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Pivotal trial data for EP0031 (A400), a next-generation Selective RET Inhibitor (SRI), in RET positive advanced NSCLC, to be presented at ASCO 2026

May 22, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – ASCO 2026, Ellipses Pharma, Kelun Biotech, clinical trials, non-small cell lung cancer, oncology

22 May 2026 — London, UK — Ellipses Pharma, a global oncology drug development company with a pipeline of innovative programmes, announced today that its partner, Kelun-Biotech, is presenting pivotal trial data for EP0031/A400, for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC), at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting Chicago, May 29 to June 2.

Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET-fusion positive non-small cell lung cancer (NSCLC), will be presented as an oral presentation scheduled on May 29, 2026, 14:36-14:48 local time (Abstract #8505: Lung Cancer – Non-Small Cell Metastatic).

The oral presentation of these data at the prestigious ASCO annual meeting, represents another major milestone in the global development of EP0031/A400 as a next generation SRI.

The data were generated in Kelun-Biotech’s Phase 2 study (NCT05265091) that evaluated the efficacy and safety of EP0031/A400 90mg orally once daily (QD) in patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic, NSCLC. EP0031/A400 demonstrated robust efficacy in both cohorts and an encouraging, manageable tolerability and safety profile. In September 2025 Kelun-Biotech submitted an NDA for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) which was accepted for review by the NMPA of China.

EP0031/A400 is being developed jointly by Ellipses and Kelun-Biotech. Ellipses has been granted an exclusive licence to develop, manufacture and commercialise this agent outside Greater China and certain Asian countries under the code EP0031.

Ellipses has an ongoing Phase 1/2 trial in US, EU, UK and UAE (EP0031-101 NCT05443126). Phase 2 cohorts are currently evaluating the combination of EP0031/A400 with platinum doublet chemotherapy in patients with RET-fusion positive NSCLC that are naïve to or have previously received 1st generation SRI. Data supporting the strong preclinical rationale for this combination strategy were recently presented at the annual European Lung Cancer Congress 2026 (ESMO Open Volume 11, Suppl 3, https://www.sciencedirect.com/science/article/pii/S2059702926007490).

Professor Sir Christopher Evans, Chairman, Ellipses Pharma, commented: “We congratulate our partners Kelun-Biotech on the tremendous progress they have made with the development of EP0031/A400 in China. The presentation of these exciting data from the pivotal trial represents a significant step in the development of this agent for patients globally. Ellipses is immensely proud to be partnering with Kelun-Biotech and continues to make significant progress with the development of EP0031/A400 for patients outside Greater China.”

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma, commented: “Congratulations to our colleagues at Kelun-Biotech on the acceptance of these data for oral presentation at ASCO. These data further establish the credentials of EP0031/A400 as a promising next-generation SRI. We look forward to continuing to build our data in the Ellipses trial to ensure EP0031/A400 is brought to Western patients as early as possible.”

About Ellipses Pharma
Ellipses is a global clinical-stage drug development company focused on progressing first- or best-in-class oncology drugs. Ellipses has a strong pipeline of first-in-class assets, including three programmes in Phase 2 clinical development and two additional programmes which are anticipated to enter Phase 1 shortly. Ellipses is supported by a global Scientific Advisory Group comprising over 300 leading Oncology Key Opinion Leaders to providing critical insights into clinical trial design. Visit: ellipses.life.

About Kelun-Biotech
Kelun-Biotec is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialisation and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumours, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the company has more than 30 ongoing innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit  kelun-biotech.com.