Adjuvant atezolizumab extends DFS for broad range of patients with stage II-IIIA NSCLC
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Adjuvant atezolizumab improved DFS among patients with non-small cell lung cancer with nodal involvement, according to study results.
Researchers — who observed the benefit across most disease stages, surgery types and chemotherapy regimens — presented the findings from the exploratory analysis of the IMpower010 trial during International Association for the Study of Lung Cancer World Conference on Lung Cancer.
“Surgical resection followed by adjuvant chemotherapy is the standard of care for patients with stage II to stage III NSCLC. The topline results of the interim analyses of the IMpower010 trial presented during the 2021 virtual ASCO meeting showed the trial met its primary endpoint of significant DFS in patients with PD-L1-expressing stage II to stage III NSCLC,” Nasser K. Altorki, MD, chief of thoracic surgery at Weill Cornell Medicine, said during a presentation. “For this current presentation, we have explored prior use of therapies — including surgery type — and their potential impact on DFS outcomes in patients receiving adjuvant atezolizumab [Tecentriq, Genentech] or best supportive care.”
As Healio previously reported, the IMpower010 trial enrolled 1,280 patients with stage IB to stage IIIA NSCLC and an ECOG performance status of 0 to 1 who underwent complete resection 4 to 12 weeks prior to enrollment.
Investigators assigned 1,269 patients to up to four 21-day cycles of cisplatin-based chemotherapy with pemetrexed, docetaxel, gemcitabine or vinorelbine. They then randomly assigned 1,005 patients (median age, 62 years; 66.9% men) 1:1 to 1,200 mg atezolizumab every 3 weeks for 16 cycles or best supportive care.
“The main reasons [some] patients were not [randomly assigned] after enrollment were patient withdrawal and disease progression,” Altorki said.
Patients in the atezolizumab and best supportive care groups had similar disease stages and underwent similar types of surgery (lobectomy, 77.7% vs. 78.5%; pneumonectomy, 15.2% vs. 16.7%; bilobectomy, 6.1% vs. 3.8%), mediastinal nodal assessment (dissection, 79.3% vs. 82.1%; sampling, 18.3% vs. 17.7%) and cisplatin-based chemotherapy. Most patients in both treatment groups received the planned four cycles of chemotherapy.
Median time from surgery to first atezolizumab treatment in the intent-to-treat population was 5.2 months, and median time to best supportive care was 5.1 months.
Results showed atezolizumab outperformed best supportive care with regard to DFS for most disease stages, surgery types and chemotherapy regimens among patients with stage II to stage IIIA disease whose tumors had PD-L1 expression of at least 1% (median DFS, not evaluable vs. 35.3 months; HR = 0.66; 95% CI, 0.5-0.88).
Among all patients with stage II to stage IIIA disease, atezolizumab conferred significantly longer median DFS than best supportive care (42.3 months vs. 35.3 months; HR = 0.79; 95% CI, 0.64-0.96).
For the intent-to-treat population, the statistical significance boundary had not yet been crossed (median DFS, not evaluable vs. 37.2 months; HR = 0.81; 95% CI, 0.67-0.99).
“Patients who participated in the IMpower010 trial, including patients with nodal involvement, saw benefit across disease stages,” Altorki said.
Perspective
Back to TopThe arms of this study were well balanced. Therefore, the effect cannot be attributed to disease heterogeneity. In addition, most patients had lobectomy, lymph node dissection and four cycles of adjuvant chemotherapy; thus, the effect cannot be attributed to practice heterogeneity or choice of chemotherapy. Also important is the fact that median time to surgery was not affected by the additional immunotherapy treatment in the adjuvant setting, and this is very important to communicate to patients.
How do we strike a balance between neoadjuvant and adjuvant therapy? We need to keep in mind that, from the patient perspective, what really matters is determining the right therapy for them. Also, is DFS enough for regulatory approval of a treatment? This is a huge ongoing discussion in the adjuvant setting. We must keep our patients in mind here. Is it fair to wait for OS data, which takes a lot longer to read out in an adjuvant trial, when we are already seeing DFS benefits in the trial? Is it ethical to withhold treatments from patients while we wait for OS?
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Altorki NK, et al. Abstract PL02.05. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer (virtual meeting); Sept. 8-14, 2021.
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