FDA Grants Priority Review to Atezolizumab as First-Line Monotherapy for Advanced Non-Small Cell Lung Cancer

The FDA has accepted Genentech’s supplemental biologics license application (sBLA) and granted priority review for atezolizumab (Tecentriq) as a first-line monotherapy for some patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC).

The FDA has accepted Genentech’s supplemental biologics license application (sBLA) and granted priority review for atezolizumab (Tecentriq) as a first-line monotherapy for patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations and with high programmed death-ligand 1 (PD-L1) expression.

The American Cancer Society estimates that more than 228,000 people will be diagnosed with lung cancer in the United States in 2020, and NSCLC accounts for 80%-85% of all lung cancers. Furthermore, it is estimated that 85% of lung cancer diagnoses are made when the disease is already in advanced stages, creating a need for stronger treatment options.

Atezolizumab is a monoclonal antibody designed to bind with PD-L1 proteins expressed on tumor cells and tumor-infiltration immune cells, blocking its interactions with both PD-1 and B7.1 receptors. Through this mechanism, the treatment may enable the reactivation of T cells, according to Genentech.

Atezolizumab’s safety and efficacy was evaluated in the Impower110 study, a phase 3, randomized, open-label study, which compared the atezolizumab monotherapy with cisplatin or carboplatin and pemetrexed or gemcitabine. Participants were PD-L1-selected, chemotherapy-naïve with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations.

The 572 enrolled participants were randomized 1:1 to receive either:

  • Atezolizumab monotherapy until loss of clinical benefit, unacceptable toxicity, or death.
  • Cisplatin or carboplatin combined with either pemetrexed or gemcitabine, followed by maintenance therapy with pemetrexed alone or best supportive care until disease progression, unacceptable toxicity, or death.

The primary efficacy endpoint is overall survival (OS) by PD-L1 subgroup. Key secondary endpoints include progression-free survival as assessed by an investigator, objective response rate, and duration of response.

According to data presented at the ESMO Congress 2019, the interim analysis of OS showed an improvement with atezolizumab by 7.1 months compared with chemotherapy alone in patients with high PD-L1 expression. OS data did not meet statistical significance in patients with medium levels of PD-L1 expression.

Safety findings for atezolizumab were consistent with its known safety profile, and no new safety signals were identified. During the trial, 12.9% of patients receiving atezolizumab reported grade 3-4 treatment-related adverse events, compared with 44.1% of patients receiving chemotherapy.

The FDA is expected to announce its approval decision by June 19, 2020.

REFERENCE

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-Line Treatment of Certain People With Advanced Non-Small Cell Lung Cancer [news release]. San Francisco, CA; February 18, 2020. Genentech website; https://www.gene.com/media/press-releases/14838/2020-02-18/fda-grants-priority-review-to-genentechs. Accessed February 19, 2020.