FDA approves aezolizumab for adjuvant treatment of stage II-IIIA NSCLC
The FDA has approved aitzolizumab for the treatment of stage II to IIIA non-small cell lung cancer after resection and platinum-based chemotherapy.
The FDA has approved aezolizumab (Tecentriq) as a treatment for patients with stage II to IIIA non-small cell lung cancer (NSCLC) after resection and platinum-based therapy in patients with tumor expression of PD-L1 of 1% or greater, as determined by an FDA-approved test.
This decision was based on the results of the Phase 3 IMpowere010 trial (NCT02486718) which compared adjuvant arezolizumab with best supportive care in patients with stage IB to IIIA NSCLC after resection and adjuvant chemotherapy.1
Out of a total of 476 patients in the efficacy analysis with stage II to IIIA disease, the median disease-free survival (DFS) was not reached (95% CI, 36.1 – not evaluable [NE]) in the atezolizumab arm versus 35.3 months (95% CI, 29.0-NE) in the best supportive care arm (RR: 0.66; 95% CI: 0.50-0, 88; P = .004).
The recommended 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, according to the FDA.
In an interim analysis reported to the 2021 American Society of Clinical Oncology (ASCO), the rate of MSS at 2 years in the indicated population was 70.2% in the atezolizumab group and 61.6% in the best supportive care group. In addition, the 3-year MSS rates were 55.7% and 49.4%, respectively.2
This was a randomized (1: 1) trial with a total of 1005 patients who underwent complete tumor resection and cisplatin-based chemotherapy receiving either 1200 mg aezolizumab every 3 weeks for 16 cycles or better supportive care 3
The results for patients with stage IB to IIIA disease showed that the statistically significant limit of MSS was not crossed in any of the treatment groups. The SSM was NE (95% CI, 36.1-NE) in 507 patients in the atezolizumab arm versus a median of 37.2 months (95% CI, 31.6-NE) in 498 patients treated in the best supportive care arm (RR: 0.81; 95% CI: 0.67-0.99; P = .04). In this group, the rate of MSS was 71.4% in the atezolizumab arm and 63.6% in the best supportive care arm after 2 years. At 3 years, the MSS rates were 57.9% and 52.6% in the atezolizumab and best supportive care arms, respectively.
Treatment-related Grade 5 adverse reactions occurred in 0.8% of patients in the atezolizumab arm and 0% in the best supportive care arm. In addition, 18.2% of patients in the atezolizumab arm withdrew from treatment compared to no patient in the best supportive care group.
Previously, azolizumab has been given priority review by the FDA for this indication in August 2021.
The FDA has also approved the VENTANA PD-L1 (SP263) assay as a companion diagnostic to help select patients with NSCLC for adjuvant therapy with arezolizumab.
- The FDA approves aezolizumab as an adjunct treatment for non-small cell lung cancer. Press release. FDA. October 15, 2021. Accessed October 15, 2021. https://bit.ly/2YVmSss
- The FDA is giving Genentech’s Tecentriq priority review as an adjuvant therapy for certain people with early-onset non-small cell lung cancer. Press release. Genentech, member of the Roche group. August 3, 2021. Accessed October 15, 2021. https://bwnews.pr/3iiHG4E
- Wakelee HA, Altorki NK, Zhou C, et al. IMpower010: Main results of a global phase III study comparing aezolizumab with best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). J Clin Oncol. 2021; 39 (suppl 15): 8500. doi: 10.1200 / JCO.2021.39.15_suppl.8500