VENTANA PD-L1 Assay Granted Approval by the FDA as a Companion Diagnostic for Atezolizumab in Select NSCLC Population

The VENTANA PD-L1 Assay, a companion diagnostic for atezolizumab in select patients with non–small cell lung cancer, was approved by the FDA based on the phase 3 Impower010 trial.

The VENTANA PD-L1 (SP263) Assay has been approved by the FDA as a companion diagnostic test to determine eligibility for treatment with atezolizumab (Tecentriq) in patients with non–small cell lung cancer (NSCLC), according to a press release from developer Roche.1

The assay was assessed as part of the phase 3 IMpower010 (NCT02486718) and was utilized to identify patients whose tumors expressed levels of PD-L1.

“Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options,” Thomas Schinecker, chief executive officer at Roche Diagnostics, said in a press release. “We are proud to offer a companion diagnostic PD-L1 test that identifies [patients with lung cancer] who may qualify for Tecentriq therapy. With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment.”

The IMpower010 trial, results of which led to the FDA approval of atezolizumab in patients with stage II to IIIA NSCLC who have undergone resection and platinum-based therapy, selected eligible patients based on PD-L1 status as determined by the VENTANA PD-L1 Assay.2

To be eligible for treatment on the trial, patients needed have completely resected stage IB to IIIA disease, and stage IB tumors needed to be a minimum of 4 cm. An ECOG performance status of 0 or 1 was also required.

A total of 1280 patients received 1 to 4 cycles of treatment with cisplatin with the addition of pemetrexed, gemcitabine, docetaxel, or vinorelbine and were subsequently randomized 1:1 to receive either 1200 mg of atezolizumab ever 21 days for 16 cycles (n = 1005) or best supportive care (n = 1005).

The study’s primary end points were investigator-assessed disease-free survival (DFS) and PD-L1 expression of at least 1%, as identified by the experimental assay. Additionally, key secondary end points included overall survival (OS) in the intent-to-treat population and DFS in patients whose tumors were considered to be PD-L1 high.

Findings from the IMpower010 study, which were presented at the 2021 American Society of Clinical Oncology Annual Meeting,3 highlighted a median DFS of 42.3 months in the atezolizumab arm (n = 422; 95% CI, 36.0–not evaluable) compared with 35.3 months in the best supportive care arm (n = 440; 95% CI, 30.4-46.4; HR, 0.79; 95% CI, 0.64-0.96; P = .02). Additionally, investigators observed a 2-year DFS rate of 70.2% in those who received atezolizumab vs 61.6% in those who received best supportive care. The 3-year DFS rates were 55.7% and 49.4% in both arms, respectively.

In terms of safety, any-grade adverse effects (AEs) were reported in 92.7% and 70.7% of patients in the atezolizumab and best supportive care groups, respectively. Moreover, grade 3/4 AEs were reported in 21.8% and 11.5% of patients, respectively. Grade 5 treatment-related AEs were reported in 0.8% of those in the atezolizumab group and no patients in the best supportive care group.


  1. Roche’s VENTANA PD-L1 (SP263) ssay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab). News release. Roche. October 22, 2021. Accessed October 22, 2021.
  2. FDA approves atezolizumab as adjuvant treatment for non–small cell lung cancer. News Release. FDA. October 15, 2021. Accessed October 22, 2021.
  3. 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