Amgen backed to advance treatment for potentially lethal lung cancer
The multinational biopharma company, which has operations on Cambridge Science Park, reveals that its solution tarlatamab (IMDYLLTRA®), has been granted a conditional marketing authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The approval is for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy – including platinum-based chemotherapy.
SCLC is an aggressive lung cancer subtype that accounts for approximately 15 per cent of lung cancers. ES-SCLC is characterised by rapid tumour growth and metastatic spread. Patients with SCLC are often diagnosed after the cancer has reached an advanced stage because symptoms do not typically appear early in the disease.
Tony Patrikios, Executive Medical Director, Amgen UK & Ireland, says: “The MHRA’s granting of a conditional marketing authorisation for tarlatamab is a significant step forward for people living with small cell lung cancer.
“More than 34,000 people die from lung cancer in the UK each year. There is a vital need for novel treatments, particularly for the extensive stage of small cell lung cancer, where outcomes are especially poor. This licence brings us one step closer to offering a new treatment option to eligible patients.”
The conditional marketing authorisation is based on results from the Phase 2 open label, multicentre study DeLLphi-301, which evaluated tarlatamab in patients with ES-SCLC who had failed two or more prior lines of treatment.
Results from the study found that tarlatamab at the 10 mg every two weeks (Q2W) dose (N=99) demonstrated an objective response rate (ORR) of 41 per cent (95 per cent Confidence Interval [CI]: 32 to 52) and a median duration of response (DoR) of 9.7 months (range: 5.9, not estimable [NE]).
IMDYLLTRA (tarlatamab) is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of tumour cells and CD3 expressed on the surface of T cells.
The bispecific binding of tarlatamab to T cells and DLL3-positive tumour cells triggers T-cell activation, production of inflammatory cytokines, release of cytotoxic proteins, which results in redirected lysis of tumour cells.
A biotech innovator since 1980, Amgen remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today.
In the UK, Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. As a regional hub, it employs around 650 people in the UK and Ireland across its commercial, R & D and corporate functions.