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Pasi Antero Jänne



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    FP01 - Early Stage/Localized Disease (ID 111)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP01.05 - The ASCENT Trial: A Phase II Study of Neoadjuvant/Adjuvant Afatinib, Chemoradiation +/- Surgery for Stage III EGFR-Mutant NSCLC (ID 3752)

      00:00 - 00:00  |  Author(s): Pasi Antero Jänne

      • Abstract
      • Slides

      Introduction

      The ADAURA trial showed benefit to adjuvant osimertinib in stage III EGFR-mutant (EGFRm) NSCLC, but the role of TKI induction is unknown. In 2011, we began ASCENT, a phase II trial of neoadjuvant and adjuvant afatinib in addition to standard of care (SOC) curative-intent therapy for EGFRm stage III NSCLC (NCT01553942). The study closed early for slow accrual. This is the final analysis.

      Methods

      ASCENT enrolled patients with EGFRm, stage IIIA/B (AJCC 7th ed.) NSCLC amenable to curative-intent chemoradiation therapy (CRT) ± surgery. Resectability was determined by the treating multidisciplinary team at diagnosis. Patients received neoadjuvant afatinib 40mg QD x 2 months, then concurrent CRT (up to 4 cycles of cisplatin/pemetrexed and 3D conformal RT or intensity-modulated RT personalized to tumor size, site, operability) +/- surgery and an optional 2 years of adjuvant afatinib. The primary outcome was objective response rate (ORR) to neoadjuvant afatinib. Major pathologic response (MPR) was defined as < 10% residual tumor at resection, complete pathologic response (CPR) as no residual tumor.

      Results

      19 patients (14F/5M), median age 56 (range 34-75) were enrolled. 12 had EGFR del19, 7 L858R. 10 were classified as potentially resectable stage IIIA at diagnosis, 9 as unresectable IIIA/B. All completed two months of neoadjuvant afatinib; 5 (26%) required afatinib dose reduction. The ORR after neoadjuvant afatinib was 11/19 (58%; 95% CI, 33-80%). 1 patient initially deemed inoperable became a surgical candidate based on response to neoadjuvant afatinib; 2 patients progressed on neoadjuvant afatinib or exhibited findings that clarified their presenting stage as IV; both discontinued the protocol. The remaining 17 patients proceeded to CRT with pre-op median radiotherapy dose of 54 Gy (range 45-66; n=10), definitive median dose of 67 Gy (range 63-72; n=7). Among 10 patients who underwent resection (all via lobectomy), the MPR rate was 70% (6 MPR, 1 CPR). 13 (68%) patients started adjuvant afatinib after surgery (7) or definitive CRT (6); 4 completed 2 years, 3 discontinued early (median 1.5 months), 2 recurred during adjuvant afatinib and 4 remain on adjuvant therapy. Key grade 3/4 toxicities included rash (n=6), diarrhea (5), esophagitis (3), nausea (3), pneumonitis (2) and febrile neutropenia (1); there were no treatment-related deaths. With median follow-up of 30.6 months (range 3.1-96.3), 9 (47%) patients have recurred, with 5/9 having CNS-only recurrence. Recurrences occurred in 3/10 surgical patients and 5/7 definitive CRT patients. Median PFS was 34.6 months (95% CI 16.9-66.1) and median OS was 69.1 months (95% CI 29.4-NR). 2-year OS is 88% (95% CI 59-97%).

      Conclusion

      In stage III EGFRm NSCLC, 2 months of neoadjuvant afatinib is associated with an ORR comparable to that seen in advanced disease and does not impair receipt of SOC chemoradiotherapy ± surgery. PFS and OS are favorable in this single-arm study. The high rate of CNS-only recurrence highlights a potential for improved outcomes with more CNS-penetrant EGFR TKIs. Along with the interim results of ADAURA, these results support genotype-directed therapies in stage III EGFRm NSCLC, though the optimal sequence of TKI therapy will need to be defined.

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    IS03 - Industry Symposium Sponsored by Daiichi-Sankyo: Antibody Drug Conjugates (ADC) as Therapeutic Options for Advanced NSCLC: Opportunities and Challenges (ID 279)

    • Event: WCLC 2020
    • Type: Industry Symposium
    • Track:
    • Presentations: 1
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      IS03.03 - Emerging ADC Targets for the Treatment of Late-Line NSCLC (ID 4317)

      11:45 - 12:45  |  Presenting Author(s): Pasi Antero Jänne

      • Abstract

      Abstract not provided

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    MA11 - Expanding Targetable Genetic Alterations in NSCLC (ID 251)

    • Event: WCLC 2020
    • Type: Mini Oral
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
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      MA11.03 - Trastuzumab Deruxtecan in HER2-Mutated Metastatic Non-Small Cell Lung Cancer (NSCLC): Interim Results of DESTINY-Lung01 (ID 1587)

      14:15 - 15:15  |  Author(s): Pasi Antero Jänne

      • Abstract

      Introduction

      Trastuzumab deruxtecan (T-DXd) is a novel antibody-drug conjugate composed of an anti-HER2 antibody, cleavable tetrapeptide-based linker, and topoisomerase I inhibitor payload. In a phase 1 trial, patients with HER2-mutated non-small cell lung cancer (NSCLC) who received T-DXd had a confirmed objective response rate (ORR) of 72.7% (8/11) (Tsurutani et al, Cancer Discov 2020). DESTINY-Lung01 (NCT03505710) is an ongoing, multicenter, phase 2 study of T-DXd in patients with non-squamous NSCLC overexpressing HER2 or containing a HER2-activating mutation. We report data for the cohort with HER2-activating mutations after a median follow-up of 8.0 mo (range, 1.4-14.2 mo). This abstract was previously presented at ASCO 2020.

      Methods

      Patients were treated with T-DXd 6.4 mg/kg every 3 weeks. The primary endpoint was confirmed ORR (complete response [CR] + partial response [PR]) by independent central review (ICR). Additional endpoints were disease control rate (DCR; CR + PR + stable disease), duration of response (DOR), progression-free survival (PFS), and safety.

      Results

      Updated data to be presented at the meeting. At data cutoff (25 Nov 2019), 42 patients (64.3% female) had received T-DXd. Median age was 63.0 years (range, 34-83 years; < 65 y, 59.5%); 45.2% had CNS metastases; ECOG performance status was 0 in 23.8% of patients and 1 in 76.2%. HER2 mutations were predominantly in the kinase domain (90.5%). Most patients (90.5%) had prior platinum-based chemotherapy and 54.8% had anti–PD-1 or –PD-L1 treatment. The median number of prior treatment lines was 2 (range, 1-6). Median treatment duration was 7.75 mo (range, 0.7-14.3 mo); 45.2% of patients remained on treatment.

      Confirmed ORR by ICR among the 42 patients was 61.9% (95% CI, 45.6%-76.4%). At data cutoff, median DOR was not reached, and 16 of 26 responders remained on treatment. DCR was 90.5% (95% CI, 77.4%-97.3%) and estimated median PFS was 14.0 mo (95% CI, 6.4-14.0 mo).

      All patients (42/42) had treatment-emergent adverse events (TEAEs); 64.3% were grade ≥ 3 (52.4% drug-related), including decreased neutrophil count (26.2%) and anemia (16.7%). There were 5 cases (11.9%) of drug-related interstitial lung disease (ILD) as adjudicated by an independent committee (all grade 2, no grade ≥ 3) and 1 case of grade 1 ILD is pending adjudication. TEAEs led to dose interruption in 25 patients (59.5%), dose reduction in 16 patients (38.1%), and treatment discontinuation in 10 patients (23.8%).

      Conclusion

      T-DXd demonstrated promising clinical activity with high ORR and durable responses in patients with HER2-mutated NSCLC. The safety profile was generally consistent with previously reported studies.

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    OA04 - New Data from Rare EGFR Alterations (ID 223)

    • Event: WCLC 2020
    • Type: Oral
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 2
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      OA04.03 - Mobocertinib in NSCLC With EGFR Exon 20 Insertions: Results From EXCLAIM and Pooled Platinum-Pretreated Patient Populations (ID 3186)

      11:45 - 12:45  |  Author(s): Pasi Antero Jänne

      • Abstract

      Introduction

      Mobocertinib is a potent first-in-class tyrosine kinase inhibitor (TKI) designed to target EGFR exon 20 insertion (EGFRex20ins) mutations. We report first results from the EXCLAIM extension cohort of a phase 1/2 study (NCT02716116) and results in patients with EGFRex20ins-mutant NSCLC who received prior platinum-based therapy from the dose-escalation/expansion parts of the study and the EXCLAIM extension cohort.

      Methods

      This 3-part, open-label, multicenter study included dose-escalation/expansion cohorts and the EXCLAIM extension cohort. Data are presented for all patients treated in EXCLAIM (N=96) and for platinum-pretreated patients from the dose-escalation/expansion cohorts (n=28) and from EXCLAIM (n=86); all received mobocertinib 160 mg orally QD. Enrolled patients had locally advanced/metastatic EGFRex20ins NSCLC, ECOG performance status 0–1, and ≥1 prior line of therapy for locally advanced/metastatic disease. The primary endpoint is confirmed ORR assessed by IRC per RECIST v1.1.

      Results

      In EXCLAIM, 96 patients were enrolled and treated; median age, 59 years [range: 27–80]; female, 65%; Asian, 69%; ≥2 prior systemic anticancer lines, 49% (range: 1–4). Median time on treatment was 6.5 months (range: 0–14). Confirmed ORR was 23% (22/96; 95% CI: 15%–33%) per IRC and 32% (95% CI: 23%–43%) per investigator; median DoR (Kaplan-Meier estimates) was not mature; median PFS was 7.3 months. See Table. In the analysis of platinum-pretreated patients (n=114), median age, 60 years [range: 27–84]; female, 66%; Asian, 60%; ≥2 prior systemic anticancer lines, 59% (range: 1–7). Median time on treatment was 7 months (range: 0–31); 38 patients (33%) remained on treatment as of 29-May-2020. Confirmed ORR was 26% (30/114; 95% CI: 19%–35%) per IRC and 35% (40/114; 26%–45%) per investigator. Median PFS was 7.3 months: 12-month PFS rate was 33% (95% CI: 21%–47%). Responses were observed among all prespecified subgroups, including Asian/non-Asian patients and those with/without baseline stable brain metastases. The most common treatment-related adverse events (TRAEs; ≥30%): diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), decreased appetite (32%), dry skin (30%), and vomiting (30%); grade ≥3 TRAEs (≥5%): diarrhea (22%), anemia (5%), and dyspnea (5%). Nineteen patients (17%) discontinued due to AEs, most commonly diarrhea (4%) and nausea (4%). The safety profile observed in EXCLAIM was largely consistent with that observed in the platinum-pretreated population.

      table for submission.jpg

      Conclusion

      Mobocertinib demonstrated clinically meaningful benefit in previously treated patients with NSCLC and EGFRex20ins mutations, with a manageable safety profile.

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      OA04.05 - Trastuzumab Deruxtecan in HER2-Overexpressing Metastatic Non-Small Cell Lung Cancer: Interim Results of DESTINY-Lung01 (ID 1419)

      11:45 - 12:45  |  Author(s): Pasi Antero Jänne

      • Abstract

      Introduction

      Trastuzumab deruxtecan (T-DXd) is a novel antibody-drug conjugate composed of an anti-HER2 antibody, cleavable tetrapeptide-based linker, and topoisomerase I inhibitor payload. DESTINY-Lung01 (NCT03505710) is an ongoing, multicenter, phase 2 study evaluating T-DXd in 2 separate cohorts of patients with unresectable and/or metastatic nonsquamous non-small cell lung cancer (NSCLC): overexpressing HER2 (centrally confirmed, IHC 2+ or 3+) or containing a HER2-activating mutation. We have previously shown promising activity of T-DXd in patients with HER2-mutated NSCLC (confirmed objective response rate [cORR] by independent central review [ICR], 61.9%; Smit ASCO 2020). Here we report data from an interim analysis of the HER2-overexpressing cohort.

      Methods

      Patients with HER2-overexpressing metastatic NSCLC were treated with T-DXd 6.4 mg/kg every 3 weeks. The primary endpoint was ORR (CR + PR) by ICR. Additional endpoints were disease control rate (DCR; CR + PR + stable disease), duration of response (DOR), progression-free survival (PFS), and safety.

      Results

      At data cutoff (May 31, 2020), 49 patients had received T-DXd. Median age was 63 years (range, 37-85 years); 61.2% were male; 34.7% had CNS metastases at enrollment; 32.7% were never-smokers. 79.6% of patients (n=39) had HER2 IHC 2+ and 20.4% (n = 10) had HER2 IHC 3+. 91.8% of patients had received prior platinum-based chemotherapy and 73.5% had received anti−PD-1/PD-L1 treatment; median number of prior regimens was 3 (range, 1-8). Median treatment duration was 18.0 weeks (range, 3.0-57.1 weeks); 22.4% of patients remained on treatment.

      Confirmed ORR by ICR was 24.5% (95% CI, 13.3%-38.9%), including 1 CR and 11 PRs; IHC 2+, 25.6% (95% CI, 13.0%-42.1%); IHC 3+, 20.0% (95% CI, 2.5%-55.6%). Median DOR was 6.0 months (95% CI, 3.2-NE months); DCR was 69.4% (95% CI, 54.6%-81.8%); estimated median PFS was 5.4 months (95% CI, 2.8-7.0 months).

      All patients had ≥ 1 treatment-emergent adverse event (TEAE); the most common any-grade TEAEs were nausea (59.2%), decreased appetite (38.8%), and fatigue (32.7%). Grade ≥ 3 TEAEs were reported in 73.5% of patients (55.1% drug-related); the most common were decreased neutrophil count (20.4%) and fatigue (10.2%). There were 8 cases (16.3%) of drug-related interstitial lung disease (ILD) as adjudicated by an independent committee (grade 1, n = 2; grade 2, n = 3; grade 5, n = 3). TEAEs were associated with dose interruption in 26 patients (53.1%), dose reduction in 17 patients (34.7%), and treatment discontinuation in 11 patients (22.4%).

      Conclusion

      In this interim analysis, T-DXd demonstrated preliminary evidence of antitumor activity in heavily pretreated patients with HER2-overexpressing NSCLC. The safety profile of T-DXd was generally manageable, but ILD remains a known serious risk that requires proactive monitoring and care. An additional cohort to evaluate T-DXd 5.4 mg/kg in patients with HER2-overexpressing NSCLC has opened and started enrollment to further understand and characterize the safety and efficacy profile of T-DXd in this population.

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    P01 - Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics (ID 227)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics
    • Presentations: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P01.03 - Phase 1 Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Combination with Osimertinib in Patients with Locally Advanced or Metastatic EGFR-mutated NSCLC (ID 3576)

      00:00 - 00:00  |  Presenting Author(s): Pasi Antero Jänne

      • Abstract
      • Slides

      Introduction

      Although first-line treatment with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib has improved survival for patients with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC), acquired resistance to osimertinib remains an unmet medical need. HER3 is expressed in the majority of EGFRm NSCLC. Patritumab deruxtecan is a novel, investigational HER3 directed antibody drug conjugate which has demonstrated preliminary single-agent activity in EGFRm NSCLC. In preclinical models of EGFRm NSCLC, osimertinib has been shown to increase membrane HER3 expression, increase the rate of internalization of patritumab deruxtecan, and enhance tumor growth inhibition by patritumab deruxtecan. These observations suggest that patritumab deruxtecan in combination with osimertinib might improve tumor response in patients who have progressed on osimertinib therapy. This Phase 1 study (U31402-A-U103) evaluates patritumab deruxtecan in combination with osimertinib, focusing on patients with locally advanced or metastatic EGFRm NSCLC who have progressed on first-line osimertinib therapy.

      Methods

      This is an open-label, 2-part study of patritumab deruxtecan in combination with osimertinib. Patients will be enrolled at ~40 study sites across North America, Europe, and Asia. In the Dose Escalation part, patients with locally advanced or metastatic NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) and progression during or after treatment with osimertinib will be enrolled. Patients will receive 1.6, 3.2, 4.8, or 5.6 mg/kg patritumab deruxtecan intravenously (IV) every 3 weeks (Q3W) in combination with 40 or 80 mg osimertinib orally (PO) once daily (QD). Patients will be enrolled in each cohort as guided by safety (dose-limiting toxicities) using a Bayesian logistic regression model. The primary objectives in the Dose Escalation part are the assessment of safety and tolerability of the combination and identification of a recommended combination dose (RCD). In the Dose Expansion part, patients will be randomized 1:1 to receive either patritumab deruxtecan and osimertinib at the RCD (Arm 1, ~60 patients) or patritumab deruxtecan 5.6 mg/kg IV Q3W (Arm 2, ~60 patients). A third arm (Arm 1b, ~60 patients) might be added to study 2 provisional RCDs. The primary objective in Dose Expansion (Arms 1, 2, and 1b) is further evaluation of efficacy of the combination. The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR). Other efficacy assessments will include ORR by investigator assessment; duration of response, disease control rate, time to response, progression-free survival as assessed by BICR and investigator; and overall survival. If the RCD includes an osimertinib dose of 80 mg PO QD, approximately 30 patients without prior treatment in the locally advanced or metastatic setting will also be enrolled and treated at the RCD in a separate cohort (Cohort 3); the primary objective is evaluation of safety and tolerability. A tumor sample after progression on osimertinib (or prior to study entry for Cohort 3) is required for all patients for retrospective evaluation of HER3 and other biomarker analyses. Estimated total study duration is 42 months. The study is estimated to begin in 2021.

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      P01.04 - Dynamics of Molecular Markers in EGFR-Mutated NSCLC Patients Treated with Patritumab Deruxtecan (HER3-DXd; U3-1402) (ID 3570)

      00:00 - 00:00  |  Presenting Author(s): Pasi Antero Jänne

      • Abstract
      • Slides

      Introduction

      Patritumab deruxtecan is an investigational human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate (ADC) with a topoisomerase I inhibitor payload, and it has shown preliminary antitumor activity in patients with previously treated metastatic or locally advanced epidermal growth factor receptor (EGFR)-mutated non–small cell lung cancer (NSCLC) in an ongoing phase 1 study (NCT03260491). Here we present initial observations from comprehensive genomic profiling in tumor tissue and circulating tumor DNA (ctDNA), tumor HER3 expression and its association with prior treatment and with the clinical activity of patritumab deruxtecan, and dynamic changes in a ctDNA panel during study treatment.

      Methods

      We evaluated tumor tissue and peripheral blood samples from 56 patients with EGFR-mutated NSCLC treated with 5.6 mg/kg patritumab deruxtecan (intravenously once every 3 weeks) after failure of EGFR tyrosine kinase inhibitor (TKI). Blood samples for ctDNA were collected before each dose and at the end of treatment. Pre-treatment tumor samples were evaluated by immunohistochemistry for HER3 expression. Genomic profiling of pre-treatment tumor tissue and analyses of ctDNA were performed using the Oncomine™ Comprehensive Assay v3 and the GuardantOMNI™ panel, respectively. In addition, serial ctDNA samples were analyzed using the Biodesix platform to detect changes in the presence of four types of EGFR mutated alleles: Ex19Del, L858R, T790M, and C797S.

      Results

      To be drafted when final data are available.

      Conclusion

      To be drafted when final data are available.

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    P34 - Pathology - Liquid Biopsy (ID 104)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P34.04 - Circulating Tumor DNA (ctDNA) as a Marker of Progressive Disease in Patients with Advanced Lung Cancer  (ID 3421)

      00:00 - 00:00  |  Author(s): Pasi Antero Jänne

      • Abstract
      • Slides

      Introduction

      ctDNA is a novel, non-invasive biomarker that is increasingly investigated and used in the care of patients with cancer. Early applications of this technology relied on its ability to identify the presence of clinically actionable mutations, e.g. the detection of EGFR sensitizing mutation at diagnosis. Recently, there has been growing interest in whether the longitudinal kinetics of this biomarker can predict clinically meaningful endpoints. Ongoing studies are investigating its potential role as a surrogate biomarker of response. However, its ability to predict progression has not been thoroughly investigated, outside of anecdotal data that EGFR T790M concentration levels rise earlier than radiographic progression in some patients progressing on erlotinib. Here, we investigate ctDNA’s ability to predict radiographic progression in advanced lung cancer patients receiving third-generation EGFR TKIs.

      Methods

      Three early-stage clinical trials of third-generation EGFR inhibitors performed at our institution in which patients underwent routine plasma monitoring and standard imaging were studied. Forty patients with detectable EGFR sensitizing mutation (L858R=27.5%; Exon 19 Deletion= 72.5%) in plasma at baseline were analyzed. All patients had stage IV non-small cell lung cancer (NSCLC) and had experienced past progression on EGFR TKI; 92.5% of patients had histopathology-confirmed EGFR T790M mutation at the start of trial. Retrospective analysis was performed to identify date of progressive disease (as defined by RECIST1.1 criteria). ctDNA was assessed via digital droplet PCR and analyzed to identify the date of “plasma progression”, defined as any rise of EGFR sensitizing mutation relative to the prior draw or lack of at least a 50% decrease in ctDNA concentration by the first day of cycle two (21-day cycles).

      Results

      Plasma progression was identified at or before radiographic progression in thirty-three of forty patients (82.5%). Of the ten patients with CNS only progression, plasma progression was identified in 60% of those at or before radiographic progression. Of the thirty patients who had non-CNS progression, plasma progression was identified in 90% of those at or before radiographic progression. Plasma progression occurred at a median of 0.95 months (Range: 0-9.7 months) before radiographic progression in our cohort. Of thirty-two plasma progression events called where a subsequent ctDNA draw was available in the absence of clinical change between results, there were only five “false positives” where the subsequent draw had undetectable ctDNA.

      Conclusion

      These data identify the rise in circulating tumor DNA, “plasma progression”, as a strong predictor of radiographic progressive disease in patients with EGFR mutant NSCLC undergoing targeted therapy with third generation TKIs. Plasma progression was highly sensitive at capturing radiographic progression in non-CNS progression, though its lower performance overall in the subset of patients with CNS only progression is consistent with prior data of low systemic ctDNA shed among CNS tumors (both primary and metastatic). These data lay the groundwork for future studies including the incorporation of ctDNA kinetics into routine clinical care, especially to identify and/or inform progressive disease. Further investigation into early plasma progression relative to radiographic progression may harbour interesting insights about mechanisms of resistance.

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    PS01 - Presidential Symposium (Japanese, Mandarin, Spanish Translation Available) (ID 143)

    • Event: WCLC 2020
    • Type: Plenary
    • Track: N.A.
    • Presentations: 1
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      PS01.08 - Discussant (ID 4252)

      07:00 - 09:00  |  Presenting Author(s): Pasi Antero Jänne

      • Abstract

      Abstract not provided

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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
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      PS02.08 - Discussant (ID 4291)

      18:00 - 20:00  |  Presenting Author(s): Pasi Antero Jänne

      • Abstract

      Abstract not provided