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Perran Fulden Yumuk
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P47 - Small Cell Lung Cancer/NET - Biology / Translational (ID 234)
- Event: WCLC 2020
- Type: Posters
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P47.14 - Clinicopathologic Features of Large Cell Neuroendocrine Carcinoma of Lung (ID 1252)
00:00 - 00:00 | Presenting Author(s): Perran Fulden Yumuk
- Abstract
Introduction
Large cell neuroendocrine carcinoma of lung (LCNEC) are high-grade neuroendocrine tumors with poor prognosis and 5-year overall survival (OS) is approximately 40% even in early stage disease. We aimed to analyze clinicopathological features of patients with pulmonary LCNEC in our institution.
Methods
Data of 33 (1.9%) patients with pulmonary LCNEC diagnosed and treated between 2012 and 2019 at our center was retrospectively recorded.
Results
Median age was 60 (range 47-81) (table 1). Lobectomy was performed in 8 (24.2%) cases with clinical stage 1-2 disease and out of these platin based chemotherapy (CT) was administered to 5. Three cases with stage 3 disease received definitive chemoradiotherapy (CRT) with full dose cisplatin - etoposide (PE). Distant recurrence developed in 3 operated and 1 stage 3 cases. Among patients with metastatic disease, 14 (%66.6) were treated with PE as first line, while 7 (%33.3) with other platin based regimens. Progression free survival (PFS) with PE was 5.1 (95% CI, 2.3-5.2) months, and 4.8 (95% CI, 0.2-5.4) months with other regimens. OS with PE was 12.4 (95% CI, 2.7-11.3) months, while it was 18.4 (95% CI, 1.5-34.5) months with other regimens. There were no significant difference between these two groups’ for PFS or OS (p=0.83; p=0.28, respectively). In all stage 4 patients, 44% received only one line CT. Median follow up time for whole group was 34.7 months, 24 patients died, and OS was 13 months.
Conclusion
In our study, <60 age and de novo metatatic disease were determined as independent prognostic factors for OS. There was no significant difference between groups receiving PE and other platinum based regimens in terms of PFS or OS. Interpreting our results was difficult due to limited sample size.
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P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P84.03 - GLASS: Global Lorlatinib for ALK(+) and ROS1(+) Retrospective Study: Real World Data of 123 NSCLC Patients (ID 3172)
00:00 - 00:00 | Author(s): Perran Fulden Yumuk
- Abstract
Introduction
Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1(+) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib.
Methods
This is an international, multicenter, retrospective study, which aimed to describe the efficacy and safety of lorlatinib in previously treated ALK/ROS1(+) NSCLC. All patients were treated through an early access program, when no other targeted therapy was available.123 patients were enrolled retrospectively (data cut-off 1/1/2019). Outcome and response were defined by each investigator upon RECIST 1.1 criteria.
Results
From March 2015 to January 2019, 106 ALK(+) and 17 ROS1(+) patients were recruited from 8 different countries. The ALK(+) cohort included 50% males, 73% never-smokers and 68% with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60% and 62%, with disease control rates (DCR) of 91% and 88% respectively. Mean duration of therapy (DoT) was 23.9±1.6 months and median overall survival (mOS) was 89.1±19.6 months. ROS1 cohort enrolled 53% males, 65% never-smokers and 65% had brain metastases. EC and IC RR were 62% and 67% with DCR of 92% and 78% respectively. Median DoT was 18.1±2.5 months and mOS of 90.3±24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters.
The most common adverse events of any grade were peripheral edema (48%), hyperlipidemia (47%), weight gain (25%) and fatigue (30%). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18% of patients.
Conclusion
Lorlatinib shows outstanding extracranial and intracranial efficacy in ALK or ROS1(+) NSCLC. The observed mOS of 89±19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90±24 months is unprecedented for ROS1(+) NSCLC.
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PS01 - Presidential Symposium (Japanese, Mandarin, Spanish Translation Available) (ID 143)
- Event: WCLC 2020
- Type: Plenary
- Track: N.A.
- Presentations: 1
- Moderators:
- Coordinates: 1/30/2021, 07:00 - 09:00, Scientific Program Auditorium
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PS01.09 - Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo as 1L Therapy for Metastatic NSCLC of PD-L1 TPS ≥50%: KEYNOTE-598 (ID 4248)
07:00 - 09:00 | Author(s): Perran Fulden Yumuk
- Abstract
- Presentation
Introduction
In KEYNOTE-024, pembrolizumab monotherapy significantly improved survival versus platinum-doublet chemotherapy in patients with metastatic NSCLC with PD-L1 TPS ≥50% and no targetable EGFR or ALK aberrations. We conducted the randomized, double-blind, phase 3 KEYNOTE-598 study (NCT03302234) to determine whether adding ipilimumab to pembrolizumab improved efficacy over pembrolizumab alone in this population.
Methods
Eligible patients were randomized 1:1 to ipilimumab 1 mg/kg Q6W or saline placebo for up to 18 cycles; patients in both arms received pembrolizumab 200 mg Q3W for up to 35 cycles. Randomization was stratified by ECOG PS (0 vs 1), region (East Asia vs not East Asia), and histology (squamous vs nonsquamous). Treatment differences in the primary endpoints of OS and PFS (RECIST v1.1; blinded, independent central review) were assessed by the stratified log-rank test in the ITT population. The protocol-specified first interim analysis (IA1) was planned to occur when ~255 deaths occurred and ~12 months after the last participant was randomized. Nonbinding futility criteria at IA1 were differences in the restricted mean survival time (RMST) between pembro–ipi and pembro–placebo of ≤0.2 at the maximum observation time and ≤0.1 at 24 months of follow-up.
Results
Between 12‑January‑2018 and 22‑August‑2019, 568 participants were randomized to pembro–ipi (n=284; 282 treated) and pembro–placebo (n=284; 281 treated). As of 01‑September‑2020, median (range) study follow-up was 20.6 months (12.4-31.7), treatment was ongoing in 21.3% in the pembro–ipi arm vs 23.8% in the pembro–placebo arm, and median number of treatment cycles was 10 vs 15. Baseline characteristics were balanced between arms. With 272 deaths, median OS was 21.4 months for pembro–ipi vs 21.9 months for pembro–placebo (HR, 1.08 [95% CI, 0.85-1.37]; P = 0.74). RMST differences were –0.56 at the maximum observation time and –0.52 at 24 months, which met the futility criteria. With 372 events, median PFS was 8.2 months for pembro–ipi vs 8.4 months for pembro–placebo (HR, 1.06 [95% CI, 0.86-1.30]; P = 0.72). ORR was 45.4% in both arms; median DOR was 16.1 months for pembro–ipi vs 17.3 months for pembro–placebo. Treatment-related AEs occurred in 76.2% of pembro–ipi recipients vs 68.3% of pembro–placebo recipients, were of grade 3-5 in 35.1% vs 19.6%, led to death in 2.5% vs 0%, and led to discontinuation of any treatment in 25.2% vs 10.7%. Immune-mediated AEs and infusion reactions occurred in 44.7% of pembro–ipi recipients vs 32.4% of pembro–placebo recipients, were grade 3-5 in 20.2% vs 7.8%, led to death in 2.1% vs 0%, and led to discontinuation of any treatment in 14.9% vs 5.3%. Based on the observed efficacy and safety, the external data monitoring committee recommended that the study be stopped due to futility and that participants discontinue ipi/placebo.
Conclusion
Adding ipilimumab to pembrolizumab does not improve efficacy and is associated with greater toxicity than pembrolizumab alone as first-line therapy for metastatic NSCLC with PD-L1 TPS ≥50% and no targetable EGFR or ALK aberrations. These data confirm pembrolizumab monotherapy as a standard-of-care for this population.
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PS02 - Presidential Symposium (Re-Broadcast) (Japanese, Mandarin, Spanish Translation Available) (ID 275)
- Event: WCLC 2020
- Type: Plenary
- Track: N.A.
- Presentations: 1
- Moderators:
- Coordinates: 1/30/2021, 18:00 - 20:00, Scientific Program Auditorium
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PS02.09 - Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo as 1L Therapy for Metastatic NSCLC of PD-L1 TPS ≥50%: KEYNOTE-598 (ID 4292)
18:00 - 20:00 | Author(s): Perran Fulden Yumuk
- Abstract
Introduction
In KEYNOTE-024, pembrolizumab monotherapy significantly improved survival versus platinum-doublet chemotherapy in patients with metastatic NSCLC with PD-L1 TPS ≥50% and no targetable EGFR or ALK aberrations. We conducted the randomized, double-blind, phase 3 KEYNOTE-598 study (NCT03302234) to determine whether adding ipilimumab to pembrolizumab improved efficacy over pembrolizumab alone in this population. Methods
Eligible patients were randomized 1:1 to ipilimumab 1 mg/kg Q6W or saline placebo for up to 18 cycles; patients in both arms received pembrolizumab 200 mg Q3W for up to 35 cycles. Randomization was stratified by ECOG PS (0 vs 1), region (East Asia vs not East Asia), and histology (squamous vs nonsquamous). Treatment differences in the primary endpoints of OS and PFS (RECIST v1.1; blinded, independent central review) were assessed by the stratified log-rank test in the ITT population. The protocol-specified first interim analysis (IA1) was planned to occur when ~255 deaths occurred and ~12 months after the last participant was randomized. Nonbinding futility criteria at IA1 were differences in the restricted mean survival time (RMST) between pembro–ipi and pembro–placebo of ≤0.2 at the maximum observation time and ≤0.1 at 24 months of follow-up. Results
Between 12‑January‑2018 and 22‑August‑2019, 568 participants were randomized to pembro–ipi (n=284; 282 treated) and pembro–placebo (n=284; 281 treated). As of 01‑September‑2020, median (range) study follow-up was 20.6 months (12.4-31.7), treatment was ongoing in 21.3% in the pembro–ipi arm vs 23.8% in the pembro–placebo arm, and median number of treatment cycles was 10 vs 15. Baseline characteristics were balanced between arms. With 272 deaths, median OS was 21.4 months for pembro–ipi vs 21.9 months for pembro–placebo (HR, 1.08 [95% CI, 0.85-1.37]; P = 0.74). RMST differences were –0.56 at the maximum observation time and –0.52 at 24 months, which met the futility criteria. With 372 events, median PFS was 8.2 months for pembro–ipi vs 8.4 months for pembro–placebo (HR, 1.06 [95% CI, 0.86-1.30]; P = 0.72). ORR was 45.4% in both arms; median DOR was 16.1 months for pembro–ipi vs 17.3 months for pembro–placebo. Treatment-related AEs occurred in 76.2% of pembro–ipi recipients vs 68.3% of pembro–placebo recipients, were of grade 3-5 in 35.1% vs 19.6%, led to death in 2.5% vs 0%, and led to discontinuation of any treatment in 25.2% vs 10.7%. Immune-mediated AEs and infusion reactions occurred in 44.7% of pembro–ipi recipients vs 32.4% of pembro–placebo recipients, were grade 3-5 in 20.2% vs 7.8%, led to death in 2.1% vs 0%, and led to discontinuation of any treatment in 14.9% vs 5.3%. Based on the observed efficacy and safety, the external data monitoring committee recommended that the study be stopped due to futility and that participants discontinue ipi/placebo. Conclusion
Adding ipilimumab to pembrolizumab does not improve efficacy and is associated with greater toxicity than pembrolizumab alone as first-line therapy for metastatic NSCLC with PD-L1 TPS ≥50% and no targetable EGFR or ALK aberrations. These data confirm pembrolizumab monotherapy as a standard-of-care for this population.
