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Suresh S. Ramalingam
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MA05 - Improving Outcomes in Locoregional NSCLC II (ID 901)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 13:30 - 15:00, Room 105
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MA05.01 - E6508: Phase II Study of Immunotherapy with Tecemotide and Bevacizumab after Chemoradiation in Unresectable Stage III NS-NSCLC (ID 13853)
13:30 - 13:35 | Author(s): Suresh S. Ramalingam
- Abstract
- Presentation
Background
Chemoradiation (CRT) is standard of care for unresectable stage III NSCLC. Tecemotide is a MUC1 antigen-specific cancer immunotherapy. Bevacizumab is considered to have a significant role in immune modulation. Immunotherapy in combination with VEGF blockade was tested in this phase II trial combining tecemotide and bevacizumab in patients with stage III NS- NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
Subjects with stage III NS- NSCLC suitable for definitive CRT received carboplatin(C) AUC 2 + paclitaxel(P) 45 mg/m2 weekly + 66 Gy/33fx/6.5wk and consolidation C AUC 6 + P 225 mg/m2 q21 days x 2. Patients with CR/PR/SD were then registered onto Step 2 (S2). S2 was 6 weekly tecemotide injections followed by q6 weekly injections and bevacizumab 15 mg/kg q3 weeks for up to 34 doses. The primary endpoint was safety of tecemotide and bevacizumab after CRT and consolidation. The proportion of circulating dendritic cells and their expression of CD40, HLA-DR and CD123 (IL-3R) were analyzed by flow cytometry at various time points.
4c3880bb027f159e801041b1021e88e8 Result
70 patients were enrolled from Dec 2010 to Oct 2014; 68 started therapy, and 39 completed CRT and consolidation therapy. Reasons for discontinuation included progression (11) and toxicity (10). 33 patients were registered to S2. The median number of S2 cycles was 12 (range 2-34). S2 toxicity: gr 3 N=9 (6 hypertension), gr 4 N=1, gr 5 N=1. Among the treated and eligible patients (n=31), from study entry, the median PFS was 14.3 (95% CI 11.0-22.2), OS was 40.1 (95% CI 21.7-NA) months. A correlative trend of increased expression of CD40 and HLA-DR on CD11c+ cells was observed at cycle 7 (week 21) of S2.
8eea62084ca7e541d918e823422bd82e Conclusion
This cooperative group trial met its endpoint, demonstrating tolerability of tecemotide and bevacizumab after CRT and consolidation in NS-NSCLC pts. In this select group of patients, therapy with tecemotide and bevacizumab was associated with encouraging PFS and OS.
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MA15 - Colliding Approaches - EGFR and Immunotherapy (ID 916)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 13:30 - 15:00, Room 107
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MA15.03 - PD-L1 Expression in Untreated EGFRm Advanced NSCLC and Response to Osimertinib and SoC EGFR-TKIs in the FLAURA Trial (ID 12989)
13:40 - 13:45 | Presenting Author(s): Suresh S. Ramalingam
- Abstract
- Presentation
Background
In the Phase III FLAURA trial (NCT02296125), osimertinib significantly improved PFS relative to SoC EGFR-TKIs (gefitinib/erlotinib) in patients with untreated Ex19del/L858R positive (EGFRm) NSCLC. EGFRm NSCLC tumors can exhibit high PD-L1 expression, an important biomarker for immunotherapy treatment decisions. The frequency and clinical relevance of exhibiting both biomarkers prior to treatment are unclear. We report PD-L1 expression in patients with EGFRm advanced NSCLC and association with clinical outcomes following EGFR-TKI treatment.
a9ded1e5ce5d75814730bb4caaf49419 Method
Tissue samples from 994 patients with advanced NSCLC were screened for EGFR Ex19del/L858R mutations for enrolment in FLAURA; 556 were randomized to treatment. 197 tissue-blocks from the screened population (including EGFR mutation-positive and -negative samples) were tested for PD-L1 using the SP263 (Ventana) immunohistochemical assay; positive tumour cell (TC) staining PD-L1 TC≥25% and TC≥1% thresholds were applied. PFS was investigator-assessed, per RECIST 1.1, according to PD-L1-expressers (TC≥1%) or -negatives (TC<1%) in randomized patients.
4c3880bb027f159e801041b1021e88e8 Result
193/197 blocks had sufficient tumor tissue for staining. 65/193 patients were EGFR mutation-negative. 128/193 patients were EGFR mutation-positive: 106/128 were randomized to treatment (osimertinib: 54; SoC: 52). The table presents PD-L1 expression according to EGFR mutation status. For PD-L1-expressers (TC≥1%), median PFS was 18.4 months for osimertinib and 6.9 months for SoC (HR 0.30 [95% CI 0.15, 0.60]). For PD-L1-negative patients (TC<1%), median PFS was 18.9 months for osimertinib and 10.9 months for SoC (HR 0.37 [95% CI 0.17, 0.74]).
8eea62084ca7e541d918e823422bd82e ConclusionPD-L1 TC≥1%, n (%)
PD-L1 TC≥25%, n (%)
EGFR mutation-negative (n=65)
Screened population (n=65)
44 (68)
23 (35)
EGFR mutation-positive (n=128)
Screened population (n=128)
65 (51)
10 (8)
Randomized to treatment (n=106)
52 (49)
8 (8)
Randomized to osimertinib (n=54)
28 (52)
3 (6)
Randomized to SoC EGFR-TKI (n=52)
24 (46)
5 (10)
There was PFS benefit with osimertinib versus SoC regardless of whether tumors were PD-L1-expressers (TC≥1%) or -negatives (TC<1%). Using the TC≥25% threshold, PD-L1 prevalence was lower in EGFR mutation-positive than mutation-negative samples; there were insufficient patients with TC≥25% tumors for PFS assessment.
These results support the efficacy of EGFR-TKIs, including osimertinib, as first-line treatment of EGFRm advanced NSCLC, irrespective of PD-L1 expression.
6f8b794f3246b0c1e1780bb4d4d5dc53Only 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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MA18 - Modelling, Decision-Making and Population-Based Outcomes (ID 920)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 13:30 - 15:00, Room 201 F
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MA18.10 - Evolving Immunotherapy Practice Patterns in Advanced NSCLC: Analysis of an Online Treatment Decision Tool (ID 13848)
14:30 - 14:35 | Author(s): Suresh S. Ramalingam
- Abstract
- Presentation
Background
Checkpoint immunotherapy (IO) is revolutionizing NSCLC therapy. We have previously published results of an online decision support tool designed to provide clinicians with education and expert guidance (Chow et al: JTO 2015). Here we report an analysis of a recently updated version of this online tool, capturing the impact of emerging IO options.
a9ded1e5ce5d75814730bb4caaf49419 Method
From June 2016 to July 2017, the NSCLC decision tool was updated to incorporate new treatment options for 280 different case scenarios. Briefly, oncologists entered patient and disease characteristics and then their planned treatment into the tool. Afterwards recommendations from 5 lung cancer experts were provided for that specific patient scenario.
4c3880bb027f159e801041b1021e88e8 Result
This analysis includes 1481 individual cases entered by 863 practicing oncologists between June 2016 and April 2018 (USA 19%, Europe 33%, Rest of World 48%). During this time, treatment choices for EGFR and ALK cancers by oncologists closely resemble those of experts. After approval of 1st-line pembrolizumab for patients with high PD-L1 expression, oncologists recommended pembrolizumab less often than experts (67% vs 95%). In the 2nd-line setting following platinum chemotherapy, both tumor histology and PD-L1 expression level impacted treatment recommendations (see Table). For PD-L1 expression < 1%, recommendations between oncologists and experts differed substantially.
Second-line setting after platinum chemotherapy Participants' Treatment Choice Experts' Treatment Choice 2016 2017 2016 2017 Nonsquamous PD-L1 (≥ 1%) 54% IO
34% CT
(n = 35)
79% IO
15% CT
(n = 47)100% IO
85% IO
15% CT
PD-L1 (< 1%) 28% IO
65% CT
(n = 104)49% IO
41% CT
(n = 63)40% IO
55% CT
75% IO
25% CT
Squamous PD-L1 (≥ 1%) 62% IO
25% CT
(n = 24)74% IO
4% CT
(n = 23)100% IO
100% IO
PD-L1 (< 1%) 28% IO
65% CT
(n = 74)
38% IO
40% CT
(n = 45)
85% IO
15% CT
80% IO
20% CT
8eea62084ca7e541d918e823422bd82e Conclusion
This updated analysis of an online NSCLC decision-making tool integrates recent changes to the treatment landscape in 2017, capturing emerging patterns in IO therapy. Compared to earlier versions, practicing oncologist’s choice of 1st-line EGFR- and ALK- targeted therapy more closely tracked with experts during this period, while selection of IO differs from expert recommendations. A detailed analysis of expert versus online user data will be presented.
6f8b794f3246b0c1e1780bb4d4d5dc53Only 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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OA05 - Clinical Trials in IO (ID 899)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 13:30 - 15:00, Room 106
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OA05.01 - Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy (ID 12922)
13:30 - 13:40 | Author(s): Suresh S. Ramalingam
- Abstract
- Presentation
Background
Treatment options are limited for lung cancer patients whose disease has progressed on anti-PD-(L)1 therapy. HDAC inhibitors may synergize with PD-(L)1 inhibition to overcome resistance. We report the interim results of a Phase 2 trial of entinostat (ENT), a class I selective histone deacetylase (HDAC) inhibitor, plus pembrolizumab (PEMBRO) in patients with NSCLC previously treated with anti-PD-(L)1 therapy.
a9ded1e5ce5d75814730bb4caaf49419 Method
ENCORE-601 is an open-label study evaluating the combination of ENT + PEMBRO in patients with recurrent or metastatic NSCLC and prior progression on anti-PD-1/PD-L1 therapy. Patients were eligible irrespective of histology or baseline PD-L1 expression. Patients were treated with ENT 5 mg PO weekly and PEMBRO 200 mg IV Q3W. The primary endpoint was ORR as assessed by irRECIST. Tumor biopsies and blood samples for immune correlates were taken prior to and during treatment in a subset of patients. A total of 70 patients will be enrolled.
4c3880bb027f159e801041b1021e88e8 Result
Of 57 patients with anti-PD-(L)1 resistant/refractory NSCLC, the confirmed objective response rate with ENT + PEMBRO was 11% (6 of 57, 95% CI: 4-21%). Of 49 patients with post-baseline tumor measurements, 47% had at least some reduction in tumor. Anti-PD-(L)1 therapy was the most recent line of therapy in 38 of 57 patients, and the median time from last dose of prior anti-PD-(L)1 to study entry was 67 days. The median duration of response with ENT + PEMBRO was 5 months, with the longest over 14 months. Of the 6 responders, four were PD-L1 negative at study entry. Response was associated with a higher median baseline level of peripheral classical monocytes (CD14+CD16-HLA-DRhi) with 16.9% of total live PBMCs in responders (n=6) compared to 8.2% in non-responders (n=45). 5 patients (8.8%) experienced Grade 3/4 related irAEs (2 events each of pneumonitis and colitis, 1 event of hyperthyroidism). In addition, 19 patients (33.3%) experienced other Grade 3/4 related AEs with only fatigue, anemia, hypophosphatemia, and hyponatremia occurring in more than 1 patient. Additional correlative analyses to identify biomarkers of response, including whole exome sequencing and RNAseq, are in progress.
8eea62084ca7e541d918e823422bd82e Conclusion
ENT + PEMBRO demonstrated anti-tumor activity and acceptable safety in patients with NSCLC who have progressed on prior PD-(L)1 blockade. Ongoing analysis of immune correlates may identify strategies for effective patient selection.
6f8b794f3246b0c1e1780bb4d4d5dc53Only 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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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-112 - Osimertinib vs Standard of Care (SoC) EGFR-TKI as First-Line Treatment in Chinese Patients With EGFRm Advanced NSCLC (ID 12211)
16:45 - 18:00 | Author(s): Suresh S. Ramalingam
- Abstract
Background
Osimertinib is an irreversible, central nervous system (CNS) active EGFR-TKI, selective for both EGFRm and T790M resistance mutations. FLAURA (NCT02296125) is a PhIII, double-blind, randomized study assessing efficacy and safety of osimertinib vs SoC EGFR-TKI (erlotinib/gefitinib) in first-line patients with EGFRm advanced NSCLC. FLAURA results (556 patients, globally) are published. We present the China cohort results.
a9ded1e5ce5d75814730bb4caaf49419 Method
The cohort included self-identified Chinese patients, enrolled in China. Eligible patients: ≥18 years, Ex19del/L858R EGFRm advanced NSCLC, no prior EGFR-TKI/systemic anti-cancer therapy for advanced disease. Neurologically stable patients with CNS metastases were allowed, if definitive treatment/corticosteroids were completed ≥2 weeks before enrolment. Patients were randomized 1:1 to osimertinib 80 mg once daily (qd) orally or SoC EGFR-TKI (gefitinib 250 mg qd orally selected by all Chinese sites), stratified by mutation status (Ex19del/L858R). Primary endpoint: progression-free survival (PFS) by RECIST v1.1, per investigator. Data cutoff: 10/01/2018.
4c3880bb027f159e801041b1021e88e8 Result
Overall, 136 patients were randomized (osimertinib n=71; SoC n=65); 19 were also included in the global analysis. Baseline characteristics were balanced across arms (osimertinib/SoC): female 61/71%; smoking history 25/23%; WHO performance status 1 90/80%; Ex19del 51/51%, L858R 49/49%; CNS metastases 24/32%.
Efficacy endpoint Osimertinib
n=71SoC
n=65PFS events, total patients
(% maturity)40
(56%)51
(78%)PFS hazard ratio (HR)*
(95% CI)0.56 (0.37, 0.85); p=0.007 Median PFS, months
(95% CI)17.8
(13.6, 20.7)9.8
(8.3, 13.8)Objective response rate (ORR),
% (95% CI)83%
(72, 91)75%
(63, 85)Median duration of response (DoR), months
(95% CI)16.4
(12.3, NC)10.9
(8.3, 13.8)*A hazard ratio <1 favours osimertinib. PFS benefit was observed across all subgroups, irrespective of EGFR mutation status and including patients with/without CNS metastases at study entry. Median total treatment duration: osimertinib, 18.9 months; SoC, 13.6 months. No new safety signals were reported. Numerical increase in grade ≥3 AEs was reported in the osimertinib arm (49%) versus SoC arm (23%). Most grade ≥3 AEs in the osimertinib arm were investigator-reported laboratory and disease-related AEs; incidence of non-laboratory-related events was low. AEs leading to discontinuation: osimertinib, 13%; SoC, 6%. In the osimertinib arm, most AEs leading to discontinuation were fatal disease-related events.
8eea62084ca7e541d918e823422bd82e Conclusion
Osimertinib improved PFS vs SoC EGFR-TKI (HR: 0.56) as first-line treatment in Chinese patients with EGFRm advanced NSCLC, consistent with the global analysis.
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P1.01-88 - Osimertinib Maintenance After Definitive Chemoradiation in Patients with Unresectable EGFRm-Positive Stage III NSCLC (LAURA) (ID 13684)
16:45 - 18:00 | Author(s): Suresh S. Ramalingam
- Abstract
Background
The standard of care for patients with stage III unresectable NSCLC is definitive platinum-based chemoradiation, regardless of epidermal growth factor receptor mutation (EGFRm) status. There is evidence that following chemoradiation, patients with EGFRm-positive NSCLC have superior local control but inferior distant control, including an increased incidence of CNS metastases, compared with patients with EGFR wild type (EGFRwt)-NSCLC. This supports the rationale for evaluation of EGFR tyrosine kinase inhibitor (TKI) maintenance in EGFRm-positive patients without disease progression following chemoradiation. Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both sensitizing EGFR and T790M mutations. It has shown superior progression-free survival (PFS) vs. standard EGFR-TKIs in first-line treatment of patients with EGFRm-positive advanced NSCLC, including patients with or without CNS metastases at trial entry.1 These data further support the rationale for evaluation of osimertinib in the even earlier disease setting of EGFR-TKI-naïve stage III NSCLC following definitive chemoradiation where it has the potential to prevent/delay progression, including in the CNS, and improve survival compared with chemoradiation alone.
a9ded1e5ce5d75814730bb4caaf49419 Method
LAURA is a double-blind, randomized, placebo-controlled, multicenter, phase 3 study designed to assess efficacy and safety of osimertinib as maintenance therapy in patients with locally advanced, unresectable, EGFRm-positive, stage III NSCLC without disease progression following definitive platinum-based chemoradiation therapy. All patients will have tumors bearing exon 19 deletion or L858R mutation (centrally or locally confirmed by cobas®EGFR Mutation Test v2), age >18 years, and a WHO performance status of 0-1. Patients will have received prior concurrent (CCRT) or sequential (SCRT) chemoradiation treatment (including ≥2 cycles of platinum-based chemotherapy and radiation of 60 Gy ±10% [54-66 Gy]). Key exclusion criteria include a history of interstitial lung disease, symptomatic pneumonitis following chemoradiation, other unresolved toxicity >Grade 2, cardiac abnormalities, and inadequate organ function. Approximately 200 patients will be randomized 2:1 to osimertinib 80 mg oral once daily or placebo, within 6 weeks of completion of chemoradiation, until disease progression. Stratification factors are prior chemoradiation strategy (CCRT vs SCRT), tumor stage (IIIA vs IIIB/IIIC), and China vs non-China. The primary endpoint is RECIST 1.1 assessed PFS based on blinded independent central review (BICR). Key secondary endpoints include time to CNS PFS, overall survival, objective response rate, disease-related symptoms and health-related QoL, safety and tolerability, and pharmacokinetics. Study enrollment will commence from July 2018.
1Soria et al N Engl J Med 2018; 378:113-125
4c3880bb027f159e801041b1021e88e8 Result
Section not applicable
8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable
6f8b794f3246b0c1e1780bb4d4d5dc53
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P1.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 948)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.16-47 - Adjuvant Targeted Therapy Following Standard Adjuvant Therapy for Resected NSCLC: An Initial Report from ALCHEMIST (Alliance A151216) (ID 12828)
16:45 - 18:00 | Author(s): Suresh S. Ramalingam
- Abstract
Background
The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) was launched in 2014 across the National Clinical Trials Network (NCTN) of the National Cancer Institute (NCI). This trial platform aims to enroll up to 8300 patients with resected high-risk non-small cell lung cancer (NSCLC) to facilitate enrollment to adjuvant targeted therapy trials following completion of standard adjuvant therapy, and to collect biospecimens for clinical and investigational genomics. On 5/1/2016, the study was expanded to include squamous NSCLC and PDL1 testing to facilitate enrollment to a new immunotherapy study.
a9ded1e5ce5d75814730bb4caaf49419 Method
Eligible patients have completely resected NSCLC, stage IB (>4cm) to IIIA by AJCC 7. Eligibility window extends 75-285 days post-op depending upon receipt of adjuvant chemotherapy and/or radiation. Molecular testing of EGFR, ALK, PDL1 is performed centrally (depending on the histology and testing results) and results are returned to sites within 7-21 days. FFPE tissue and blood are collected by the NCI for genomic analysis. Appropriate patients may then enroll to one of three therapeutic trials studying single agent adjuvant targeted therapy (erlotinib NCT02193282, crizotinib NCT02201992, or nivolumab NCT02595944) versus observation.
4c3880bb027f159e801041b1021e88e8 Result
As of March 19, 2018, 2945 patients have been enrolled from 575 sites within the US, with a median enrollment of 98/month (range: 71-133) in 2017. Central molecular testing was completed in 83%-92% of appropriate patients: EGFR L858R/19del was detected in 395 of 2468 patients (16.0%), ALK FISH was positive in 106 of 2458 patients (4.3%), and PDL1 IHC was >1% in 902 of 1464 patients (61.6%). Adequate tissue and blood for whole exome sequencing (WES) was collected on 1928 patients (65.5%), and enrollment plasma (added January 2017) has been collected on 885 patients (30.1%). Of 1960 patients deemed to be eligible for the adjuvant treatment trials with sufficient follow-up, 560 (28.6%) were enrolled; those enrolled were younger (p=0.01) and had higher N stage (<0.01) than those not enrolled. The primary reason for eligible patients not enrolling to treatment trials was lack of interest in further adjuvant therapy (53%).
8eea62084ca7e541d918e823422bd82e Conclusion
ALCHEMIST has achieved an enrollment of ~100 patients/month with resected high-risk NSCLC. This initial report demonstrates the feasibility of central molecular testing for enrollment to adjuvant targeted therapies. Efforts are ongoing to plan clinically-informed genomic analyses of tumor and plasma, as well as the planning of new treatment arms that leverage this ongoing trial platform.
Support: U10CA180821, U10CA180882, U10CA180820, U10CA180868, U10CA180888; ClinicalTrials.gov Identifier: NCT02194738
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 978)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.12-06 - SLFN11 Expression and Efficacy of PARP Inhibitor Therapy in Extensive Stage Small Cell Lung Cancer: ECOG-ACRIN 2511 Study (ID 14113)
12:00 - 13:30 | Author(s): Suresh S. Ramalingam
- Abstract
Background
Veliparib (V),an oral small molecule inhibitor of poly (ADP) ribose polymerase (PARP) enhanced cytotoxic chemotherapy in preclinical models of small cell lung cancer (SCLC). The combination of V with cisplatin/etoposide (CE) doublet showed efficacy improvement as first-line therapy of extensive stage SCLC (ES-SCLC) with adjusted PFS HR: 0.63 1-sided p=0.01. There was differential treatment effect by strata (adjusted treatment HR comparing CE+V: CE: 0.34; 80% CI: 0.22 - 0.51; 1-sided p<0.001 for male patients with high tumor burden versus adjusted HR: 0.81 80% CI: 0.60 - 1.09; 1-sided p=0.18 for other patients subsets) highlighting the need to identify patient subset most likely to benefit. SLFN11 expression was previously shown to be associated with benefit of V when combined with temozolomide in relapsed SCLC and also predicted benefit of CE in preclinical models. We assessed the utility of SLFN11 as a predictive biomarker in the context of E2511 frontline clinical trial.
a9ded1e5ce5d75814730bb4caaf49419 Method
Archival tissue samples collected from patients with ES-SCLC enrolled and treated on E2511 study was employed for biomarker analysis looking at SLFN11 expression by immunohistochemistry. The study has 88% power to detect a PFS hazard ratio of 0.5 comparing SLFN11 (+) and (-) patients using a one-sided 0.025 level logrank test.
4c3880bb027f159e801041b1021e88e8 Result
There was an imbalance between control and experimental arms in the Male/abnormal LDH stratum (in strata) with respect to Age: p=0.006; malignant pleural effusion: p=0.095 and T stage: p=0.02. Median PFS was 5.1 mos on CE (95% CI 4.1-6.1) vs. 6.2 mos on CE+V (95% CI 5.9-8.8); HR=0.32, p=0.002 (unadjusted); median OS on CE was 8.8 mos (95% CI 6.6-11.1) vs. 9.5 mos on CE+V (95% CI 7.8-12.8); HR=0.76, p=0.39. Clinical outcome differences based on SLFN11 expression is ongoing and will be presented at the meeting.
8eea62084ca7e541d918e823422bd82e Conclusion
Pending ongoing analysis of correaltion of biomarker with clinical outcomes
6f8b794f3246b0c1e1780bb4d4d5dc53
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PC07 - The Future of Cytotoxic Chemotherapy in Advanced NSCLC (ID 846)
- Event: WCLC 2018
- Type: Pro-Con Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 13:30 - 15:00, Room 202 BD
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PC07.01 - Debate 2: Chemotherapy Will Become a Thing of the Past in the Management of Advanced NSCLC - For (ID 11629)
14:10 - 14:30 | Presenting Author(s): Suresh S. Ramalingam
- Abstract
- Presentation
Abstract not provided
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