Innovative clinical research on rare gene variants in lung cancer has made important progress

Recently, the team of Li Yangqiu, a researcher at the First Affiliated Hospital of Jinan University/School of Basic Medicine and Public Health, and the team of Professor Wu Yilong of Guangdong Provincial People’s Hospital have made important progress in innovative clinical research on rare gene variants in lung cancer. The results were published in Nature – Medicine.

This study proposes a new clinical trial model for patients with rare gene mutations for the first time, and creates a more efficient clinical research design idea for comprehensively collecting research data of patients with rare driver gene variants and exploring the most reasonable treatment options.

CTONG1702 and CTONG1705 study designs. Photo courtesy of the research team

In order to allow more patients to receive cutting-edge drug treatment, the research team adopted a new clinical trial model, and specially set up three groups, namely strict enrollment cohort, compassionate use cohort and real-world cohort. As of December 2021, the research team screened a total of 48 cases of HER2-mutated advanced treatment-naïve lung cancer from 932 patients with treatment-naïve advanced lung cancer through next-generation gene sequencing, among which 28 patients were enrolled in the strict enrollment cohort, 12 cases in the compassionate use cohort and the real-world cohort, respectively.

The results showed that the efficacy rate of pirrotinib in the strict enrollment cohort was 35.7%, the median progression-free survival was 7.3 months, and the median overall survival was 14.3 months, and the response rate of the sympathetic cohort receiving pirotinib was 16.7%. The median progression-free survival was 4.7 months and the median overall survival was 14.2 months, while none of the real-world cohorts received clinical routine antitumor therapy showed antitumor efficacy, with median progression-free survival and median overall survival of 3.0 months and 12.2 months, respectively.

In terms of drug safety, serious side effects greater than or equal to grade 3 in the strict enrollment cohort were relatively small, with only 10.7% incidence, while serious side effects in the compassionate use group almost tripled to 33.3%, but no permanent discontinuation of the drug was required due to side effects in either group. Side effects are basically similar to those of other targeted drugs and are controllable.

This study is the first clinical trial to deepen the effectiveness from the perspective of study design, which provides a very good case for future clinical studies of rare targets, and also provides a new perspective for the comprehensive evaluation of a research drug, which is very prospective and practical. (Source: China Science News, Zhu Hanbin, Su Qianyi)

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