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Giuseppe Giaccone
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MA 02 - Emerging Targets (ID 656)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:Ravi Salgia, Shun Lu
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 511 + 512
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MA 02.02 - Phase 2 Study of Pembrolizumab Plus CC-486 vs Pembrolizumab Plus Placebo in Previously Treated Patients with Advanced NSCLC (ID 8581)
11:05 - 11:10 | Author(s): Giuseppe Giaccone
- Abstract
- Presentation
Background:
Studies have demonstrated that epigenetic modifiers, such as azacitidine, may sensitize tumor cells to treatment with checkpoint inhibitors, such as pembrolizumab (pembro). Efficacy and safety results from a phase 2, randomized, double-blind study of pembro in combination with CC-486, an oral formulation of azacitidine, vs pembro+placebo (PBO) for 2L treatment of advanced NSCLC are reported.
Method:
Patients aged ≥ 18 years with stage IIIB/IV NSCLC with only 1 prior platinum-based chemotherapy were randomized 1:1 (stratified by histology) to pembro 200 mg day 1 plus either CC-486 300 mg or placebo days 1-14 of a 21-day cycle. Primary endpoint was PFS. Key secondary endpoints included OS, ORR and safety.
Result:
51 and 49 patients were randomized to the pembro+CC-486 and pembro+PBO arms. Baseline characteristics were generally balanced between treatment groups. Efficacy results are shown in Table 1. Median duration of treatment for pembro+CC-486 vs pembro+PBO was 14 vs 24 weeks, and median number of cycles was 5 vs 7. The most common grade 3/4 TEAEs associated with pembro+CC-486 were nausea (14%), vomiting (12%), asthenia (10%), and diarrhea (8%), vs diarrhea (6%), asthenia (6%) and pneumonia (6%) with pembro+PBO. Patients treated with pembro+CC-486 vs pembro+PBO experienced a higher rate of pembro dose interruptions (29% vs 16%) and discontinuations (20% vs 10%), and a higher rate of CC-486 or PBO dose interruptions (61% vs 24%) and discontinuations (33% vs 12%). Gastrointestinal events, asthenia/fatigue, and elevated transaminase levels were the most common TEAEs leading to discontinuations.
Conclusion:
The addition of CC-486 to pembro did not improve the primary endpoint of PFS compared with pembro+PBO. PD-L1 expression did not appear to be predictive of CC-486 treatment efficacy. The increase in TEAEs in the combination arm, particularly gastrointestinal (nausea and vomiting), which are known to be associated with CC-486, may have influenced treatment exposure.Efficacy Endpoints Pembro + CC-486 n = 51 Pembro + PBO n = 49 Overall PFS, median, months 3.1 4.0 ORR, n (%) 10 (19.6) 7 (14.3) By PD-L1 Level at Baseline n = 45 n = 44 PFS, median, months ≥ 50% ≥ 1%-49% 0% 5.5 1.6 3.6 8.0 1.4 3.9 ORR, % ≥ 50% ≥ 1%-49% 0% 37.5 20.0 18.5 37.5 0.0 7.1
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MA 06 - Lung Cancer Biology I (ID 660)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Biology/Pathology
- Presentations: 1
- Moderators:N. Motoi, Keith M Kerr
- Coordinates: 10/16/2017, 15:45 - 17:30, Room 501
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MA 06.05 - Discussant - MA 06.01, MA 06.02, MA 06.03, MA 06.04 (ID 10770)
16:05 - 16:20 | Presenting Author(s): Giuseppe Giaccone
- Abstract
- Presentation
Abstract not provided
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MS 01 - Clinical Development of Novel Agents (ID 523)
- Event: WCLC 2017
- Type: Mini Symposium
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:S. Mandrekar, M. Mori
- Coordinates: 10/16/2017, 11:00 - 12:30, Main Hall
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MS 01.03 - Innovative Trial Designs: What is the Minimal Burden of Proof for Drug Approval? (ID 7642)
11:40 - 12:00 | Presenting Author(s): Giuseppe Giaccone
- Abstract
- Presentation
Abstract not provided
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-050 - Impact of Steroid Use for Immune Related Adverse Events on Outcomes in Non-Small Cell Lung Cancer (NSCLC) Treated with Checkpoint Inhibitors (ID 10286)
09:30 - 09:30 | Author(s): Giuseppe Giaccone
- Abstract
Background:
Checkpoint inhibitors targeting PD-1 and PD-L1 have emerged as the standard of care for patients with NSCLC. While generally well tolerated, immune related adverse events (irAEs) are a known complication and when serious, may require use of systemic corticosteroids. The impact of steroid use on checkpoint inhibitor efficacy remains unclear. Previous data suggest comparable response rates among patients who require steroids and those who do not. Here, we seek to confirm those findings and explore the impact of systemic steroids for irAEs on time to treatment failure (TTF) in patients with NSCLC.
Method:
Retrospective analysis was performed on all patients with advanced NSCLC at five institutions who received a checkpoint inhibitor (anti-PD-1 or anti-PD-L1 antibody) between January 1, 2011 and April 1, 2017. TTF was defined as the time from initiating therapy to start of a new therapy, last day of follow up or death. Development of any irAE and use of systemic corticosteroids was noted and median TTF and RR were compared between subgroups.
Result:
We identified 141 eligible patients with NSCLC treated with checkpoint inhibitors. Nineteen patients were excluded from the final analysis due to lack of any follow up or receipt of investigational agents or combinations. For the 122 evaluable patients, median TTF and RR were 169 days and 18%. A total of 30 (25%) patients developed any irAEs with median TTF and RR of 497 days and 32%. A total of 11 (9%) patients received systemic corticosteroids for irAEs. Among the patients who received steroids for irAEs, the median TTF and RR were 502 days and 27%. Our observation failed to demonstrate a statistically significant difference in median TTF among patients who received steroids and those who did not (p=0.4155).
Conclusion:
These retrospective data do not demonstrate a difference in response or treatment failure among patients who received steroids for irAEs and support the use of steroids when necessary.
