![]() ![]() For I-O plus chemotherapy, patients with higher PD-L1 expression levels had longer survival than patients with lower PD-L1 expression levels, regardless of histology. These findings indicate that there remains room for improvement of real-world survival outcomes in patients with advanced NSCLC who receive 1L single I-O-agent–based regimens and for identifying subgroups of patients not benefitting from treatment with current I-O regimens. The survival estimates were generally lower than those reported in pivotal trials even when excluding patients not eligible for or enrolled in clinical trials. This real-world study presents one of the largest and most comprehensive analyses to date evaluating outcomes with 1L I-O plus chemotherapy or I-O monotherapy in patients with advanced NSCLC. Table 4 OS with I-O monotherapy stratified by subgroup. Patients remaining on 1L therapy by end of follow-up Number of 1L I-O therapy administrations, median (range) Table 3 Baseline demographics and clinical characteristics in patients treated with I-O monotherapy (January 2016–June 2020). Overall, 23 % of patients went on to receive 2L therapy ( Table 1). The median rwTTP while on treatment was 8.9 (95 % CI, 8.1–9.8) months in the squamous cohort and 9.1 (95 % CI, 8.4–9.7) months in the non-squamous cohort. A total of 350 (43 %) of patients with squamous disease and 1221 (35 %) of patients with non-squamous disease were alive on 1L treatment at last follow-up. ![]() The median number of 1L I-O therapy administrations was 6 (range, 1–78) for patients in both the squamous and non-squamous cohorts. The median duration of therapy was 5.6 (95 % confidence interval, 5.1–6.5) months and 5.6 (95 % CI, 5.1–6.0) months in patients with squamous and non-squamous histology, respectively (Supplemental Fig. Median follow-up was 5.7 months and 6.5 months in patients with squamous and non-squamous histology, respectively. Meanwhile, among patients with non-squamous disease, the most common combination was pembrolizumab plus platinum-based therapy and pemetrexed (93 %) ( Table 1). Time from advanced NSCLC diagnosis to index date, monthsĪmong patients with squamous disease, the most common I-O plus chemotherapy regimen was pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (94 %). ![]() MedwireNews is an independent medical news service provided by Springer Healthcare.Table 1 Baseline demographics and clinical characteristics in patients treated with I-O plus chemotherapy (January 2016–June 2020).ĭisease stage at initial diagnosis, n (%) “Therefore, the treatment decision should be made on an individual basis after a discussion of the relative risks and benefits and consideration of patient-specific factors,” they conclude. The pembrolizumab–chemotherapy combination “has shown a high level of activity” in patients with PD-L1-negative tumors, but the findings are less clear for PD-L1-positive tumors, say Paz-Ares et al. They write in The New England Journal of Medicine that these results alongside those of three other phase III trials “suggest that pembrolizumab has a role in the first-line treatment of metastatic NSCLC, regardless of histologic subtype or PD-L1 tumor proportion score.” The investigators suggest that the higher rate of discontinuation in the pembrolizumab study arm could partly be attributed to the longer duration of treatment, at an average of 6.3 months versus 4.7 months for the placebo group. Grade 3 or worse AEs occurred in a comparable 69.8% and 68.2% of patients in the pembrolizumab and placebo groups, respectively, and led to discontinuation of all treatment components in a corresponding 12.2% and 6.4% of participants, and to death in 8.3% and 6.4%. The adverse events (AEs) were “as expected” for the agents, with no new safety signals, reports the team. They point out, however, that the upper limit of the 95% confidence interval for the last group exceeded 1. For instance, the HR for death was 0.61 for patients with a PD-L1 tumor proportion score (TPS) of less than 1%, 0.57 for a TPS of 1–49%, and 0.64 for a TPS of at least 50%. Luis Paz-Ares (Hospital Universitario 12 De Octubre, Madrid, Spain) and co-researchers note that improvements in both endpoints were seen across all prespecified subgroups, including by PD-L1 expression. Progression-free survival, the other primary endpoint, was also prolonged with the addition of the PD-1 inhibitor to chemotherapy, at a median of 6.4 months versus 4.8 months with chemotherapy alone, and an HR for disease progression or death of 0.56. This was significantly longer than the median of 11.3 months achieved by the patients given placebo plus chemotherapy and equated to a hazard ratio (HR) for death of 0.64. ![]()
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