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Poster Display session 1

4256 - Long-term avelumab treatment in patients with advanced non-small cell lung cancer (NSCLC): post hoc analyses from JAVELIN Solid Tumor

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Borys Hrinczenko

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

B. Hrinczenko1, D. Spigel2, N. Iannotti3, H.P. Safran4, M.H. Taylor5, J. Bennouna6, S. Goel7, J. Leach8, D.J. Wong9, K. Kelly10, C. Verschraegen11, M. Bajars12, J. Manitz13, M. Ruisi14, J.L. Gulley15

Author affiliations

  • 1 Division Of Hematology/oncology, Michigan State University, MI 48910 - Michigan/US
  • 2 Lung Cancer Research Program, Sarah Canon Research Institute, Nashville/US
  • 3 Medical Oncology, Hematology/Oncology Associates of the Treasure Coast, Port St Lucie/US
  • 4 Hematology Oncology, Lifespan Cancer Institute, Providence/US
  • 5 Phase 1 Clinical Trials, OHSU Knight Cancer Institute - Northwest Portland, 97210 - Portland/US
  • 6 Digestive And Lung Oncology Department, CHU du Nantes - Hôtel-Dieu, 44093 - Nantes/FR
  • 7 Medical Oncology, Montefiore Medical Center(East campus) - Medical Park at Eastchester Albert Einstein Cancer Center, 10461 - Bronx/US
  • 8 Oncology Research, Virginia Piper Cancer Institute, Minneapolis/US
  • 9 Medicine, Hematology/oncology, UCLA - School of Medicine, 90095 - Los Angeles/US
  • 10 University Of California, Davis Comprehensive Cancer Center, Sacramento/US
  • 11 Division Of Medical Oncology, Ohio State University Comprehensive Cancer Center, Columbus/US
  • 12 Global Clinical Development, EMD Serono, Inc, Billerica/US
  • 13 Global Biostatistics, EMD Serono, Inc, Billerica/US
  • 14 Global Clinical Development, EMD Serono, Billerica/US
  • 15 Genitourinary Malignancies Branch And Laboratory Of Tumor Immunology And Biology, Center For Cancer Research, National Cancer Institute, 20892 - Bethesda/US

Resources

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Abstract 4256

Background

Avelumab, a human IgG1 anti–PD-L1 monoclonal antibody, is an approved treatment for metastatic Merkel cell carcinoma and platinum-treated urothelial carcinoma. We performed descriptive post hoc analyses to explore characteristics of patients with NSCLC from the JAVELIN Solid Tumor phase I trial (NCT01772004) who received long-term avelumab treatment (>2-yrs) as a surrogate for long-term clinical benefit.

Methods

Patients with NSCLC were pooled from 2 dose-expansion cohorts enrolled with no prior treatment for metastatic/recurrent disease (first-line [1L]) or with disease progression after prior platinum doublet therapy (second-line [2L]). PD-L1 expression in tumor cells was assessed using the Dako 73-10 assay.

Results

As of 24 Oct 2018, duration of avelumab treatment was >2-yrs in 35 of 340 patients (10.3%) and ≤2-yrs in 305 of 340 (89.7%). At baseline (data cutoff: 15 Feb 2017), patients who subsequently received >2-yr vs ≤ 2-yr treatment had a higher proportion with prior radiotherapy (51.4% vs 37.0%), better performance status (ECOG PS 0 in 37.1% vs 28.9%), a lower proportion with liver (11.4% vs 19.0%) or bone (14.3% vs 22.3%) metastases, and a smaller tumor burden (median, 52 vs 70 mm). A higher proportion of patients with >2-yr vs ≤ 2-yr treatment had clinical benefit (response or stable disease) on prior chemotherapy (40.0% vs 25.9%, respectively; not applicable in 31.4% vs 39.7%; not evaluable in 17.1% vs 8.2%). The proportion with PD-L1+ tumors was comparable in those with >2-yr or ≤ 2-yr treatment using PD-L1 cutoffs of ≥ 1% (68.6% vs 61.0%) and ≥80% (25.7% vs 23.0%), although a high proportion were nonevaluable for PD-L1 expression (25.6%). Of patients with >2-yr treatment, 18 continued treatment after RECIST-defined progression and had a decrease in tumor burden or maintained clinical benefit.

Conclusions

Retrospective post hoc analyses suggest that patients with NSCLC who had long-term benefit with 1L or 2L avelumab had better performance status, less aggressive disease, prior radiotherapy, and previous benefit on chemotherapy at baseline.

Clinical trial identification

NCT01772004.

Editorial acknowledgement

ClinicalThinking; funded by Merck Healthcare KGaA and Pfizer Inc.

Legal entity responsible for the study

Merck Healthcare KGaA.

Funding

Merck Healthcare KGaA and Pfizer Inc.

Disclosure

B. Hrinczenko: Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): Merrimack Pharma; Research grant / Funding (institution): Endocyte; Research grant / Funding (institution): Amgen. D. Spigel: Leadership role: Cetennial Medical Center; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): AbbVie; Advisory / Consultancy, Research grant / Funding (institution): Foundation Medicine; Advisory / Consultancy, Research grant / Funding (institution): GlaxoSmithKline; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck & Co.; Advisory / Consultancy: Moderna Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Nektar; Advisory / Consultancy, Research grant / Funding (institution): Takeda; Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: TRM Oncology; Advisory / Consultancy: Precision Oncology; Advisory / Consultancy: Evelo Therapeutics; Advisory / Consultancy: Illumina; Advisory / Consultancy: PharmaMar; Research grant / Funding (institution): University of Texas Southwestern Medical Center - Simmons Cancer Center; Research grant / Funding (institution): G1 Therapeutics; Research grant / Funding (institution): Neon Therapeutics; Research grant / Funding (institution): Celldex; Research grant / Funding (institution): Clovis Oncology; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution), Travel / Accommodation / Expenses: EMD Serono; Research grant / Funding (institution): Acerta Pharma; Research grant / Funding (institution): Oncogenex; Research grant / Funding (institution): Astellas Pharma; Research grant / Funding (institution): GRAIL; Research grant / Funding (institution): Transgene; Research grant / Funding (institution): Aeglea Biotherapeutics; Research grant / Funding (institution): Tesaro; Research grant / Funding (institution): Ipsen; Research grant / Funding (institution): ARMO BioSciences; Research grant / Funding (institution): Millennium; Travel / Accommodation / Expenses: Genzyme; Travel / Accommodation / Expenses: Intuitive Surgical; Travel / Accommodation / Expenses: Purdue Pharma; Travel / Accommodation / Expenses: Spectrum Pharmaceuticals; Research grant / Funding (institution): Sysmex. M.H. Taylor: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eisai ; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Blueprint; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Loxo; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Array ; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: ArQule, Inc. J. Bennouna: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): Merck KGaA. S. Goel: Research grant / Funding (institution): EMD Serono. J. Leach: Full / Part-time employment, Employed as of Sep 2016 to Sep 2017: PRA Health Sciences ; Research grant / Funding (institution): Dynarax ; Research grant / Funding (institution): Geistlich . D.J. Wong: Research grant / Funding (institution): EMD Serono; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Merck & Co.; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): KURA Oncology; Research grant / Funding (institution): Roche-Genentech; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Regeneron; Research grant / Funding (institution): FSTAR; Research grant / Funding (institution): Astellas. K. Kelly: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck & Co.; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AbbVie; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): EMD Serono; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Genentech; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Research grant / Funding (self): Regeneron; Research grant / Funding (self): Five Prime; Travel / Accommodation / Expenses: Lilly; Licensing / Royalties: UpToDate. M. Bajars: Full / Part-time employment: EMD Serono. J. Manitz: Full / Part-time employment: EMD Serono. M. Ruisi: Full / Part-time employment: EMD Serono. J.L. Gulley: Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): Bavarian Nordic; Research grant / Funding (institution): Astellas Medivation; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): NantBioScience; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Merck & Co. All other authors have declared no conflicts of interest.

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