CE label expansion has been given to the VENTANA PD-L1 assay for patients with non-small cell lung cancer as a companion diagnostic for atezolizumab.
Based on the results of the phase 3 IMpower010 study, the VENTANA PD-L1 (SP263) assay has gained CE label expansion as a companion diagnostic (CDx) for atezolizumab (Tecentriq) in non-small cell lung cancer (NSCLC), according to Roche.1
The VENTANA PD-L1 assay works to determine the patients with NSCLC who may derive benefit from treatment with atezolizumab immunotherapy with the hope of reducing their risk of disease recurrence or death by more than half.
Previously, atezolizumab was approved on October 15, 2021, for patients with PD-L1-positive NSCLC as adjuvant treatment following surgery and platinum-based chemotherapy. With this new label expansion, Roche can strengthen the portfolio of this CDx and further work to improve personalized healthcare for better patient outcomes.
"With early detection of lung cancer, it is possible to give patients more treatment options and potentially improve a patient's outcome," said Jill German, head of pathology lab at Roche Diagnostics, in the press release. "We are proud to offer a PD-L1 test that may qualify lung cancer patients for Tecentriq therapy. With this latest expansion, clinicians can consider multiple targeted immunotherapy options with one test to quickly determine the right treatment for each patient."
Currently, the standard-of-care for patients with early-stage lung cancer is to remove the tumor and often followed by chemotherapy. Still, nearly half of these patients end up having their cancer return after completion of surgery.
The VENTANA PD-L1 assay was used in the Impower010 study (NCT02486718), which provided the data used as the basis of atezolizumab’s approval in patients with PD-L1-positive NSCLC. The study included 1280 patients with stage IB to IIIA tumors that were 4 cm or greater who had an ECOG performance status of 0 or 1. Patients also were required to have undergone a lobectomy and have tumor tissue available for PD-L1 analysis.2
All patients received 4, 21-day cycles of cisplatin-based chemotherapy, until unacceptable toxicity, disease relapse, or the patient decided to discontinue treatment. Once the 4 cycles were completed, patients were randomized into 1 of 2 arms. In the experimental arm, patients received atezolizumab at a dose of 1200 mg every 3 weeks for 16, 21-day cycles with periodic chest x-rays performed. In the control arm, patients were given best supportive care also with periodic chest X-rays.
The primary end point of the study is disease-free survival (DFS) with secondary end points including overall survival (OS), percentage of patients disease-free at 5 years, percentage of patients who experience and adverse event, the percentage of patients with anti-therapeutic antibodies to the study drug, maximum plasma concentration, and minimum serum concentration.
Findings presented at the 2022 World Conference on Lung Cancer showed a trend toward improved OS vs best supportive care in patients with resected NSCLC. The OS benefit was also impacted by PD-L1 expression levels.3
At a median follow-up of 46 months, the median OS in patients with PD-L1 expression of 1% or more was not reached in the atezolizumab group (n = 248) or best supportive care group (n = 228; HR, 0.71; 95% CI, 0.49-1.03). At 36 months and 60 months, the OS rates were 82.1% and 76.8% in the atezolizumab group vs 78.9% and 67.5% in the best supportive care group, respectively.
In all randomized patients, the median OS was not reached in the atezolizumab (n = 442) and best supportive care groups (n = 440; HR, 0.95; 95% CI, 0.74-1.24). OS events occurred in 26.0% and 26.4% of patients in each respective group. Moreover, the median OS was also not reached in the intent-to-treat (ITT) population, the atezolizumab (n = 507), or best supportive care (n = 498) cohorts (HR, 0.995; 95% CI, 0.78-1.28; P = .9661). OS events were reported in 25.0% and 24.9% of patients in each group, respectively.
In regard to safety, there were no new safety signals associated with atezolizumab. In the experimental arm, 92.5% of patients experienced adverse events (AE) vs 70.9% of patients in the control arm. Grade 3/4 AEs were observed in 21.8% of those in the experimental arm and 11.5% in the control arm, and serious AEs were reported in 17.6% of patients. Additionally, 0.8% of patients in the experimental arm had grade 5 treatment-related Aes, and AEs led to treatment discontinuation in 18.2% of patients treated with atezolizumab.