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Atezolizumab approved by MHRA for non-small cell lung cancer

Atezolizumab (Tecentriq) has been approved by the MHRA for use in England for the treatment of non-small cell lung cancer (NSCLC)

Atezolizumab (Tecentriq) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for patients with non-small cell lung cancer (NSCLC).

Around 85% of lung cancers in the UK are due to NSCLC and according to the World Health Organization, there were 2.21 million cases of lung cancer in 2020 and which resulted in 1.80 million deaths. Moreover, 5-year survival among those with NSCLC is poor, with data from England showing that only around 3 in 20 people survive to five years after their diagnosis.

Immunotherapy, which is a novel method of lung cancer treatment, uses monoclonal antibodies directed against immune-checkpoint molecules including the programmed cell death 1 (PD-1) receptor or its ligand (PD-L1).

In the UK, NICE has approved atezolizumab (Tecentriq) as an option for untreated metastatic NSCLC in adults if their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells and where tumours do not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

The MHRA has decided that atezolizumab (Tecentriq) can be used in whose have undergone surgery and chemotherapy as such patients are at risk of cancer relapse.

Atezolizumab (Tecentriq) clinical efficacy

Data on the effectiveness of atezolizumab comes from the IMpower010 clinical trial, a Phase III, global, multicentre, open-label, randomised study designed to compare the efficacy of atezolizumab treatment versus best supportive care in participants with Stage IB-Stage IIIA NSCLC following resection and adjuvant chemotherapy.

The trial recruited 1005 patients who were randomised to atezolizumab (n=507) or best supportive care (n=498). After a median follow-up of 32·2 months, atezolizumab treatment improved disease-free survival compared to best supportive care (hazard ratio, HR = 0·66, 95% CI 0·50–0·88, p=0·0039), i.e., the risk of recurrence, new primary NSCLC, or death with atezolizumab was reduced by 34% compared to best supportive care.

In a further trial, IMpower110, the efficacy of atezolizumab combined with cisplatin or carboplatin chemotherapy and with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in PD-L1-selected, chemotherapy-naïve participants with Stage IV non-squamous or squamous NSCLC. The published results showed that the median overall survival was 7.1 months longer in the atezolizumab group than in the chemotherapy group (20.2 months vs. 13.1 months).

According to the NHS, more than 850 patients in England are expected to be eligible for the drug in the first year and this is predicted to rise to more than 1000 in the third year. Amanda Pritchard, chief executive of NHS England, said, “The NHS has a strong track record of securing rapid access to cutting-edge, new treatments for our patients, and this is the latest rapid access agreement that places an innovative treatment in the hands of frontline NHS staff, supporting them to continue to deliver world-class patient care.”