FDA Grants Priority Review to Atezolizumab for the Treatment of Non–Small Cell Lung Cancer

Atezolizumab, which previously demonstrated positive results in the IMpower010 trial, was granted a priority review by the FDA for use in non–small cell lung cancer.

Atezolizumab (Tecentriq) has been granted priority review by the FDA for early non–small cell lung cancer (NSCLC), according to a press release from Genentech.1

The designation was based on the interim results of the phase 3 IMpower010 study (NCT02486718), which investigated the safety and efficacy of adjuvant atezolizumab compared with best supportive care following surgery or platinum-based chemotherapy. Results from the study indicated that the atezolizumab regimen reduced risk of disease recurrence or death by 34% (HR = 0.66; 95% CI, 0.50-0.88) in patients with stage II-IIIA NSCLC. At the interim analysis, the median DFS was had not yet reached for the atezolizumab group but was noted as being 35.3 months for the best supportive care group.

The study’s primary findings have since been presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.2 The updated results indicated that the median DFS for those treated atezolizumab in the overall patient population was 42.3 months (n = 442; 95% CI, 36.0–not evaluable), compared with 35.3 months for best supportive care (n = 440; 95% CI, 30.4- 46.4; HR, 0.79; 95% CI, 0.64-0.96; P = .02). The 2-year DFS rate in the overall patient population was 70.2% in the atezolizumab group versus 61.6% in best supportive care group. Moreover, the 3-year DFS rates were 55.7% and 49.4% for atezolizumab and best supportive care, respectively.

“Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible,” Levi Garraway, MD, PhD, chief medical officer and head of global and product development at Genetech, said in a press release.

A total of 1005 patients were randomized in a 1:1 fashion to receive either a 1200 mg dose of intravenous atezolizumab for 16 cycles for a total of 21 days each or best supportive care, consisting of cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed for 21-day cycles.

In order to be eligible for the trial, patients needed to have a PD-L1 tumor expression of 1% or more.

Additional findings from the data presented at ASCO indicated that in patients with stage IB-IIIA the statistical significance boundary for DFS was not crossed in both groups. In the intent to treat population, the median DFS was non-evaluable (NE) for those treated with atezolizumab (n = 507; 95% CI, 36.1-NE) compared with 37.2 months for the best supportive care arm (n = 498; 95% CI, 31.6-NE; HR, 0.81; 95% CI, 0.67-0.99; P = .04). The DFS rate after 2-years was 71.4% and 63.6% for atezolizumab and best supportive care groups, respectively. Moreover, the 3-year DFS was 57.9% for atezolizumab and 52.6% for the best supportive care.

In terms of safety, grade 5 treatment-related adverse effects occurred in 0.8% in the atezolizumab group and 0% in the best supportive care group. In the atezolizumab group, 18.2% of patients had withdrawn from treatment vs no patients in the best supportive care group.

“For the first time, we are seeing that an immunotherapy is effective when used to treat early-stage lung cancer. The IMpower010 trial demonstrates that, for certain patients, atezolizumab can delay progression to advanced disease, and perhaps even the need for more aggressive therapy. This could be an important advance in our understanding of immunotherapy and a step forward for many patients with lung cancer,” Julie R. Gralow, MD, FACP, FASCO, chief medical officer and executive vice president at ASCO concluded.

The study will continue to assess DFS in the intent-to-treat population, as well as overall survival which was immature at the interim analysis. The FDA is currently reviewing this application under the Real-Time Oncology Review pilot program and the target action date for approval is December 1, 2021.

References:

1. FDA grants priority review to Genentech’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer. News Release. August 3, 2021. Accessed August 3, 2021. https://bwnews.pr/3iiHG4E

2. Wakelee HA, Altorki NK, Zhou C, et al. IMpower010: Primary results of a phase III global study of atezolizumab versus 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