With another day spent amid loads of abstracts and sessions, here is another dose of important ones from Lung Cancer.
Abstract #8500: A first Phase III study of any immuno-oncology therapy to show disease-free survival (DFS) in Adjuvant NSCLC setting, predominantly in the PD-L1-positive population: IMpower010 Study
According to the interim findings of this global phase III study, adjuvant Tecentriq (atezolizumab) exhibited a statistically significant DFS in stage II to IIIA NSCLC patients, especially those with PD-L1–positive tumors, as compared to ideal supportive therapy. With a hazard ratio (HR) of 0.79, Tecentriq had a DFS efficacy of 42.3 months in Stage II–IIIA compared to 35.3 months with best supportive care (BSC). The median DFS with Tecentriq was not attained in the PD-L1 tumor cells (TC) higher than or equal to 1% group, compared to 35.3 months with BSC. Overall survival (OS) data, according to Roche, at the time of evaluation was immature and has not been fully evaluated, however a trend towards the OS improvement seen in PD-L1 tumor cells (TC) ≥1% Stage II-IIIA population. In patients with PD-L1 ≥1%, the Hazard ratio (HR) [95% confidence intervals (CI)] was 0.66 (n=476), which indicates a 34% reduction in risk and disease recurrence. In PD-L1 <1% patients, Tecentriq did not show any benefit [HR=0.97 (95% CI)]. In Stage IB-IIIA, the findings showed a stratified HR of 0.81. Tecentriq’s safety profile was consistent with previous Tecentriq monotherapy experience across indications and lines of treatment. In this study, in the Tecentriq arm, any cause of adverse events (AEs) were reported in 97.2% Atezolizumab arm vs. 70.7% in BSC. Grade 3/4 occurrences were reported in 21.8% and 11.5%. Treatment-related adverse events (AEs) of grade 5 occurred in 0.8% of patients in the Tecentriq arm. Additionally, Immune-mediated AEs were higher in the Tecentriq arm (~51.7% vs. 9.5%). The results of this Phase III trial in the adjuvant context are clinically significant as there is a great unmet need in the early lung cancer setting. Roche will continue with the planned follow-up DFS analysis in the overall intent-to-treat (ITT) group, which did not cross the threshold at the time of analysis.
Expert Views:
Despite the Phase III IMpower010 achieving its major outcome, most experts believe that the acceptability of Roche's Tecentriq as an adjuvant treatment in NSCLC is doubtful or might be slow, as was the case with AstraZeneca's EGFR inhibitor Tagrisso in the adjuvant setting. Even though the drug has been authorized by the FDA as an adjuvant treatment for particular EGFR mutations, the cancer community has been slow to adopt it as the standard of care due to the lack of a significant survival advantage.
Have a look at more such abstracts from the ASCO21 event here.
