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2022 AACR: ORR exceeds 60%, local innovative drug Gumetinib is expected to bring a new treatment option for METex14 skip mutation NSCLC patients!

 Last Update: 2022-05-18
 Source: Internet
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2022（2022 AACR）48—13，

The study showed that in the treatment of patients with non-small cell lung cancer (NSCLC) carrying MET MET exon 14 (MET ex14 MET ) skipping mutations, the overall population objective response rate ( overall population objective response rate ( overall population objective response rate ( ORR )) ) was 60.

Screenshot of Professor Lu Shun's AACR report

Screenshot of Professor Lu Shun 's AACR report Screenshot of Professor Lu Shun's AACR report

Progress in rare target therapy for lung cancer continues, and any " small group " is worth seeing

The progress of rare target therapy for lung cancer is constantly progressing, and any rare target therapy for lung cancer is constantly progressing, and any " small group and small group " is worth seeing .

In China, both the incidence and mortality of lung cancer rank first among malignant tumors

Abnormal activation of the MET pathway can lead to the development of tumors, and the main forms include MET ex14 MET skipping mutation, MET amplification, MET protein overexpression, MET kinase domain mutation, and MET fusion

Professor Lu Shun said: " The research on the MET target series has a history of almost 38 years, but the first and second generation MET tyrosine kinase inhibitors ( TKIs ) have been used in gastric cancer, liver cancer and lung cancer.

The related research on the MET ex14 MET jump mutation is in full swing, but there are still some “ distance ” and challenges to be put into practice

Ingenious research design, ingenious research design, GLORY GLORY research research " " Going abroad and going abroad " "

The GLORY study is a global, multicenter, single-arm, open-label study of patients with locally advanced or metastatic MET ex14 skipping mutations who have received no more than 2 prior systemic therapies or who have not received systemic therapy (intolerant or unsuitable for chemotherapy) NSCLC patients .

The GLORY study is a global, multicenter, single-arm, open-label study of MET ex14 MET -skipping mutations locally advanced or with no more than 2 prior systemic therapies or no systemic therapy (intolerant or unsuitable for chemotherapy).

To be more objective and impartial, the primary endpoint of the GLORY study was ORR as assessed by the Blinded Independent Review and Review Committee ( BIRC ) .

It is worth mentioning that Gumetinib is a domestic original drug, and its pivotal Phase II GLORY study is being carried out globally, including not only Chinese NSCLC patients, but also Japanese NSCLC patients .

Both efficacy and safety, Gumetinib brings new hope Gumetinib brings both efficacy and safety, Gumetinib brings new hope

Judging from the baseline tumor history of the patients enrolled in the global pivotal Phase II GLORY study, 87.

Efficacy results showed that : 66.

At the same time, Gumetinib demonstrated durable tumor remission: the median DoR was 8.

Brain metastasis is the most common metastatic site of lung cancer, and it is also one of the important factors affecting the survival time and quality of life of lung cancer patients
.
The average survival time of lung cancer patients with brain metastases is only 1-2 months, and the treatment is more difficult ^[6]^[6]
.
How to efficiently and safely curb the tumor progression of patients with brain metastases from lung cancer has become an urgent dilemma in the field of lung cancer diagnosis and treatment
.
However , the good curative effect of gumetinib in patients with brain metastases has demonstrated its powerful ability to enter the brain, breaking through the bottleneck of "refractory brain metastases from lung cancer", and providing more patients with brain metastases at baseline .
NSCLC patients bring hope that Gumetinib has shown good curative effect in patients with brain metastases, exerted its powerful ability to enter the brain, broke through the good curative effect of Gumetinib in patients with brain metastases, and played a role in With its powerful ability to enter the brain, it has broken through the bottleneck of "refractory lung cancer brain metastases are refractory to lung cancer brain metastases" , which is the bottleneck of brain metastasis for more baselines, and the existence of brain metastasis for more baselines.
NSCLC patients bring hope NSCLC patients bring hope - 8 of 10 subjects with brain metastases achieved partial responses ( PR, assessed by BIRC ); meanwhile, 5 patients whose brain metastases were selected as target lesions in the investigator's assessment also achieved intracranial tumor remission .

Professor Lu Shun said: " The extremely impressive ORR and DCR of the global pivotal Phase II GLORY study confirmed that gumetinib can bring rapid and deep remission to patients with MET ex14 skipping mutation NSCLC , which is expected to further translate into long-term benefits .
Efficacy DoR
Global pivotal Global pivotal Phase II GLORY GLORY study extremely impressive ORR ORR , , DCR DCR confirms that gumetinib can be used for MET ex14 MET ex14 MET skipping mutation Mutant NSCLC NSCLC patients bring rapid and deep remission, which is expected to further translate into long-term benefits .

Patients experience rapid and deep remission, which is expected to further translate into long-term benefits
.
The long-term efficacy DoR DoR shows the hard power of Gumetinib to bring long-term relief to patients
.
It also shows the hard power that Gumetinib can bring long-term relief to patients
.
It also shows the hard power of Gumetinib to bring long-term relief to patients.
”

From the point of view of safety data, common treatment-related adverse events ( TRAE , ≥10% ) had a low incidence of grade 3 or above AEs , especially liver and kidney toxicity.
to the dual benefit of efficacy and safety .
It means that it can bring dual benefits of efficacy and safety to patients .
It means that it can bring dual benefits of efficacy and safety to patients

Looking forward to the future, the road to MET target therapy in China will surely go wider and farther

Looking to the future, China Looking to the future, the road to MET - targeted therapy in China will surely go wider and farther The road to targeted therapy will surely go wider and farther

Although the MET ex14 skipping mutation accounts for only a small part of the NSCLC population in China, considering the huge base of NSCLC patients in China, any " small group " deserves to be seen and paid attention to
.
What is more worth mentioning is that the data results of the global pivotal Phase II GLORY study will have a significant impact on the precise clinical practice of NSCLC patients in China, Japan and even more regions .

Although the MET ex14 MET skipping mutation accounts for only a small part of the NSCLC population in China, considering the large base of NSCLC patients in China, any " small group " deserves to be seen and paid attention to
.
What is more worth mentioning is that the data results of the global pivotal Phase II GLORY study will have a significant impact on the precise clinical practice of NSCLC patients in China, Japan and even more regions .

At the same time, the global pivotal Phase II GLORY study can also answer more clinical questions, such as the timing of medication – the GLORY study included both treatment-naive and treatment-experienced patients, and the significant benefit of gumetinib was seen in both populations At the same time, Gumetinib also showed an advantageous trend of first-line use .
For clinicians, the timing of administration of gumetinib is more flexible, and it is also expected to cover more NSCLC patients with MET ex14 skipping mutations .

At the same time, the global pivotal Phase II GLORY study can also answer more clinical questions, such as the timing of medication – the GLORY study included both treatment-naive and treatment-experienced patients, and the significant benefit of gumetinib was seen in both populations At the same time, Gumetinib also showed an advantageous trend of first-line use .
For clinicians, the timing of administration of Gumetinib is more flexible, and it is expected to cover more The timing is more flexible, and it is also expected to cover more NSCLC patients with MET ex14 skipping mutations .
patients .
patient

Professor Lu Shun said: " Gumetinib has proven its application value in patients with MET ex14 skipping mutation NSCLC , and we are also actively conducting clinical research in patients with solid tumors with MET amplification and MET protein overexpression, to further explore suitable Gumetinib is the target patient of precise targeted therapy, and strives to benefit more patients .
It is believed that with the progress of Gumetinib , the survival status of NSCLC patients with MET ex14 skipping mutation in China will be improved.
floor ' .
"

Professor Lu Shun said: " Gumetinib has proven its application value in patients with MET ex14 MET skipping mutation NSCLC , and we are also actively conducting clinical research in patients with solid tumors with MET amplification and MET protein overexpression, and further exploration Target patients who are suitable for the precise targeted therapy of Gumetinib, and strive to benefit more patients .
It is believed that with the progress of Gumetinib , the survival status of NSCLC patients with MET ex14 MET skipping mutation in China will also be improved.
one floor ' .
"

What is even more surprising is that the MET inhibitor Gumetinib Tablets (R&D code: SCC244 ) has been officially included in the list of priority review varieties (acceptance number: CXHS2200010 country, publicity date: 2022-02-17 ), " meaning that in In the near future, Chinese patients with MET ex14 skipping mutation NSCLC will usher in a new and powerful treatment option! It means that in the near future, China means that in the near future, Chinese MET ex14 MET ex14 MET skipping mutation NSCLC patients will receive Welcome to a new and powerful treatment option! Patients will usher in a new and powerful treatment option! ” said Professor Lu Shun
.

references:

[1] Sung H, Ferlay J, Siegel RL, et al.
Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].
CA: a cancer journal for clinicians, 2021, 71 ( 3 ) : 209-249.
[1] Sung H, Ferlay J, Siegel RL, et al.
Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].
CA: a cancer journal for clinicians , 2021, 71 ( 3 ) :209-249.

[2] Zhou Ye , Yu Yan .
MET ex14 skipping mutation and non-small cell lung cancer [J].
International Journal of Oncology , 2021, 48(6): 366-369.

[2] Zhou Ye , Yu Yan .
MET ex14 skipping mutation and non-small cell lung cancer [J].
International Journal of Oncology , 2021, 48(6): 366-369.
[2] Zhou Ye , Yu Yan .
MET ex14 MET Jumping mutation and non-small cell lung cancer [J].
International Journal of Oncology , 2021, 48(6): 366-369.

[3] Yin Limei , Lu Yu .
Research progress of MET ex14 skipping mutation in non-small cell lung cancer [J].
China Lung Cancer Journal , 2018, 21(7): 553-559.

[3] Yin Limei , Lu Yu .
Research progress of MET ex14 skipping mutation in non-small cell lung cancer [J].
China Journal of Lung Cancer, 2018, 21(7):553-559.
[3] Yin Limei , Lu Yu .
MET ex14 Research progress of MET skipping mutation in non-small cell lung cancer [J].
China Lung Cancer Journal , 2018, 21(7): 553-559.

[4] Socinski MA, Pennell NA, Davies KD.
MET Exon 14 Skipping Mutations in Non-Small-Cell Lung Cancer: An Overview of Biology, Clinical Outcomes, and Testing Considerations.
JCO Precis Oncol.
2021;5:PO.
20.
00516.

[5]Awad MM, Lee JK, Madison R, et al.
Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (Sa) and potential acquired resistance (Ar) mechanisms[J].
JCO.
2020;38(15_suppl ): 9511-9511.

[6] Oncologists Branch of Chinese Medical Doctor Association .
Medical Oncology Branch of China Association for the Promotion of International Exchanges in Healthcare .
"Chinese Guidelines for the Treatment of Brain Metastases from Lung Cancer ( 2021 Edition)" Chinese Journal of Oncology , March 2021 , Vol.
43 , Issue 3 , Chin J Oncol , March 2021 , Vol.
43 , No.
3 [6] Oncologists Branch of Chinese Medical Doctor Association .
Medical Oncology Branch of China Association for the Promotion of International Exchange of Healthcare .
"Chinese Guidelines for Treatment of Brain Metastases from Lung Cancer ( 2021 Edition )" Chinese Journal of Oncology March 2021 Volume 43 Issue 3 Chin J Oncol , March 2021 , Vol.
43 , No.
3

Expert Profile

Expert profileExpert profile

Professor Lu Shun

Professor Lu Shun Professor Lu Shun

Shanghai Chest Hospital

Shanghai Chest Hospital Shanghai Chest Hospital

Chief physician, doctoral supervisor, second-level professor , young and middle-aged experts with outstanding contributions to national health, leading talents in Shanghai, outstanding academic leaders in Shanghai, chief expert of national key special projects, enjoying special allowances from the State Council

Shanghai Jiaotong University Affiliated Chest Hospital, Director of Shanghai Lung Cancer Clinical Center

Director of China Anti-Cancer Association, former chairman of Lung Cancer Professional Committee

Executive Director of the Chinese Society of Clinical Oncology ( CSCO ), Vice Chairman of the Sisco Foundation

Vice Chairman of DIA China Advisory Committee

Former Chairman of Shanghai Medical Association Oncology Society

Member of the Standing Committee of the Chinese Medical Association Oncology Society, Chairman of the Lung Cancer Professional Committee

Vice President of Oncology Branch of Shanghai Medical Association, Head of Specialist Training Team

Member of the Publications Committee of the International Association for the Study of Lung Cancer ( IASLC )

Representative of the American Society of Clinical Oncology ( ASCO) in China

Deputy Editor-in-Chief of Journal of Thoracic Oncology , the official journal of the International Association for the Study of Lung Cancer , and editorial board member of The Oncologist

Executive Director of Shanghai Anti-Cancer Association

Vice Chairman of Precision Medicine Branch of China Medical Biotechnology Association

As the person in charge, he presided over the Ministry of Science and Technology's national key projects for chronic diseases, international cooperation projects; national major new drug innovation projects, 2 sub-projects of 863 major projects ; key projects and general projects of the National Natural Science Foundation of China

The first prize of China Anti-Cancer Association Science and Technology Award; the first prize of Shanghai Medical Science and Technology Award; the second prize of Huaxia Medical Science and Technology Award; the first prize of Shanghai Science and Technology Progress Award; Shanghai Jiaotong University President Award ; Outstanding Specialist Nomination Award, 2021 " WuXi AppTec Life Chemistry Research Award "

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