The phase-3 trial in 52 hospitals in China is ongoing, but the researchers say the combination therapy should be offered as a first-line treatment for these patients.
As reported in The Lancet Respiratory Medicine, Dr. Caicun Zhou of Tongji University and colleagues recruited patients with non-squamous NSCLC without EGFR and ALK alteration.
Four hundred and twelve participants (median age, 60; 71% men) were randomized to either 4-6 cycles of carboplatin (area under curve, 5 mg/mL/min) plus pemetrexed (500 mg/m2) with or without camrelizumab (200 mg) every three weeks, followed by maintenance therapy with camrelizumab plus pemetrexed or pemetrexed alone. Medication was administered intravenously on day 1 of each 3-week treatment cycle.
The two primary endpoints were PFS in all patients and in patients who were PD-L1 positive.
At the interim analysis, at a median follow-up of 11.9 months, PFS was significantly prolonged overall with camrelizumab plus chemotherapy versus chemotherapy alone (hazard ratio, 0.60).
The most common grade 3 or worse treatment-related adverse events were decreased neutrophil count (38% of patients in the camrelizumab plus chemotherapy group versus 30% for chemotherapy alone); decreased white blood cell count (20% vs. 14%); anemia (19% vs. 11%), and lowered platelet count (17% vs. 12%).
Serious treatment-related adverse events were reported in 36% of those in the camrelizumab plus chemotherapy group and 13% of those on chemotherapy alone.
Summing up, the authors state, "The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations. The trial is being continued to collect long-term outcomes in all patients and carry out confirmatory statistical testing for progression-free survival in the PD-L1-positive population."
Dr. Hossein Borghaei, Chief, Division of Thoracic Medical Oncology, Fox Chase Cancer Center, commented by email to Reuters Health, "This is one of many recent studies showing the efficacy of chemo combined with a checkpoint inhibitor. In this study, there are very few patients with PD-L1 >50%. It appears that benefit is seen regardless of PD-L1 level."
"All checkpoint inhibitors appear to offer a similar benefit when combined with standard chemotherapy. Therefore, chemo plus a checkpoint inhibitor is the standard of care in most patients with NSCLC."
Dr. Ravi Salgia, Professor and Chair, Department of Medical Oncology and Therapeutics Research at City of Hope in Duarte, California, commented by phone. "I have no concerns about the study, but I think we need a placebo-controlled, double-blind study to confirm the findings."
"Using PFS as an endpoint is okay," he told Reuters Health, "but it would be nice to get overall survival, as well. Also, the study had more males than females; this is an important issue as we think not only about ancestral origins but also also about gender differences."
City of Hope is already using the combined approach based on earlier data, he said. "The treat approved in NCCN guidelines, and the Centers for Medicare and Medicaid Services does, as well. That said, it's still important to individualize therapy."
Dr. Zhou did not respond to requests for a comment.
The study was funded by Jiangsu Hengrui Medicine, Lianyungang, China. Three coauthors are with the company.
SOURCE: https://bit.ly/3svCihI The Lancet Respiratory Medicine, online December 18, 2020.
By Marilynn Larkin
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