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The 2022 European Lung Cancer Congress (ELCC) will be held from March 30 to April 2, local time
.
Patients with resectable non-small cell lung cancer (NSCLC) have a high risk of postoperative local recurrence and distant metastasis, and the prognosis of such patients remains to be improved
.
At the 2022 ELCC conference, two studies led by Chinese scholars explored the efficacy of osimertinib and the new drug HR-1316 in neoadjuvant therapy and perioperative period, respectively
.
In addition, the ADAURA study updated the updated results of the mainland Chinese population
.
NEOS Study | Neoadjuvant Osimertinib in NSCLC: The First Prospective Study Data Update Background The NEOS study (ChiCTR1800016948) is a multicenter, single-arm phase II study.
Good efficacy and acceptable safety profile in patients with resectable EGFR-mutant NSCLC
.
At this conference, Professor Lv Chao from Peking University Cancer Hospital orally reported the final efficacy and safety results of osimertinib neoadjuvant therapy
.
Methods Eligible patients aged 18-75 years with resectable, stage II-IIIB (T3-4N2), EGFR-mutant lung adenocarcinoma received osimertinib (80 mg PO QD) for 6 weeks.
, sequential surgical resection
.
The primary endpoint was investigator-assessed objective response rate (ORR) according to RECIST v1.
1 criteria
.
Secondary endpoints included safety, R0 resection rate, quality of life, major pathologic response (MPR) rate, pathologic complete response (pCR) rate, and N2 downstaging rate
.
Figure Study Design Results Between October 17, 2018, and June 8, 2021, a total of 88 patients were screened and 40 patients were finally included.
.
Thirty-eight patients completed 6 weeks of osimertinib neoadjuvant therapy with an ORR of 71% (27/38) and a disease control rate (DCR) of 100%
.
Thirty-two patients underwent surgery (50% robotic-assisted thoracoscopic lung surgery; 50% thoracotomy), and 94% (30/32) of patients achieved R0 resection
.
Of the 28 pathologically evaluable patients, 11% achieved MPR, of which 1 (4%) achieved pCR
.
46% (13/28) of patients had a pathological response of ≥50%
.
Figure Efficacy Analysis During neoadjuvant therapy, 30 (75%) patients experienced treatment-related adverse events (TRAEs), of which 3 (8%) had grade 3 TRAEs
.
There were no adverse events leading to discontinuation of neoadjuvant therapy
.
Table of Safety Analysis Conclusions This study is the largest prospective study of osimertinib neoadjuvant therapy for NSCLC so far
.
Osimertinib has shown satisfactory efficacy and acceptable safety in neoadjuvant therapy, and is a promising and potential treatment option for patients with resectable EGFR-mutant NSCLC
.
New drug HR-1316: for resectable perioperative NSCLC with a major pathological response of 55.
9% Background SHR-1316 is a humanized IgG4 monoclonal PD-L1 antibody that shows good antitumor activity in solid tumors
.
This Phase Ib/III study evaluated the efficacy and safety of SHR-1316+chemotherapy versus placebo+chemotherapy for the perioperative treatment of resectable NSCLC
.
At this ELCC conference, the results of the Phase Ib study led by Professor Wu Yilong of Guangdong Provincial People's Hospital and Professor Zhong Wenzhao of Guangdong Lung Cancer Research Institute were announced
.
Methods Eligible patients were resectable stage II and III (IIIA and T3N2M0 IIIB), non-EGFR/ALK mutant NSCLC
.
Enrolled patients received 3 cycles of neoadjuvant SHR-1316 (iv, 20 mg/kg on day 1), nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), and carboplatin (area under the curve).
[AUC] 5, 5 mg/ml/min on day 1), 21 days as a cycle, sequential surgical resection
.
Subsequently, patients will further receive 16 cycles of adjuvant SHR-1316 (20 mg/kg on day 1)
.
The primary endpoint was MPR according to blinded independent pathology review (BIPR), defined as 10% viable tumor cells in the resected specimen
.
If MPR>55%, a phase III study will be initiated
.
Results of study design From July 14, 2020, to May 12, 2021, a total of 37 patients received SHR-1316+chemotherapy neoadjuvant therapy, of which 34 patients received subsequent surgery
.
At data cutoff on November 26, 2021, 19 of 34 (55.
9%, 95% CI 39.
5-71.
1) patients who underwent surgery achieved MPR and 11 (32.
4%, 95% CI 19.
1-49.
2) patients achieved pCR
.
Table MPR analysis of patients who received neoadjuvant therapy Among the 37 patients who received neoadjuvant therapy, 26 (70.
3%, 95% CI 54.
2-82.
5) patients achieved an objective response, of which 1 achieved a complete response (CR), and 25 achieved an objective response The patient achieved a partial response (PR)
.
DCR reached 97.
3%
.
Treatment-related adverse events (AEs) occurred in 37 (100%) patients with best response in target lesions from baseline
.
Grade 3 or higher treatment-related AEs occurred in 29 (78.
4%) patients
.
No treatment-related deaths occurred
.
Conclusion SHR-1316 + nab-paclitaxel + carboplatin neoadjuvant therapy shows a high MPR rate in patients with resectable NSCLC with good safety.
Based on the results of the phase Ib study, further phase III studies will be carried out
.
ADAURA Study: Chinese Subgroup Data Update Background Osimertinib is a third-generation EGFR-TKI, and studies have confirmed that osimertinib shows good efficacy in patients with NSCLC (including nervous system [CNS] metastases)
.
EGFR-sensitizing mutations are more common in Chinese NSCLC patients
.
The global phase III ADAURA study showed that adjuvant osimertinib treatment significantly improved resectable stage II-IIIA (HR=0.
17, P<0.
0001) and IB-IIIA (HR=0.
20, P<0.
0001) patients compared with placebo <0.
0001) disease-free survival (DFS) of patients with EGFR-sensitive mutant NSCLC
.
At this conference, the study led by Academician He Jie and Prof.
Wang Jie of Cancer Hospital of Chinese Academy of Medical Sciences, Prof.
Wu Yilong of Guangdong Provincial People's Hospital, and Prof.
Lu Shun of Chest Hospital Affiliated to Shanghai Jiaotong University announced the efficacy and safety of Chinese subgroups.
data
.
Methods ADAURA study included adult patients with completely resected, EGFR-sensitive mutant stage IB/II/IIIA NSCLC, WHO PS 0-1
.
Patients with prior adjuvant chemotherapy were allowed to enroll
.
Patients were randomized 1:1 to receive osimertinib (80 mg once daily) or placebo until completion of 3 years of treatment or until disease recurrence or drug discontinuation
.
The primary endpoint was investigator-assessed DFS in patients with stage II-IIIA, and secondary endpoints included DFS in the overall population (IB-IIIA), overall survival (OS), and safety
.
The Chinese subgroup analysis was an exploratory analysis
.
Data cutoff date is January 17, 2020
.
Results A total of 682 patients were included in the world, and 159 patients in mainland China were included in this analysis, including 77 and 82 in the osimertinib and placebo groups, respectively
.
Baseline characteristics of the two treatment groups were balanced and comparable, with a median age of 61 vs 60 years, 60% vs 60% women, 45% vs 40% stage IB patients, and stage II-IIIA patients 55% vs 60%, 47% vs 38% of patients with exon 19 deletions, and 62% vs 71% of patients with prior adjuvant chemotherapy
.
At data cutoff, among patients with stage II-IIIA, median DFS was not reached in the osimertinib group and 18.
3 months in the placebo group (DFS HR 0.
16, P<0.
0001; maturity 40%)
.
Primary endpoint: DFS analysis of patients with stage II/IIIA NSCLC Among patients with stage IB-IIIA, median DFS was not reached and 24.
9 months, respectively (DFS HR 0.
18, P<0.
0001; maturity 27%)
.
Secondary endpoint: DFS analysis of patients with stage IB/IIIA NSCLC A DFS benefit with osimertinib versus placebo was observed in all prespecified subgroups
.
The safety results of osimertinib were consistent with the established safety results of the global cohort
.
The results of subgroup analysis concluded that the efficacy and safety results of the ADAURA study in the Chinese population were consistent with the global population
.
The findings support 3-year adjuvant osimertinib therapy for Chinese patients with resectable stage IB-IIIA EGFR-sensitive NSCLC
.
References: 1.
Osimertinib asneoadjuvant therapy in patients with EGFR mutated resectable stage II-IIIB lungadenocarcinoma (NEOS): Updated results.
81MO.
2022ELCC.
2.
HR-1316 vs placebo in combination with chemotherapy as perioperative treatment in patients with resectable stage II/ IIINSCLC: A randomized, double-blind, multicenter, phase Ib/III trial .
84P.
2022ELCC.
3.
Adjuvant osimertinib in patients (pts) with stage IBeIIIA EGFR mutation-positive (EGFRm) NSCLC after complete tumor resection: ADAURA China subgroup analysis .
85P.
2022ELCC.
Editor: XY Review: XY Typesetting: Wenting Execution: Wenting Master Classroom, scan the code to enter▼▼▼
.
Patients with resectable non-small cell lung cancer (NSCLC) have a high risk of postoperative local recurrence and distant metastasis, and the prognosis of such patients remains to be improved
.
At the 2022 ELCC conference, two studies led by Chinese scholars explored the efficacy of osimertinib and the new drug HR-1316 in neoadjuvant therapy and perioperative period, respectively
.
In addition, the ADAURA study updated the updated results of the mainland Chinese population
.
NEOS Study | Neoadjuvant Osimertinib in NSCLC: The First Prospective Study Data Update Background The NEOS study (ChiCTR1800016948) is a multicenter, single-arm phase II study.
Good efficacy and acceptable safety profile in patients with resectable EGFR-mutant NSCLC
.
At this conference, Professor Lv Chao from Peking University Cancer Hospital orally reported the final efficacy and safety results of osimertinib neoadjuvant therapy
.
Methods Eligible patients aged 18-75 years with resectable, stage II-IIIB (T3-4N2), EGFR-mutant lung adenocarcinoma received osimertinib (80 mg PO QD) for 6 weeks.
, sequential surgical resection
.
The primary endpoint was investigator-assessed objective response rate (ORR) according to RECIST v1.
1 criteria
.
Secondary endpoints included safety, R0 resection rate, quality of life, major pathologic response (MPR) rate, pathologic complete response (pCR) rate, and N2 downstaging rate
.
Figure Study Design Results Between October 17, 2018, and June 8, 2021, a total of 88 patients were screened and 40 patients were finally included.
.
Thirty-eight patients completed 6 weeks of osimertinib neoadjuvant therapy with an ORR of 71% (27/38) and a disease control rate (DCR) of 100%
.
Thirty-two patients underwent surgery (50% robotic-assisted thoracoscopic lung surgery; 50% thoracotomy), and 94% (30/32) of patients achieved R0 resection
.
Of the 28 pathologically evaluable patients, 11% achieved MPR, of which 1 (4%) achieved pCR
.
46% (13/28) of patients had a pathological response of ≥50%
.
Figure Efficacy Analysis During neoadjuvant therapy, 30 (75%) patients experienced treatment-related adverse events (TRAEs), of which 3 (8%) had grade 3 TRAEs
.
There were no adverse events leading to discontinuation of neoadjuvant therapy
.
Table of Safety Analysis Conclusions This study is the largest prospective study of osimertinib neoadjuvant therapy for NSCLC so far
.
Osimertinib has shown satisfactory efficacy and acceptable safety in neoadjuvant therapy, and is a promising and potential treatment option for patients with resectable EGFR-mutant NSCLC
.
New drug HR-1316: for resectable perioperative NSCLC with a major pathological response of 55.
9% Background SHR-1316 is a humanized IgG4 monoclonal PD-L1 antibody that shows good antitumor activity in solid tumors
.
This Phase Ib/III study evaluated the efficacy and safety of SHR-1316+chemotherapy versus placebo+chemotherapy for the perioperative treatment of resectable NSCLC
.
At this ELCC conference, the results of the Phase Ib study led by Professor Wu Yilong of Guangdong Provincial People's Hospital and Professor Zhong Wenzhao of Guangdong Lung Cancer Research Institute were announced
.
Methods Eligible patients were resectable stage II and III (IIIA and T3N2M0 IIIB), non-EGFR/ALK mutant NSCLC
.
Enrolled patients received 3 cycles of neoadjuvant SHR-1316 (iv, 20 mg/kg on day 1), nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), and carboplatin (area under the curve).
[AUC] 5, 5 mg/ml/min on day 1), 21 days as a cycle, sequential surgical resection
.
Subsequently, patients will further receive 16 cycles of adjuvant SHR-1316 (20 mg/kg on day 1)
.
The primary endpoint was MPR according to blinded independent pathology review (BIPR), defined as 10% viable tumor cells in the resected specimen
.
If MPR>55%, a phase III study will be initiated
.
Results of study design From July 14, 2020, to May 12, 2021, a total of 37 patients received SHR-1316+chemotherapy neoadjuvant therapy, of which 34 patients received subsequent surgery
.
At data cutoff on November 26, 2021, 19 of 34 (55.
9%, 95% CI 39.
5-71.
1) patients who underwent surgery achieved MPR and 11 (32.
4%, 95% CI 19.
1-49.
2) patients achieved pCR
.
Table MPR analysis of patients who received neoadjuvant therapy Among the 37 patients who received neoadjuvant therapy, 26 (70.
3%, 95% CI 54.
2-82.
5) patients achieved an objective response, of which 1 achieved a complete response (CR), and 25 achieved an objective response The patient achieved a partial response (PR)
.
DCR reached 97.
3%
.
Treatment-related adverse events (AEs) occurred in 37 (100%) patients with best response in target lesions from baseline
.
Grade 3 or higher treatment-related AEs occurred in 29 (78.
4%) patients
.
No treatment-related deaths occurred
.
Conclusion SHR-1316 + nab-paclitaxel + carboplatin neoadjuvant therapy shows a high MPR rate in patients with resectable NSCLC with good safety.
Based on the results of the phase Ib study, further phase III studies will be carried out
.
ADAURA Study: Chinese Subgroup Data Update Background Osimertinib is a third-generation EGFR-TKI, and studies have confirmed that osimertinib shows good efficacy in patients with NSCLC (including nervous system [CNS] metastases)
.
EGFR-sensitizing mutations are more common in Chinese NSCLC patients
.
The global phase III ADAURA study showed that adjuvant osimertinib treatment significantly improved resectable stage II-IIIA (HR=0.
17, P<0.
0001) and IB-IIIA (HR=0.
20, P<0.
0001) patients compared with placebo <0.
0001) disease-free survival (DFS) of patients with EGFR-sensitive mutant NSCLC
.
At this conference, the study led by Academician He Jie and Prof.
Wang Jie of Cancer Hospital of Chinese Academy of Medical Sciences, Prof.
Wu Yilong of Guangdong Provincial People's Hospital, and Prof.
Lu Shun of Chest Hospital Affiliated to Shanghai Jiaotong University announced the efficacy and safety of Chinese subgroups.
data
.
Methods ADAURA study included adult patients with completely resected, EGFR-sensitive mutant stage IB/II/IIIA NSCLC, WHO PS 0-1
.
Patients with prior adjuvant chemotherapy were allowed to enroll
.
Patients were randomized 1:1 to receive osimertinib (80 mg once daily) or placebo until completion of 3 years of treatment or until disease recurrence or drug discontinuation
.
The primary endpoint was investigator-assessed DFS in patients with stage II-IIIA, and secondary endpoints included DFS in the overall population (IB-IIIA), overall survival (OS), and safety
.
The Chinese subgroup analysis was an exploratory analysis
.
Data cutoff date is January 17, 2020
.
Results A total of 682 patients were included in the world, and 159 patients in mainland China were included in this analysis, including 77 and 82 in the osimertinib and placebo groups, respectively
.
Baseline characteristics of the two treatment groups were balanced and comparable, with a median age of 61 vs 60 years, 60% vs 60% women, 45% vs 40% stage IB patients, and stage II-IIIA patients 55% vs 60%, 47% vs 38% of patients with exon 19 deletions, and 62% vs 71% of patients with prior adjuvant chemotherapy
.
At data cutoff, among patients with stage II-IIIA, median DFS was not reached in the osimertinib group and 18.
3 months in the placebo group (DFS HR 0.
16, P<0.
0001; maturity 40%)
.
Primary endpoint: DFS analysis of patients with stage II/IIIA NSCLC Among patients with stage IB-IIIA, median DFS was not reached and 24.
9 months, respectively (DFS HR 0.
18, P<0.
0001; maturity 27%)
.
Secondary endpoint: DFS analysis of patients with stage IB/IIIA NSCLC A DFS benefit with osimertinib versus placebo was observed in all prespecified subgroups
.
The safety results of osimertinib were consistent with the established safety results of the global cohort
.
The results of subgroup analysis concluded that the efficacy and safety results of the ADAURA study in the Chinese population were consistent with the global population
.
The findings support 3-year adjuvant osimertinib therapy for Chinese patients with resectable stage IB-IIIA EGFR-sensitive NSCLC
.
References: 1.
Osimertinib asneoadjuvant therapy in patients with EGFR mutated resectable stage II-IIIB lungadenocarcinoma (NEOS): Updated results.
81MO.
2022ELCC.
2.
HR-1316 vs placebo in combination with chemotherapy as perioperative treatment in patients with resectable stage II/ IIINSCLC: A randomized, double-blind, multicenter, phase Ib/III trial .
84P.
2022ELCC.
3.
Adjuvant osimertinib in patients (pts) with stage IBeIIIA EGFR mutation-positive (EGFRm) NSCLC after complete tumor resection: ADAURA China subgroup analysis .
85P.
2022ELCC.
Editor: XY Review: XY Typesetting: Wenting Execution: Wenting Master Classroom, scan the code to enter▼▼▼
