In May, the European Commission extended the use of atezolizumab and osimertinib in non-small cell lung cancer, following the evaluation of alterations in molecular biomarkers

On May 5, the European Commission approved the anti-PD-L1 monoclonal antibody atezolizumab (Tecentriq, Roche) for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression, with no EGFR activating mutations or ALK alterations.
This approval is based on the results of the phase 3 IMpower110 study, published on NEJM on October 2020.
This study showed that atezolizumab monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (20.2 versus 13.1 months) in patients with stage IV NSCLC and with high PD-L1 expression, but without alterations (SNP, In/Del, rearrangements) of EGFR and ALK genes.

An updated analysis of the study results was presented at the World Conference on Lung Cancer 2020, last January, which confirmed the superiority of atezolizumab over chemotherapy in patients with high PD-L1 expression. In fact, after a median follow-up of 31.3 months, median OS in the atezolizumab arm was the same as observed in the previous analysis (20.2 months); in the chemotherapy arm, median OS was 14.7 months. Median progression-free survival (PFS) also improved in the atezolizumab arm compared with chemotherapy arm: 8.2 versus 5 months. Moreover, in this updated analysis, the anti-PD-L1 inhibitor continued to demonstrate improvements versus chemotherapy in terms of response to treatment. The ORR was 40.2% and 28.6% in the atezolizumab arm and in the chemotherapy arm respectively, whereas the median DOR was 38.9 months vs 8.3 months respectively.
Finally, the immunotherapy improved the safety of therapy as well: the incidence of treatment-related grade 3-4 adverse events was 14.3% among patients treated with atezolizumab and 44.9% among patients treated with chemotherapy.
With this approval, atezolizumab has currently five approved indications in Europe for lung cancer: four in NSCLC, as a single agent or in combination with targeted therapies and/or chemotherapies, and one for first-line treatment of extensive-stage SCLC patients, in combination with carboplatin and etoposide.

On May 28, osimertinib (Tagrisso, Astra Zeneca), a third-generation EGFR tyrosine kinase inhibitor, was approved in the European Union for the adjuvant treatment of adult patients with early-stage non-small cell lung cancer (NSCLC), whose tumours have some EGFR mutations: exon 19 deletions or exon 21 L858R substitution.
The EC approval is based on positive results from the ADAURA phase 3 trial, published on NEJM on October 2020 as well.
In the overall trial population of patients with stage IB-IIIA NSCLC and with EGFR ex19del or EGFR L858R mutations, adjuvant treatment with osimertinib reduced the risk of disease recurrence or death by 80% compared with placebo. Also, a statistically significant and clinically meaningful improvement in disease free survival (DFS) was observed for osimertinib in the same patients.
The safety and tolerability of osimertinib in this trial was consistent with previous trials in the metastatic setting.
Osimertinib was already approved in EU for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Finally, always in May, the European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended the approval of cemiplimab (Libtayo, Regeneron Ireland) for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in >50% of tumour cells, with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. Cemiplimab was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).

The new approvals and recommendations about atezolizumab, osimertinib and cemiplimab confirm and reinforce the central role of assessing specific biomarkers for therapies based on molecular targeted drugs.

Diatech Pharmacogenetics offers complete solutions for the analysis of EGFR mutations and fusion genes in NSCLC, based on Real Time RT-PCR and NGS.

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  1. Roche Press Release, 5 May 2021. Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer.
  2. Herbst RS, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. N Engl J Med 2020:383:1328–39
  3. Herbst RS, et al. IMpower110: updated OS analysis of atezolizumab vs platinum-based chemotherapy as first-line treatment in PD-L1–selected NSCLC [WCLC 2020 Poster FP13.03].
  4. AstraZeneca Press Release, 28 May 2021. Tagrisso approved in the EU for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer.
  5. Wu YL, et al; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723.
  6. Regeneron Press Release, 24 May 2021. Libtayo® (cemiplimab) Receives Positive CHMP Opinion for the Treatment in Europe of Two Advanced Cancers