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Lin Deng



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    MA11 - Immunotherapy in Special Populations and Predictive Markers (ID 135)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      MA11.06 - A PII Study of Toripalimab, a PD-1 mAb, in Combination with Chemotherapy in EGFR+ Advanced NSCLC Patients Failed to Prior EGFR TKI Therapies (Now Available) (ID 1160)

      14:00 - 15:30  |  Author(s): Lin Deng

      • Abstract
      • Presentation
      • Slides

      Background

      EGFR TKI is the standard 1st line therapy for the patients (pts) with advanced NSCLC harboring EGFR mutations. While PD-1 checkpoint blockade has become an integral component of disease management for EGFR wild type NSCLC pts at various settings, platinum-based chemotherapy is still the standard of care for EGFR mutated NSCLC pts who progress after EGFR targeting therapy. Early attempts to combine EGFR TKI with checkpoint blockade had resulted in exacerbated immune related toxicity in the lung. Here we aimed to prospectively evaluate toripalimab, a humanized PD-1 mAb approved for 2nd line treatment of melanoma, in combination with chemotherapy to treat EGFR mutated NSCLC pts after failure of EGFR targeting therapy.

      Method

      This is a phase II, multicenter, open-label, single-arm study for pts with EGFR activating mutations who have failed prior EGFR-TKI therapies without T790M mutation or failed osimertinib treatment. Pts were treated with 240mg or 360mg fixed dose toripalimab once every 3 weeks in combination with carboplatin and pemetrexed for up to 6 cycles, followed by toripalimab plus pemetrexed maintenance therapy until disease progression or intolerable toxicity. Primary endpoint was objective response rate (ORR) at week 12 as assessed by investigator per RECIST v1.1 once every 6 weeks. Secondary endpoints were safety, ORR, DOR, DCR, TTR, PFS, OS, PK and immunogenicity.

      Result

      f14_2_1_3_pub.png

      Forty pts were enrolled from Apr 25, 2018 to March 22, 2019 with 52.5% female pts and a median age of 57.5. 57.5% pts harbored EGFR exon19 deletion while 42.5% pts had exon21 L858R mutation. Only 1 pt had T790M mutation who progressed after osimertinib treatment. In ITT population, 13 confirmed partial response (PR) and 22 stable disease (SD) were observed at week 12 for a 32.5% ORR. As of Jul 25 2019, among 40 pts, 20 confirmed PR and 15 SD were observed for a 50% ORR (95% CI, 33.8% to 66.2%) and an 87.5% DCR (95% CI, 73.2% to 95.8%). Median progression free survival (PFS) was 7.0 months, and median duration of response (DOR) was 7.0 months. Treatment emergent adverse events (TEAE) occurred in 39 (97.5%) of the pts, grade 3 or higher events occurred in 25 (62.5%) of pts including two deaths. Most common AE included leukopenia, neutropenia, thrombocytopenia, anemia, nausea, and loss of appetite. Treatment discontinuation due to AE occurred in 4 (10%) of the pts.

      Conclusion

      Anti-PD-1 mAb, toripalimab in combination with carboplatin and pemetrexed has shown a promising anti-tumor efficacy with a tolerable safety profile for advanced NSCLC patients with EGFR mutated who progressed after EGFR TKI therapies. Pts will be continuously monitored for safety and efficacy readouts (DOR, PFS and OS). A phase III registration study will be initiated in May 2019.

      (Clinical trial information: NCT03513666)

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    P1.13 - Staging (ID 181)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Staging
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.13-03 - Lung Adenocarcinomas Manifesting as Radiological Part-Solid Nodules Define a Special Clinical Subtype (ID 35)

      09:45 - 18:00  |  Author(s): Lin Deng

      • Abstract

      Background

      According to guidelines from the Fleischner Society in 2017, subsolid nodules are categorized into pure ground glass nodules (pGGNs) having only a GGO component and part-solid nodules having both GGO and solid components on thin-section computed tomography (TS-CT). Persistent part-solid nodules with solid components ≥ 6mm should be considered highly suspicious.Clinicopathologic features and prognostic predictors of radiological part-solid lung adenocarcinomas were unclear.

      Method

      We retrospectively compared clinicopathologic features and survivals of part-solid tumors with those of pure ground glass nodules (pGGNs) and pure solid tumors receiving surgery at Fudan University Shanghai Cancer Center, and evaluated prognostic implications of consolidation-to-tumor ratio (CTR), solid component size and tumor size for part-solid lung adenocarcinomas.

      figure 1副本.png

      Result

      911 patients and 988 pulmonary nodules (including 329 part-solid nodules (PSNs), 501 pGGNs & 158 pure solid nodules) were analyzed. More female patients (P=0.015) and non-smokers (P=0.003) were seen in PSNs than those in pure solid nodules. Prevalence of lymphatic metastasis was lower in PSNs than that in pure solid tumors (2.2% vs 27%, P=0.000). 5-year lung cancer specific recurrence free survival (LCS-RFS) and overall survival (OS) of PSNs were worse than those of pGGNs (P<0.001; P=0.042), but better than those of pure solid tumors (P<0.001; P<0.0001), respectively. CTR (OR: 12.90; 95% CI: 1.85-90.04), solid component size (OR: 1.45; 95% CI: 1.28-1.64) and tumor size (OR: 1.23; 95% CI: 1.15-1.31) could predict pathologic invasive adenocarcinoma for PSNs. None of them could predict the prognosis. Patients receiving sublobar resection had comparable prognoses with those receiving lobectomy (5-year LCS-RFS: P=0.178; 5-year LCS-OS: P=0.319). Prognostic differences between patients with systemic lymph node dissection (sLND) and those without sLND were statistically insignificant.

      Table1 Baseline clinicopathologic characteristics of objects in this study

      All

      N=988

      Part Solid nodule

      N=329

      Pure Ground Glass nodule

      N=501

      Pure Solid nodule

      N=158
      P value
      Age (Mean±SD) 56.49±10.83 58.89±9.71 53.64±10.86 60.54±10.52 0.000
      Gender 0.015
      Male 277(30.4) 91 (28.9) 124 (28.2) 62 (39.5)
      Female 634(69.6) 224 (71.1) 315 (71.8) 95 (60.5)
      Smoking status 0.003
      Smoker 153(16.8) 52 (16.5) 62(14.1) 39(24.8)
      Non-smoker 758(83.2) 263(83.5) 377(85.9) 118(75.2)
      Tumor size(mm) 15.14±7.38 20.51±7.18 10.22±3.84 19.54±5.58 0.000
      Location 0.009
      RUL 364 (36.8) 126 (38.3) 197 (39.3) 41 (25.9)
      RML 67 (6.8) 21 (6.4) 29 (5.8) 17 (10.7)
      RLL 181 (18.3) 48(14.6) 93 (18.6) 40 (25.3)
      LUL 266 (26.9) 98 (29.8) 130 (25.9) 38 (24)
      LLL 110 (11.2) 36 (10.9) 52 (10.4 ) 22 (14.1)
      Surgery 0.000
      Wedge resection 456(46.2) 72(21.9) 370(73.8) 14(8.9)
      Segmentectomy 97(9.8) 33(10.0) 58(11.6) 6(3.8)
      Lobectomy 435(44.0) 224(68.1) 73(14.6) 138(87.3)
      Pathology 0.000
      AIS/MIA 509(51.5) 56(17.0) 447(89.2) 6(3.8)
      IAD 479(48.5) 273(83.0) 54(10.8) 152(96.2)
      Lepidic predominant 154(32.6) 104(38.8) 30(55.5) 30(55.5) 0.000
      Solid/Micropapillary predominant 21(4.5) 4(1.5) 1(1.9) 16(3.4) 0.000
      Acinar/Papillary predominant 290(61.4) 157(58.6) 22(40.7) 111(74.0) 0.000
      Mucinous adenocarcinoma 7(1.5) 3(1.1) 1(1.9) 3(2.0) 0.753
      Pathologic N status 0.000
      N0 904 (94.9) 305(97.8) 488 (100) 111(73)

      N1/2 48(5.1) 7(2.2) 0 (0) 41 (27)
      Conclusion

      Part-solid lung adenocarcinoma showed different clinicopathologic features compared with pure solid tumor. CTR, solid component size and tumor size could not predict the prognosis. Part-solid lung adenocarcinomas define one special clinical subtype.