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Leora Horn
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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): Leora Horn
- 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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OA10 - Right Patient, Right Target & Right Drug - Novel Treatments and Research Partnerships (ID 910)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 10:30 - 12:00, Room 106
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OA10.04 - Afatinib With or Without Cetuximab for EGFR-Mutant Non-Small Cell Lung Cancer: Safety and Efficacy Results from SWOG S1403 (ID 14014)
11:05 - 11:15 | Author(s): Leora Horn
- Abstract
- Presentation
Background
Several EGFR tyrosine kinase inhibitors (TKIs) are used for the treatment of EGFR-mutant non-small cell lung cancer (NSCLC), however resistance inevitably develops. The combination of the irreversible ErbB family TKI afatinib and the EGFR monoclonal antibody cetuximab was previously shown to overcome resistance to first-line EGFR TKIs. To attempt to delay resistance, we conducted a randomized trial of afatinib plus cetuximab versus afatinib alone in treatment-naïve patients with advanced EGFR-mutant NSCLC (NCT02438722).
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with previously-untreated EGFR-mutant NSCLC were randomized to afatinib 40mg PO daily plus cetuximab 500mg/m2 IV every 2 weeks or afatinib 40mg PO daily. The study was designed to accrue a total of 212 patients, comparing progression-free survival (PFS) between the arms at the 1-sided 0.025 level when 134 PFS events had been observed. Secondary objectives included comparison of overall survival (OS), time to treatment discontinuation (TTD), and toxicity. An interim analysis evaluating early stopping for futility occurred when at least 64 PFS events were reported.
4c3880bb027f159e801041b1021e88e8 Result
Between March 26, 2015 and April 23, 2018, 170 eligible patients were accrued: 86 to afatinib/cetuximab and 84 to afatinib. Median age was 66.4 years, 66% were female, 64% had an EGFR exon 19 deletion mutation and 36% had an L858R point mutation. With 109 events observed, there was no improvement in PFS with the combination compared to single-agent (HR 1.17, 95% CI 0.80-1.73, P = 0.42, median 10.6 months vs 13.1 months). OS was also not improved with the addition of cetuximab (HR 1.23, 95% CI 0.62-2.44, P = 0.55, median 26.9 months vs not reached). TTD was similar between the two groups (HR 0.95, 95% CI 0.64-1.39, P = 0.79, median 12.5 months vs 12.2 months). Grade > 3 treatment-related adverse events (AEs) were more common among patients treated with afatinib/cetuximab, and more patients in the combination arm required at least 1 dose reduction of afatinib (57% vs 26%). However, treatment discontinuations due to AEs were similar between the two groups (11.6% vs 10.7%).
8eea62084ca7e541d918e823422bd82e Conclusion
There was no difference in PFS, OS or TTD with the addition of cetuximab to afatinib for treatment-naïve patients with EGFR-mutant NSCLC. The trial was closed to accrual at the interim analysis having met the criteria for futility. Correlative analysis of tumor tissue and blood from patients is ongoing.
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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OA12 - Novel Therapies in MET, RET and BRAF (ID 921)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 15:15 - 16:45, Room 106
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OA12.01 - Phase II Data for the MET Inhibitor Tepotinib in Patients with Advanced NSCLC and MET Exon 14-Skipping Mutations (ID 12896)
15:15 - 15:25 | Author(s): Leora Horn
- Abstract
- Presentation
Background
A subset (3%) of NSCLCs harbor mutations of the MET proto-oncogene that cause MET exon 14 skipping (METex14) and accumulation of active MET lacking a juxtamembrane domain. We report interim data from a single-arm phase II trial (NCT02864992) investigating the efficacy and safety of the potent, selective tyrosine-protein kinase MET inhibitor tepotinib in patients with METex14-skipping mutation-positive (METex14+) NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
Recruitment of ≤120 adult patients with advanced METex14+ NSCLC without EGFR-activating mutations or ALK rearrangements is ongoing. METex14+ mutations are identified in FPE tumor (T) material and/or plasma (L; 60 patients each, overlap anticipated) by a central laboratory. Patients receive tepotinib 500mg QD until disease progression, intolerable toxicity, or withdrawal. Primary endpoint: objective response rate (ORR). Secondary endpoints include safety.
4c3880bb027f159e801041b1021e88e8 Result
Forty-one patients have been treated to date; data are available for 34 (median age 73.5 years; 23 male; 24/8 Caucasian/Asian; prior lines of therapy: 0, n=12; 1, n=11; 2, n=10; 3, n=1; stage IVA, n=4; stage IV, n=29; stage IIIB, n=1). Treatment is ongoing in 24 patients. Based on investigator assessment, 13/22 (59.1%) evaluable patients responded: 1 had a confirmed complete response; 12 had a confirmed partial response (PR); 3 (13.6%) had stable disease for ≥12 weeks (SD). Based on independent review, 9/22 (40.9%) had a confirmed PR; 5 (22.7%) had SD. Duration of response >12 months in 2 patients. Twenty (58.8%) patients have experienced tepotinib-related treatment-emergent adverse events (TRTEAEs), including serious TRTEAEs in 3 (8.8%): pneumonia =1, generalized oedema=1, interstitial lung disease=1, and grade ≥3 TRTEAEs in 6 (17.6%): generalized oedema=1, pneumonia=1, ALT increased=1, AST increased=1, amylase increased=2, gamma GT increased=1, lipase increased=1, hyperkalemia=1; no TRTEAEs were grade ≥4 or led to death. Five (14.7%) patients have died.
8eea62084ca7e541d918e823422bd82e Conclusion
Tepotinib 500mg QD has promising activity in METex14+ NSCLC, with a favorable safety profile.
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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P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 3
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.13-02 - eXalt3: Phase 3 Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer Patients (ID 13294)
16:45 - 18:00 | Presenting Author(s): Leora Horn
- Abstract
Background
Ensartinib (X-396) is a novel, potent ALK small molecule tyrosine kinase inhibitor (TKI). It is well-tolerated and has shown promising activity in NSCLC patients in a phase 1/2 study in patients that were both ALK TKI naïve and patients that received prior crizotinib, as well as those with CNS metastases. The safety profile of ensartinib appears to be different from other ALK TKIs.
a9ded1e5ce5d75814730bb4caaf49419 Method
In this global, phase 3, open-label, randomized study, approximately 270 patients with ALK+ NSCLC who have received no prior ALK TKI and up to one prior chemotherapy regimen will be randomized with stratification by prior chemotherapy (0/1), performance status (0-1/2), brain metastases at screening (absence/presence), and geographic region (Asia /other), to receive oral ensartinib (225 mg, once daily) or crizotinib (250mg, twice daily) until disease progression or intolerable toxicity.
Eligibility also includes patients ≥ 18 years of age, stage IIIB or IV ALK+ NSCLC. Patients are required to have measurable disease per RECIST 1.1, adequate organ function, and an ECOG PS of ≤2. Adequate tumor tissue (archival or fresh biopsy) must be available for central testing. The primary endpoint is progression-free survival assessed by independent radiology review based on RECIST v. 1.1 criteria. Secondary efficacy endpoints include overall survival, response rates (overall and central nervous system [CNS]), PFS by investigator assessment, time to response, duration of response, and time to CNS progression. The study has > 80% power to detect a superior effect of ensartinib over crizotinib in PFS at a 2-sided alpha level of 0.05.
Phase 3 recruitment began in June, 2016 and currently has 98 active sites in 21 countries. The duration of recruitment will be approximately 28 months. This study is registered with ClinicalTrials.Gov as NCT02767804.
4c3880bb027f159e801041b1021e88e8 Result
Section not applicable
8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable
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P1.13-03 - Ensartinib Treatment Beyond Disease Progression in Stage IV ALK+ Non-Small Cell Lung Cancer (ID 13293)
16:45 - 18:00 | Presenting Author(s): Leora Horn
- Abstract
Background
Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC) patients (pts) benefit from receiving ALK tyrosine kinase inhibitors (TKIs); however, despite initial activity, resistance invariably develops. Disease progression (PD) is sometimes limited to progression which occurs in only one or a few sites and may not occur systemically. Local treatment with radiation while continuing treatment with ensartinib may enable prolonged benefit beyond progression.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients who were ALK TKI naïve or had received prior ALK treatment received ensartinib 225mg QD until PD or unacceptable toxicity or investigator discretion. The primary endpoint was safety and tolerability, and the secondary endpoint was pharmacokinetic and preliminary biological activity. Tumor assessment was performed locally every 8 weeks. Post-progression treatment with ensartinib was allowed if the investigator felt the patient was still receiving benefit from ensartinib. Cycles were approximately every 28 days, and radiation therapy after Cycle 1 for isolated CNS metastases was permitted if there was no evidence of progressive disease elsewhere. Post-progression treatment data were captured and analyzed.
4c3880bb027f159e801041b1021e88e8 Result
As of the data cut-off (May 01, 2018), 12 pts with progression continued ensartinib treatment post progression (67% with progression only in the CNS, 75% of which had CNS lesions at baseline and 33% with progression only outside the CNS). Of the 12 pts, half of the patients were ALK TKI naïve and half had received at least one prior ALK TKI. Six pts received radiation therapy at the time of initial progression. The initial median Progression Free Survival (PFS) of the 12 pts with post progression treatment was 15.7 months and median secondary PFS (date of initial progression to the date of second progression or end of treatment) was 5.7 months for a combined duration of therapy of 23.8 months. A significantly longer duration of continued therapy was observed in patients who received radiation treatment than those who did not 8.6 mos vs 3.5 mos. The secondary PFS was longer in treatment naïve pts than in pts who received a prior ALK TKI, 7.7 mos vs 5 mos. After the initial progression, excluding lesions treated with radiation therapy, secondary stable disease was observed in 92% of patients. No new or additional safety risk was identified in the pts post progression.
8eea62084ca7e541d918e823422bd82e Conclusion
Ensartinib may have clinical benefit in selected patients with NSCLC if continued post-progression. Secondary PFS was longer in patients treated with radiation therapy. Ensartinib was generally well tolerated in these patients treated post progression.
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P1.13-44 - Safety, PK, and Preliminary Antitumor Activity of the Oral EGFR/HER2 Exon 20 Inhibitor TAK-788 in NSCLC (ID 12373)
16:45 - 18:00 | Author(s): Leora Horn
- Abstract
Background
TAK-788 (AP32788) is an investigational tyrosine kinase inhibitor (TKI) with potent, selective preclinical activity against activating EGFR and HER2 mutations, including exon 20 insertions. We report early results of a phase 1/2 first-in-human, open-label, multicenter study of TAK-788 (NCT02716116).
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with advanced non-small cell lung cancer (NSCLC) refractory to standard therapy received daily oral doses (5–120 mg) of TAK-788 in the ongoing dose-escalation phase (3+3 design). Preliminary antitumor activity (by RECIST v1.1), safety, and PK are reported for patients who received ≥1 dose.
4c3880bb027f159e801041b1021e88e8 Result
As of 8-Sep-2017, 34 patients (median age, 60 y; female, 65%; ≥2 prior anticancer therapies, 88%; Table) were treated with TAK-788; 10 remain on treatment at data cutoff. AUC0‑24,ss increased in a dose-proportional manner over the dose range evaluated; the effective t1/2 was ~16 (range 6–28) h. The most common treatment-emergent AEs (TEAEs; ≥20%) were diarrhea (47%), nausea (26%), and fatigue (21%). Grade ≥3 TEAEs in ≥2 patients (excluding disease progression) were dyspnea (n=3, 9%) and anemia, asthenia, dehydration, lung infection, pleural effusion, pneumonia, and pneumonitis (n=2 each, 6%). Two DLTs, both pneumonitis, were reported (80 mg, grade 3; 120 mg, grade 5). Of 14 evaluable patients, 3 had PR (80 mg, n=2, both confirmed; 120 mg, single PR awaiting confirmation), 6 had SD (40 mg, n=3; 80 mg, n=2; 120 mg, n=1), and 5 had PD as best response (40 mg, n=3; 80 mg, n=1; 120 mg, n=1). All patients with PR had EGFR exon 20 insertions.
8eea62084ca7e541d918e823422bd82e Conclusion
TAK-788 exhibits antitumor activity in patients with EGFR exon 20 insertions with an AE profile consistent with other EGFR TKIs. Phase 2 will begin after determination of the RP2D, with 4 molecularly defined cohorts in NSCLC. Updated data will be presented, including the recommended phase 2 dose (RP2D).
Baseline Characteristics 5 mg
(n=4)10 mg
(n=5)20 mg
(n=5)40 mg
(n=6)80 mg
(n=7)120 mg
(n=7)Total
(n=34)Mutation type,a %
Common EGFR mutations (exon 19 deletion / L8585R) 25 20 0 0 0 0 6 EGFR-T790M+ 0 0 0 0 14 0 3 EGFR exon 20 insertion 50 40 60 83 71 57 62 HER2 0 20 40 17 14 29 21 a One patient (20 mg) had both EGFR and HER2 mutations; 1 patient (80 mg) had EGFR exon 20 insertion + T790M.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.10 - Prevention and Tobacco Control (Not CME Accredited Session) (ID 959)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.10-05 - Provider Medical Specialty Influences Smoking Cessation Counseling at an Academic Medical Center and Veterans Affairs in U.S. Mid-South (ID 12820)
16:45 - 18:00 | Author(s): Leora Horn
- Abstract
Background
Tobacco accounts for 11.5% of deaths worldwide and approximately 30% of U.S. cancer deaths. Smoking cessation counseling using the 5 A’s (Ask, Advise, Assess, Assist, Arrange) is standard-of-care for all smokers. We tested the hypothesis that certain provider characteristics (general internal medicine [GIM], those with lung cancer screening [LCS] knowledge, and those who perceive smoking cessation as very effective) would be associated with smoking cessation counseling.
a9ded1e5ce5d75814730bb4caaf49419 Method
We surveyed all GIM, pulmonology, hematology/oncology, and gynecology providers (physicians/advanced practice providers) at a large academic institution in the Mid-South and affiliated VA from February to May 2017. The primary predictor variables were provider characteristics including: specialty, LCS guideline knowledge (high knowledge=identified start age 55, 30 pack-years, current & former smokers), and perceived effectiveness of smoking cessation, colonoscopy, and pap smear at reducing cancer mortality (very/moderately/minimally/not effective). The primary outcome was self-reported smoking cessation counseling using the 5 A’s within the past year. Data were summarized using counts, proportions, and medians. We used multivariable logistic regression adjusted for years in practice and healthcare system to evaluate the association of medical specialty with counseling. Logistic regressions of perceived effectiveness and LCS guideline knowledge as predictors of counseling were further adjusted for specialty.
4c3880bb027f159e801041b1021e88e8 Result
Of 625 providers invited, 407 (65%) responded, 378 (60.5%) questionnaires were analyzed, of which 58% were GIM, 19% hematology/oncology, 13% gynecology, 10% pulmonology. There were 255 of 350 providers (73%) who reported performing smoking cessation counseling within the past year (77% GIM vs 77% pulmonology vs 57% hematology/oncology vs 72% gynecology, χ2 p=0.013). In adjusted multivariable logistic regression, GIM (aOR 2.52 95% CI 1.40,4.54;p=0.002) and pulmonology (aOR 2.52 95% CI 1.00,6.36;p=0.05) providers were more likely to perform smoking cessation counseling than hematology/oncology providers.
41% vs 59% of those who provided counseling had high LCS knowledge vs low LCS knowledge. Fewer providers (71%) reported smoking cessation as very effective at reducing cancer-specific mortality compared to colonoscopy (77%) and pap-smear (74%). Perceived effectiveness and high LCS guideline knowledge did not predict smoking cessation counseling (aOR 1.1 95% CI 0.64,1.8;p=0.78;aOR 1.2 95% CI 0.72,2.0 p=0.47 respectively).
8eea62084ca7e541d918e823422bd82e Conclusion
Providers in general internal medicine and pulmonology were more likely than those in hematology/oncology to report performing smoking cessation counseling. Perceived effectiveness and LCS guideline knowledge did not predict smoking cessation counseling. Targeted interventions, especially in hematology/oncology, are needed to increase smoking cessation counseling using the 5 A’s. Future education should also address knowledge gaps in smoking cessation effectiveness and LCS guidelines.
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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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PC07.03 - Debate 1: For Wild-Type NSCLC, Which Will Be the Preferred Strategy: IO Alone versus Chemo + IO - IO Alone (ID 11631)
13:30 - 13:50 | Presenting Author(s): Leora Horn
- Abstract
- Presentation
Abstract not provided
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PL02 - Presidential Symposium - Top 5 Abstracts (ID 850)
- Event: WCLC 2018
- Type: Plenary Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 08:15 - 09:45, Plenary Hall
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PL02.07 - IMpower 133: Primary PFS, OS and Safety in a PH1/3 Study of 1L Atezolizumab + Carboplatin + Etoposide in Extensive-Stage SCLC (ID 12892)
09:00 - 09:10 | Author(s): Leora Horn
- Abstract
- Presentation
Background
First-line (1L) standard-of-care treatment for extensive-stage small cell lung cancer (ES-SCLC) is platinum (carboplatin or cisplatin) with etoposide. Despite high initial response rates, there has been limited progress in the last two decades and outcomes remain poor with a median overall survival (OS) of ~10 months. IMpower133 (NCT02763579), a global Phase 1/3, double-blind, randomized, placebo-controlled trial evaluated efficacy and safety of adding atezolizumab, a humanized monoclonal anti–PD-L1 antibody, or placebo to 1L carboplatin and etoposide in ES-SCLC.
Patients with measurable (RECIST v1.1) ES-SCLC, ECOG performance status 0 or 1, who had not received prior systemic treatment for ES-SCLC were enrolled. PD-L1 immunohistochemical testing was not required. Patients were randomized 1:1 to receive four 21-day cycles of carboplatin (AUC 5 mg/mL/min IV, Day 1) plus etoposide (100 mg/m2 IV, Days 1-3) with either atezolizumab (1200 mg IV, Day 1) or placebo, followed by maintenance therapy with atezolizumab or placebo until intolerable toxicity or progressive disease per RECIST v1.1. Patients meeting predefined criteria could receive treatment beyond progression. Co-primary endpoints were OS and investigator-assessed progression-free survival (PFS). Adverse events (AEs) were graded per NCI-CTCAE v4.0. Blood-based tumor mutation burden (bTMB) was assessed using prespecified cutoffs of ≥16 vs. <16 and ≥10 vs. <10 mutations/Mb.
In total, 201 patients were randomized to the atezolizumab group, and 202 to the placebo group. Median follow-up was 13.9 months. Median OS was 12.3 months in the atezolizumab group and 10.3 months in the placebo group (hazard ratio [HR] 0.70 [95% confidence interval (CI): 0.54, 0.91; P=0.0069]). Median PFS was 5.2 months and 4.3 months, respectively (HR 0.77 [95% CI: 0.62, 0.96; P=0.017]). OS and PFS benefits were consistent across key patient subgroups. Investigator-assessed confirmed objective response rates were 60.2% and 64.4% in the atezolizumab and placebo groups, respectively; median duration of response, 4.2 and 3.9 months. Exploratory analyses showed OS survival benefits in subgroups above and below prespecified bTMB cutoffs. Grade 3-4 treatment-related AEs were reported in 56.6% vs. 56.1% patients in atezolizumab vs. placebo groups, respectively; serious treatment-related AEs occurred in 22.7% and 18.9% patients, respectively.
Addition of atezolizumab to carboplatin and etoposide provided a significant improvement in OS and PFS in 1L ES-SCLC in an all-comer patient population. No unexpected safety signals were identified. Atezolizumab plus carboplatin and etoposide may represent a new standard regimen for patients with untreated ES-SCLC.
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