Pharmaceutical Technology

Amgen and MediLink to collaborate on SCLC combination therapy

The companies will collaborate to hold a global Phase I combination trial of YL201 and Amgen’s Imdelltra for small cell lung cancer.

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.

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.

GlobalData is the parent company of Pharmaceutical Technology.

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 2 023, 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.