YL201/IMDELLTRA combination therapy could offer a novel, synergistic action against ES-SCLC. Credit: Sebastian Kaulitzki/ Shutterstock

Amgen and MediLink Therapeutics have agreed to a research and supply collaboration to develop a combination therapy for extensive-stage small cell lung cancer (ES-SCLC).

Suzhou, China-based biotech MediLink announced the agreement in a 7 October release. Amgen will orchestrate a global Phase I trial investigating a combined regimen of its DLL3-/CD3-targeting T cell engager Imdelltra (tarlatamab) with MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 in ES-SCLC.

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For the Phase I study, MediLink will supply YL201, an ADC that has already shown promise as a monotherapy for ES-SCLC. The drug targets the immune checkpoint protein B7-H3, overexpressed on malignant and cancer-initiated cells, to deliver MediLink’s tumour microenvironment activable LINker-payload (TMALIN)-based ADC.

Given the broad presence of B7-H3 expression in cancers, YL201 could have a wide application. At the European Society of Medical Oncology meeting (ESMO) 2024, MediLink announced data from a Phase I/II trial investigating the drug in advanced solid tumours including SCLC. It is currently being investigated in four Phase I and II studies (NCT06394414, NCT05434234, NCT06057922, NCT06241846), with a Phase III trial planned (NCT06612151) in relapsed SCLC.

Amgen’s Imdelltra has also demonstrated potential in this indication. Following an accelerated approval for treating ES-SCLC in May 2024, Imdelltra generated $12m, as per its Q2 earnings report. Annual revenue is expected to expand as the drug gains approval in other markets, and reach $1bn by 2030, as estimated by GlobalData. The drug acts by binding both DLL3, a protein highly expressed in SCLC cells, and CD3, expressed in T cells, to promote lysis of cancer cells by the immune system.

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ES-SCLC is a particularly aggressive carcinoma with a notably poor prognosis. It accounts for roughly two-thirds of SCLC cases, comprising around 15% of the 2.4 million new lung cancer cases worldwide each year. Current therapeutic options for SCLC include Merck & Co’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab), AstraZeneca’s Imfinzi (durvalumab), and Roche’s Tecentriq (atezolizumab).

MediLink is developing ADCs across several other cancer indications as well. In October 2023, it sold the developmental and commercialisation rights outside of China for its HER3-targeting ADC to BioNTech for $70m upfront in a deal including $1bn in milestone payments. In January 2024, the company partnered with Roche to develop YL211 in solid tumours, a deal worth a further $1bn. Earlier this year it presented positive safety data on YL202/BNT326 for NSCLC and breast cancer at the American Society of Clinical Oncology (ASCO) meeting 2024.