the China NMPA for adult 2L ITP. The NDA, supported by the positive results of the Phase III ESLIM-01 trial, was accepted in January 2024 and granted Priority Review. An approval decision is expected in 2025. Our June 2024 Update provides an overview of sovleplenib’s profile and the China opportunity.
  • In China, standard of care for adult ITP is corticosteroids, which are effective for around a third of patients, followed by TPO/TPO-RA (thrombopoietin/ thrombopoietin receptor agonists) in the 2L setting. However, with most patients ultimately becoming refractory to treatment, or lost to follow up, there is focus on new targeted therapies that could address this unmet need.
  • As ITP is a chronic disease, the long-term data at ASH 2024 showing maintenance of the ORR and DRR is highly relevant and continues to position sovleplenib as a potentially best-in-class Syk inhibitor vs Rigel’s first-in-class fostamatinib (approved as Tavalisse in the US, Europe, and Japan) which showed an 43% ORR and 18% DRR. Sovleplenib also appears to induce a more durable response than Sanofi’s BTK inhibitor rilzabrutinib (currently under US and EU regulatory review); LUNA3 Phase III data was also presented at ASH 2024 demonstrating a 65% ORR and 23% DRR.

Trinity Delta view: Sovleplenib is an important pipeline asset for HUTCHMED and one that is expected to make an important contribution to future growth. With a 2025 approval decision pending, launch planning is well advanced with a modest specialty immunology sales and marketing team supplementing the existing commercial infrastructure. Clinical data, including that recently presented at ASH 2024, confirm an attractive efficacy and safety profile, including longer-term, in a highly pre-treated patient group. Ex-China, an international Phase Ib bridging study is underway and regulatory discussions are ongoing regarding Phase III programme design, with a strategic partner sought for global development/commercialisation. Our current HUTCHMED valuation is $6.10bn/£5.09bn/HK$47.61bn, or $35.03/ADS and 584p/HK$54.64 per share.

Lighthouse

9 December 2024

Price (US ADS)
(UK share)
(SEHK share)
$17.06
265.7p
HK$26.90
Market Cap
 
$3.10bn
£2.27bn
HK$23.44bn
ExchangesNASDAQ
AIM London
SEHK
SectorHealthcare
Company CodesHCM
HCM.L
0013.HK
Corporate clientYes
Price (US ADS)
(UK share)
(SEHK share)
$18.48
292.0p
HK$28.80
Market Cap
 
$3.22bn
£2.54bn
HK$25.10bn
ExchangesNASDAQ
AIM London
SEHK
SectorHealthcare
Company CodesHCM
HCM.L
0013.HK
Corporate clientYes

Company description

HUTCHMED is a Hong Kong headquartered biopharma focused on discovering, developing and commercializing innovative targeted therapeutics and immunotherapies to treat cancer and autoimmune diseases. It has a diverse pipeline of first-in-class/best-in-class selective oral TKIs in development 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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