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3. Durvalumab with or without tremelimumab versus the EXTREME regimen as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck: KESTREL, a randomized, open-label, phase III study

Author

Psyrri, A., Fayette, J., Harrington, K., Gillison, M., Ahn, M.-J., Takahashi, S., Weiss, J., Machiels, J.-P., Baxi, S., Vasilyev, A., Karpenko, A., Dvorkin, M., Hsieh, C.-Y., Thungappa, S.C., Segura, P.P., Vynnychenko, I., Haddad, R., Kasper, S., Mauz, P.-S., Baker, V., He, P., Evans, B., Wildsmith, S., Olsson, R.F., Yovine, A., Kurland, J.F., Morsli, N., and Seiwert, T.Y.

Published
2023
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6. Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study

Author

Simonelli, M., Garralda, E., Eskens, F., Gil-Martin, M., Yen, C.-J., Obermannova, R., Chao, Y., Lonardi, S., Melichar, B., Moreno, V., Yu, M.-L., Bongiovanni, A., Calvo, E., Rottey, S., Machiels, J.-P., Gonzalez-Martin, A., Paz-Ares, L., Chang, C.-L., Mason, W., Lin, C.-C., Reardon, D.A., Vieito, M., Santoro, A., Meng, R., Abbadessa, G., Menas, F., Lee, H., Liu, Q., Combeau, C., Ternes, N., Ziti-Ljajic, S., and Massard, C.

Published
2022
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7. Pan-Asian adaptation of the EHNS–ESMO–ESTRO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with squamous cell carcinoma of the head and neck

Author

Keam, B., Machiels, J.-P., Kim, H.R., Licitra, L., Golusinski, W., Gregoire, V., Lee, Y.G., Belka, C., Guo, Y., Rajappa, S.J., Tahara, M., Azrif, M., Ang, M.K., Yang, M.-H., Wang, C.-H., Ng, Q.S., Wan Zamaniah, W.I., Kiyota, N., Babu, S., Yang, K., Curigliano, G., Peters, S., Kim, T.W., Yoshino, T., and Pentheroudakis, G.

Published
2021
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8. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer

Author

Cohen, EEW, Licitra, LF, Burtness, B, Fayette, J, Gauler, T, Clement, PM, Grau, JJ, del Campo, JM, Mailliez, A, Haddad, RI, Vermorken, JB, Tahara, M, Guigay, J, Geoffrois, L, Merlano, MC, Dupuis, N, Krämer, N, Cong, XJ, Gibson, N, Solca, F, Ehrnrooth, E, and Machiels, J-PH

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Dental/Oral and Craniofacial Disease, Rare Diseases, Cancer, Clinical Research, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Administration, Intravenous, Administration, Oral, Afatinib, Antimetabolites, Antineoplastic, Biomarkers, Tumor, Biopsy, Carcinoma, Squamous Cell, Disease-Free Survival, Head and Neck Neoplasms, Humans, Methotrexate, Neoplasm Metastasis, Neoplasm Recurrence, Local, Predictive Value of Tests, Quinazolines, Squamous Cell Carcinoma of Head and Neck, afatinib, methotrexate, HNSCC, biomarker, phase III, EGFR, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the phase III LUX-Head & Neck 1 (LUX-H&N1) trial, second-line afatinib significantly improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Here, we evaluated association of prespecified biomarkers with efficacy outcomes in LUX-H&N1.Patients and methodsRandomized patients with R/M HNSCC and progression following ≥2 cycles of platinum therapy received afatinib (40 mg/day) or methotrexate (40 mg/m2/week). Tumor/serum samples were collected at study entry for patients who volunteered for inclusion in biomarker analyses. Tumor biomarkers, including p16 (prespecified subgroup; all tumor subsites), EGFR, HER2, HER3, c-MET and PTEN, were assessed using tissue microarray cores and slides; serum protein was evaluated using the VeriStrat® test. Biomarkers were correlated with efficacy outcomes.ResultsOf 483 randomized patients, 326 (67%) were included in the biomarker analyses; baseline characteristics were consistent with the overall study population. Median PFS favored afatinib over methotrexate in patients with p16-negative [2.7 versus 1.6 months; HR 0.70 (95% CI 0.50-0.97)], EGFR-amplified [2.8 versus 1.5 months; HR 0.53 (0.33-0.85)], HER3-low [2.8 versus 1.8 months; HR 0.57 (0.37-0.88)], and PTEN-high [1.6 versus 1.4 months; HR 0.55 (0.29-1.05)] tumors. Afatinib also improved PFS in combined subsets of patients with p16-negative and EGFR-amplified tumors [2.7 versus 1.5 months; HR 0.47 (0.28-0.80)], and patients with p16-negative tumors who were EGFR therapy-naïve [4.0 versus 2.4 months; HR 0.55 (0.31-0.98)]. PFS was improved in afatinib-treated patients who were VeriStrat 'Good' versus 'Poor' [2.7 versus 1.5 months; HR 0.71 (0.49-0.94)], but no treatment interaction was observed. Afatinib improved tumor response versus methotrexate in all subsets analyzed except for those with p16-positive disease (n = 35).ConclusionsSubgroups of HNSCC patients who may achieve increased benefit from afatinib were identified based on prespecified tumor biomarkers (p16-negative, EGFR-amplified, HER3-low, PTEN-high). Future studies are warranted to validate these findings.Clinical trial registrationNCT01345682.

Published
2017

12. Safety of systemic anti-cancer treatment in oncology patients with non-severe COVID-19: a cohort study

Author

van Marcke, C., Honoré, N., van der Elst, A., Beyaert, S., Derouane, F., Dumont, C., Aboubakar Nana, F., Baurain, J. F., Borbath, I., Collard, P., Cornélis, F., De Cuyper, A., Duhoux, F. P., Filleul, B., Galot, R., Gizzi, M., Mazzeo, F., Pieters, T., Seront, E., Sinapi, I., Van den Eynde, M., Whenham, N., Yombi, J. C., Scohy, A., van Maanen, A., and Machiels, J. P.

Published
2021
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13. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study

Author

Pant, S, Schuler, M, Iyer, G, Witt, O, Doi, T, Qin, S, Tabernero, J, Reardon, D, Massard, C, Minchom, A, Lugowska, I, Carranza, O, Arnold, D, Gutierrez, M, Winter, H, Stuyckens, K, Crow, L, Najmi, S, Hammond, C, Thomas, S, Santiago-Walker, A, Triantos, S, Sweiti, H, Loriot, Y, Greco, M, Coward, J, Joshua, A, Karapetis, C, Hart, C, Zhang, A, Prenen, H, Goeminne, J, Machiels, J, Rottey, S, Corassa, M, Molin, G, Tiscoski, K, Jardim, D, Mak, M, Fu, W, Yao, H, Huang, J, Jiang, H, Chen, B, Yan, D, Yang, Y, Le Tourneau, C, Penel, N, Salas, S, Blay, J, Brachet, P, Durando, X, Emambux, S, Ravaud, A, Folprecht, G, Ahrens, M, Golf, A, Haag, G, Lordick, F, Desuki, A, Cazzaniga, M, Ciardiello, F, Milella, M, Koyama, T, Hirooka, Y, Okamoto, W, Aogi, K, Kuboki, Y, Lee, J, Kim, S, Ahn, M, Chang, J, Kim, Y, Nam, D, Park, J, Paz-Ares, L, Moreno, V, Cervantes, A, Calvo, M, Falcon, A, Gonzalez, A, Martinez Bueno, A, Garcia-Corbacho, J, Longo, F, Yen, C, Chen, J, Hou, M, Chao, Y, Rau, K, Chiu, T, Feng, Y, Hsu, C, Huang, W, Lai, K, Yeh, S, Palmer, D, Welsh, L, Plummer, R, Bilen, M, Arrowsmith, E, Spigel, D, Zandberg, D, Doroshow, D, Lu-Emerson, C, Moezi, M, Paulson, S, Ward, P, Chaves, J, Grigg, C, Hussein, A, Manda, S, Monticelli, M, Qamar, R, Richey, S, Tamura, D, Wilks, S, Pant S., Schuler M., Iyer G., Witt O., Doi T., Qin S., Tabernero J., Reardon D. A., Massard C., Minchom A., Lugowska I., Carranza O., Arnold D., Gutierrez M., Winter H., Stuyckens K., Crow L., Najmi S., Hammond C., Thomas S., Santiago-Walker A., Triantos S., Sweiti H., Loriot Y., Greco M. A., Coward J., Joshua A., Karapetis C., Hart C., Zhang A., Prenen H., Goeminne J. -C., Machiels J. -P., Rottey S., Corassa M., Molin G. Z. D., Tiscoski K., Jardim D. L. F., Mak M., Fu W., Yao H., Huang J., Jiang H., Chen B., Yan D., Yang Y., Le Tourneau C., Penel N., Salas S., Blay J. -Y., Brachet P. -E., Durando X., Emambux S., Ravaud A., Folprecht G., Ahrens M., Golf A., Haag G. M., Lordick F., Desuki A., Cazzaniga M., Ciardiello F., Milella M., Koyama T., Hirooka Y., Okamoto W., Aogi K., Kuboki Y., Lee J., Kim S. -B., Ahn M. -J., Chang J. H., Kim Y. -M., Nam D. -H., Park J. -S., Paz-Ares L., Moreno V., Cervantes A., Calvo M., Falcon A., Gonzalez A., Martinez Bueno A., Garcia-Corbacho J., Longo F., Yen C. -J., Chen J. -S., Hou M. -F., Chao Y., Rau K. -M., Chiu T. -J., Feng Y. -H., Hsu C. -H., Huang W. -T., Lai K. -M., Yeh S. -P., Palmer D., Welsh L., Plummer R., Bilen M., Arrowsmith E., Spigel D. R., Zandberg D. P., Doroshow D., Lu-Emerson C., Moezi M., Paulson S., Reardon D., Ward P., Chaves J., Grigg C., Hussein A., Manda S., Monticelli M., Qamar R., Richey S. L., Tamura D., Wilks S., Pant, S, Schuler, M, Iyer, G, Witt, O, Doi, T, Qin, S, Tabernero, J, Reardon, D, Massard, C, Minchom, A, Lugowska, I, Carranza, O, Arnold, D, Gutierrez, M, Winter, H, Stuyckens, K, Crow, L, Najmi, S, Hammond, C, Thomas, S, Santiago-Walker, A, Triantos, S, Sweiti, H, Loriot, Y, Greco, M, Coward, J, Joshua, A, Karapetis, C, Hart, C, Zhang, A, Prenen, H, Goeminne, J, Machiels, J, Rottey, S, Corassa, M, Molin, G, Tiscoski, K, Jardim, D, Mak, M, Fu, W, Yao, H, Huang, J, Jiang, H, Chen, B, Yan, D, Yang, Y, Le Tourneau, C, Penel, N, Salas, S, Blay, J, Brachet, P, Durando, X, Emambux, S, Ravaud, A, Folprecht, G, Ahrens, M, Golf, A, Haag, G, Lordick, F, Desuki, A, Cazzaniga, M, Ciardiello, F, Milella, M, Koyama, T, Hirooka, Y, Okamoto, W, Aogi, K, Kuboki, Y, Lee, J, Kim, S, Ahn, M, Chang, J, Kim, Y, Nam, D, Park, J, Paz-Ares, L, Moreno, V, Cervantes, A, Calvo, M, Falcon, A, Gonzalez, A, Martinez Bueno, A, Garcia-Corbacho, J, Longo, F, Yen, C, Chen, J, Hou, M, Chao, Y, Rau, K, Chiu, T, Feng, Y, Hsu, C, Huang, W, Lai, K, Yeh, S, Palmer, D, Welsh, L, Plummer, R, Bilen, M, Arrowsmith, E, Spigel, D, Zandberg, D, Doroshow, D, Lu-Emerson, C, Moezi, M, Paulson, S, Ward, P, Chaves, J, Grigg, C, Hussein, A, Manda, S, Monticelli, M, Qamar, R, Richey, S, Tamura, D, Wilks, S, Pant S., Schuler M., Iyer G., Witt O., Doi T., Qin S., Tabernero J., Reardon D. A., Massard C., Minchom A., Lugowska I., Carranza O., Arnold D., Gutierrez M., Winter H., Stuyckens K., Crow L., Najmi S., Hammond C., Thomas S., Santiago-Walker A., Triantos S., Sweiti H., Loriot Y., Greco M. A., Coward J., Joshua A., Karapetis C., Hart C., Zhang A., Prenen H., Goeminne J. -C., Machiels J. -P., Rottey S., Corassa M., Molin G. Z. D., Tiscoski K., Jardim D. L. F., Mak M., Fu W., Yao H., Huang J., Jiang H., Chen B., Yan D., Yang Y., Le Tourneau C., Penel N., Salas S., Blay J. -Y., Brachet P. -E., Durando X., Emambux S., Ravaud A., Folprecht G., Ahrens M., Golf A., Haag G. M., Lordick F., Desuki A., Cazzaniga M., Ciardiello F., Milella M., Koyama T., Hirooka Y., Okamoto W., Aogi K., Kuboki Y., Lee J., Kim S. -B., Ahn M. -J., Chang J. H., Kim Y. -M., Nam D. -H., Park J. -S., Paz-Ares L., Moreno V., Cervantes A., Calvo M., Falcon A., Gonzalez A., Martinez Bueno A., Garcia-Corbacho J., Longo F., Yen C. -J., Chen J. -S., Hou M. -F., Chao Y., Rau K. -M., Chiu T. -J., Feng Y. -H., Hsu C. -H., Huang W. -T., Lai K. -M., Yeh S. -P., Palmer D., Welsh L., Plummer R., Bilen M., Arrowsmith E., Spigel D. R., Zandberg D. P., Doroshow D., Lu-Emerson C., Moezi M., Paulson S., Reardon D., Ward P., Chaves J., Grigg C., Hussein A., Manda S., Monticelli M., Qamar R., Richey S. L., Tamura D., and Wilks S.

Abstract

Background: FGFR alterations are reported across various malignancies and might act as oncogenic drivers in multiple histologies. Erdafitinib is an oral, selective pan-FGFR tyrosine kinase inhibitor with activity in FGFR-altered advanced urothelial carcinoma. We aimed to evaluate the safety and activity of erdafitinib in previously treated patients with FGFR-altered advanced solid tumours. Methods: The single-arm, phase 2 RAGNAR study was conducted at 156 investigative centres (hospitals or oncology practices that are qualified oncology study centres) across 15 countries. The study consisted of four cohorts based on tumour histology and patient age; the results reported in this Article are for the primary cohort of the study, defined as the Broad Panel Cohort, which was histology-agnostic. We recruited patients aged 12 years or older with advanced or metastatic tumours of any histology (except urothelial cancer) with predefined FGFR1–4 alterations (mutations or fusions according to local or central testing). Eligible patients had disease progression on at least one previous line of systemic therapy and no alternative standard therapy available to them, and an Eastern Cooperative Oncology Group performance status of 0–1 (or equivalent for adolescents aged 12–17 years). Patients received once-daily oral erdafitinib (8 mg/day with provision for pharmacodynamically guided up-titration to 9 mg/day) on a continuous 21-day cycle until disease progression or intolerable toxicity. The primary endpoint was objective response rate by independent review committee according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1, or Response Assessment In Neuro-Oncology (RANO). The primary analysis was conducted on the treated population of the Broad Panel Cohort. This ongoing study is registered with ClinicalTrials.gov, number NCT04083976. Findings: Patients were recruited between Dec 5, 2019, and Feb 15, 2022. Of 217 patients treated with erdafitinib, 97 (45%) pa

Published
2023

14. 43O A dose-escalation study of TNO155 (TN) in combination with spartalizumab (SPA) or ribociclib (RIB) in adults with advanced solid tumors

Author

Santa Gadea, O. Saavedra, primary, Machiels, J-P., additional, Soo, R.A., additional, Wong, M., additional, Ma, B.B.Y., additional, Zander, T., additional, Wang, Y., additional, Lin, J.J., additional, Gambardella, V., additional, Zhao, J., additional, Nakhla, K., additional, Yang, S., additional, Kodack, D., additional, Moody, S., additional, and Yamamoto, N., additional

Published
2024
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15. 32P Tumor-agnostic plasma assay for circulating tumor DNA predicts outcome in recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with a PD-1 inhibitor

Author

Honoré, N., primary, Van Der Elst, A., additional, Dietz, A., additional, Van Marcke de Lummen, C., additional, Helaers, R., additional, Mendola, A., additional, Dahou, H., additional, Marbaix, E., additional, Poncin, R., additional, Seront, E., additional, Schmitz, S., additional, Limaye, N., additional, Galot, R., additional, and Machiels, J-P., additional

Published
2023
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16. 155P A phase I study exploring the safety and tolerability of the small-molecule PD-L1 inhibitor INCB099280 in select advanced solid tumors

Author

Prenen, H., primary, Lesimple, T., additional, Robert, M., additional, Machiels, J-P., additional, Delafontaine, B.R., additional, Tomasini, P., additional, Meniawy, T., additional, Kotecki, N., additional, Van Cutsem, E., additional, Piha-Paul, S.A., additional, Schweizer, M.T., additional, Gadgeel, S., additional, Kondo, S., additional, Ouali, K., additional, Kuboki, Y., additional, Daniel, J., additional, Ebiana, V., additional, Howe, J., additional, Spitz, S., additional, and Italiano, A., additional

Published
2023
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18. 186P Post-anti-PD1 tumor characterization of HPV-negative R/M SCCHN: An EORTC IMMUcan sub-project

Author

Van Der Elst, A., primary, Saboya, D. Herrero, additional, Michon, L., additional, Morfouace, M., additional, Liechti, R., additional, Schulz, D., additional, Devanand, P., additional, Galot, R., additional, Essabar, A., additional, Pancaldi, V., additional, Merlevede, J., additional, Hong, H.S., additional, Martignetti, L., additional, Lefebvre, C., additional, Even, C., additional, Le Tourneau, C., additional, Daste, A., additional, Lucas, S., additional, Saintigny, P., additional, and Machiels, J-P., additional

Published
2023
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21. Corrigendum to ‘Salivary gland cancer: ESMO–European Reference Network on Rare Adult Solid Cancers (EURACAN) Clinical Practice Guideline for diagnosis, treatment and follow-up’

Author

van Herpen, C., primary, Vander Poorten, V., additional, Skalova, A., additional, Terhaard, C., additional, Maroldi, R., additional, van Engen, A., additional, Baujat, B., additional, Locati, L.D., additional, Jensen, A.D., additional, Smeele, L., additional, Hardillo, J., additional, Costes Martineau, V., additional, Trama, A., additional, Kinloch, E., additional, Even, C., additional, and Machiels, J.-P., additional

Published
2023
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24. Patient (pt) reported pain and health-related quality of life (HRQoL) by genomic loss of heterozygosity (gLOH) status in men with metastatic castration-resistant prostate cancer (mCRPC) receiving talazoparib (TALA): TALAPRO-1

Author

Saad, F., primary, Stenzl, A., additional, Mehra, N., additional, Stirling, A., additional, Renard, V., additional, Machiels, J-P., additional, Dorff, T., additional, Maruzzo, M., additional, Nazari, J., additional, Bhattacharyya, H., additional, Healy, C., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2022
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25. LBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC)

Author

Machiels, J-P., primary, Tao, Y., additional, Burtness, B., additional, Tahara, M., additional, Rischin, D., additional, Alves, G.V., additional, Lima, I.P.F., additional, Hughes, B.G.M., additional, Pointreau, Y., additional, Aksoy, S., additional, Laban, S., additional, Greil, R., additional, Burian, M., additional, Hetnal, M., additional, Licitra, L.F., additional, Swaby, R., additional, Zhang, Y., additional, Gumuscu, B., additional, Bidadi, B., additional, and Siu, L.L., additional

Published
2022
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26. 658MO Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040

Author

Soulieres, D., primary, Harrington, K.J., additional, Le Tourneau, C., additional, Silva, J.D., additional, Licitra, L.F., additional, Ahn, M-J., additional, Soria, A., additional, Machiels, J-P., additional, Mach, N., additional, Mehra, R., additional, Burtness, B., additional, Lin, J., additional, Lerman, N., additional, Gumuscu, B., additional, and Cohen, E.E.W., additional

Published
2022
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29. LBA36 A randomised phase II study to evaluate the efficacy and safety of androgen deprivation therapy (ADT) vs chemotherapy (CT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancers

Author

Licitra, L.F.L., Locati, L.D., Digue, L., Even, C., Psyrri, A., Clement, P.M., Ochsenreither, S., Delord, J-P., Moro, C., Machiels, J-P., Fuereder, T., Govaerts, A-S., Quattrone, P., De Cecco, L., Perrone, F., Rasschaert, M., Nzokirantevye, A., Joaquim, A., Venslovaite, E., and Fortpied Lefevre, C.

Published
2024
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36. Phase II study of everolimus in patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract: clinical activity, molecular response, and biomarkers

Author

Seront, E., Rottey, S., Sautois, B., Kerger, J., D'Hondt, L.A., Verschaeve, V., Canon, J.-L., Dopchie, C., Vandenbulcke, J.M., Whenham, N., Goeminne, J.C., Clausse, M., Verhoeven, D., Glorieux, P., Branders, S., Dupont, P., Schoonjans, J., Feron, O., and Machiels, J.-P.

Published
2012
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39. Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors.

Author

Rottey S., Clarke J., Aung K., Machiels J.-P., Markman B., Heinhuis K.M., Millward M., Lolkema M., Patel S.P., De Souza P., Duca M., Curigliano G., Santoro A., Koyama T., Brown M., Vezina H., He C., Siu-Chung Chu Q., Rottey S., Clarke J., Aung K., Machiels J.-P., Markman B., Heinhuis K.M., Millward M., Lolkema M., Patel S.P., De Souza P., Duca M., Curigliano G., Santoro A., Koyama T., Brown M., Vezina H., He C., and Siu-Chung Chu Q.

Abstract

Purpose: To assess the safety and tolerability of BMS-986148, a mesothelin-directed antibody-drug conjugate (ADC)+/-nivolumab, in patients with selected tumors. Patients and Methods: In an international phase I/IIa study [NCT02341625 (CA008-002)], patients received BMS-986148 monotherapy (0.1-1.6 mg/kg intravenously (i.v.) every 3 weeks or 0.4 or 0.6 mg/kg i.v. once weekly; n=96) or BMS-986148 0.8 mg/kg nivolumab 360 mg i.v. every 3 weeks (n = 30). The primary endpoint was safety and tolerability. Result(s): In CA008-002, the most common (>= 10%) treatmentrelated adverse events (TRAEs) included increased aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase. Grade 3/4 TRAEs occurred in 42 patients (49%) receiving BMS-986148 every 3 weeks monotherapy, three (25%) receiving BMS-986148 once-weekly monotherapy, and 10 (33%) receiving BMS-986148 + nivolumab every 3 weeks. Overall, 17 of 126 patients (13%) discontinued because of a TRAE. The MTD of BMS-986148 was 1.2 mg/kg i.v. every 3 weeks. The safety profile of BMS-986148 nivolumab was similar to that of BMS-986148 monotherapy (0.8 mg/kg). Active ADC exposures increased in a dose-proportional manner with both dosing regimens (every 3 weeks and once weekly). Preliminary clinical activity was observed with BMS-986148 +/- nivolumab. No association between mesothelin expression and response was detected. Conclusion(s): BMS-986148 _ nivolumab demonstrated a clinically manageable safety profile and preliminary evidence of clinical activity, supporting additional studies combining directed cytotoxic therapies with checkpoint inhibitors as potential multimodal therapeutic strategies in patients with advanced solid tumors.Copyright © 2022 American Association for Cancer Research Inc.. All rights reserved.

Published
2022

41. Salivary gland cancer:ESMO-European Reference Network on Rare Adult Solid Cancers (EURACAN) Clinical Practice Guideline for diagnosis, treatment and follow-up

Author

van Herpen, C., Vander Poorten, V., Skalova, A., Terhaard, C., Maroldi, R., van Engen, A., Baujat, B., Locati, L. D., Jensen, A. D., Smeele, L., Hardillo, J., Martineau, V. Costes, Trama, A., Kinloch, E., Even, C., Machiels, J. P., van Herpen, C., Vander Poorten, V., Skalova, A., Terhaard, C., Maroldi, R., van Engen, A., Baujat, B., Locati, L. D., Jensen, A. D., Smeele, L., Hardillo, J., Martineau, V. Costes, Trama, A., Kinloch, E., Even, C., and Machiels, J. P.

Published
2022

42. Isatuximab plus atezolizumab in patients with advanced solid tumors:results from a phase I/II, open-label, multicenter study

Author

Simonelli, M., Garralda, E., Eskens, F., Gil-Martin, M., Yen, C. J., Obermannova, R., Chao, Y., Lonardi, S., Melichar, B., Moreno, V., Yu, M. L., Bongiovanni, A., Calvo, E., Rottey, S., Machiels, J. P., Gonzalez-Martin, A., Paz-Ares, L., Chang, C. L., Mason, W., Lin, C. C., Reardon, D. A., Vieito, M., Santoro, A., Meng, R., Abbadessa, G., Menas, F., Lee, H., Liu, Q., Combeau, C., Ternes, N., Ziti-Ljajic, S., Massard, C., Simonelli, M., Garralda, E., Eskens, F., Gil-Martin, M., Yen, C. J., Obermannova, R., Chao, Y., Lonardi, S., Melichar, B., Moreno, V., Yu, M. L., Bongiovanni, A., Calvo, E., Rottey, S., Machiels, J. P., Gonzalez-Martin, A., Paz-Ares, L., Chang, C. L., Mason, W., Lin, C. C., Reardon, D. A., Vieito, M., Santoro, A., Meng, R., Abbadessa, G., Menas, F., Lee, H., Liu, Q., Combeau, C., Ternes, N., Ziti-Ljajic, S., and Massard, C.

Abstract

Background: The anti-CD38 antibody isatuximab is approved for the treatment of relapsed/refractory multiple myeloma, but there are no data on its efficacy in solid tumors. This phase I/II study (NCT03637764) assessed the safety and activity of isatuximab plus atezolizumab (Isa + Atezo), an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with immunotherapy-naive solid tumors: epithelial ovarian cancer (EOC), glioblastoma (GBM), hepatocellular carcinoma (HCC), and squamous cell carcinoma of the head and neck (SCCHN). Patients and methods: Phase I assessed safety, tolerability, pharmacokinetics, pharmacodynamics, and the recommended phase II dose (RP2D) of isatuximab 10 mg/kg intravenously (i.v.) every week for 3 weeks followed by once every 3 weeks + atezolizumab 1200 mg i.v. every 3 weeks. Phase II used a Simon's two-stage design to assess the overall response rate or progression-free survival rate at 6 months (GBM cohort). Interim analysis was carried out at 6 months following first dose of the last enrolled patient in each cohort. Pharmacodynamic biomarkers were tested for CD38, PD-L1, tumor-infiltrating immune cells, and FOXP3+ regulatory T cells (Tregs) in the tumor microenvironment (TME). Results: Overall, 107 patients were treated (EOC, n = 18; GBM, n = 33; HCC, n = 27; SCCHN, n = 29). In phase I, Isa + Atezo showed an acceptable safety profile, no dose-limiting toxicities were observed, and RP2D was confirmed. Most patients experienced ≥1 treatment-emergent adverse event (TEAE), with ≤48.5% being grade ≥3. The most frequent TEAE was infusion reactions. The study did not continue to stage 2 based on prespecified targets. Tumor-infiltrating CD38+ immune cells were reduced and almost cleared after treatment. Isa + Atezo did not significantly modulate Tregs or PD-L1 expression in the TME. Conclusions: Isa + Atezo had acceptable safety and tolerability. Clinical pharmacodynamic evaluation revealed efficient target engagement of isatuximab via treatm

Published
2022

45. Patient-reported pain by baseline pain status in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) receiving Talazoparib (TALA): TALAPRO-1

Author

Stenzl, A., primary, Saad, F., additional, De Bono, J.S., additional, Higano, C.S., additional, Barthelemy, P., additional, Dorff, T., additional, Mehra, N., additional, Scagliotti, G.V., additional, Machiels, J-P., additional, Renard, V., additional, Maruzzo, M., additional, Gurney, H., additional, Stirling, A., additional, Cynthia, G.H., additional, Bhattacharyya, H., additional, Arondekar, B., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2021
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46. Health-Related Quality of Life (HRQoL) in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) receiving Talazoparib (TALA): TALAPRO-1

Author

Stenzl, A., primary, Saad, F., additional, De Bono, J.S., additional, Higano, C.S., additional, Barthelemy, P., additional, Dorff, T., additional, Mehra, N., additional, Scagliotti, G.V., additional, Machiels, J-P., additional, Renard, V., additional, Maruzzo, M., additional, Gurney, H., additional, Stirling, A., additional, Healy, C.G., additional, Bhattacharyya, H., additional, Arondekar, B., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2021
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47. 581P Patient (pt) reported pain in men with metastatic castration-resistant prostate cancer (mCRPC) receiving talazoparib (TALA): TALAPRO-1

Author

Saad, F., primary, de Bono, J.S., additional, Barthelemy, P., additional, Dorff, T., additional, Mehra, N., additional, Scagliotti, G., additional, Stirling, A., additional, Machiels, J-P., additional, Renard, V., additional, Maruzzo, M., additional, Higano, C.S., additional, Gurney, H.P., additional, Healy, C., additional, Bhattacharyya, H., additional, Arondekar, B., additional, Niyazov, A., additional, and Fizazi, K., additional

Published
2021
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48. 580P TALAPRO-1: Talazoparib (TALA) monotherapy in metastatic castration-resistant prostate cancer (mCRPC) with DNA damage response alterations (DDRm) - Exploration of non-DDR mutational landscape and potential associations with antitumor activity

Author

Mehra, N., primary, de Bono, J., additional, Laird, A.D., additional, Barthélémy, P., additional, Delva, R., additional, Dorff, T., additional, Maruzzo, M., additional, Stirling, A., additional, Machiels, J-P., additional, Dumez, H., additional, Renard, V., additional, Hopkins, J., additional, Albacker, L.A., additional, Chen, H-C., additional, Healy, C., additional, Chelliserry, J., additional, van Oort, I.M., additional, Scagliotti, G., additional, and Fizazi, K., additional

Published
2021
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