Sugemalimab demonstrated safe and efficacious results when given after concurrent chemoradiation therapy or short-course chemoradiation therapy for patients with lung cancer.
Sugemalimab after concurrent chemoradiation therapy or short-course chemoradiation therapy demonstrated improved progression-free survival (time during and after treatment when the patient lives without disease progression) over placebo, and could become a standard of care for patients with unresectable stage 3 lung cancer, according to recent study results.
The data — which was presented at the 2022 World Conference on Lung Cancer — indicated that after the median progression-free survival was 10.5 months in the sugemalimab group, compared to 6.2 months in the placebo group. Moreover, the progression-free survival rates were superior (meaning that a higher percentage of patients did not experience disease progression) with sugemalimab at 12, 24 and 36 months.
When assessing progression-free survival by chemoradiotherapy type, investigators reported rates of 73.3% and 92.7% following treatment with sugemalimab and placebo, respectively, after a median follow-up of 30.6 months and 27.8 months in both groups among patients treated with short-course radiotherapy.
The median progression-free survival in the sugemalimab group was 8.1 months and 4.1 months in the placebo group for those who underwent short-course radiotherapy. Additionally, the 12-month, 24-month and 36-month progression free survival rates in both groups were 38.8% versus 12.7%, 30.5% versus 7.6%, and 18.1% versus 0.0%, respectively.
“Concurrent chemoradiotherapy followed by immunotherapy is the standard of care for patients with unresectable stage 3 lung (non-small cell lung cancer). (However), almost 50% did not receive concurrent chemoradiotherapy and only received sequenced chemoradiotherapy,” explained Dr. Yi-Long Wu, tenured professor at Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences and Guangdong Lung Cancer Institute, during the presentation.
Among patients treated with concurrent chemoradiotherapy, the progression-free survival rates were 53.8% and 61.2% after a median of 22.4 months and 20 months of follow up in the sugemalimab and placebo groups, respectively. The median progression-free survival was 15.7 months for the sugemalimab group and 8.3 months for the placebo group. At 12, 24 and 36 months, the progression free survival rates across the sugemalimab and placebo groups were 54.8% versus 42.1%, 42.5% versus 34.0% and 34.1% versus 0.0%, respectively.
The trial included a total of 381 patients who were randomly assigned to receive either intravenous sugemalimab or intravenous placebo. The population included patients with stage 3 disease who hadn’t progressed following concurrent chemoradiotherapy or short course radiotherapy.
The primary goal of the study was progression free survival, and secondary end points included overall survival (time from diagnosis or treatment start when patients are alive) and safety.
In terms of other findings, the overall survival rate in the sugemalimab group was 33.3% after a median follow-up of 27.1 months and 42.9% after a median follow-up of 23.5 months. The median overall survival was not reached in the sugemalimab group because so many patients were alive at the point of data collection, and was 25.9 months in the placebo group. The overall survival rates for the sugemalimab group vs placebo at 12, 24, and 36 months were 86.0% versus 83.2%, 67.6% versus 55.0%, and 55.8% versus 29.5%, respectively.
Nearly all patients experienced treatment related side effects in both the sugemalimab (97.3%) and placebo groups (96%). Serious side effects occurred in 78.4% and 27.8% of patients, and 4.7% and 2.4% had to discontinue treatment, respectively. The most common side effects associate with sugemalimab included immune-mediate lung disease, rash, hypothyroidism and pneumonitis.
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