medwireNews: Adjuvant treatment with atezolizumab is associated with a trend toward improved overall survival (OS) relative to best supportive care (BSC) in people with resected stage II–IIIA non-small-cell lung cancer (NSCLC) positive for PD-L1, indicate IMpower010 results.
There was no such OS benefit with use of the PD-L1 inhibitor among all randomized participants with stage II–IIIA disease nor in the intention-to-treat (ITT) population, which additionally included patients with stage IA disease, reported Enriqueta Felip (Vall d'Hebron University Hospital, Barcelona, Spain) at the IASLC World Conference on Lung Cancer 2022 in Vienna, Austria.
Nevertheless, she believes that “these data support the previously reported positive benefit–risk profile of adjuvant atezolizumab in PD-L1-positive non-small-cell lung cancer.”
The first interim analysis of the phase 3 trial at a median follow-up of 32 months showed a significant disease-free survival (DFS) benefit with adjuvant atezolizumab versus BSC in patients with stage II–IIIA disease and tumoral PD-L1 expression of at least 1% as well as in all stage II–IIIA patients. These findings led to the approval of atezolizumab in the adjuvant setting in USA, Europe, and other countries, said Felip.
For the current presentation she focused on a prespecified interim analysis for OS, conducted at a median follow-up of 45–46 months.
Among the 476 patients with PD-L1-positive (tumor cell expression ≥1%), stage II–IIIA NSCLC, the hazard ratio (HR) for death of 0.71 favored adjuvant treatment with atezolizumab 1200 mg every 3 weeks for up to a year over BSC, albeit with only a trend toward statistical significance.
The median OS was unreached in both the atezolizumab and BSC groups, and the respective 36-month OS rates were 82.1% and 78.9%, while the rates at 60 months were 76.8% and 67.5%.
In all stage II–IIIA patients (n=882), the HR for the comparison of atezolizumab and BSC was a nonsignificant 0.950 and it was a nonsignificant 0.995 in the ITT population (n=1005).
Turning to the safety data, Felip said that “[a]fter an additional 13 months of follow-up, the safety profile remains broadly unchanged, with no new or unexpected safety signals, and is consistent with the known safety profile of atezolizumab.”
Treatment-related adverse events (TRAEs) of grade 3 or 4 were experienced by 10.7% of atezolizumab-treated patients and none of those given BSC, while TRAEs of grade 5 occurred in 0.8% and 0.0%, respectively.
A total of 18.2% of patients in the atezolizumab group discontinued treatment due to AEs compared with none of those in the BSC group.
“IMpower010 will continue to the final DFS analysis, with further OS follow-up and analyses,” concluded Felip.
Benjamin Besse, from Gustave Roussy in Villejuif, France, who discussed the presentation, said that “we have enough evidence to use adjuvant immunotherapy in stage II and IIIA resected NSCLC.”
But he urged caution with respect to subgroup data from trials, highlighting that these should just be used to generate hypotheses.
Finally, Besse said that he hopes that “in academia we will be able to do de-escalation trials with these very expensive drugs.”
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IASLC World Conference on Lung Cancer 2022; Vienna, Austria: 6–9 August