Top

Published in:

01-09-2020 | NSCLC | Review Article

Sequential blinded treatment decisions in ALK-positive non-small cell lung cancers in the era of precision medicine

Authors: J. Remon, F. Tabbò, B. Jimenez, A. Collazo, J. de Castro, S. Novello

Published in: Clinical and Translational Oncology | Issue 9/2020

Abstract

Next-generation ALK TKIs have become the new standard of care in first-line setting in advanced ALK-positive NSCLC patients. However, sequential strategies at progression are relevant, as may have an impact on patients’ outcome. In this commentary we discuss whether genomic-tailored strategies at progression would be more suitable for improving outcome of ALK-positive NSCLC patients.

Camidge DR, Dziadziuszko R, Peters S, Mok T, Noe J, Nowicka M, Gadgeel SM, Cheema P, Pavlakis N, de Marinis F, Cho BC, Zhang L, Moro-Sibilot D, Liu T, Bordogna W, Balas B, Müller B, Shaw AT. Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study. J Thorac Oncol. 2019;14:1233–43. https://doi.org/10.1016/j.jtho.2019.03.007.CrossRefPubMed

Mok T, Shaw AT, Camidge RD, Gadgeel SM, Rosell R, Dziadziuszko R, et al. Final PFS, updated OS and safety data from the randomised, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALk + NSCLC. Ann Oncol. 2019;30(Suppl_5):V602–60.

Camidge DR, Kim HR, Ahn M-J, Yang JC-H, Han J-Y, Lee J-S, Hochmair MJ, Li JY-C, Chang G-C, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim D-W, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med. 2018;379:2027–39. https://doi.org/10.1056/NEJMoa1810171.CrossRefPubMed

Camidge R, Kim HR, Ahn M-J, Yang JC-H, Han J-Y, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim D-W, Griesinger F, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Ni Q, Zhang P, Popat S. Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK + NSCLC: updated results from the phase III ALTA-1L trial. Ann Oncol. 2019. https://doi.org/10.1093/annonc/mdz446.CrossRefPubMedPubMedCentral

Duruisseaux M, Besse B, Cadranel J, Pérol M, Mennecier B, Bigay-Game L, Descourt R, Dansin E, Audigier-Valette C, Moreau L, Hureaux J, Veillon R, Otto J, Madroszyk-Flandin A, Cortot A, Guichard F, Boudou-Rouquette P, Langlais A, Missy P, Morin F, Moro-Sibilot D. Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget. 2017;8:21903–17. https://doi.org/10.18632/oncotarget.15746.CrossRefPubMedPubMedCentral

Solomon BJ, Kim D-W, Wu Y-L, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in ALK-mutation-positive non-small-cell lung cancer. J Clin Oncol. 2018;36:2251–8. https://doi.org/10.1200/JCO.2017.77.4794.CrossRefPubMed

Basler L, Kroeze SGC, Guckenberger M. SBRT for oligoprogressive oncogene addicted NSCLC. Lung Cancer. 2017;106:50–7. https://doi.org/10.1016/j.lungcan.2017.02.007.CrossRefPubMed

Gainor JF, Dardaei L, Yoda S, Friboulet L, Leshchiner I, Katayama R, Dagogo-Jack I, Gadgeel S, Schultz K, Singh M, Chin E, Parks M, Lee D, DiCecca RH, Lockerman E, Huynh T, Logan J, Ritterhouse LL, Le LP, Muniappan A, Digumarthy S, Channick C, Keyes C, Getz G, Dias-Santagata D, Heist RS, Lennerz J, Sequist LV, Benes CH, Iafrate AJ, Mino-Kenudson M, Engelman JA, Shaw AT. Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer. Cancer Discov. 2016;6:1118–33. https://doi.org/10.1158/2159-8290.CD-16-0596.CrossRefPubMedPubMedCentral

Yoda S, Lin JJ, Lawrence MS, Burke BJ, Friboulet L, Langenbucher A, Dardaei L, Prutisto-Chang K, Dagogo-Jack I, Timofeevski S, Hubbeling H, Gainor JF, Ferris LA, Riley AK, Kattermann KE, Timonina D, Heist RS, Iafrate AJ, Benes CH, Lennerz JK, Mino-Kenudson M, Engelman JA, Johnson TW, Hata AN, Shaw AT. Sequential ALK inhibitors can select for lorlatinib-resistant compound ALK mutations in ALK-positive lung cancer. Cancer Discov. 2018;8:714–29. https://doi.org/10.1158/2159-8290.CD-17-1256.CrossRefPubMedPubMedCentral

10.

Shaw AT, Kim D-W, Mehra R, Tan DSW, Felip E, Chow LQM, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL, Engelman JA. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014;370:1189–97. https://doi.org/10.1056/NEJMoa1311107.CrossRefPubMedPubMedCentral

11.

Gettinger SN, Zhang S, Hodgson JG, Bazhenova L, Burgers S, Kim D-W, Tan DS-W, Koh HA, Ho JCM, Viteri Ramirez S, Shaw AT, Weiss GJ, Langer CJ, Huber RM, Ahn M-J, Reichmann WG, Kerstein D, Rivera VM, Camidge DR. Activity of brigatinib (BRG) in crizotinib (CRZ) resistant patients (pts) according to ALK mutation status. JCO. 2016;34:9060. https://doi.org/10.1200/JCO.2016.34.15_suppl.9060.CrossRef

12.

Wolf J, Helland A, Oh IJ, Migliorno MR, Dziadziuszko R, de Castro J et al. Phase 3 ALUR study of alectinib in pretreated ALK + NSCLC: final efficacy, safety and targeted genomic sequencing analyses. J Thoracic Oncol 2019 (WCLC 201, OA 02.07) (n.d.).

13.

Shaw AT, Solomon BJ, Besse B, Bauer TM, Lin C-C, Soo RA, Riely GJ, Ou S-HI, Clancy JS, Li S, Abbattista A, Thurm H, Satouchi M, Camidge DR, Kao S, Chiari R, Gadgeel SM, Felip E, Martini J-F. ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer. J Clin Oncol. 2019;37:1370–9. https://doi.org/10.1200/JCO.18.02236.CrossRefPubMedPubMedCentral

14.

Shaw AT, Kim TM, Crinò L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18:874–86. https://doi.org/10.1016/S1470-2045(17)30339-X.CrossRefPubMed

15.

Novello S, Mazières J, Oh I-J, de Castro J, Migliorino MR, Helland Å, Dziadziuszko R, Griesinger F, Kotb A, Zeaiter A, Cardona A, Balas B, Johannsdottir HK, Das-Gupta A, Wolf J. Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study. Ann Oncol. 2018;29:1409–16. https://doi.org/10.1093/annonc/mdy121.CrossRefPubMedPubMedCentral

16.

Reckamp K, Lin HM, Huang J, Proskorovsky I, Reichmann W, Krotneva S, Kerstein D, Huang H, Lee J. Comparative efficacy of brigatinib versus ceritinib and alectinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer. Curr Med Res Opin. 2019;35:569–76. https://doi.org/10.1080/03007995.2018.1520696.CrossRefPubMed

17.

Lin JJ, Zhu VW, Schoenfeld AJ, Yeap BY, Saxena A, Ferris LA, Dagogo-Jack I, Farago AF, Taber A, Traynor A, Menon S, Gainor JF, Lennerz JK, Plodkowski AJ, Digumarthy SR, Ou S-HI, Shaw AT, Riely GJ. Brigatinib in patients with alectinib-refractory ALK-positive NSCLC. J Thorac Oncol. 2018;13:1530–8. https://doi.org/10.1016/j.jtho.2018.06.005.CrossRefPubMedPubMedCentral

18.

Descourt R, Perol M, Rousseau-Bussac G, Planchard D, Mennecier B, Wislez M, Cortot A, Guisier F, Galland L, Dô P, Schott R, Dansin E, Arrondeau J, Auliac J-B, Chouaid C. Brigatinib in patients with ALK-positive advanced non-small-cell lung cancer pretreated with sequential ALK inhibitors: a multicentric real-world study (BRIGALK study). Lung Cancer. 2019;136:109–14. https://doi.org/10.1016/j.lungcan.2019.08.010.CrossRefPubMed

19.

Stinchcombe T, Doebele RC, Wang XF, Gerber DE, Horn L, Camidge DR. Preliminary results of single arm phase 2 trial of brigatinib in patients (pts) with progression disease (PD) after next-generation (NG) anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) in ALK + non-small cell lung cancer (NSCLC). JCO. 2019;37:9027. https://doi.org/10.1200/JCO.2019.37.15_suppl.9027.CrossRef

20.

Novello S, Brustugun OT, Cadranel J, Griesinger F, Hochmair MJ, Pérol M, Popat S, Bent-Ennakhil N, Kruhl C, Felip E. Brigatinib in ALK TKI-pretreated ALK + metastatic non-small cell lung cancer (mNSCLC): the use via expanded access to brigatinib (UVEA-Brig) study. Ann Oncol. 2019. https://doi.org/10.1093/annonc/mdz260.067.CrossRefPubMedPubMedCentral

21.

Horn L, Infante JR, Reckamp KL, Blumenschein GR, Leal TA, Waqar SN, Gitlitz BJ, Sanborn RE, Whisenant JG, Du L, Neal JW, Gockerman JP, Dukart G, Harrow K, Liang C, Gibbons JJ, Holzhausen A, Lovly CM, Wakelee HA. Ensartinib (X-396) in ALK-positive non-small cell lung cancer: results from a first-in-human phase I/II, multicenter study. Clin Cancer Res. 2018;24:2771–9. https://doi.org/10.1158/1078-0432.CCR-17-2398.CrossRefPubMedPubMedCentral

22.

Hida T, Seto T, Horinouchi H, Maemondo M, Takeda M, Hotta K, Hirai F, Kim YH, Matsumoto S, Ito M, Ayukawa K, Tokushige K, Yonemura M, Mitsudomi T, Nishio M. Phase II study of ceritinib in alectinib-pretreated patients with anaplastic lymphoma kinase-rearranged metastatic non-small-cell lung cancer in Japan: ASCEND-9. Cancer Sci. 2018;109:2863–72. https://doi.org/10.1111/cas.13721.CrossRefPubMedPubMedCentral

23.

Solomon BJ, Besse B, Bauer TM, Felip E, Soo RA, Camidge DR, Chiari R, Bearz A, Lin C-C, Gadgeel SM, Riely GJ, Tan EH, Seto T, James LP, Clancy JS, Abbattista A, Martini J-F, Chen J, Peltz G, Thurm H, Ou S-HI, Shaw AT. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018;19:1654–67. https://doi.org/10.1016/S1470-2045(18)30649-1.CrossRefPubMed

24.

Lin JJ, Schoenfeld AJ, Zhu VW, Yeap BY, Chin E, Rooney M, Plodkowski AJ, Digumarthy SR, Dagogo-Jack I, Gainor JF, Ignatius Ou S-H, Riely GJ, Shaw AT. Efficacy of platinum/pemetrexed combination chemotherapy in ALK-positive non-small cell lung cancer refractory to second-generation ALK inhibitors. J Thorac Oncol. 2019. https://doi.org/10.1016/j.jtho.2019.10.014.CrossRefPubMedPubMedCentral

25.

Lin JJ, Riely GJ, Shaw AT. Targeting ALK: precision medicine takes on drug resistance. Cancer Discov. 2017;7:137–55. https://doi.org/10.1158/2159-8290.CD-16-1123.CrossRefPubMedPubMedCentral

26.

McCoach CE, Blakely CM, Banks KC, Levy B, Chue BM, Raymond VM, Le AT, Lee CE, Diaz J, Waqar SN, Purcell WT, Aisner DL, Davies KD, Lanman RB, Shaw AT, Doebele RC. Clinical utility of cell-free DNA for the detection of ALK fusions and genomic mechanisms of ALK inhibitor resistance in non-small cell lung cancer. Clin Cancer Res. 2018;24:2758–70. https://doi.org/10.1158/1078-0432.CCR-17-2588.CrossRefPubMedPubMedCentral

27.

Dagogo-Jack I, Rooney MM, Lin JJ, Nagy RJ, Yeap BY, Hubbeling H, Chin E, Ackil J, Farago AF, Hata AN, Lennerz JK, Gainor JF, Lanman RB, Shaw AT. Treatment with next-generation ALK inhibitors fuels plasma ALK mutation diversity. Clin Cancer Res. 2019. https://doi.org/10.1158/1078-0432.CCR-19-1436.CrossRefPubMedPubMedCentral

28.

Horn L, Whisenant JG, Wakelee H, Reckamp KL, Qiao H, Leal TA, Du L, Hernandez J, Huang V, Blumenschein GR, Waqar SN, Patel SP, Nieva J, Oxnard GR, Sanborn RE, Shaffer T, Garg K, Holzhausen A, Harrow K, Liang C, Lim LP, Li M, Lovly CM. Monitoring therapeutic response and resistance: analysis of circulating tumor DNA in patients with ALK + lung cancer. J Thorac Oncol. 2019;14:1901–11. https://doi.org/10.1016/j.jtho.2019.08.003.CrossRefPubMedPubMedCentral

29.

Paweletz CP, Lau CJ, Oxnard GR. Does testing error underlie liquid biopsy discordance? JCO Precis Oncol. 2019. https://doi.org/10.1200/PO.18.00408.CrossRefPubMed

30.

Shaw AT, Friboulet L, Leshchiner I, Gainor JF, Bergqvist S, Brooun A, Burke BJ, Deng Y-L, Liu W, Dardaei L, Frias RL, Schultz KR, Logan J, James LP, Smeal T, Timofeevski S, Katayama R, Iafrate AJ, Le L, McTigue M, Getz G, Johnson TW, Engelman JA. Resensitization to crizotinib by the lorlatinib ALK resistance mutation L1198F. N Engl J Med. 2016;374:54–61. https://doi.org/10.1056/NEJMoa1508887.CrossRefPubMed

Title: Sequential blinded treatment decisions in ALK-positive non-small cell lung cancers in the era of precision medicine
Authors: J. Remon
F. Tabbò
B. Jimenez
A. Collazo
J. de Castro
S. Novello
Publication date: 01-09-2020
Publisher: Springer International Publishing
Keywords: NSCLC
Tyrosine Kinase Inhibitors
NSCLC
Tyrosine Kinase Inhibitors
Alectinib
Brigatinib
Ceritinib
Crizotinib
Lorlatinib
Published in: Clinical and Translational Oncology / Issue 9/2020
Print ISSN: 1699-048X
Electronic ISSN: 1699-3055
DOI: https://doi.org/10.1007/s12094-020-02290-1

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 9/2020

The effect of metformin on gastric cancer in patients with type 2 diabetes: a systematic review and meta-analysis

Prognostic value of HPV status among patients with hypopharyngeal carcinoma: a population-based study

Genomic profiling in oncology clinical practice

Precision medicine in Ewing sarcoma: a translational point of view

Eastern Spanish experience with nivolumab in metastatic renal cell carcinoma

Resistin is associated with overall survival in non-small cell lung cancer patients during nivolumab treatment

Keynote webinar | Spotlight on antibody–drug conjugates in cancer