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R. Huber
Moderator of
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ED09 - Advances in Lung Cancer Screening (ID 277)
- Event: WCLC 2016
- Type: Education Session
- Track: Radiology/Staging/Screening
- Presentations: 4
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ED09.01 - Radiological Advances in Lung Cancer Screening (ID 6473)
14:30 - 14:50 | Author(s): M. Prokop
- Abstract
- Presentation
Abstract not provided
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ED09.02 - Risk Prediction Modelling in Lung Cancer Screening Programs (ID 6474)
14:50 - 15:10 | Author(s): M. Tammemägi
- Abstract
- Presentation
Abstract not provided
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ED09.03 - Overdiagnosis in Lung Cancer Screening (ID 6475)
15:10 - 15:30 | Author(s): C.A. Powell
- Abstract
Abstract not provided
Information from this presentation has been removed upon request of the author.
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ED09.04 - Cost Effectiveness of CT Screening (ID 6477)
15:30 - 15:45 | Author(s): B. Pyenson
- Abstract
- Presentation
Abstract not provided
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Author of
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OA08 - Targeted Therapies in Brain Metastases (ID 381)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:D. Ball, B. Perin
- Coordinates: 12/05/2016, 16:00 - 17:30, Schubert 1
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OA08.06 - Brigatinib Activity in Patients with ALK+ NSCLC and Intracranial CNS Metastases in Two Clinical Trials (ID 4374)
16:55 - 17:05 | Author(s): R. Huber
- Abstract
- Presentation
Background:
Patients treated with crizotinib often experience disease progression in the brain. Brigatinib, an investigational next-generation ALK inhibitor, is being evaluated in an ongoing phase 1/2 trial (Ph1/2) and an ongoing pivotal phase 2 trial (ALTA).
Methods:
In Ph1/2, patients with advanced malignancies, including ALK+ NSCLC, received 30–300 mg brigatinib per day. In ALTA, patients with crizotinib-resistant advanced ALK+ NSCLC received 90 mg qd (arm A) or 180 mg qd with a 7-day lead-in at 90 mg (arm B). Efficacy (in both trials) and safety (in ALTA) are reported for ALK+ NSCLC patients with brain metastases at baseline.
Results:
In Ph1/2 and ALTA, 50/79 (63%; IRC-assessed) and 154/222 (69%; investigator-assessed) of ALK+ NSCLC patients, respectively, had baseline brain metastases. In Ph1/2 (n=50), median age was 53 years, 76% received prior chemotherapy, and 8% were crizotinib-naive. In ALTA (n=154), median age was 52 years; 75% received prior chemotherapy. As of November 16, 2015, 25/50 (50%) patients were receiving brigatinib in Ph1/2; as of February 29, 2016, 101/154 (66%) patients were receiving brigatinib in ALTA. For patients with measurable lesions, confirmed iORR was 53% in Ph1/2 and 42%/67% in ALTA A/B (Table). Among patients with only nonmeasurable lesions (Ph1/2, n=31; ALTA A/B, n=54/n=55), 35% had confirmed complete resolution of lesions in Ph1/2; 7%/18% had confirmed complete resolution in ALTA A/B. For all evaluable patients with baseline brain metastases, median intracranial PFS was 15.6 months in Ph1/2 (n=46) and 15.6/12.8 months in ALTA A/B (n=80/n=73). Most common treatment-emergent adverse events in ALTA in patients with baseline brain metastases (n=151 treated): nausea (A/B, 32%/43%), headache (30%/30%), diarrhea (18%/36%), cough (21%/30%), vomiting (25%/26%); grade ≥3 (excluding neoplasm progression): increased blood CPK (1%/11%), hypertension (4%/7%), increased lipase (3%/3%), pneumonia (1%/4%).
Conclusion:
Brigatinib has demonstrated substantial clinical activity in ALK+ NSCLC patients with brain metastases in both Ph1/2 and ALTA.IRC-Assessed Confirmed Intracranial Response Rates for Patients With Measurable Brain Metastases at Baseline
Any No rad/active[a] Ph1/2[b] n=15 n=9 iORR 8(53) 6(67) iDCR 13(87) 8(89) ALTA[c] Arm A n=26 n=19 iORR 11(42) 8(42) iDCR 22(85) 16(84) Arm B n=18 n=15 iORR 12(67) 11(73) iDCR 15(83) 14(93) Data are n(%) iDCR=intracranial disease control rate iORR=intracranial objective response rate IRC=independent review committee [a]No prior brain radiotherapy (Ph1/2); active (untreated or treated and progressed) brain lesions (ALTA) [b]NCT01449461; last scan date: October 8, 2015 [c]NCT02094573; last scan date: April 14, 2016
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-027 - Clinical and Histological Features Associated with SUV in FDG-PET-CT in Patients with Adenocarcinoma of the Lung (ID 4783)
14:30 - 14:30 | Author(s): R. Huber
- Abstract
Background:
FDG-PET-CT is increasingly used for staging and treatment monitoring in NSCLC. The prognostic and possibly predictive value of the standardized-uptake-value (SUV), and the clinical, molecular and pathological features contributing to SUV levels have not been well described.
Methods:
We retrospectively reviewed the records of patients staged with FDG-PET-CT and correlated SUV values before and during treatment with clinical and pathological features of the tumour including CRP as a marker of systemic inflammation, adenocarcinoma subtype (solid, lepidic etc.), and Ki67, as a marker of tumour proliferation.
Results:
190 patients with adenocarcinoma of the lung were identified. 110 had FDG-PET-CT staging and were included in this analysis. Tumour subtypes were as follows: 50.0% solid, 16.4% acinar, 9.1% papillary, 7.3% lepidic, 1.8% micropapillary, 15.4% other. 70 patients received systemic treatment and 40 were treated surgically. The mean primary-tumour-SUV for all patients was 11.1 (for patients treated medically, 13.5, and for those treated surgically, 8.6). Ki67 expression in the tumour was lowest in the group with SUV < 10 (38.6%) and highest in the group with SUV > 20 (56.0). The group with SUV 11-19 had a moderate Ki67 expression (47.9%). In patients with surgical tumour samples there was a trend towards higher SUV in patients with tumours showing 30% or more solid growth pattern (mean SUV 11.4) and lower SUV in patients with any lepidic growth (mean SUV 4.0) (p=0.002). Systemic markers of inflammation were significantly higher in patients whose tumours had SUV>10 (mean CRP, 2.3 mg/dl; mean leukocytes, 9.7 G/L) than in patients with low-SUV tumours (<5) (mean CRP, 0.4 mg/dl, p=0.0186; mean leukocytes, 7.2 G/L, p=0.014).
Conclusion:
Multiple factors appear to be associated with higher or lower SUV values, including adenocarcinoma subtype, proliferation index of the tumour and systemic inflammation. These factors should be taken into account when interpreting FDG-PET-CT SUV values in clinical practice. The correlation of FDG-PET-CT SUV values with inflamed tumour phenotypes, and the possible predictive value of SUV for response to immune therapies, should be further investigated.
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-035 - Frequency and Clinical Relevance of EGFR-Mutations and EML4-ALK-Translocations in Octagenarians with NSCLC (ID 5923)
14:30 - 14:30 | Author(s): R. Huber
- Abstract
Background:
Novel therapies targeting genetic alterations have improved response rates and overall survival for some patients with NSCLC; however, only a minority of caucasian patients with lung cancer benefit from these treatments. Testing for EGFR mutation and ALK translocation is recommended for all patients with advanced adenocarcinoma, but the highest occurance of these driver mutations has been described in younger patients, females, and those with little or no smoking history. The frequency of driver mutations in elderly and very elderly patients has not been described.
Methods:
We reviewed the charts of all patients over age 70 treated at our centre in 2015 and assessed the frequency of EGFR and ALK testing. We report the frequency of EGFR and ALK alterations in patients aged 70-74 , 75-79 and >80 years.
Results:
Out of 179 patients diagnosed at our centre in 2015, 15 were 80 years or older at the time of first diagnosis and 7 of 15 had non-squamous histology. Among these very elderly patients, 3 patients were found to have EML4-ALK translocations and 2 patients were found to have EGFR mutation (1 Del19, 1 L858R). This represents a 71% frequency of treatable driver mutations in octagenarians with non-squamous NSCLC. Rates of genetic drivers were somewhat lower, but still clinically relevant, in non-squamous NSCLC patients aged 70-74 (27.0%) and 75-79 (26.7%).
Conclusion:
Very elderly patients (>80 years of age) with non-squamous NSCLC were found to have high rates of the driver alterations EGFR mutation and ALK translocation. This is clinically relevant, as this often frail and comorbid population may not be suitable for treatment with cytotoxic chemotherapy and may benefit from first line treatment with a targeted tyrosine kinase inhibitor. Testing for these genetic alterations should not be restricted to younger patients. The biology of lung cancer in the very elderly may differ from that of moderately elderly patients, as the longevity of these patients may select for individuals more resistant to, or with little exposure to, environmental carcinogens.
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-011 - Phase 2 Study of MM-121 plus Chemotherapy vs. Chemotherapy Alone in Heregulin-Positive, Locally Advanced or Metastatic NSCLC (ID 4158)
14:30 - 14:30 | Author(s): R. Huber
- Abstract
Background:
The role of the HER3 receptor and its ligand heregulin (HRG) in the progression of multiple cancers has been well established. Seribantumab (MM-121) is a fully human, monoclonal IgG2 antibody that binds to the HRG domain of HER3, blocking HER3 activity. The correlation between the level of HRG mRNA in tumor tissue and progression free survival (PFS) were retrospectively analyzed in three completed randomized Phase 2 studies of seribantumab plus standard of care (SOC) versus SOC alone (NSCLC, breast cancer and ovarian cancer). In each of these studies, high levels of HRG mRNA predicted shortened PFS for patients who received SOC treatment, while the addition of seribantumab to SOC improved PFS for patients with HRG-positive (HRG+) tumors. This is consistent with the hypothesis that HRG expression defines a drug tolerant cancer cell phenotype shielded from the effects of cytotoxic or targeted therapies and that blockade of HRG-induced HER3 signaling by seribantumab counters the effects of HRG on cancer cells, with the potential to improve outcomes for HRG+ patients. It is estimated that up to approximately 50% of cases of all solid tumor indications are HRG+. This HRG expression may contribute to rapid clinical progression in a subset of patients with poor prognosis.
Methods:
In the ongoing randomized, open-label, international, Phase 2 study, NSCLC patients with HRG+ tumors are being prospectively selected using a HRG RNA in situ hybridization assay performed on a recent tumor tissue sample collected via fine needle aspiration, core needle biopsy or excision. Approximately 560 patients will be screened to support enrollment of 280 HRG+ patients, who will be randomized in a 2:1 ratio to receive seribantumab plus investigator’s choice of docetaxel or pemetrexed, or docetaxel or pemetrexed alone. Patients will be wild-type for EGFR and ALK and will have progressed following one to three systemic therapies, one of which must be an anti-PD-1 or anti-PD-L1 therapy, for locally advanced and/or metastatic disease. Overall survival (OS) is the primary endpoint of the study and secondary endpoints include PFS, objective response rate and time to progression. Safety and health-related quality of life will also be assessed. An interim analysis is planned when 50% of final OS events have been reported. Enrollment has been initiated with approximately 80 sites expected to participate worldwide. Clinical Trials Registry number: NCT02387216
Results:
Section not applicable
Conclusion:
Section not applicable
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-013 - Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Central Assessment and Updates from ALTA, a Pivotal Randomized Phase 2 Trial (ID 4046)
14:30 - 14:30 | Author(s): R. Huber
- Abstract
Background:
Brigatinib, an investigational next-generation ALK inhibitor, has yielded promising activity in crizotinib-treated ALK+ NSCLC patients in a phase 1/2 trial (NCT01449461). As responses and adverse events (AEs) varied with starting dose, two brigatinib regimens are under evaluation in ALTA (NCT02094573).
Methods:
Patients with crizotinib-refractory advanced ALK+ NSCLC were randomized 1:1 to receive brigatinib at 90 mg qd (arm A) or 180 mg qd with a 7-day lead-in at 90 mg (arm B) and stratified by presence of brain metastases at baseline and best response to prior crizotinib. Primary endpoint was investigator-assessed confirmed ORR per RECIST v1.1.
Results:
222 patients were enrolled (arm A, n=112/arm B, n=110). Median age (A/B) was 51/57 years, 55%/58% were female, 74%/74% previously received chemotherapy, and 71%/67% had brain metastases. As of February 29, 2016, 64/112 (57%) patients in arm A and 76/110 (69%) patients in arm B were receiving brigatinib; median follow-up was 7.8/8.3 months. The Table shows investigator-assessed endpoints by arm and subgroup for select baseline characteristics. Independent review committee–assessed endpoints (A/B, n=112/n=110; as of May 16, 2016): confirmed ORR 48%/53%, median PFS 9.2/15.6 months. Any-grade treatment-emergent AEs (≥25% overall frequency; A/B, n=109/n=110 treated): nausea (33%/40%), diarrhea (19%/38%), headache (28%/27%), cough (18%/34%); grade ≥3 events (excluding neoplasm progression; ≥3% frequency): hypertension (6%/6%), increased blood CPK (3%/9%), pneumonia (3%/5%), increased lipase (4%/3%). A subset of pulmonary AEs with early onset (median onset: Day 2) occurred in 14/219 (6%) treated patients (3%, grade ≥3); 7/14 patients were successfully retreated. No such events occurred after escalation to 180 mg in arm B.
Conclusion:
In each arm, brigatinib yielded substantial responses and prolonged PFS, with an acceptable safety profile. 180 mg with 90 mg lead-in was not associated with increased early pulmonary events and showed a consistent improvement in efficacy, compared with 90 mg, particularly with respect to PFS.Investigator-Assessed Endpoints by Arm and Subgroup
Confirmed ORR, n/N(%) Median PFS, months Arm A B A+B A B A+B All patients 50/112(45) 59/110(54) 109/222(49) 9.2 12.9 11.1 Prior chemotherapy Yes 35/83(42) 44/81(54) 79/164(48) 8.8 12.9 11.8 No 15/29(52) 15/29(52) 30/58(52) 9.2 8.1 9.2 Race Asian 18/39(46) 18/30(60) 36/69(52) 8.8 11.1 11.1 Non-Asian 32/73(44) 41/80(51) 73/153(48) 9.2 12.9 11.8 Brain metastases at baseline Yes 31/80(39) 43/74(58) 74/154(48) 9.2 11.8 11.1 No 19/32(59) 16/36(44) 35/68(51) 7.4 15.6 15.6 Best response to prior crizotinib Partial+complete 36/71(51) 47/73(64) 83/144(58) 11.1 15.6 15.6 Other 14/41(34) 12/37(32) 26/78(33) 7.4 12.9 9.2 ORR=objective response rate PFS=progression-free survival
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SC18 - Precision Screening for Lung Cancer (ID 342)
- Event: WCLC 2016
- Type: Science Session
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:A. Nicholson, G. Ostoros
- Coordinates: 12/06/2016, 16:00 - 17:30, Lehar 1-2
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SC18.03 - Lung Cancer Screening, COPD and Cardiovascular Diseases (ID 6673)
16:40 - 17:00 | Author(s): R. Huber
- Abstract
- Presentation
Abstract not provided
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