medwireNews: Adding nivolumab to carboplatin, paclitaxel, and bevacizumab significantly prolongs progression-free survival (PFS) in people with advanced nonsquamous non-small-cell lung cancer (NSCLC) without sensitizing mutations, research shows.
Furthermore, the benefit was seen regardless of PD-L1 expression level, report Kazuhiko Nakagawa (Kindai University Faculty of Medicine, Osaka, Japan) and colleagues in the Annals of Oncology.
For the phase 3 TASUKI-52 trial, Nakagawa and team randomly assigned 448 patients from Japan, Korea, and Taiwan to receive up to six cycles of nivolumab 360 mg (n=273) or placebo (n=275) in combination with carboplatin at an AUC of 6, paclitaxel 200 mg/m2, and bevacizumab 15 mg/kg every 3 weeks, followed by maintenance nivolumab or placebo with bevacizumab until disease progression or unacceptable toxicity.
All participants had stage IIIB/IV or recurrent nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations and had not received prior systemic therapy for metastatic disease.
After a median 13.7 months of follow-up, the researchers found that people in the nivolumab group had a significant 44% lower risk for disease progression or death than those in the placebo group, with median PFS durations of 12.1 and 8.1 months, respectively.
“The median PFS of 12.1 months is the longest among all phase III studies for non-squamous NSCLC without driver mutations,” Nakagawa et al remark.
The authors also note that the PFS benefit with nivolumab was apparent across all subgroups, including those grouped by PD-L1 expression. For PD-L1 negative patients, median PFS was 13.6 months with nivolumab versus 8.4 months with placebo.
The objective response rate was significantly higher in the nivolumab group than in the placebo group, at 61.5% and 50.5%, respectively, while the median response durations were a respective 11.0 and 7.0 months.
Median overall survival was 25.4 months with nivolumab and 24.7 months without, but Nakagawa and team point out that the survival data are currently immature, and fewer patients in the nivolumab arm received immune checkpoint inhibitors as subsequent anticancer therapy than in the placebo arm (6.3 vs 38.5%)
The investigators also report that no new safety signals were observed and the incidence of treatment-related adverse events of grade 3 or 4 was comparable between the two arms, affecting 73.6% and 72.0% of patients given nivolumab and placebo, respectively.
There were five treatment-related deaths in the nivolumab group and four in the placebo group.
Nakagawa and co-authors conclude: “The TASUKI-52 regimen is […] a viable new treatment strategy for the initial treatment of patients with metastatic non-squamous NSCLC.”
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Ann Oncol 2021; doi:10.1016/j.annonc.2021.06.004