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Xingya Li
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FP14 - Targeted Therapy - Clinically Focused (ID 252)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP14.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study (ID 3605)
00:00 - 00:00 | Author(s): Xingya Li
- Abstract
Introduction
Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutant stage IB–IIIA resected NSCLC. This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in adjuvant setting in patients with EGFR mutant stage II-IIIA NSCLC.
Methods
In this randomized, open-label, phase 3 study, eligible patients aged 18-70 years who had completely resected (R0), stage II-IIIA EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed for non-squamous carcinoma). Patients were stratified by clinical stage (II vs IIIA), EGFR mutation type (exon 19 vs 21), and resection methods (lobectomy vs pneumonectomy). The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety.
Results
A total of 365 patients were screened, and 322 patients (161 for each arm) were enrolled from 29 centers across China between June 2015 and July 2019. Thirty-nine patients had major protocol violations and were excluded, leaving 283 patients in full analysis set (151 in icotinib arm and 132 in chemotherapy arm, respectively). 53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively. At the data cutoff (March 31, 2020) for the pre-specified interim analysis, 98 out of 196 (50%) events were recorded with a median follow-up of 24.9 months (95% CI, 22.1 to 28.8). In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001). Analyses of DFS based on stratification criteria and vital demographic and prognostic factors showed consistent benefits of icotinib treatment across subgroups. The 3-year DFS was 63.9% in the icotinib group and 32.5% in the chemotherapy group. It is immature to perform OS analysis with14 (9.3%) patients in the icotinib group and 14 (10.6%) patients in the chemotherapy group died, respectively. Adverse events of grade 3 or 4 were observed in 10.9% of the patients in the icotinib group and 61.2% in the chemotherapy group. Treatment-related serious adverse events occurred in 2 (1.3%) patients in the icotinib group and 19 (13.7%) patients in the chemotherapy group. No interstitial pneumonia or treatment-related death was observed in each group.
Conclusion
Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile. Icotinib can provide a new treatment option for stage II-IIIA NSCLC patients with activating EGFR mutation.
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JICC01 - Joint IASLC-CAALC-CSCO Session: The Truth and Myth of Oral Anti-VEGFR Inhibitors for Advance NSCLC (ID 276)
- Event: WCLC 2020
- Type: Workshop
- Track: N.A.
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 07:00 - 09:00, Scientific Program Auditorium
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JICC01.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study (ID 4275)
07:00 - 09:00 | Author(s): Xingya Li
- Abstract
- Presentation
Introduction
Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutant stage IB–IIIA resected NSCLC. This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in adjuvant setting in patients with EGFR mutant stage II-IIIA NSCLC. Methods
In this randomized, open-label, phase 3 study, eligible patients aged 18-70 years who had completely resected (R0), stage II-IIIA EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed for non-squamous carcinoma). Patients were stratified by clinical stage (II vs IIIA), EGFR mutation type (exon 19 vs 21), and resection methods (lobectomy vs pneumonectomy). The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. Results
A total of 365 patients were screened, and 322 patients (161 for each arm) were enrolled from 29 centers across China between June 2015 and July 2019. Thirty-nine patients had major protocol violations and were excluded, leaving 283 patients in full analysis set (151 in icotinib arm and 132 in chemotherapy arm, respectively). 53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively. At the data cutoff (March 31, 2020) for the pre-specified interim analysis, 98 out of 196 (50%) events were recorded with a median follow-up of 24.9 months (95% CI, 22.1 to 28.8). In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001). Analyses of DFS based on stratification criteria and vital demographic and prognostic factors showed consistent benefits of icotinib treatment across subgroups. The 3-year DFS was 63.9% in the icotinib group and 32.5% in the chemotherapy group. It is immature to perform OS analysis with14 (9.3%) patients in the icotinib group and 14 (10.6%) patients in the chemotherapy group died, respectively. Adverse events of grade 3 or 4 were observed in 10.9% of the patients in the icotinib group and 61.2% in the chemotherapy group. Treatment-related serious adverse events occurred in 2 (1.3%) patients in the icotinib group and 19 (13.7%) patients in the chemotherapy group. No interstitial pneumonia or treatment-related death was observed in each group. Conclusion
Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile. Icotinib can provide a new treatment option for stage II-IIIA NSCLC patients with activating EGFR mutation.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P77 - Immunotherapy (Phase II/III Trials) - Combining Different Immunotherapeutic Approaches (ID 254)
- Event: WCLC 2020
- Type: Posters
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P77.03 - A Phase II Study of KN046 (Bispecific Anti-PD-L1/CTLA-4) in Patients (pts) with Metastatic Non-Small Cell Lung Cancer (NSCLC) (ID 1665)
00:00 - 00:00 | Author(s): Xingya Li
- Abstract
Introduction
KN046 is a novel bispecific antibody that blocks PD-L1 interaction with PD1 and CTLA-4 interaction with CD80/CD86. This multiple-cohort, single-arm phase II study evaluates preliminary safety and efficacy of KN046 in subjects with metastatic non-small cell lung cancer (NSCLC).
Methods
Eligible patients (pts) were advanced NSCLC without EGFR mutation or ALK fusions, progressed on 1st line platinum-based chemotherapy but not treated with any PD-(L)1 immune checkpoint inhibitor. All pts were given KN046 3 mg/kg (Cohort A) or 5 mg/kg (Cohort B) Q2W IV up to disease progression, intolerable toxicity, etc. Efficacy evaluation was performed by investigators per RECIST 1.1 every 8 weeks and safety and tolerability assessed per NCI-CTCAE v5.0.
Results
As of the July 27, 2020, 30 pts enrolled in Cohort A and 33 in Cohort B. Median age 59 years, male/female 51/12, PS 0/1 9/54, squamous NSCLC/Non-squamous NSCLC 23/40. ≥ Grade 3 treatment related treatment emergent adverse events (TRAEs) were seen in 21 (33.3%) pts, treatment related severe adverse events (SAE) 16 (25.4%) pts, immune related adverse events (irAEs) 34 (54.0%) pts, ≥ Grade 3 irAEs 11 (17.5%) pts. Common (≥ 10%) TRAEs were infusion related reaction (16, 25.4%), anemia (14, 22.2%), rash (13, 20.6%), hyperglycemia (12, 19.0%), abnormal hepatic function (10, 15.9%), hypothyroidism (10, 15.9%), alanine aminotransferase increased (8, 12.7%), asthenia (8, 12.7%), aspartate aminotransferase increased (7, 11.1%) and pruritus (7, 11.1%). Safety profile was comparable between two cohorts.
As of cutoff date, 24 (37.5%) pts remained on the study treatment, and 39 (60.9%) pts discontinued treatment due to disease progression (n=27), AE (n=7), poor patient compliance (n=4) and one death. Median duration of drug exposure was 14 weeks (two to 56 weeks). ORR and DCR were 10.7% and 82.1%, 15.6% and 62.5% in cohort A and cohort B, respectively. Median PFS were 3.7 (2.9, 7.3), 3, 6 and 9-month PFS rate (95% CI) were 64.1% (49.4, 75.5), 36.6% (23.0, 50.4) and 34.2% (20.9, 47.9), 3, 6 and 9-month OS rate (95% CI) were 91.4% (80.5, 96.3), 86.9% (74.2, 93.6) and 81.0% (65.8, 89.9). In squamous NSCLC, median PFS was 7.3 (3.7, NE), 3, 6 and 9-month PFS rate (95% CI) was 80.0% (54.9, 92.0), 55.9% (27.0, 77.2) and 46.6% (19.0, 70.3), 3, 6 and 9-month OS rate (95% CI) were 100.0% (100.0,100.0), 88.2% (60.2, 96.9) and 88.2% (60.2, 96.9).
Conclusion
The bispecific antibody, KN046 was well tolerated and effective as 2nd line treatment of advanced NSCLC. KN046 showed promising PFS and OS benefit in squamous NSCLC.
