The 2022 CSCO | Intensive Study, Innovative Drug Clinical Research Data Session 2 was successfully held in the cloud

preface

The 25th National Congress of Clinical Oncology and the 2022 CSCO Annual Conference were held
from November 5th to 12th.
The conference focuses on the clinical frontier of oncology, invites well-known experts and scholars at home and abroad to make wonderful progress reports or lectures, and strives to comprehensively and accurately reflect new concepts and new trends
in the field of clinical oncology.
On November 12, the 2nd session of innovative drug clinical research data was held in the cloud, and 11 professors brought 13 latest researches to share the research results and progress
of new drugs in various fields around liver cancer, pancreatic cancer, gastric cancer, lymphoma and other fields.

Innovative Drug Clinical Research Data Session 2 Session 1

In the ascendant, new drugs in the field of solid tumors shine

The part was co-chaired by Professor Xu Ruihua, Chairman of the Chinese Society of Clinical Oncology (CSCO), Professor Xu Ruihua of the Cancer Prevention and Treatment Center Affiliated to Sun Yat-sen
University, Vice President of the Chinese Society of Clinical Oncology (CSCO), Professor Qin Shukui of Nanjing Jinling Hospital, former President of the Chinese Society of Clinical Oncology (CSCO), and Professor Li Jin of the Oriental Hospital Affiliated to Tongji University.
Professor Xu Ruihua said that the CSCO Annual Meeting is a grand event in the field of clinical oncology in China, which has received extensive attention
from experts and scholars at home and abroad.
Innovative Drug Clinical Research Data Session 2 brings together the academic achievements of many experts in recent years, showing the development of
anti-tumor drugs in China.
Professor Qin Shukui pointed out that the establishment of a special field for clinical research data of innovative drugs is conducive to promoting the development of anti-tumor drugs in China and helping the development and marketing of more and better anti-tumor drugs
.
Professor Li Jin said that the special session on clinical research data of innovative drugs has been held for many years, and it has been further improved this year, reflecting China's support for the creation of new anti-tumor drugs and actively contributing
to "Healthy China 2030".

1

Prof.
Fei Han: An open-label, non-randomized, multicenter phase II clinical study of EGFR-targeted ADC-MRG003 in the treatment of relapsed/metastatic nasopharyngeal carcinoma (NPC).

MRG003 is the first EGFR-targeted ADC drug
with the highest clinical progress in China in China.
This review included patients
with relapsed metastatic NPC who had previously progressed or relapsed or were not tolerated after treatment with at least first-line platinum-containing regimens and PD-1 inhibitor systems.
As of June 8, 2022, the Phase ALA efficacy exploration phase study has been completed, and a total of 61 subjects
have been enrolled.
The efficacy of the phase lla study showed that MRG003 was significantly effective in patients with relapsed/metastatic NPC who progressed after receiving at least first-line platinum-containing chemotherapy ± PD-1 inhibitors, with an overall population ORR of 47.
4% (27/57) and a DCR of 79.
0% (45/57); In the 2.
0 mg/kg dose group, the ORR was 39.
3% (11/28) and the DCR was 71.
4% (20/28).
In the 2.
3 mg/kg dose group, the ORR was 55.
2% (16/29) and the DCR was 86.
2% (25/29).

The results of the LLA phase clinical study suggest that the safety and tolerability of the 2.
0mg/kg and 2.
3mg/kg doses are good, and the adverse events are mostly grade 1-2, and the overall safety is controllable
.

2

Professor Qin Shukui: International multicenter phase III clinical study of carrelizumab combined with apatinib versus sorafenib first-line treatment for unresectable or metastatic hepatocellular carcinoma: general population and Chinese subgroup results

This study is the first international multicenter phase III clinical study (NCT03764293) in which PD-1/PD-L1 monoclonal antibody combined with antivascular targeted small molecule TKI compared with sorafenib in the first-line treatment of unresectable or metastatic HCC has achieved the longest OS benefit
to date 。 In the global population, carrelizumab plus apatinib had better PFS and OS benefits than sorafenib in first-line treatment of advanced HCC, with a median PFS of 5.
6 versus 3.
7 months (HR 0.
52, 95% CI 0.
41 to 0.
65, unilateral p<0.
0001) and a median OS of 22.
1 versus 15.
2 months (HR 0.
62, 95% CI 0.
49-0.
80, unilateral p<0.
0001).
<b11> 。 The trend of survival benefit of this combination regimen in the Chinese subgroup was consistent with that of the general population, with a median PFS of 5.
6 vs 3.
7 months (HR 0.
50, 95% CI 0.
40-0.
64, unilateral p<0.
0001) and a median OS of 22.
1 vs 15.
6 months (HR 0.
67, 95% CI 0.
51-0.
88, unilateral 000=0.
0016).
<b12> 。 Carrelizumab plus apatinib had a significantly better ORR than sorafenib (25.
4% vs.
5.
9% ;P<0.
0001) and demonstrated a durable remission benefit (median DOR: 14.
8 months, 95% CI 8.
4-NR, up to 25.
9+ months).
<b13> Carrelizumab combined with apatinib was safe and well tolerated, and no new safety signals were found, providing a new preferred regimen
for first-line unresectable or metastatic HCC.

3

Professor Qin Shukui: National multicenter phase III clinical trial of nibutuzumab combined with gemcitabine versus gemcitabine for the treatment of K-Ras wild-type locally advanced or metastatic pancreatic cancer (NOTABLE study) – results of further survival follow-up

The NOTABLE study is a prospective, randomized controlled, double-blind, multicenter phase III clinical trial with baseline screening of K-Ras gene, and the combination of molecular targeted drugs and chemotherapy drugs for the treatment of selected patients with pancreatic cancer, aiming to evaluate the efficacy and safety
of nimotuzumab combined with gemcitabine in the treatment of K-Ras wild-type locally advanced or metastatic pancreatic cancer 。 The results suggest that for locally advanced or metastatic pancreatic cancer of K-Ras wild type, treatment with the molecularly targeted drug nimotuzumab combined with the chemotherapy drug gemcitabine can significantly prolong the survival time of patients, and this regimen may become the preferred treatment
for locally advanced or metastatic pancreatic cancer of K-Ras wild type.
NOTABLE research ushered in a new era
of biomarker-based targeted therapy for pancreatic cancer.

4

Professor Meng Zhiqiang: Phase II clinical study of SHR-1701 combined with familtinib in the treatment of advanced pancreatic cancer and biliary tract cancer

This study is a single-center, open-label, multi-cohort, exploratory study, the primary research index is ORR, and the secondary research indicators include DCR, PFS, OS, safety, biomarker exploration, etc
.
The results suggest that the phase II clinical study of SHR-1701 combined with famitinib in the treatment of advanced biliary tract cancer is progressing smoothly, and its good clinical efficacy and safety
have been preliminarily demonstrated.
It is worth expanding the sample size to further confirm efficacy and safety
through RCT studies.
In addition, how to exert the mechanism of combined anti-tumor research still needs to be further explored
.

5

Professor Chen Zhendong: Safety safety, tolerability and preliminary antitumor activity of seltratinib combined with tislelizumab in patients with locally progressed unresectable or metastatic gastric cancer and gastroesophageal junction cancer

This is an open-label, multicenter, non-randomized, multi-cohort phase II clinical trial (NCT03941873).

Preliminary data
from the Phase II portion of the study in the cohort of locally progressive, unresectable or advanced gastric/gastroesophageal junction cancer without PD-(L)1 antibody therapy are reported.
The results suggest that the combination therapy of strilitinib and tislelizumab has shown good efficacy and controllable safety
in patients with advanced gastric cancer and gastroesophageal junction cancer who have been treated before.
In patients with gastric cancer and gastroesophageal junction cancer not previously treated with PD-1 or PD-L1 antibodies, the reported ORR of strantinib in combination with tislelizumab was 12.
5%, the DCR was 66.
7%, and the median PFS was 3.
4 months
.
After treatment with strotinib in combination with tislelizumab, soluble VEGF and IP-10 in the blood increased, and soluble VEGFR2 decreased
.
The clinical value of combination therapy with strilitinib and tislelizumab in this population needs to be further explored
.

6

Prof.
Jingpei Li: Predictive value of ctDNA in neoadjuvant therapy with immunotherapy combined with chemotherapy for esophageal squamous cell carcinoma

This study is a prospective, multicenter, single-arm II clinical trial that explores the value
of ctDNA in neoadjuvant therapy with immunotherapy for esophageal squamous cell carcinoma.
The results showed that ctDNA clearance was significantly correlated with pathological response in esophageal cancer patients, and the ctDNA zero clearance rate was significantly higher in the pCR group than in the pCR group (9/16 vs 6/29, P=0.
036).

In addition, imaging diagnostic results aided by ctDNA clearance showed an accuracy of 70.
59% for pCR/non-pCR prediction
.
For patients with operable locally advanced esophageal cancer, how different treatment combination models can balance efficacy and adverse reactions still needs to be explored
.
Neoadjuvant immunity plus chemoradiotherapy/chemotherapy improves pCR, but whether it translates into a survival benefit remains to be confirmed
.
Professor Li said that although esophageal cancer immunotherapy is difficult to say accurate at present, precision must be the future development direction
of esophageal cancer immunotherapy.

Innovative Drug Clinical Research Data Session 2 Session 2

Exploration continues, and the research and development of new anti-tumor drugs has reached a new high

The part was co-chaired
by Professor Wu Yilong, former President of the Chinese Society of Clinical Oncology (CSCO), current Chairman of the Steering Committee, Guangdong Provincial People's Hospital, Professor Shen Lin of Peking University Cancer Hospital and Professor Huang Huiqiang of Sun Yat-sen University Cancer Center.
Professor Wu Yilong pointed out that the clinical research data session of innovative drugs, as a special session with characteristics in the CSCO annual meeting, provides a window
for displaying the current status of anti-tumor new drug research in China.
Professor Shen Lin and Professor Huang Huiqiang also expressed their expectations for the holding of this special session on clinical research data of innovative drugs, and wished the session a successful session
.

1

Prof.
Lin Shen: Long-term efficacy and safety summary analysis of larotinib in the treatment of tropomyosin receptor kinase (TRK) fusion cancer patients

This report presents an extended dataset of long-term follow-up of LAROTINIB in adults and children with TRK fusion cancer, based on efficacy data and safety data evaluated by the central review, from three clinical trials (NCT02576431, NCT02122913, and NCT02637687) in patients with non-primary CNS TRK fusion cancer (NCT02576431, NCT02122913, and NCT02637687).

。 The results suggest that in this extended analysis and long-term follow-up, larotinib in TRK fusion cancer patients consistently showed stable and durable objective remissions, with good long-term safety, and no new safety signals
were found.
These data underscore the importance of testing NTRK gene fusions to determine which patients may benefit from TRK inhibitors, particularly in patients
with no previously identified oncogenic drivers.

2

Prof.
Xicheng Wang: A multicenter, randomized, open-label, biarmial, phase II study with a safe lead-in period: evaluating the treatment of Cornefenib + cetuximab regimen versus irinotecan + cetuximab regimen or FOLIFIRI (5-fluorouracil[5-FU]/folic acid [FA]/irinotecan) + cetuximab regimen for the treatment of Chinese patients with metastatic colorectal cancer with BRAF V600E mutation

The NAUTICAL CRC study is a bridging study designed to demonstrate the same efficacy of the combination of cannefenib and cetuximab at the same dose as the Beiacon CRC at the same dose as the BEACON CRC in Chinese mainland patients with BRAF V600E mutation metastatic CRC who received 1 or 2 previous regimens and had the same efficacy as the combination of cannefenib and cetuximab prior to the randomization phase The safety and tolerability
of two-agent therapy was evaluated in the safety introduction (SLI) section prior to randomization 。 In the SLI cohort of the NAUTICAL CRC study, patients did not show dose-limiting toxicity
after receiving connefenib in combination with cetuximab.
The safety and tolerability of connecutrid combined with cetuximab was found to be consistent
with the results of the BEACON CRC study.
WITH THE AGREEMENT OF THE DATA MONITORING COMMITTEE, THE NAUTICAL CRC STUDY COULD ENTER THE KEY RANDOMIZED RESEARCH COMPONENT
.
This study is actively recruiting adult patients
with metastatic CRC with BRAF V600E mutation who have progressed after receiving 1 or 2 previous treatment regimens at more than 30 research centers nationwide.

3

Professor Qing Zhou: Results of phase Ia study of KRAS G12C inhibitor IBI351 (GFH925) monotherapy in advanced solid tumors

This study enrolled patients with pathologically confirmed KRAS G12C mutations with advanced solid tumors not treated with KRAS G12C inhibitors, with primary endpoints of safety, tolerability, and incidence of DLT, and secondary endpoints including PK, ORR, DCR, TTR, PFS, and OS
。 The results of the study suggested that 67 subjects with KRAS G12C mutations in stage la received IBI351 (GFH925) monotherapy, demonstrating good safety and tolerability, and 92.
5% of subjects had at least one treatment-related adverse event (TRAE), most of which were grade
1-2.
IBI351 (GFH925) monotherapy initially demonstrates encouraging signs of efficacy in patients with advanced lung/colorectal/pancreatic cancer who have failed or are intolerant to KRASG12C
mutations who have failed or tolerated previous standard therapy.
In the 600 mg BID dose group for advanced lung cancer with KRAS G12C mutation, the ORR was 61.
9% and the DCR was 100%.

Sustained therapeutic remission
was observed in colorectal and pancreatic cancer subjects with KRAS G12C mutation.
IBI351 is underway in a single-arm registry study for advanced non-small cell lung cancer carrying the KRAS G12C mutation
.

4

Professor Xichun Hu: Phase I study data of A166 in patients with locally advanced or metastatic solid tumors expressing HER2

This study is a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of A166 in patients with locally advanced or metastatic solid tumors expressing HER2, divided into two parts
: dose escalation and dose expansion.
At present, a total of 81 subjects are enrolled in the two parts, and the data update results of 58 subjects with HER2-positive breast cancer (23 in the 4.
8 mg/kg group and 35 in the 6.
0 mg/kg group) are reported this time
.
The results of the study suggest that A166 is safe and controllable at extended doses of 4.
8mg/kg and 6.
0mg/kg, no ≥ grade 3 interstitial lung disease, and the incidence and severity of hematological toxicity and gastrointestinal toxicity common to commonly used chemotherapy drugs and other ADCs are lower, special ocular adverse events can be expected, controllable and recoverable, and no new safety events
have been observed 。 In patients with multi-line HER2-positive advanced breast cancer, A166 showed definite antitumor activity at both 4.
8 mg/kg and 6.
0 mg/kg doses, and the recommended stage III dose of A166 was 4.
8 mg/kg
.
A166 has completed clinical registration for HER2-positive breast cancer third-line and above indications, and it is expected to bring new treatment options
to the third-line and above population of HER2-positive breast cancer in China.

5

Professor Deng Qi: PD-1 inhibitors/PD-1 inhibitors combined with chemotherapy as salvage therapy for CD19 CAR-T cell therapy failure/re-progression in patients with relapsed/refractory DLBCL

This study aims to establish a rescue treatment plan targeting human CD19 CAR-T cells for patients with relapsed refractory B-cell lymphoma/acute B-lymphoblastic leukemia and murine CD19 CAR-T cell therapy, so as to improve the efficacy of relapsed and refractory cases and prolong survival
.
The results suggest that patients who receive only PR on CD19 CAR-T therapy with R/R DLLBL should receive PD-1 inhibitor-based salvage therapy as soon as possible, or may bring greater benefit
to patients than receiving PD-1 inhibitors after full progression of CAR-T therapy.

6

Prof.
Huang Huiqiang: GEMSTONE-201: A multicenter, single-arm, phase II clinical study of sugemalimab in the treatment of relapsed refractory extranodal NK/T-cell lymphoma (R/R ENKTL).

The GEMSTONE-201 study, the largest anti-PD-1/L1 monoclonal antibody against R/R ENKTL to date, aims to evaluate the efficacy and safety
of sugemalimab in the treatment of R/R ENKTL.
The results suggest that sugemalimab shows sustained and long-acting antitumor activity
in patients with R/R ENKTL.
IRRC assessed ORR of 46.
2%, CR rate of 37.
2%, median DoR not yet reached, 1-year DoR rate of 86%.

The investigators' assessment was highly consistent with the results of IRRC assessment, with a consensus rate of 97.
1%, a >1-year OS rate of 68.
6%, a 2-year OS rate of 54.
6%, and a median OS that has not yet been reached
.
Suchaelimab is well tolerated by monotherapy and its safety profile in patients with ENKTL is consistent with the known safety profile of its monotherapy in other tumors, and sugemalimab offers a new and effective treatment option
for patients with R/R ENKTL.

7

Prof.
Huang Huiqiang: A Phase Ib study to evaluate the safety and efficacy of nuclear output protein (XPO1) inhibitors (ATG-010) in combination with investigator-selected chemotherapy regimens (ICE or GemOx regimens) in patients with relapsed or refractory T and NK cell lymphoma (TOUCH study)

To explore the safety and efficacy
of ATG-010 in combination with chemotherapy (ICE or GemOx regimen) sequential ATG-010 monotherapy maintenance therapy in patients with relapsed or refractory T and NK cell lymphoma.
The results suggest that ATG-010 combined with GemOx has a good safety profile and outstanding efficacy in patients with relapsed/refractory T and NK cell lymphoma, especially in PTCL-NOS and ENKTL subtypes, providing a new treatment option for patients with relapsed refractory T and NK cell lymphoma, which deserves further study
.

summary

Professor Wu Yilong concluded that from the research and results displayed in the special session of innovative drug clinical research data, he saw the current research status and latest progress of anti-tumor new drugs in China, and brought together the efforts
of many experts and scholars.
It is precisely because of the development of these clinical studies and the development, approval and marketing of new drugs that the accessibility of new anti-tumor drugs in China has been improved, so that Chinese cancer patients can have better treatment opportunities and obtain better treatment effects
.
In the future, in the creation of new anti-tumor drugs in China, we should vigorously develop "me better", strive to solve clinical problems more deeply, shorten the gap with international new drugs, and continue to develop
.

Editor: Uni

Typesetting: Uni

Execution: Traveler

This platform is designed to deliver more medical information
to healthcare professionals.
The content published on this platform cannot replace professional medical guidance in any way, nor should it be regarded as diagnosis and treatment advice
.
If such information is used for purposes other than understanding medical information, this platform does not assume relevant responsibilities
.
The content published by this platform does not mean that it agrees with its description and views
.
If copyright issues are involved, please contact us and we will deal with
it as soon as possible.