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FDA Approves Atezolizumab for Non–Small Cell Lung Cancer

Non–small cell lung cancer.

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech) for the adjuvant treatment of patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have a programmed death ligand 1 (PD-L1) expression on ≥1% of tumor cells. Atezolizumab is approved for use following resection and platinum-based chemotherapy in this patient population.

The FDA has also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems), a diagnostic device that will select patients with NSCLC for adjuvant treatment with atezolizumab.

"Novel adjuvant strategies are needed to optimize outcomes after complete surgical resection in patients with early-stage NSCLC," wrote Enriqueta Felip, MD, Head of the Lung Cancer Unit in the Oncology Department at the Vall D'Hebron University Hospital in Barcelona, Spain, and colleagues, in the published results of the IMpower010 clinical trial (NCT02486718), on which the approval was based. "We aimed to evaluate adjuvant atezolizumab versus best supportive care after adjuvant platinum-based chemotherapy in these patients."

A total of 1,280 patients with completely resected stage IB to IIA NSCLC enrolled in this multicenter, open-label, phase 3 trial. Patients were randomized 1:1 to receive either 1,200 mg atezolizumab every 21 days for 16 cycles or one year, or best supportive care (observation and regular scans for disease recurrence) after one to four cycles of platinum-based adjuvant chemotherapy. The primary end point was investigator-assessed disease-free survival. The patient population used to measure this primary end point included 476 patients who had a PD-L1 expression of ≥1%.

Median disease-free survival was not reached in the atezolizumab treatment arm, compared with 35.3 months in the best supportive care arm. In a subgroup of patients with PD-L1 expression of ≥50%, atezolizumab produced a disease-free survival hazard ratio of 0.43. Among patients with PD-L1 expression between 1% and 49%, the disease-free hazard ratio was 0.87.

The most common adverse reactions and laboratory abnormalities occurring in at least 10% of patients receiving atezolizumab were increased aspartate aminotransferase, increased blood creatinine, increased alanine aminotransferase, hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.

"IMpower010 showed a disease-free survival benefit with atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage II–IIIA NSCLC, with pronounced benefit in the subgroup whose tumors expressed PD-L1 on 1% or more of tumor cells, and no new safety signals," concluded Dr. Felip and colleagues in their September 2021 publication in The Lancet. "Atezolizumab after adjuvant chemotherapy offers a promising treatment option for patients with resected early-stage NSCLC."

The recommended dose of atezolizumab is 840 mg every two weeks, 1,200 mg every three weeks, or 1,680 mg every four weeks for up to one year.

For More Information

Felip E, Altorki N, Zhou C, et al (2021). Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB–IIIA non-small cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet, 398(10308):1344-1357. DOI:10.1016/S0140-6736(21)02098-5

Clinicaltrials.gov (2021). Study to assess safety and efficacy of atezolizumab (MPDL3280A) compared to best supportive care following chemotherapy in patients with lung cancer (IMpower010). NLM identifier: NCT02486718.

Tecentriq® (atezolizumab) prescribing information (2021). Genentech. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s042lbl.pdf

US Food & Drug Administration (2021). FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-non-small-cell-lung-cancer

Image credit: Librepath. Licensed under CC BY-SA 3.0


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