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  • NSCLC, metastatic
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NSCLC, metastatic

1176P - Open-label, dose escalation, phase I/II study to assess safety, tolerability, immunogenicity and preliminary clinical activity of the therapeutic cancer vaccine PDC*lung01 with or without anti-programmed death-1 (PD-1) treatment in patients with non-small cell lung cancer (NSCLC)

Presentation Number
1176P
Speakers
  • Johan F. Vansteenkiste (Leuven, Belgium)
Date
Mon, 12.09.2022

Abstract

Background

PDC*lung01 (IMP) is a therapeutic cancer vaccine consisting of an irradiated plasmacytoid dendritic cell line loaded with HLA-A*02:01 restricted peptides (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin and Melan-A) and able to prime and expand peptide-specific CD8+ T cells in vitro and in vivo, and is synergistic with anti-PD-1.

Methods

HLA-A*02 positive NSCLC patients are enrolled in 4 cohorts: resected stage II/IIIA in adjuvant setting treated with low dose (A1) or high dose (A2) of IMP as single agent following standard of care; or stage IV NSCLC with measurable disease, PD-L1 tumour proportion score ≥50% and no targetable driver mutation, treated with low dose (B1) or high dose (B2) of IMP in combination to pembrolizumab. The IMP is administered by subcutaneous and intravenous route weekly for 6 consecutive doses. Safety, tolerability and immune response are assessed and in addition clinical activity for B cohorts. We report here on the first 3 cohorts that have been completed.

Results

Of the 25 patients (6 in A1, 12 in A2 and 7 in B1) that started treatment, 22 received at least 5 doses and were evaluable. Treatment-related AEs were all Grade 1-2 and 1 Grade 3 with no dose-limiting toxicity (DLT) observed. Six patients experienced a serious adverse event (SAE), but none was considered related to the IMP. An antigen-specific CD8+ T-cell response was induced against the lung antigens of the IMP in 33%, 45% and 67% of evaluable patients in respectively A1, A2 and B1 cohort. The best objective response in 6 evaluable patients of the B1 cohort, according to RECIST criteria included 4 partial responses, 1 stable disease and 1 progressive disease with an objective response rate (ORR) of 66.7% (80% CI 33.3% - 90.7%).

Conclusions

PDC*lung01 treatment was feasible with an acceptable safety profile and was found to be biologically active to trigger an antitumor immune response in a significant number of patients. Interestingly, a very promising ORR was observed in combination with pembrolizumab in first line setting in stage IV patients. Updated results will be presented.

Clinical trial identification

NCT03970746.

Legal entity responsible for the study

PDC*line Pharma SAS.

Funding

PDC*line Pharma SAS.

Disclosure

J.F. Vansteenkiste: Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, Daichi Sankyo, MSD, Pfizer, Roche, Janssen, Merck, Novartis, PDCline, Sanofi; Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Novartis, Janssen, Elil-Lilly, Roche; Financial Interests, Institutional, Research Grant: MSD. I. Demedts: Financial Interests, Personal, Other, invited speaker and participation in advisory board meetings: AstraZeneca, BMS, Boehringer, GSK, Lilly, MSD, Novartis, Pfizer, Roche, Takeda. E. Pons-Tostivint: Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Daiichi Sankyo, Sanofi, PDC Line, Takeda. B. Colinet: Financial Interests, Personal, Advisory Board: MSD, Sanofi, J&J, Boehringer Ingelheim, Amgen, AZ, Roche; Financial Interests, Personal, Invited Speaker: Sanofi; Non-Financial Interests, Invited Speaker, Association Francophone Belge d'Oncologie Thoracique: AFBOT. K. Cuppens: Financial Interests, Personal, Advisory Board: Hoffmann-La Roche, AstraZeneca, Merck Sharp Dohme, Bristol-Myers-Squibb, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Pfizer, Bristol-Myers-Squibb; Financial Interests, Personal, Expert Testimony: Merck Sharp Dohme, AstraZeneca. L. Greillier: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, MSD, Novartis, Sanofi, Takeda, Roche; Financial Interests, Personal, Invited Speaker: Lilly, Pfizer, Roche; Financial Interests, Institutional, Invited Speaker: AstraZeneca, AbbVie, BMS, MSD, Novartis, Sanofi, Takeda, Pfizer, PharmaMar. D. Moro-Sibilot: Financial Interests, Personal, Advisory Board: Lilly, Roche, BMS, MSD, AbbVie, AbbVie, Becton Dickinson, Pfizer, Takeda, AstraZeneca, Boehringer Ingelheim, Novartis, GSK; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Funding, IFCT clinical trials: Pfizer; Financial Interests, Institutional, Funding: Roche, AbbVie, AstraZeneca. M. Pérol: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, BMS, Lilly, Novartis, Takeda, Gritstone, Sanofi, Pfizer, Amgen, Janssen, GlaxoSmithKline; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, Boehringer Ingelheim, Takeda, Illumina, Pfizer, Roche; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Takeda, Boehringer Ingelheim. M. Sebastian: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Novartis, Takeda, Lilly, BMS, MSD, Merck, Johnson, Amgen; Financial Interests, Personal, Invited Speaker: Roche, GSK; Financial Interests, Institutional, Research Grant: AstraZeneca. M. Skrzypski: Financial Interests, Personal, Invited Speaker, Sponsored lecture: Boehringer Ingelheim; Non-Financial Interests, Principal Investigator, National PI (Poland) for PDC-LUNG-101 trial.: PDC*line Pharma. M. Collodoro: Financial Interests, Personal, Full or part-time Employment, QC manager at PDC*line Pharma: PDC*line Pharma. J. Plumas: Financial Interests, Personal, Full or part-time Employment, I am CSO of PDC*line Pharma: PDC*line Pharma; Financial Interests, Personal, Stocks/Shares: PDC*line Pharma. C. Debruyne: Financial Interests, Institutional, Sponsor/Funding: PDC*line Pharma; Financial Interests, Institutional, Stocks/Shares: PDC*line Pharma. A. Sibille: Financial Interests, Institutional, Advisory Board: Merck Sharp Dome, AstraZeneca, Bristol Myers Squibb, Roche, Pfizer. All other authors have declared no conflicts of interest.

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NSCLC, metastatic

999P - JIN-A02, a fourth-generation, highly effective tyrosine kinase inhibitor with intracranial activity, targeting EGFR C797S mutations in NSCLC

Presentation Number
999P
Speakers
  • Mi Ran Yun (Seoul, Korea, Republic of)
Date
Mon, 12.09.2022

Abstract

Background

Even though epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) have improved treatment outcomes for EGFR-driven NSCLC, resistance inevitably emerges and disease often progresses due to brain metastasis. The C797S is the most significant resistance mutation to occur after 3rd generation TKIs treatment. JIN-A02 is an orally available EGFR-TKI targeting C797S mutation with high brain penetration.

Methods

Cellular activities of JIN-A02 were evaluated on phosphorylation-EGFR expression with AlphaLISA assay and on EGFR mutants with patients-derived cell (PDC) and patients-derived organoid (PDO). Different type of allelic relationship was also assessed in all models by whole exome sequencing. Patients-derived xenografts (PDX) was used to assess antitumor activities of JIN-A02. For in vivo intracranial activity, NCI-H1975 cell line derived tumor xenograft was used.

Results

In AlphaLISA assay, JIN-A02 showed high potency in EGFRex19del/T790M/C797S (IC50=4.7 nM, Ba/F3), EGFRL858R/T790M/C797S (IC50=12.8 nM, NCI-H1975 LTC). JIN-A02 strongly inhibited cellular activity of in trans model (IC50=89.7 nM, PDO) and in cis model (IC50=92.1 nM, PDC) of EGFRex19del/T790M/C797S. It appears to be superior to osimertinib (IC50 >4,000 nM for both cells). In addition, JIN-A02 showed comparable potency to osimertinib in EGFRex19del/T790M (IC50=84.4 nM for PC-9GR), and EGFRL858R/T790M (IC50=73.3 nM for NCI-H1975). In the PDX mouse model (YHIM-1094, EGFRex19del/T790M/C797S), JIN-A02 delayed tumor growth at a dose of 30 mg/kg. In the brain metastases model, antitumor activity of JIN-A02 was observed with intracranial implanted NCI-H1975 tumors.

Conclusions

JIN-A02 is highly potent EGFR-TKI for various EGFR targeted mutations including in cis and trans EGFRex19del/T790M/C797S and shows intracranial activity. Based on these robust activities for EGFR mutants, JIN-A02 is expected to provide a potential therapeutic opportunity for NSCLC.

Legal entity responsible for the study

Ji Eun Jung, Daan Cancer Laboratory, Yonsei University College of Medicine.

Funding

J INTS Bio.

Disclosure

All authors have declared no conflicts of interest.

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NSCLC, metastatic

1019P - Pattern of clinical activity of anticancer vaccine OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in phase III Atalante-1 randomized trial

Presentation Number
1019P
Speakers
  • Maria Rosario Garcia Campelo (A Coruña, Spain)
Date
Mon, 12.09.2022

Abstract

Background

OSE2101 (Tedopi) is an anticancer vaccine increasing overall survival (OS) with HR of 0.59 (p=0.017) versus Standard of Care Chemotherapy (SoC CT) in the population of interest (PoI) of HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (ESMO 2021 #47LBA). The objective of this analysis was to explore the pattern of activity of OSE2101.

Methods

118 NSCLC EGFR and ALK negative patients were randomized (2:1) in OSE2101 or SoC (docetaxel or pemetrexed) in the PoI. OS of OSE2101 versus SoC was described according to best response (partial response (PR), Stable Disease (SD) and Progressive Disease (PD)) and to the administration of post progression anticancer treatment. OS was described in Late Progressors (LP) defined as no RECIST 1.1 nor clinical PD within the first 6 months after randomization.

Results

Median (95%CI) OS in months by best response and by post progression anticancer treatment are described in the table. 16 (20%) patients fulfilled the criteria for Late Progressors with OSE2101. Late Progressors included 4 (25%) patients with PR and 12 (75%) patients with prolonged SD. mOS was 14.7 months with 1-year OS rate of 68%. mPFS was 8.8 months with 23% of patients progression-free at 1-year.

mOS (months) OSE2101 n=80 SoC n=38
By Best Response
PR n=6 11.2 (5.4, NE) n=7 13.8 (2.6, NE) HR=0.75 (0.18, 3.23)
SD n=36 13.1 (8.8, 16.8) n=19 9.4 (6.5, 12.2) HR=0.61 (0.33, 1.14)
PD n=32 8.0 (5.4, 11.1) n=7 5.0 (1.0, 7.2) HR=0.45 (0.19, 1.04)
By Post Progression anticancer treatment
With anticancer treatment n=55 13.5 (9.6,16.6) n=16 10.6 (7.2, 16.1) HR=0.71 (0.38, 1.30)
Without anticancer treatment n=25 6.3 (3.6, 7.6) n=22 4.5 (2.3, 8.3) HR=0.76 (0.41, 1.41)

Conclusions

In advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO, OS was longer with OSE2101 versus SoC regardless the use of post progression anticancer treatment. By Best Response to study treatement, OS was longer with OSE2101 in patients with Stable Disease or Progressive Disease compared to SoC. Late progressors with OSE2101 were mainly driven by long Stable Disease. These data suggest that the cancer vaccine OSE2101 may act as an anti-tumor brake in controlling the tumor growth regardless of best response.

Clinical trial identification

EudraCT: 2015-003183-36; NCT02654587.

Editorial acknowledgement

We thank Pierre Attali (Medical Expert, MD) and François Montestruc (Statistics, eXYSTAT) for their support in the writing of the abstract.

Legal entity responsible for the study

Ose Immunotherapeutics.

Funding

Ose Immunotherapeutics.

Disclosure

M.R. Garcia Campelo: Financial Interests, Personal, Advisory Role: Roche/Genentech, MSD Oncology, AstraZeneca, Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Takeda, Boehringer Ingelheim, Janssen Oncology; Financial Interests, Personal, Speaker’s Bureau: Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Novartis, Takeda, Boehringer Ingelheim, MSD Oncology, Sanofi/Aventis, Janssen Oncology, Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche/Genentech, MSD Oncology, Pfizer. E. Felip: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith Kline, Janssen, Medical Trends, Merck Sharp & Dohme, Pfizer, Puma, Sanofi, Takeda, Merck Serono, Peptomyc, Regeneron, Syneos Health, F. Hoffmann-La Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Eli Lilly, Medscape, Merck Sharp & Dome, Peervoice, Pfizer, Springer, Touch Medical, Amgen, F. Hoffmann-La Roche, Janssen, Medical Trends, Merck Serono; Financial Interests, Personal, Invited Speaker, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme Corp, AstraZeneca AB, Daiichi Sankyo Inc, Exelixis Inc, Merck KGAA, Janssen Cilag International NV, GlaxoSmithKline Research & Development Limited, AbbVie Deutschland GmbH & Co KG, Novartis Farmaceutica SA, Bayer Consumer Care AG, Takeda Pharmaceuticals International, Boehringer Ingelheim International GmbH, Pfizer S.L.U., Amgen Inc, Bristol-Myers Squibb International Corporation (BMS), Mirati Therapeutics Inc; Non-Financial Interests, Leadership Role, President Elect (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of ESMO Nominating Committee and Compliance Committee: ESMO; Non-Financial Interests, Leadership Role, Member of Board of Directors and the Executive Committee (2017-Sept 2021): IASLC (International Association for the Study of Lung Cancer); Non-Financial Interests, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform). B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, BMS, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals. F. Cappuzzo: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Mirati, Novocure, OSE, and MSD; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, Mirati, PharmaMar, Novocure, Ose, Galecto and MSD. F. Denis: Financial Interests, Personal, Invited Speaker, lecture: Chugai; Financial Interests, Personal, Invited Speaker, Lecture: AstraZeneca, Merck, Takeda; Financial Interests, Institutional, Advisory Board, Institution receiver was Hyperion. Collaboration stopped in March 2020: Slvan; Financial Interests, Institutional, Invited Speaker, Institution (Hyperion) has participations in Kelindi (non-oncological software editor): Kelindi; Financial Interests, Institutional, Stocks/Shares, Hyperion has stocks in Kelindi (non-oncological software editor): Kelindi; Non-Financial Interests, Member: ASCO. W. Hilgers: Financial Interests, Personal, Advisory Board: AstraZeneca, Janssen; Financial Interests, Personal, Other, Honoraria: MSD Oncology. D. Debieuvre: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Janssen, Pfizer, Ose Immunotherapeutics, Novartis, Sanofi-Aventis, Amgen, Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Funding: Roche, AstraZeneca, Janssen, MSD, Pfizer, BMS, Lilly, Boehringer Ingelheim, GSK, Chugaï, Chiesi, Novartis, Takeda, Bayer, Sanofi-Aventis. D. Galetta: Financial Interests, Personal, Advisory Board: Roche, Boheringer Ingelheim, Eli Lilly Italia, AstraZeneca Italia, Takeda; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Other, Small cell lung cancer translational study: AstraZeneca Italia. S. Viteri Ramirez: Financial Interests, Personal, Advisory Board: Merck Healthcar KGAA Germany, Bristol Myers Squibb S.A. U, Puma Biotechnology; Financial Interests, Personal, Invited Speaker: Takeda Farmaceutica España SA, MSD de España SA, AstraZeneca Farmaceutica Spain, Roche Farma SA; Financial Interests, Personal, Expert Testimony: Reddy Pharma Iberia SAU. W. Schuette: Financial Interests, Personal, Other, Honoraria: Roche, MSD, Novartis; Financial Interests, Personal, Advisory Board: Roche, MSD, Novartis. A. Zer: Financial Interests, Personal, Invited Speaker: Roche, BMS, MSD, Takeda, Pfizer, Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca, Steba, Oncohost; Financial Interests, Personal, Stocks/Shares: Nixio; Financial Interests, Institutional, Research Grant: BMS. B. Vasseur: Financial Interests, Personal, Full or part-time Employment: Ose Immunotherapeutics; Financial Interests, Personal, Other, Actions: Ose Immunotherapeutics. R. Dziadziuszko: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, SeattleGenetics, Pfizer, Takeda, Regeneron, MSD, Bristol Myers-Squibb, PharmaMar, Bayer; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, FoundationMedicine; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Roche, AstraZeneca, MSD, Amgen, Celon Pharma, Pfizer, Novartis, Brsitol Myers-Squibb, Eli Lilly, Loxo; Financial Interests, Invited Speaker: BeiGene, Ardigen, Ose Immunotherapeutics; Financial Interests, Personal and Institutional, Other, Subinvestigator and ad hoc Consultant: PDC* line Pharma; Non-Financial Interests, Institutional, Product Samples: Novartis, Pfizer, AstraZeneca, Roche; Other, Travel: Roche, Bristol Myers-Squibb, AstraZeneca. G. Giaccone: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Research Grant: Karyopharm. All other authors have declared no conflicts of interest.

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NSCLC, metastatic

1024P - Net treatment benefit of OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in phase III Atalante-1 randomized trial

Presentation Number
1024P
Speakers
  • Marc E. Buyse (Louvain-la-Neuve, Belgium)
Date
Mon, 12.09.2022

Abstract

Background

OSE2101 (Tedopi) is an anticancer vaccine that increased overall survival (OS) (HR 0.59, p=0.017) versus Standard of Care Chemotherapy in the population of interest (PoI N=118) of patients with IO secondary resistance after sequential CT-IO (ESMO 2021 #47LBA). The Net Treatment Benefit (NTB) is an original method combining efficacy and safety endpoints to test the overall improvement in health outcome between 2 treatments (Buyse M. Stat Med 2010). NTB was assessed in the overall population (N=219) from whom OS improvement of OSE2101 (HR 0.86, p=0.35) was lower than in PoI.

Methods

NTB was tested by comparing prioritized outcomes using Generalized Paired Wise Comparisons (GPC). The prioritized outcomes were OS, then time to worsening ECOG (threshold=2 months) followed by severe adverse events, progression free survival (shorter vs. longer than 2 months) and Quality of Life (threshold=5 points on Global Health Status of EORTC-QLQC30). Analysis was stratified using the 3 strata of the study (histology, best response to 1rst line, line of prior IO) and enrollment time (before vs during COVID-19). Sensitivity analyses used no stratification, different thresholds of clinical relevance and PoI.

Results

In the primary analysis (1088 pairs), NTB was 19% and reached statistical significance in favor of OSE2101 (p=0.035). In unstratified analysis (11120 pairs), NTB was 11% (p=0.188). In the PoI (388 pairs), NTB was 22% (p stratified=0.074) and 28% (p=0.014) in unstratified analysis (3040 pairs). Although the primary analysis was statistically positive, results were not consistent in some sensitivity analyses due to the limited sample size and the impact of stratification factors.

Conclusions

An overall improvement in health outcome was observed with OSE2101 in the overall population of advanced NSCLC after IO failure with a NTB of 19% over SoC. In PoI with IO secondary resistance after CT-IO, the NTB was 22%. Post-hoc analyses are ongoing intended to explain the variability of NTB and will be detailed.

Clinical trial identification

EudraCT: 2015-003183-36; NCT02654587.

Editorial acknowledgement

We thank Pierre Attali (Medical Expert, MD) for his support in the writing of the abstract.

Legal entity responsible for the study

Ose Immunotherapeutics.

Funding

Ose Immunotherapeutics.

Disclosure

M.E. Buyse: Financial Interests, Personal, Officer, Chief Scientific Officer: IDDI; Financial Interests, Personal, Invited Speaker, Board Member: CluePoints; Financial Interests, Personal, Stocks/Shares: IDDI, CluePoints. F. Montestruc: Financial Interests, Personal, Member of the Board of Directors, CEO of the Company: eXYSTAT SAS; Financial Interests, Institutional, Other, Statistician Consultant: AbbVie, Biocodex, Geneuro, Gensight, Guerbet, Imcheck, Ose Immunotherapeutics, Pfizer, Takeda; Non-Financial Interests, Personal, Other, Statistician Consultant and Training: Institut Pasteur. J. Chiem: Financial Interests, Personal, Full or part-time Employment: IDDI. V. Deltuvaite-Thomas: Financial Interests, Personal, Full or part-time Employment: IDDI. S. Salvaggio: Financial Interests, Personal, Full or part-time Employment, Working as a statistician: International Drug Development Institute. M.R. Garcia Campelo: Financial Interests, Personal, Advisory Role: Roche/Genentech, MSD Oncology, AstraZeneca, Bristol-Myers Squibb, Pfizer, Novartis, Takeda, Boehringer Ingelheim, Janssen Oncology; Financial Interests, Personal, Speaker’s Bureau: Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Novartis, Takeda, Boehringer Ingelheim, MSD Oncology, Sanofi/Aventis, Janssen Oncology, Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche/Genentech, MSD Oncology, Pfizer. F. Cappuzzo: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Mirati, Novocure, OSE, and MSD; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, Mirati, PharmaMar, Novocure, OSE, Galecto and MSD. S. Viteri Ramirez: Financial Interests, Personal, Advisory Board: Merck Healthcare KGAA Germany, Bristol Myers Squibb S.A. U, Puma Biotechnology; Financial Interests, Personal, Invited Speaker: Takeda Farmaceutica España SA, MSD de España SA, AstraZeneca Farmaceutica Spain, Roche Farma SA; Financial Interests, Personal, Expert Testimony: Reddy Pharma Iberia SAU. W. Schuette: Financial Interests, Personal, Other, Honoraria: Roche, MSD, Novartis; Financial Interests, Personal, Advisory Role: Roche, MSD, Novartis. A. Zer: Financial Interests, Personal, Invited Speaker: Roche, BMS, MSD, Takeda, Pfizer, Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca, Steba, Oncohost; Financial Interests, Personal, Stocks/Shares: Nixio; Financial Interests, Institutional, Research Grant: BMS. S. Comis: Financial Interests, Personal, Full or part-time Employment: Ose Immunotherapeutics. B. Vasseur: Financial Interests, Personal, Full or part-time Employment: Ose Immunotherapeutics; Financial Interests, Personal, Other, Actions: Ose Immunotherapeutics. R. Dziadziuszko: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Seattle Genetics, Pfizer, Takeda, Regeneron, MSD, Bristol Myers-Squibb, PharmaMar, Bayer; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Foundation Medicine; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Roche, AstraZeneca, MSD, Amgen, Celon Pharma, Pfizer, Novartis, Brsitol Myers-Squibb, Eli Lilly, Loxo; Financial Interests, Invited Speaker: BeiGene, Ardigen, Ose Immunotherapeutics; Financial Interests, Personal and Institutional, Other, Subinvestigator and ad hoc Consultant: PDC* line Pharma; Non-Financial Interests, Institutional, Product Samples: Novartis, Pfizer, AstraZeneca, Roche; Other, Travel: Roche, Bristol Myers-Squibb, AstraZeneca. G. Giaccone: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Research Grant: Karyopharm. B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, EISAI, Genzyme Corporation, Inivata, Ipsen, Turning Point Therapeutics. E. Felip: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith Kline, Janssen, Medical Trends, Merck Sharp & Dohme, Pfizer, Puma, Sanofi, Takeda, Merck Serono, Peptomyc, Regeneron, Syneos Health, F. Hoffmann-La Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Eli Lilly, Medscape, Merck Sharp & Dome, Peervoice, Pfizer, Springer, Touch Medical, Amgen, F. Hoffmann-La Roche, Janssen, Medical Trends, Merck Serono; Financial Interests, Personal, Invited Speaker, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme Corp, AstraZeneca AB, Daiichi Sankyo Inc, Exelixis Inc, Merck KGAA, Janssen Cilag International NV, GlaxoSmithKline Research & Development Limited, AbbVie Deutschland GmbH & Co KG, Novartis Farmaceutica SA, Bayer Consumer Care AG, Takeda Pharmaceuticals International, Boehringer Ingelheim International GmbH, Pfizer S.L.U., Amgen Inc, Bristol-Myers Squibb International Corporation (BMS), Mirati Therapeutics Inc; Non-Financial Interests, Leadership Role, President Elect (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of ESMO Nominating Committee and Compliance Committee: ESMO; Non-Financial Interests, Leadership Role, Member of Board of Directors and the Executive Committee (2017-Sept 2021): IASLC (International Association for the Study of Lung Cancer); Non-Financial Interests, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform). All other authors have declared no conflicts of interest.

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NSCLC, metastatic

1113P - Real-world multicentre cohort of 1L pembrolizumab alone or in combination with platinum-based chemotherapy in NSCLC PD-L1 ≥ 50%

Presentation Number
1113P
Speakers
  • Elvire Pons-Tostivint (Nantes, Cedex 1, France)
Date
Mon, 12.09.2022

Abstract

Background

Pembrolizumab alone (IO) or with platinum-based chemotherapy (CT-IO) are 1L standard of care for advanced non-small cell lung cancer (NSCLC) patients with PD-L1 ≥ 50%. This retrospective, multicentre study assessed real-world use of both strategies.

Methods

Patients with advanced NSCLC PD-L1 ≥ 50% were included if they received IO or CT-IO from 12-2019 (non-squamous) or 06-2020 (squamous), corresponding to the reimbursement date in France for each subtype. Disease characteristics were collected from 8 Hospitals. Overall survival (OS) and real-word progression-free-survival (rwPFS) were estimated using Kaplan-Meier methodology. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% CIs, and a cox model with inverse propensity treatment weighting was carried out.

Results

Among the 243 patients included, 141 (58%) received IO and 102 (42%) CT-IO. Characteristics were detailed in the table. With a median follow-up of 11.5 months (95% CI, 10.4 – 13.3), median OS was not reached (NR) but no difference was observed between both groups (p=0.51). Early deaths at 3 months were 11% (95% CI 4.6 – 16.9) and 15.2% (95% CI 9.0 – 20.9) in CT-IO and IO groups (p=0.32). Median rwPFS was 11.3 months (95% CI 7.2 – NR) in CT-IO and 10.6 months (95% CI 7.1 – NR) in IO (p=0.76). After adjustment on age, ECOG, histology, brain metastases, liver metastases and tobacco status, no significant difference was found for OS between groups, neither in the multivariate [HR 1.07 (95% CI 0.61 – 1.86), p=0.8] nor in the propensity analysis [HR 0.99 (95% CI 0.60-1.65), p=0.99]. Same conclusion was done for rwPFS in the multivariate [HR 0.98 (95% CI 0.64 – 1.51), p=0.93] and the propensity analysis [HR 1.11 (95% CI 0.74-1.65), p=0.62].

n (%) IO-mono (n=158) CT-IO (n=102) p-value
Sex (Men) 82 (58.2) 57 (55.9) 0.793
Age, Median [range] 68 [47 - 92] 61 [35 - 81] <0.001
ECOG 0 – 1 106 (75.2) 84 (82.3) 0.209
Smoking status Never Current or past 12 (8.8) 124 (91.2) 3 (3.0) 96 (97.0) 0.104
Histology Non-squamous 115 (81.6) 97 (95.1) 0.002
PDL1 90-100 50 - 89 59 (41.8) 82 (58.2) 49 (48.0) 53 (52.0) 0.362
Symptomatic disease at diagnosis Yes 102 (72.3) 90 (88.2) 0.002
Corticoids at diagnosis ≥ 10 mg/day < 10 mg/day None 19 (13.8) 2 (1.4) 117 (84.8) 22 (22.2) 1 (1.0) 76 (76.8) 0.215
Tumor stage Locally-advanced Metastatic 26 (18.4) 115 (81.6) 6 (5.9) 96 (94.1) 0.004
Only 1 M+ site 50 (43.5) 33 (34.3) 0.006
Brain M+ 26 (23.4) 37 (39.4) 0.003

Conclusions

Younger patients, those with a symptomatic disease and brain metastases were more prone to be proposed CT-IO. However, sparing the chemotherapy in 1L does not appear to impact survival outcomes, even regarding early deaths.

Legal entity responsible for the study

Pons-Tostivint Elvire.

Funding

Has not received any funding.

Disclosure

E. Pons-Tostivint: Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Daiichi Sankyo, Sanofi, PDC line, Takeda. All other authors have declared no conflicts of interest.

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