FDA OKs Atezolizumab for First-Line Treatment of PD-L1 High NSCLC


Atezolizumab demonstrated a significant overall survival benefit in individuals with high PD-L1 expression compared with chemotherapy.


The FDA has approved atezolizumab (Tecentriq, Roche) as an initial treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression or PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumor area with no EGFR or ALK genomic tumor aberrations, according to a press release. 

Globally, lung cancer is the leading cause of death, claiming 1.76 million lives each year. NSCLC is the most prevalent type of lung cancer, comprising approximately 85% of all lung cancer cases, according to Roche.

Atezolizumab is a monoclonal antibody that binds with and inhibits the PD-L1 protein, which is expressed on tumor cells and tumor-infiltrating immune cells, which may result in the activation of T-cells. The drug also has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines, and chemotherapies throughout a wide range of cancer types.

The approval marked atezolizumab’s fourth indication in metastatic NSCLC and fifth indication in lung cancer overall in the United States.

The FDA’s approval was based on the phase 3, randomized, open-label IMpower110 study, which evaluated the efficacy of atezolizumab monotherapy compared to cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in 572 PD-L1-selected, chemotherapy-naïve patients with stage 4 non-squamous or squamous NSCLC.

Participants were randomized to receive either atezolizumab monotherapy until disease progression, loss of clinical benefit as determined by the investigator, unacceptable toxicity or death; or cisplatin or carboplatin combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until progression of the disease, unacceptable toxicity, or death.

Results from the interim analysis showed that atezolizumab monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.20 versus 13.10 months; hazard ratio [HR]=0.59, 95% CI: 0.40-0.89; p=0.0106) in patients with high PD-L1 expression.

According to the study, grade 3 to 4 treatment-related adverse events (AEs) were reported in 12.9% of participants being treated with atezolizumab, as opposed to 44.1% in individuals who received chemotherapy.

“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development. “Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”

In the news release, Roche said that they intend to continue to pursue multiple ongoing and planned phase 3 studies of atezolizumab for treatment of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers, alone and in combination with other treatments.


1. FDA approves Roche’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer. News Release. Roche; May 19, 2020. Accessed May 19, 2020. https://www.roche.com/media/releases/med-cor-2020-05-19.htm

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