FDA Grants Priority Review to Tecentriq for Adjuvant Treatment of Early NSCLC, Reducing Recurrence Risk by 34%

On August 3, 2021, Genentech, a member of the Roche Group, announced that the U.S. FDA granted Priority Review designation for the supplemental Biologics License Application (sBLA) of its blockbuster PD-L1 inhibitor Tecentriq (atezolizumab) as adjuvant treatment for patients with non-small cell lung cancer (NSCLC) following surgery and platinum-based chemotherapy. The press release noted that this marks the first cancer immunotherapy to achieve clinically meaningful positive results in a Phase 3 clinical trial for the adjuvant treatment of early-stage lung cancer.

This application is based on the positive interim analysis results from the global Phase III IMpower010 clinical trial. The trial enrolled a total of 1,005 patients and was designed to evaluate the efficacy and safety of Tecentriq compared with best supportive care (BSC) following surgical resection and up to four cycles of platinum-based chemotherapy in patients with stage IB–IIIA PD-L1–expressing non-small cell lung cancer (NSCLC).

Trial results demonstrated that, compared with BSC, Tecentriq reduced the risk of disease recurrence by 34% (HR=0.66, 95% CI: 0.50–0.88). At a median follow-up of 32.8 months, the median disease-free survival (DFS) in the Tecentriq group had not been reached, compared with 35.3 months in the BSC group. The safety data from the trial were consistent with the known safety profile of the drug, and no new safety signals were identified.

▲ Efficacy results of Tecentriq in patients with stage II-IIIA NSCLC and PD-L1-expressing tumors (Image source: Reference [2])

Non-small cell lung cancer accounts for approximately 80–85% of all lung cancers, and roughly half of patients with early-stage disease still experience cancer recurrence after surgery. Tecentriq is a monoclonal antibody that specifically binds to the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors, thereby reactivating immune T cells to kill tumor cells.

Note: The original text has been abridged.

References:

[1] FDA Grants Priority Review to Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-small Cell Lung Cancer. Retrieved August 3, 2021, from https://www.businesswire.com/news/home/20210802005854/en

[2] Roche Analyst Event Tuesday, 08 June 2021. Retrieved June 9, 2021, from https://www.roche.com/dam/jcr:abb117c0-b9aa-48a5-8d41-6d20002849b5/en/asco-annual-meeting-2021-presentation.pdf

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