The IMPower131 study also showed results for atezolizumab plus chemotherapy in the treatment of advanced squamous NSCLC, which enrolled 1,021 patients with previously untreated advanced squamous NSCLC and randomly assigned them 1:1:1 to receive atezolizumab plus carboplatin plus paclitaxel, atezolizumab plus carboplatin plus nab-paclitaxel (referred to as the A + CnP group), or carboplatin plus nab-paclitaxel (referred to as the CnP group). In addition to KEYNOTE 407, various clinical trials, such as IMPOWER131, Checkmate 227, and Checkmate 9LA ( 4- 6), have also demonstrated the effectiveness of ICIs as the first line chemotherapy in treating advanced stage of NSCLC. ICIs have brought about a revolution in the treatment of NSCLC, especially for patients with advanced stages of the disease. One possible explanation for this is that 50.9% (n=143) of the patients from placebo with chemotherapy arm received subsequent anti-PD(L)1 therapy, with 117 patients crossing over to receive pembrolizumab and 26 patients receiving treatment outside of the study. In the placebo plus chemotherapy group, a flattening of the Kaplan-Meier curve was observed, which was not seen in historical chemotherapy trials before the introduction of immune checkpoint inhibitors (ICIs). In the pembrolizumab plus chemotherapy group, 55 patients completed 2 years of pembrolizumab treatment, and 38 (69%) of those patients were still alive at the data cut off. Toxicity was consistent with prior reports from KEYNOTE-407 and KEYNOTE-189 ( 2, 3). The ORR was 62.2% (95% CI: 56.2% to 68.0%) and 38.8% (95% CI: 33.1% to 44.8%) with pembrolizumab plus chemotherapy versus placebo plus chemotherapy. The combination therapy group also had a longer median PFS of 8.0 months (95% CI: 6.3 to 8.5) compared to 5.1 months (95% CI: 4.3 to 6.0) in the chemotherapy alone group. The 5-year OS rate was 18.4% (95% CI: 13.8% to 23.4%) in the combination therapy group versus 9.7% (95% CI: 6.5% to 13.7%) in the placebo plus chemotherapy group. After a median follow-up of 56.9 months (range, 49.9–66.2), the median OS was 17.2 months [95% confidence interval (CI): 13.8 to 23.4) in the combination therapy group compared to 11.6 months (95% CI: 6.5 to 13.7) in the chemotherapy alone group. The study showed that the combination therapy resulted in significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy alone. Patients were eligible to receive second-course pembrolizumab monotherapy for 17 cycles (approximately 1 year) on PD after either completing 35 cycles of pembrolizumab with a best overall response of stable disease (SD) or better or achieving a confirmed complete response (CR) per investigator assessment after receiving eight or more cycles of pembrolizumab and having received two or more cycles beyond the initial CR assessment. Crossover to pembrolizumab monotherapy in case of treatment failure in the placebo group was allowed. After induction treatment of 4 cycles, a pembrolizumab/placebo was prescribed total up to 35 cycles. The study reported the 5-year follow-up results of the KEYNOTE-407 trial, which enrolled 559 patients with previously untreated metastatic squamous non-small cell lung cancer (NSCLC) and randomized them 1:1 to receive either pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel or placebo plus carboplatin and paclitaxel/nab-paclitaxel. titled “Pembrolizumab plus chemotherapy in squamous non-small-cell lung cancer: 5-year update of the Phase III KEYNOTE-407 Study” published in the Journal of Clinical Oncology ( 1). We read with interest the article by Novello et al.
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