Supporting oncology professionals through education
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The content on this site is intended for healthcare professionals only
The Food and Drug Administration approved atezolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 1% of tumour cells, as determined by an FDA-approved test.
Today, the FDA also approved the VENTANA PD-L1 (SP263) Assay as a companion diagnostic device to select patients with NSCLC for adjuvant treatment with atezolizumab.
Efficacy was demonstrated in a multi-center, randomised, open-label trial (IMpower010, NCT02486718) in patients with stage IB (tumours ≥ 4 cm) through stage IIIA NSCLC (per UICC/AJCC staging system, 7th edition).
A total of 1005 patients who had complete tumour resection and cisplatin-based adjuvant chemotherapy were randomised (1:1) to receive atezolizumab 1200 mg every 3 weeks for 16 cycles or best supportive care (BSC).
The major efficacy outcome measure was disease-free survival (DFS) as assessed by the investigator in the primary efficacy analysis population (n=476) of patients with stage II-IIIA NSCLC with PD-L1 expression on ≥1% of tumour cells (PD-L1 ≥1% TC). Median DFS was not reached (95% CI: 36.1, NE) in patients on the atezolizumab arm compared with 35.3 months (95% CI: 29.0, NE) on the BSC arm (HR 0.66; 95% CI: 0.50, 0.88; p=0.004).
In a pre-specified secondary subgroup analysis of patients with PD-L1 TC ≥ 50% stage II-IIIA NSCLC, the DFS HR was 0.43 (95% CI: 0.27, 0.68). In an exploratory subgroup analysis of patients with PD-L1 TC 1-49% stage II-IIIA NSCLC, the DFS HR was 0.87; (95% CI: 0.60, 1.26).
The most common (≥10%) adverse reactions in patients receiving atezolizumab, including laboratory abnormalities, were increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase; as well as hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.
The recommended atezolizumab dose for this indication is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year.
View full prescribing information for atezolizumab here.
Source: FDA
The World Cancer Declaration recognises that to make major reductions in premature deaths, innovative education and training opportunities for healthcare workers in all disciplines of cancer control need to improve significantly.
ecancer plays a critical part in improving access to education for medical professionals.
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