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Mini oral session - NSCLC, metastatic

1192MO - Amivantamab monotherapy and in combination with lazertinib in post-osimertinib EGFR-mutant NSCLC: Analysis from the CHRYSALIS study

Date

19 Sep 2021

Session

Mini oral session - NSCLC, metastatic

Presenters

Natasha B. Leighl

Citation

Annals of Oncology (2021) 32 (suppl_5): S949-S1039. 10.1016/annonc/annonc729

Authors

N.B. Leighl1, C.A. Shu2, A. Minchom3, E. Felip4, S. Cousin5, B.C. Cho6, K. Park7, J. Han8, M. Boyer9, C.K. Lee10, V. Moreno Garcia11, P. Tomasini12, S. Viteri13, J. Xie14, J. Mertz15, E. Artis15, R.W. Schnepp15, R.E. Knoblauch15, M. Thayu15, J.M. Trigo Perez16

Author affiliations

  • 1 Medicine, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 2 Medicine, Columbia University Medical Center, New York/US
  • 3 Drug Development Unit, Royal Marsden Hospital/ Institute of Cancer Research, SM2 5PT - Sutton/GB
  • 4 Oncology, Vall d’Hebron University Hospital, 08035 - Barcelona/ES
  • 5 Oncologie Medicale, Institut Bergonie, 59020 - Bordeaux/FR
  • 6 Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul/KR
  • 7 Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 8 Center For Lung Cancer, National Cancer Center, Goyang/KR
  • 9 Medical Oncology, Chris O'Brien Lifehouse, Camperdown/AU
  • 10 Medical Oncology, St George Hospital, Sydney/AU
  • 11 Start Madrid Fjd, Early Phase Clinical Trials Unit, Hospital Universitario Fundacion Jimenez Díaz, 28040 - Madrid/ES
  • 12 Multidisciplinary Oncology And Therapeutic Innovations, Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Marseille/FR
  • 13 Oncology, Instituto Oncológico Dr. Rosell, Hospital Universitari Dexeus, Grupo QuironSalud, 8028 - Barcelona/ES
  • 14 Clinical Biostatistics, Janssen R&D, Spring House/US
  • 15 Oncology, Janssen R&D, Spring House/US
  • 16 Medical Oncology, Hospital Universitario Virgen de la Victoria y Regional, IBIMA, 29010 - Malaga/ES
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Resources

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Abstract 1192MO

Background

Amivantamab (ami), an epidermal growth factor receptor (EGFR)-MET bispecific antibody, has demonstrated efficacy in EGFR mutant non-small cell lung cancer (NSCLC) that progressed on osimertinib (osi), both as monotherapy and in combination with lazertinib (laz), a 3rd-generation tyrosine kinase inhibitor. Clinical outcomes of patients (pts) treated with ami monotherapy (mono) and ami in combination with laz (combo) are presented here.

Methods

CHRYSALIS is an ongoing study of ami in pts with advanced EGFR mutant NSCLC (NCT02609776). Pts who progressed on osi were pooled to form the mono group, a majority of whom were preselected for C797S/other resistance mutations or MET amplification. The combo group comprised unselected pts who had progressed on osi but were chemotherapy-naïve. Response was assessed by the investigator per RECIST v1.1.

Results

As of 19 Apr 2021, 121 pts in the mono group (85% with EGFR/MET-based resistance) and 45 in the combo group (38% with EGFR/MET-based resistance) were efficacy-evaluable, with median follow-up of 6.9 and 11.1 months, respectively. Antitumor activity was observed in the mono group, with 33 achieving partial response (PR) as best response, of which 23 were confirmed, for an overall response rate (ORR) of 19% (95% CI, 12–27). In the combo group, 1 complete response and 15 PRs were observed, all of which confirmed, for an ORR of 36% (95% CI, 22–51). Median duration of response was 5.9 months with mono, 9.6 months with combo (Table). The safety profile for both mono and combo was consistent with previously-reported safety. No new safety signals were identified.

Conclusions

Antitumor activity of ami + laz in the post-osi setting appears favorable even without molecular selection post osimertinib failure, supporting that simultaneous targeting of the extracellular and catalytic domains of EGFR provides additive benefits. Table: 1192MO

Efficacy of amivantamab monotherapy and in combination with lazertinib among efficacy-evaluablea patients

Efficacy
Monotherapy (n=121) Combination (n=45)
ORR (95% CI) 19% (12–27) 36% (22–51)
CBR (95% CI) 48% (39–57) 64% (49–78)
mDOR, month (95% CI) 5.9 (4.2–12.6) 9.6 (5.3–NR)

aPatients who had at least 2 post-baseline disease assessment or discontinued before the second assessment. CBR, clinical benefit rate (complete response, partial response, or stable disease of at least 11 weeks); mDOR, median duration of response; ORR, overall response rate; NR, not reached

Clinical trial identification

NCT02609776.

Editorial acknowledgement

Medical writing assistance was funded by Janssen Global Services, LLC. and provided by Tracy T. Cao, PhD (Janssen Global Services, LLC.).

Legal entity responsible for the study

Janssen.

Funding

Janssen.

Disclosure

N.B. Leighl: Financial Interests, Personal, Advisory Role: Xcovery; Financial Interests, Personal, Other, travel, accommodations, expenses: Merck Sharp & Dohme, Bristol Myers Squibb, Nektar, GlaxoSmithKline, Roche, AstraZeneca; Financial Interests, Personal, Other, honoraria: Boehringer Ingelheim; Financial Interests, Institutional, Funding: Novartis, Roche Canada, Guardant Health, MSD, EMD Serono, Lilly. C.A. Shu: Financial Interests, Personal, Advisory Board: Genentech, AstraZeneca, Janssen, Mirati. A. Minchom: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceuticals, Novartis Oncology, Bayer Pharmaceuticals; Financial Interests, Personal, Advisory Board: Janssen Pharmaceuticals, Merck Pharmaceuticals; Financial Interests, Personal, Other: Amgen Pharmaceuticals, Loxo Oncology; Financial Interests, Personal, Advisory Role: Faron Pharmaceuticals. E. Felip: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, Beigene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, GlaxoSmithKline, Janssen, Medical Trends, Merck Sharp & Dohme, Merck Serono, Peptomyc, Pfizer, Puma, Regeneron, Sanofi, Syneos Health, Take; Financial Interests, Personal, Speaker’s Bureau: Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Janssen, Medscape, Merck Sharp & Dohme, Merck Serono, Peervoice, Pfizer, Springer, Touch Medical; Financial Interests, Personal, Member of the Board of Directors: Grífols. B.C. Cho: Financial Interests, Personal and Institutional, Research Grant: Novartis, Bayer, AstraZeneca, Mogam Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, AbbVie, Medpacto, GI Innovation, Eli Lilly, Blueprint Medicines, Interpark Bio Convergence Corp.; Financial Interests, Personal, Advisory Board: Kanaph Therapeutics Inc., BridgeBio Therapeutics, Cyrus Therapeutics, Guardant Health; Financial Interests, Personal, Stocks/Shares: TheraCanVac Inc., Gencurix Inc., BridgeBio Therapeutics, Kanaph Therapeutics Inc., Cyrus Therapeutics, Interpark Bio Convergence Corp.; Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca, Boehringer Ingelheim, Roche, BMS, Ono, Yuhan, Pfizer, Eli Lilly, Janssen, Takeda, MSD, Medpacto, Blueprint Medicines; Financial Interests, Personal, Member of the Board of Directors: Interpark Bio Convergence Corp.; Financial Interests, Personal, Royalties: Champions Oncology; Non-Financial Interests, Personal, Other: DAAN Biotherapeutics. K. Park: Financial Interests, Personal, Advisory Role: AstraZeneca, Lilly, Ono Pharmaceutical, Bristol Myers Squibb, MSD, Blueprint Medicines, Amgen, Merck KGaA, Loxo, AbbVie, Daiichi Sankyo, Boehringer Ingelheim, Johnson & Johnson, Eisai, Puma Biotechnology; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim, AZD; Financial Interests, Personal, Funding: AstraZeneca, MSD Oncology. J. Han: Financial Interests, Personal, Advisory Role: MSD Oncology, AstraZeneca, Bristol Myers Squibb, Lilly, Novartis, Takeda, Pfizer; Financial Interests, Personal, Other, Honoraria: Roche, AstraZeneca, Bristol Myers Squibb, Takeda; Financial Interests, Personal, Funding: Roche, Pfizer, Ono Pharmaceutical, Takeda. M. Boyer: Financial Interests, Personal, Invited Speaker: Merck Sharpe & Dohme, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche, Merck Sharpe & Dohme, AstraZeneca, Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Roche, Merck Sharpe & Dohme, AstraZeneca, Amgen, Pfizer, Novartis, Bristol Myers Squibb, ImmuGene, Merck KGaA, Lilly, Janssen; Non-Financial Interests, Institutional, Principal Investigator: Roche, Merck Sharpe & Dohme, AstraZeneca, Amgen, Pfizer, Novartis, Bristol Myers Squibb, ImmuGene, Merck KGaA, Lilly, Janssen. C.K. Lee: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Pfizer, GSK, Takeda; Financial Interests, Institutional, Research Grant: AstraZeneca. V. Moreno Garcia: Non-Financial Interests, Institutional, Principal Investigator: AbbVie, Acea Bio, Adaptimmune, ADC Therapeutics, Aduro, Agenus, Amcure, Amgen, Astellas, AstraZeneca, Bayer, Beigen, BioInvent International AB, BMS, Boehringer Ingelheim, Boston, Celgene, Daiichi Sankyo, Debiopharm, Eisai, e-Therapeutics, Exelixis, Forma Therapeutics; Financial Interests, Personal, Advisory Role: Roche, Bayer, Pieris, BMS, Janssen, Basilea; Financial Interests, Personal, Other, Travel: Regeneron/Sanofi, BMS, Bayer; Financial Interests, Personal, Speaker’s Bureau: Nanobiotix, BMS, Bayer; Financial Interests, Personal, Other, Educational Grant: Medscape/Bayer. P. Tomasini: Financial Interests, Personal, Invited Speaker: AZ, Roche, BMS, Takeda, BI; Non-Financial Interests, Personal, Invited Speaker: AZ, Roche, BMS, Takeda, BI; Financial Interests, Personal, Expert Testimony: AZ, Roche, BMS, Takeda, BI; Non-Financial Interests, Personal, Expert Testimony: AZ, Roche, BMS, Takeda, BI; Non-Financial Interests, Institutional, Principal Investigator: AZ, Roche, BMS, Takeda, Amgen, Johnson & Johnson. S. Viteri: Financial Interests, Personal, Advisory Role: Roche, Bristol Myers Squibb, Janssen; Financial Interests, Personal, Speaker’s Bureau: Roche, Bristol Myers Squibb, AstraZeneca; Financial Interests, Personal, Other, travel, accommodations, expenses: MSD. J. Xie: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. J. Mertz: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. E. Artis: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. R.W. Schnepp: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. R.E. Knoblauch: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. M. Thayu: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. J.M. Trigo Perez: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Takeda; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Other, Travel grant: MSD; Financial Interests, Institutional, Research Grant: BMS; Non-Financial Interests, Personal, Advisory Role: BMS; Non-Financial Interests, Personal, Advisory Role: Merck. All other authors have declared no conflicts of interest.

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