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