Gemstone-301 studies the final PFS data announcement, and then proves the solid status of Schogly Mippling to consolidate

*For medical professionals for reading reference

Regardless of whether it is the overall population, or the synchronous or sequential phase III NSCLC patients after chemotherapy, the solidarity of the Schurge Meticipopuctification can significantly extend the mid -position PFS.

On August 6-9, 2022, the largest and most influential conference in the field of lung cancer-the World Lung Cancer Conference (WCLC) was grandly held. At this meeting, the results of the final non-progressive survival (PFS) analysis of the Gemstone-301 research were announced in the form of verbally report (Abstract number: OA02.05). The results showed that for synchronous (CCRT) or sequential chemotherapy (SCRT), the irregular III non -small cell lung carcinoma (NSCLC) patients who did not develop disease progress (NSCLC) could significantly extend the median PFS in the Schogly Mutteria. (10.5 months vs 6.2 months, HR = 0.65); Moreover, the CCRT or SCRT Asian group of Schgley Mipide's consolidation therapy has benefited significantly, of which the median PFS of the CCRT Asian group reached 15.7 months.

In response, the main researcher of the "Medical Circular Cancer Channel" invited the main researcher of Gemstone-301 research and Professor Zhou Qing of the Guangdong Provincial People's Hospital Zhou Qing in-depth interpretation of research data and clinical significance.

GemStone-301 studies the final PFS data, once again affirmed the trease monetary immune consolidation treatment position again

The Gemstone-301 Studies are a national multi-center study led by Professor Wu Yilong of Guangdong Provincial People's Hospital. In January 2022, the results of the PFS midterm analysis of the study were announced in the magazine of "Liuye Knife · Oncology". The data shows that for local advanced NSCLC patients without EGFR mutations, compared with the placebo group, the treatment of Schogly Meticoic Anti -immune consolidation treatment after CCRT or SCRT is significantly extended. To.

"The mid -term follow -up time of PFS mid -term analysis is only 14 months, and this time it announced on the WCLC's mid -PFS analysis results nearly doubled, reaching 27 months. Although the number of PFS events in the mid -term analysis has already been Mature, but with the extension of the follow -up time, the maturity of the data has been further improved. "Professor Zhou Qing introduced that the final PFS analysis released on WCLC this year shows that the Schogly Micometer Anti -Relief Group and the Placement Group Independent Review Committee (BICR ) The median PFS of the evaluation is 10.5 months and 6.2 months, respectively, HR = 0.65.

"It can be seen that the main endpoint of Gemstone-301 research-mid-position PFS still maintains positive results. And as the follow-up time is extended, the value of the two groups of medium-bit PFS has increased compared to before, and the HR value remains stable. . This time, the final PFS analysis results have affirmed the status of Schoglyab as a standard immune consolidation therapy after CCRT or SCRT patients with CCRT or SCRT patients with local advanced NSCLC patients. "Professor Zhou Qing said.

The median PFS of the CCRT Asian group reached 15.7 months, and the solid benefit of the consolidation treatment of Schogly Mutterum

The median PFS data of the CCRT and SCRT Asian groups also updated the medium PFS data on this WCLC. "The previous mid -term analysis data showed that in the CCRT Asian group, the median PFS of the Schogly Midticopo and the placebo group was 10.5 months VS 6.4 months, and the HR value was 0.66, but the PFS data was not mature at that time." Weekly. Professor Qing pointed out, "The updated PFS data has matured, and it is found that as the follow -up time is significantly extended, the median value of the CCRT Asian group has changed a lot. 15.7 months vs 8.3 months, hr = 0.71. "

"We are very happy to see that Gemstone-301 studied the CCRT Asian group, and the median PFS of patients receiving Schogly Mutterum immunomotive consolidation treatment reached 15.7 months. Nearly. Compared with PACIFIC research indirectly, Gemstone-301 studies have a higher percentage of difficult people such as III, squamous carcinoma, etc., but they still have a medium-sized PFS result similar to Pacific research. This is also this time this time One of the highlights of WCLC update data. "In addition, in the SCRT Asian group, the median PFS of the Schogly Midumi group and the placebo group is 8.1 months VS 4.1 months, which has basically not changed compared with the results of the mid -term analysis; HR is HR; HR; HR; The value is also very stable, 0.57. As the world's first immune consolidation treatment research in the SCRT sub -group, the data update once again consolidated the significant survival benefit of Schogly Mupping.

Surprise: The OS OS shows the benefit trend of the Schurgley Midticope group, and the DOR is longer

In addition to the medium-ranked PFS data, the Gemstone-301 research period (OS) data is also updated on WCLC. Although OS data is not yet mature and the median OS of the Schutli counterpart has not yet reached, the OS curve has observed the trend of very obvious separation from the control group, suggesting that the Schogly Midtopo group OS has a tendency to benefit.

Specifically, the median OS of the Schogly Maposumi group and placebo group is not reaching VS 25.9 months (HR = 0.69), of which the median OS of the SCRT Asian group is not reaching VS 24.1 months (HR = 0.60 ), The median OS in the CCRT Asian group has not reached VS 32.4 months (HR = 0.75).

In addition, the objective relief rate (ORR) of the Schurge Meticoic group and the placebo group is similar to 24.5% VS 25.2% respectively; It is 24.1 months vs 6.9 months.

Good safety, Gemstone-301 research lays the foundation for exploring more immunotherapy mode

For the clinical use of a new type of treatment model, in addition to the improvement of efficacy, safety has also attracted much attention. Judging from the toxic spectrum of GemStone-301, the CCRT or SCRT after CCRT or SCRT has good safety. The incidence of level 1 ~ 2 pneumonia in the Schurge Meticuketarium and the placebo group is 16%, and the occurrence rate of levels ≥ 3 pneumonia in the Schogly Miduration group is only 3%. Have good tolerance.

"At present, a large number of clinical studies are exploring new immunotherapy models, such as synchronous treatment of immune and radiotherapy and chemotherapy, immune and chemotherapy induction before radiotherapy. These new treatment models have made us see the trend of improvement effects, and at the same time Make more irrevocable local advanced patients who can benefit from immunotherapy earlier. However, one of these new treatment models is a problem that we are very concerned about is security. "Professor Zhou Qing said that whether it is PACIFIC research or Gemstone- The 301 study has created a new standard treatment model, laying a very good foundation for future research, and also brought about whether future research can explore whether the treatment model that further improves the efficacy while maintaining safety. It's a very big challenge.

summary

In June 2022, Schurge Dori was approved in China for synchronization or sequential chemotherapy, which has not occurred in synchronization or sequential chemotherapy, and the treatment of patients with diseases, and the treatment of NSCLC patients in Pharmaceutical III. A standard immune consolidation treatment plan, and the plan has been written into the 2022 version of the China Clinical Oncology Society (CSCO) NSCLC diagnosis and treatment guide. With the announcement of the final PFS data on the GemStone-301 on the 2022 WCLC, the future of Schogly Mutterum Immunosis Consolidation will inevitably bring more treatment benefits to patients in the domestic advanced NSCLC.

Expert Introduction

Professor Zhou Qing

Chief physician, doctoral tutor

Dean of the Cancer Hospital of Guangdong Provincial People's Hospital, Deputy Director of the Institute of Lung Cancer Institute of Guangdong Province, Director of the Third Department of Cancer Center

Vice President and Secretary -General of Chinese Chest Tumor Research Cooperation (CTONG)

Chairman of the Professional Committee of the Lung Cancer Professional Committee of the Guangdong Female Physician Association

Chairman of the Professional Committee of the Pulmonary Cancer Professional Committee of the Grass and Pharmaceutical Society of Guangdong Province

International Affair Affairs Committee

Fields: Comprehensive treatment and transformation of lung cancer multidisciplinary treatment. Molecular targeted therapy and immunotherapy of lung cancer has in -depth research on accurate treatment of lung cancer under the guidance of biomarkers.

He quoted 128 times.Scientific research and awards: Hosted one National 13th Five -Year Plan Project, Four of the National Natural Science Foundation Project, and a number of provincial scientific research topics.The main translation and translation of one, participated in more than 100 international and domestic multi -center clinical research, won one second prize of the National Science and Technology Progress Award, the first prize of the Chinese Medical Science and Technology Award, and the first prize of the Guangdong Provincial Science and Technology AwardTwo items and second prizes.

Reference materials:

[1] Y-l. Wu, q. Zhou, m. Chen, et al. Sugemalimab vs placebo after or scrt in pTS with unresectable stage III nsclc: Final PFS Analysis of a Phase 3 Study.

*This article is only used to provide scientific information to medical people, and does not represent the viewpoint of this platform

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