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Suvotenib (DZD9008, sunvozertinib) is the first and only domestic "class I new drug" in the field of lung cancer that has obtained "breakthrough therapy designation (abbreviation: BTD)" in China and the United States, and the results
of suvotinib's first Chinese registration study WU-KONG6 were reported at this year's ESMO annual meeting.
In this regard, Professor Yang Yu, Dean of i Hope Heilongjiang University, invited Professor Zhang Liangyu of Daqing Oilfield General Hospital to interpret the study, the details are as follows:
Details of the study
Background:
Suvotenib is an oral, highly selective EGFR tyrosine kinase inhibitor (TKI) for a variety of EGFR mutant subtypes, with excellent efficacy and safety, it has become the first and only domestic "Class I new drug" in the field of lung cancer that has obtained the "breakthrough therapy designation (abbreviation: BTD)" in China and the United States, and has been carried outa number of key clinical studies worldwide.
The data reported at this ESMO annual meeting comes from Suvotenib's first Chinese registration study, WU-KONG6
.
Method:
The WU-KONG6 study is an open-label, single-arm, multicenter Phase II registration study conducted in China in patients with advanced NSCLC who had previously received platinum-based chemotherapy and an EGFR exon insertion mutation (EGFR exon20ins) who received suvotinib monotherapy (300 mg QD) until disease progression or intolerable toxicity.
The primary endpoint was objective response rate (ORR) assessed by an independent review committee (BICR)
based on RECIST v1.
1.
Study design
Outcome:
As of July 31, 2022, a total of 97 patients with EGFR 20 exon insertion mutation advanced NSCLC who failed platinum-containing chemotherapy were enrolled, with a median age of 58 years, a median number of prior treatment lines of 2 lines, and a baseline of 32%of patients with brain metastases.
The results showed that: 1) the ORR confirmed by BICR was 59.
8%, which reached the main study endpoint; 2) For patients with brain metastases at baseline, the ORR was 48.
4%.
Fig.
Optimal percentage of change in target lesion size; BM: brain metastasis (brain metastasis
3) study included a total of 30 EGFR 20 exon insertion mutation subtypes, of which 71 patients had insertion mutations in the near-loop with an ORR of 62%; In 24 patients, the insertion mutation location occurred at the far loop end with an ORR of 50%.
Antitumor activity of suvotinib in different EGFR 20 exon insertion mutant subtypes; Helical insertion: C-helical insertion mutation; Near Loop: Near ring insertion mutation; Far Loop: Safety analysis of distal loop insertion mutations
:
The safety data came from the pooled analysis
of four multicenter clinical studies (WU-KONG1, WU-KONG2, WU-KONG6 and WU-KONG15) at home and abroad.
As of July 31, 2022, a total of 277 patients
with advanced NSCLC who received at least 1 dose of suvotinib were included.
The results showed that the overall safety of suvotinib was good, the common adverse event types were similar to traditional EGFR-TKIs, and the vast majority of them were grade 1-2 adverse events, which were clinically manageable (WU-KONG1 study, as an international multicenter study, covered the United States, Australia, South Korea, Japan and Taiwan; WU-KONG2 and WU-KONG6 are multicenter studies in China, and WU-KONG15 is a researcher-initiated study conducted in China).
Conclusion:
The results of the Chinese registration clinical trial showed that the ORR confirmed by BICR evaluation was 59.8% when suvotinib treated EGFR 20 exon insertion mutation advanced NSCLC, and the study reached the primary endpoint
.
i Hope time
i Hope Dean of Heilongjiang College
Prof.
Yu Yang
Review experts
Prof.
Liangyu Zhang
Doctor of Oncology, Chief Physician
Director of the Department of Radiation Oncology and Director of the First Cancer Ward of Daqing Oilfield General Hospital
Visiting scholar at Fujita Medical University, Japan
Member of the Standing Committee of Oncology Clinical Chemotherapy Committee of Chinese Anti-Cancer Association
Member of the Standing Committee of Oncology Chemotherapy Professional Committee of Chinese Association for the Promotion of Physical Health Science and Technology
Member of the MDT Committee of Precision Medicine and Oncology of the Chinese Research Hospital Association
Member of the Oncology Science Popularization Committee of the Medical Science Popularization Branch of the Chinese Medical Doctor Association
Head of the Regional Branch of Heilongjiang Lung Cancer Precision Treatment Specialist Alliance
Head of the Regional Branch of Heilongjiang Lymphoma Specialist Alliance
Professor Zhang Liangyu: Lung cancer is the second largest malignant tumor in the world, NSCLC accounts for about 85%, and the most common mutation is EGFR mutation
.
Unlike EGFR-sensitive mutations, EGFR 20 exon insertion mutations have a unique spatial structure that makes the ORR of traditional first- to third-generation EGFR-TKIs, immunotherapy and chemotherapy less than 20%.
In addition, studies have shown that 23%-39% of EGFR 20 exon insertion mutation advanced NSCLC patients have brain metastases at the beginning of treatment, and there is currently no new drug for EGFR 20 exon insertion mutation advanced NSCLC on the market in China, although EGFR-TKI drugs for the disease have been conditionally marketed in the United States in the past year, but the efficacy on brain metastases is still very limited, and the ORR is less than 20%.
。 Therefore, there is an urgent need for more efficient and safe targeted new drugs
for patients with advanced NSCLC with EGFR 20 exon insertion mutations.
WU-KONG6 (Clinical Trial Registration Number: CTR20211009) is a single-arm, open-label, open-label registration clinical trial conducted by suvotenib in China for patients with EGFR 20 exon insertion mutation advanced NSCLC who have previously received platinum-based chemotherapy, to evaluate the antitumor activity
of suvotenib in patients with EGFR 20 exon insertion mutation advanced NSCLC.
Suvotinib is an oral, high-choice TKI for multiple EGFR mutation subtypes, and with its excellent efficacy and safety, it has become the first and only Class 1 new drug
in the field of lung cancer to be recognized as a "breakthrough therapy" in China and the United States.
EGFR 20 exon insertion mutation NSCLC has long lacked effective targeted therapy, especially patients with brain metastases tend to have a worse
prognosis.
We are encouraged by the "best-in-class" clinical data from the WU-KONG6 study, which further confirms the superior clinical performance
of suvotinib.
" Up to now, 80% of patients in tumor remission are still undergoing treatment and continue to remission, and it is expected that suvotinib will bring better survival benefits
to lung cancer patients, especially those with brain metastases.
prospect
WU-KONG6 data showed that the ORR of suvotenib reached 52.
4%, and the ORR of patients with brain metastases reached 44% at baseline, showing good safety and efficacy
.
Previously, the research results of suvotenib have been included
in Cancer Discovery (IF 39.
397), one of the top ten international journals in the world with SCI impact factors in the field of oncology.
The research results of suvotenib have once again been recognized by international authoritative conferences, and we look forward to further promoting various clinical studies to benefit patients with advanced NSCLC with EGFR 20 exon insertion mutations around the world as soon as possible
.
Looking ahead, suvotinib is expected to solve the unmet clinical needs
in the field of lung cancer.