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1. Targeted therapy for advanced salivary gland carcinoma based on molecular profiling: results from MyPathway, a phase IIa multiple basket study.

Author

Meric-Bernstam, F, Hainsworth, J, Spigel, D, Bose, R, Burris, H, Sweeney, C, Beattie, M, Blotner, S, Schulze, K, Cuchelkar, V, Swanton, C, Bowles, D, Kurzrock, Razelle, and Kang, Hyunseok

Subjects
HER2-positive, advanced salivary gland carcinoma, molecular profiling, pertuzumab, targeted therapy, trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Carcinoma, Humans, Molecular Targeted Therapy, Receptor, ErbB-2, Salivary Gland Neoplasms, Salivary Glands, Trastuzumab
Abstract

BACKGROUND: Systemic therapy options for salivary cancers are limited. MyPathway (NCT02091141), a phase IIa study, evaluates targeted therapies in non-indicated tumor types with actionable molecular alterations. Here, we present the efficacy and safety results for a subgroup of MyPathway patients with advanced salivary gland cancer (SGC) matched to targeted therapies based on tumor molecular characteristics. PATIENTS AND METHODS: MyPathway is an ongoing, multiple basket, open-label, non-randomized, multi-center study. Patients with advanced SGC received pertuzumab + trastuzumab (HER2 alteration), vismodegib (PTCH-1/SMO mutation), vemurafenib (BRAF V600 mutation), or atezolizumab [high tumor mutational burden (TMB)]. The primary endpoint is the objective response rate (ORR). RESULTS: As of January 15, 2018, 19 patients with SGC were enrolled and treated in MyPathway (15 with HER2 amplification and/or overexpression and one each with a HER2 mutation without amplification or overexpression, PTCH-1 mutation, BRAF mutation, and high TMB). In the 15 patients with HER2 amplification/overexpression (with or without mutations) who were treated with pertuzumab + trastuzumab, 9 had an objective response (1 complete response, 8 partial responses) for an ORR of 60% (9.2 months median response duration). The clinical benefit rate (defined by patients with objective responses or stable disease >4 months) was 67% (10/15), median progression-free survival (PFS) was 8.6 months, and median overall survival was 20.4 months. Stable disease was observed in the patient with a HER2 mutation (pertuzumab + trastuzumab, n = 1/1, PFS 11.0 months), and partial responses in patients with the PTCH-1 mutation (vismodegib, n = 1/1, PFS 14.3 months), BRAF mutation (vemurafenib, n = 1/1, PFS 18.5 months), and high TMB (atezolizumab, n = 1/1, PFS 5.5+ months). No unexpected toxicity occurred. CONCLUSIONS: Overall, 12 of 19 patients (63%) with advanced SGC, treated with chemotherapy-free regimens matched to specific molecular alterations, experienced an objective response. Data from MyPathway suggest that matched targeted therapy for SGC has promising efficacy, supporting molecular profiling in treatment determination.

Published
2020

2. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer.

Author

Cheng, Y., Spigel, D. R., Cho, B. C., Laktionov, K. K., Fang, J., Chen, Y., Zenke, Y., Lee, K. H., Wang, Q., Navarro, A., Bernabe, R., Buchmeier, E. L., Chang, J. W.-C., Shiraishi, Y., Goksu, S. S., Badzio, A., Shi, A., Daniel, D. B., Hoa, N. T. T., and Zemanova, M.

Subjects
*PROGRESSION-free survival, *OVERALL survival, *RADIATION pneumonitis, *LUNG cancer, *DISEASE progression
Abstract

Background: Adjuvant therapy with durvalumab, with or without tremelimumab, may have efficacy in patients with limited-stage small-cell lung cancer who do not have disease progression after standard concurrent platinum-based chemoradiotherapy. Methods: In a phase 3, double-blind, randomized, placebo-controlled trial, we assigned patients to receive durvalumab at a dose of 1500 mg, durvalumab (1500 mg) plus tremelimumab at a dose of 75 mg (four doses only), or placebo every 4 weeks for up to 24 months. Randomization was stratified according to disease stage (I or II vs. III) and receipt of prophylactic cranial irradiation (yes vs. no). Results of the first planned interim analysis of the two primary end points of overall survival and progression-free survival (assessed on the basis of blinded independent central review according to the Response Evaluation Criteria in Solid Tumors, version 1.1) with durvalumab as compared with placebo (data cutoff date, January 15, 2024) are reported; results in the durvalumab-tremelimumab group remain blinded. Results: A total of 264 patients were assigned to the durvalumab group, 200 to the durvalumab-tremelimumab group, and 266 to the placebo group. Durvalumab therapy led to significantly longer overall survival than placebo (median, 55.9 months [95% confidence interval {CI}, 37.3 to not reached] vs. 33.4 months [95% CI, 25.5 to 39.9]; hazard ratio for death, 0.73; 98.321% CI, 0.54 to 0.98; P = 0.01), as well as to significantly longer progression-free survival (median 16.6 months [95% CI, 10.2 to 28.2] vs. 9.2 months [95% CI, 7.4 to 12.9]; hazard ratio for progression or death, 0.76; 97.195% CI, 0.59 to 0.98; P = 0.02). The incidence of adverse events with a maximum grade of 3 or 4 was 24.4% among patients receiving durvalumab and 24.2% among patients receiving placebo; adverse events led to discontinuation in 16.4% and 10.6% of the patients, respectively, and led to death in 2.7% and 1.9%. Pneumonitis or radiation pneumonitis with a maximum grade of 3 or 4 occurred in 3.1% of the patients in the durvalumab group and in 2.6% of those in the placebo group. Conclusions: Adjuvant therapy with durvalumab led to significantly longer overall survival and progression-free survival than placebo among patients with limited-stage small-cell lung cancer. (Funded by AstraZeneca; ADRIATIC ClinicalTrials.gov number, NCT03703297.). [ABSTRACT FROM AUTHOR]

Published
2024
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4. 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

5. 128P A phase I dose escalation and expansion trial of LYT-200: A galectin-9 antibody +/- tislelizumab

Author

Falchook, G., primary, Rasco, D., additional, Papadopoulos, K., additional, Parikh, A., additional, Mahipal, A., additional, Messersmith, W., additional, Manji, G., additional, Fu, S., additional, Sherman, E., additional, Fein, D., additional, Krop, J., additional, Korth, C., additional, Wang, J., additional, Sharma, M., additional, Spigel, D., additional, Filipovic, A., additional, and Wainberg, Z., additional

Published
2023
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6. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases

Author

Vokes, E.E., Ready, N., Felip, E., Horn, L., Burgio, M.A., Antonia, S.J., Arén Frontera, O., Gettinger, S., Holgado, E., Spigel, D., Waterhouse, D., Domine, M., Garassino, M., Chow, L.Q.M., Blumenschein, G., Jr, Barlesi, F., Coudert, B., Gainor, J., Arrieta, O., Brahmer, J., Butts, C., Steins, M., Geese, W.J., Li, A., Healey, D., and Crinò, L.

Published
2018
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9. 66O MyPathway: A multiple target, multiple basket study of targeted treatments in tissue-agnostic cohorts of patients (pts) with advanced solid tumors

Author

Friedman, C., primary, Swanton, C., additional, Spigel, D., additional, Bose, R., additional, Burris, H., additional, Yu, W., additional, Wang, Y., additional, Malato, J., additional, Price, R., additional, Darbonne, W., additional, Szado, T., additional, Schulze, K., additional, Sweeney, C., additional, Hainsworth, J., additional, Meric-Bernstam, F., additional, and Kurzrock, R., additional

Published
2022
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10. P1.15-11 Durvalumab + Olaparib vs Durvalumab Alone as Maintenance Therapy in Metastatic NSCLC: Outcomes from the Phase 2 ORION Study

Author

Ahn, M-j., primary, Spigel, D., additional, Bondarenko, I., additional, Kalinka, E., additional, Cho, B.C., additional, Sugawara, S., additional, Galffy, G., additional, Shim, B.Y., additional, Kislov, N., additional, Nagarkar, R., additional, Demedts, I., additional, Gans, S.J.M., additional, Oliva, D.M., additional, Stewart, R., additional, Lai, Z., additional, Grainger, E., additional, Shi, X., additional, and Hussein, M., additional

Published
2022
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14. P-125 Phase 1b study of RGX-202-01, a first-in-class oral inhibitor of the SLC6A8/CKB pathway, in combination with FOLFIRI and bevacizumab (BEV) in second-line advanced colorectal cancer (CRC)

Author

Hendifar, A., primary, Rosen, L., additional, McRee, A., additional, Cercek, A., additional, Basu-Mallick, A., additional, Spigel, D., additional, Tavazoie, S., additional, Rowinsky, E., additional, Szarek, M., additional, Gonsalves, F., additional, Kurth, I., additional, Andreu, C., additional, Busby, R., additional, Spector, S., additional, Darst, D., additional, Lebaka, N., additional, Bechar, N., additional, Tavazoie, M., additional, Wasserman, R., additional, and Fakih, M., additional

Published
2022
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15. 8P Pharmacokinetic (PK) profile and food effect of RP-3500, a highly potent and specific inhibitor of ataxia telangiectasia and Rad3-related (ATR) protein kinase in patients (pts) with cancer

Author

Lheureux, S., primary, Rosen, E., additional, Lee, E., additional, Spigel, D., additional, Højgaard, M., additional, Fontana, E., additional, Mettu, N.B., additional, Carter, L., additional, Patel, S., additional, Papp, R., additional, May, S., additional, Nejad, P., additional, Ulanet, D., additional, Wainszelbaum, M., additional, Manley, P., additional, Koehler, M., additional, Fretland, A.J., additional, Plummer, R., additional, and Yap, T.A., additional

Published
2022
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16. 5MO Comprehensive dose-finding strategy for single-agent RP-3500, a highly selective inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase

Author

Fontana, E., primary, Lee, E., additional, Rosen, E., additional, Spigel, D., additional, Højgaard, M., additional, Lheureux, S., additional, Mettu, N.B., additional, Carter, L., additional, Plummer, R., additional, Manley, P., additional, Ulanet, D., additional, Rimkunas, V., additional, Silverman, I.M., additional, O'Connell, J., additional, McDougall, R., additional, Wainszelbaum, M., additional, Xu, Y., additional, Koehler, M., additional, Fretland, A.J., additional, and Yap, T.A., additional

Published
2022
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17. 9P Preliminary population pharmacokinetic (popPK) co-variates and exposure response (ER) assessment of QT for RP-3500, a highly potent and specific inhibitor of ataxia telangiectasia and Rad3-related (ATR) protein kinase

Author

Lee, E., primary, Yap, T.A., additional, Fontana, E., additional, Rosen, E., additional, Spigel, D., additional, Lheureux, S., additional, Mettu, N.B., additional, Carter, L., additional, Plummer, R., additional, Patel, S., additional, McDougall, R., additional, Papp, R., additional, May, S., additional, Nejad, P., additional, Ulanet, D., additional, Wainszelbaum, M., additional, Manley, P., additional, Koehler, M., additional, Fretland, A.J., additional, and Højgaard, M., additional

Published
2022
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19. Surveillance of in situ tumor arrays reveals early environmental control of cancer immunity

Author

Yang A, Alex T. Ritter, Christine Moussion, de Andrea Ce, Zora Modrusan, Shannon J. Turley, Spigel D, Yulei Wang, Markus Brown, Price R, Thomas D. Wu, Darya Y. Orlova, Pechuan-Jorge J, Ira Mellman, Ortiz-Muñoz G, Gomez-Roca C, Sanjeev Mariathasan, Catherine B Carbone, Jonas Doerr, and Mantri

Subjects
Tumor microenvironment, medicine.anatomical_structure, Immune system, T cell, medicine.medical_treatment, Cell, medicine, Cancer research, Cytotoxic T cell, Immunotherapy, Biology, Phenotype, Immune checkpoint
Abstract

SummaryThe immune phenotype of a tumor is a key predictor of its response to immunotherapy1–4. Patients who respond to immune checkpoint blockade generally present with tumors that are infiltrated by activated T cells, a tumor-immune phenotype referred to as ‘immune inflamed’5–7. However, not all immune inflamed tumors respond to therapy, and in addition the majority of patients presents with tumors that lack T cells (‘immune desert’) or that exclude T cells in the periphery of the tumor islet (‘immune excluded’)8. Despite the importance of these tumor-immune phenotypes in patients, little is known about their development, heterogeneity or dynamics due to an inability to model these features pre-clinically.Here, we describe an approach designated STAMP (skin tumor array by micro-poration), which combines in vivo noninvasive, high-throughput time-lapse imaging with excisional biopsies and next generation sequencing to characterize the establishment of the immunological niche and follow its evolution during immunotherapy. STAMP involves the seeding of dozens to hundreds clonal tumors in the superficial dermis of a single mouse ear that can be visualized in situ over weeks to months. Using this approach, we found that genetically identical tumors could display surprisingly different immune phenotypes. Although individual tumors of the same array were populated by the same T cell clonotypes, regression or progression of individual tumors were associated with distinct patterns of spatial organization of the T cells. In situ imaging of 14K tumors revealed that immune phenotypes were not static over-time but could rather evolve with tumor growth and response to treatment. Therapy-induced or spontaneous early conversion to the immune inflamed phenotype correlated with tumor regression and enhanced cytotoxic T cell activity. Therefore, STAMP provides a flexible approach to study the relationship between tumor evolution, immune cell dynamics, and tumor microenvironment with therapeutic response.

Published
2021
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21. Durvalumab after chemoradiotherapy in stage III NSCLC: 4-year survival update from the phase III PACIFIC trial

Author

Faivre-Finn, C., Vicente, D., Kurata, T., Planchard, D., Paz-Ares, L., Vansteenkiste, J. F., Spigel, D. R., Garassino, M. C., Reck, M., Senan, S., Naidoo, J., Rimner, A., Wu, Y-L., Gray, J. E., Ozguroglu, M., Lee, K. H., Newton, M., Wang, L., Thiyagarajah, P., Antonia, S. J., Radiation Oncology, and CCA - Cancer Treatment and quality of life

Published
2020
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23. Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331

Author

Spigel, D. R., Vicente, D., Ciuleanu, T. E., Gettinger, S., Peters, S., Horn, L., Audigier-Valette, C., Pardo Aranda, N., Juan-Vidal, O., Cheng, Y., Zhang, H., Shi, M., Luft, A., Wolf, J., Antonia, S., Nakagawa, K., Fairchild, J., Baudelet, C., Pandya, D., Doshi, P., Chang, H., Reck, M., Spigel, D. R., Vicente, D., Ciuleanu, T. E., Gettinger, S., Peters, S., Horn, L., Audigier-Valette, C., Pardo Aranda, N., Juan-Vidal, O., Cheng, Y., Zhang, H., Shi, M., Luft, A., Wolf, J., Antonia, S., Nakagawa, K., Fairchild, J., Baudelet, C., Pandya, D., Doshi, P., Chang, H., and Reck, M.

Abstract

Background: Patients with relapsed small-cell lung cancer (SCLC) have few treatment options and dismal survival. Phase I/II data show activity of nivolumab in previously treated SCLC. Patients and methods: CheckMate 331 is a randomized, open-label, phase III trial of nivolumab versus standard chemotherapy in relapsed SCLC. Patients with relapse after first-line, platinum-based chemotherapy were randomized 1 : 1 to nivolumab 240 mg every 2 weeks or chemotherapy (topotecan or amrubicin) until progression or unacceptable toxicity. Primary endpoint was overall survival (OS). Results: Overall, 284 patients were randomized to nivolumab and 285 to chemotherapy. Minimum follow-up was 15.8 months. No significant improvement in OS was seen with nivolumab versus chemotherapy [median OS, 7.5 versus 8.4 months; hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.72-1.04; P = 0.11]. A survival benefit with nivolumab was suggested in patients with baseline lactate dehydrogenase <= upper limit of normal and in those without baseline liver metastases. OS (nivolumab versus chemotherapy) was similar in patients with programmed death-ligand 1 combined positive score >= 1% versus <1%. Median progression-free survival was 1.4 versus 3.8 months (HR, 1.41; 95% CI, 1.18-1.69). Objective response rate was 13.7% versus 16.5% (odds ratio, 0.80; 95% CI, 0.50-1.27); median duration of response was 8.3 versus 4.5 months. Rates of grade 3 or 4 treatment-related adverse events were 13.8% versus 73.2%. Conclusion: Nivolumab did not improve survival versus chemotherapy in relapsed SCLC. No new safety signals were seen. In exploratory analyses, select baseline characteristics were associated with improved OS for nivolumab.

Published
2021

25. FP13.03 IMpower110: Updated OS Analysis of Atezolizumab vs Platinum-Based Chemotherapy as First-Line Treatment in PD-L1–Selected NSCLC

Author

Herbst, R., primary, De Marinis, F., additional, Giaccone, G., additional, Vergnenegre, A., additional, Barrios, C., additional, Morise, M., additional, Felip, E., additional, Oprean, C., additional, Kim, Y., additional, Andric, Z., additional, Mocci, S., additional, Enquist, I., additional, Komatsubara, K., additional, Mccleland, M., additional, Deng, Y., additional, Kuriki, H., additional, Villalobos, M., additional, Phan, S., additional, Spigel, D., additional, and Jassem, J., additional

Published
2021
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28. MO01.33 CRESTONE – Clinical Study of REsponse to Seribantumab in Tumors with NEuregulin-1 (NRG1) Fusions – A Phase 2 Study of the anti-HER3 mAb for Advanced or Metastatic Solid Tumors (NCT04383210)

Author

Spigel, D., primary, Waqar, S.N., additional, Burkard, M.E., additional, Lin, J.J., additional, Chae, Y.K., additional, Socinski, M.A., additional, Gadgeel, S., additional, Reckamp, K.L., additional, Leland, S.M., additional, Plessinger, D., additional, Kunkel, L., additional, Bauman, J.R., additional, Otterson, G., additional, Halmos, B., additional, Ignatius Ou, S.-H., additional, Patil, T., additional, Elamin, Y.Y., additional, and Kim, E.S., additional

Published
2021
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30. Five-year outcomes from the randomized, phase 3 trials CheckMate 017/057: nivolumab vs docetaxel in previously treated NSCLC

Author

Lind, M., primary, Gettinger, S., additional, Borghaei, H., additional, Brahmer, J., additional, Chow, L., additional, Burgio, M., additional, De Castro Carpeno, J., additional, Pluzanski, A., additional, Arrieta, O., additional, Frontera, O. Aren, additional, Chiari, R., additional, Butts, C., additional, Wojcik-Tomaszewska, J., additional, Coudert, B., additional, Garassino, M., additional, Ready, N., additional, Felip, E., additional, Garcia, M. Alonso, additional, Waterhouse, D., additional, Domine, M., additional, Barlesi, F., additional, Antonia, S., additional, Wohlleber, M., additional, Gerber, D., additional, Czyzewicz, G., additional, Spigel, D., additional, Crino, L., additional, Eberhardt, W., additional, Li, A., additional, Marimuthu, S., additional, and Vokes, E., additional

Published
2020
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31. CheckMate 384 : essai clinique de phase 3b/4 évaluant nivolumab 480 mg toutes les 4 semaines (Q4S) vs nivolumab 240 mg toutes les 2 semaines (Q2S) chez les patients (pts) atteints d’un cancer bronchique non à petites cellules (CBNPC) avancé préalablement traité par nivolumab pendant une durée ≤ 12 mois

Author

Garon, E., primary, Reinmuth, N., additional, Falchero, L., additional, García, Y., additional, Hureaux, J., additional, Gore, I., additional, Harris, R., additional, Bidoli, P., additional, Baldini, E., additional, Ros, S., additional, Laack, E., additional, Mitchell, P., additional, Wolf, M., additional, O’byrne, K., additional, Zibdawi, L., additional, Jao, K., additional, Spigel, D., additional, Li, A., additional, Rabindran, S., additional, and Pichon, E., additional

Published
2020
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32. CheckMate 817: Safety of Flat-Dose Nivolumab Plus Weight-Based Ipilimumab for the First-line (1L) Treatment of Advanced NSCLC

Author

Paz-Ares, L., Urban, L., Audigier-Valette, C., Grossi, F., Jao, K., Aucoin, J., Linardou, H., Poddubskaya, E. Vladimirovna, Fischer, J., Fontecedro, A. Curioni, Groen, H., Vermaelen, K., Bourhaba, M., Kowalski, D., Pillai, R., Spigel, D., Ahmed, S., Hu, W., Vickery, D., Fiore, J., Ready, N., Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
Nivolumab, Ipilimumab, non-small cell lung cancer
Published
2018

33. P1.01-110 Novel Regimens Versus Standard-of-Care in NSCLC: A Phase II, Randomized, Open-Label, Platform Trial Using a Master Protocol

Author

Spigel, D., primary, Garassino, M., additional, Besse, B., additional, Sacher, A., additional, Barve, M., additional, Cousin, S., additional, Schenker, M., additional, Rogan, D., additional, Yadavilli, S., additional, Acusta, A., additional, Amit, O., additional, Leighton-Swayze, A., additional, Ballas, M., additional, Hoos, A., additional, and Reck, M., additional

Published
2019
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34. OA03.03 Initial Efficacy and Safety Results of Irinotecan Liposome Injection (nal-IRI) in Patients with Small Cell Lung Cancer

Author

Paz-Ares Rodríguez, L., primary, Spigel, D., additional, Chen, Y., additional, Jove, M., additional, Juan, O., additional, Rich, P., additional, Hayes, T., additional, Calderón, V. Gutiérrez, additional, Bernabe, R., additional, Navarro, A., additional, Dowlati, A., additional, Zhang, B., additional, Moore, Y., additional, Wang, T., additional, Nazarenko, N., additional, Ponce, S., additional, and Bunn, P., additional

Published
2019
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35. P2.01-02 CANOPY-A: A Phase 3 Study of Canakinumab as Adjuvant Therapy in Patients with Surgically Resected NSCLC

Author

Garon, E., primary, Ardizzoni, A., additional, Barlesi, F., additional, Cho, B.C., additional, De Marchi, P., additional, Goto, Y., additional, Lu, S., additional, Paz-Ares, L., additional, Spigel, D., additional, Thomas, M., additional, Mookerjee, B., additional, Arratia, P., additional, Baum, J., additional, Zewen, Z., additional, and Yang, J., additional

Published
2019
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36. MA13.05 Nab-Paclitaxel Maintenance in Squamous Non-Small Cell Lung Cancer (NSCLC): Updated Results of the Phase III ABOUND.sqm Study

Author

Spigel, D., primary, Jotte, R., additional, Aix, S., additional, Gressot, L., additional, Morgensztern, D., additional, Mccleod, M., additional, Socinski, M., additional, Daniel, D., additional, Juan, O., additional, Mileham, K., additional, West, H., additional, Page, R., additional, Reinmuth, N., additional, Knoble, J., additional, Tian, O., additional, Bhore, R., additional, Wolfsteiner, M., additional, Ong, T. Jin, additional, Gridelli, C., additional, and Thomas, M., additional

Published
2019
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37. CANOPY phase III program: Three studies evaluating canakinumab in patients with non-small cell lung cancer (NSCLC)

Author

Paz-Ares, L., primary, Garon, E.B., additional, Ardizzoni, A., additional, Barlesi, F., additional, Cho, B.C., additional, de Castro Junior, G., additional, De Marchi, P., additional, Felip, E., additional, Goto, Y., additional, Greystoke, A., additional, Lu, S., additional, Lim, D W-T, additional, Papadimitrakopoulou, V.A., additional, Reck, M., additional, Solomon, B.J., additional, Spigel, D., additional, Tan, D.S.W., additional, Thomas, M., additional, Yang, J C-H, additional, and Johnson, B., additional

Published
2019
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38. Long-term avelumab treatment in patients with advanced non-small cell lung cancer (NSCLC): Post hoc analyses from JAVELIN solid tumour

Author

Hrinczenko, B., primary, Spigel, D., additional, Iannotti, N., additional, Safran, H.P., additional, Taylor, M.H., additional, Bennouna, J., additional, Goel, S., additional, Leach, J., additional, Wong, D.J., additional, Kelly, K., additional, Verschraegen, C., additional, Bajars, M., additional, Manitz, J., additional, Ruisi, M., additional, and Gulley, J.L., additional

Published
2019
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39. Assessing the impact of subsequent checkpoint inhibitor (CPI) treatment on overall survival: Post hoc analyses from the phase III JAVELIN Lung 200 study of avelumab vs docetaxel in platinum-treated locally advanced/metastatic non-small cell lung cancer (NSCLC)

Author

Barlesi, F., primary, Özgüroğlu, M., additional, Vansteenkiste, J.F., additional, Spigel, D., additional, Yang, J C-H, additional, Bajars, M., additional, Ruisi, M., additional, Manitz, J., additional, and Park, K., additional

Published
2019
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40. IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC

Author

Spigel, D., primary, de Marinis, F., additional, Giaccone, G., additional, Reinmuth, N., additional, Vergnenegre, A., additional, Barrios, C.H., additional, Morise, M., additional, Felip, E., additional, Andric, Z.G., additional, Geater, S., additional, Özgüroğlu, M., additional, Mocci, S., additional, McCleland, M., additional, Enquist, I., additional, Komatsubara, K.M., additional, Deng, Y., additional, Kuriki, H., additional, Wen, X., additional, Jassem, J., additional, and Herbst, R.S., additional

Published
2019
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41. Trilaciclib (T) decreases myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy plus atezolizumab

Author

Daniel, D., primary, Kuchava, V., additional, Bondarenko, I., additional, Ivashchuk, O., additional, Spigel, D., additional, Dasgupta, A., additional, Reddy, S., additional, Melkadze, T., additional, Jaal, J., additional, Kudaba, I., additional, Hart, L., additional, Matitashvili, A., additional, Koynov, K.D., additional, Yang, Z., additional, Wolfe, S.G., additional, Malik, R., additional, Morris, S.R., additional, Antal, J.M., additional, and Goldschmidt, J., additional

Published
2019
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42. OA14.04 Five-Year Outcomes From the Randomized, Phase 3 Trials CheckMate 017/057: Nivolumab vs Docetaxel in Previously Treated NSCLC

Author

Gettinger, S., primary, Borghaei, H., additional, Brahmer, J., additional, Chow, L., additional, Burgio, M., additional, De Castro Carpeno, J., additional, Pluzanski, A., additional, Arrieta, O., additional, Frontera, O. Aren, additional, Chiari, R., additional, Butts, C., additional, Wojcik-Tomaszewska, J., additional, Coudert, B., additional, Garassino, M., additional, Ready, N., additional, Felip, E., additional, Garcia, M. Alonso, additional, Waterhouse, D., additional, Domine, M., additional, Barlesi, F., additional, Antonia, S., additional, Wohlleber, M., additional, Gerber, D., additional, Czyzewicz, G., additional, Spigel, D., additional, Crino, L., additional, Eberhardt, W., additional, Li, A., additional, Marimuthu, S., additional, and Vokes, E., additional

Published
2019
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43. PACIFIC: Overall Survival with Durvalumab versus Placebo after Chemoradiotherapy in Stage III NSCLC

Author

Raben, D., primary, Faivre-Finn, C., additional, Spigel, D., additional, Daniel, D., additional, Villegas, A., additional, Vincente, D., additional, Hui, R., additional, de Castro Carpeno, J., additional, Murakami, S., additional, Paz-Ares, L., additional, Özgüroğlu, M., additional, Kurata, T., additional, Chiappori, A., additional, Lee, K.H., additional, de Wit, M., additional, Poole, L., additional, Wadsworth, C., additional, Dennis, P.A., additional, and Antonia, S.J., additional

Published
2018
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44. P1.16-05 Effect of Induction Chemotherapy in the PACIFIC Study

Author

Spigel, D., primary, Vansteenkiste, J., additional, Reck, M., additional, Wakelee, H., additional, Özgüroğlu, M., additional, Daniel, D., additional, Villegas, A., additional, Vicente, D., additional, Hui, R., additional, Murakami, S., additional, Paz-Ares, L., additional, Poole, L., additional, Wadsworth, C., additional, Dennis, P., additional, and Antonia, S., additional

Published
2018
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45. P2.12-04 Liposomal Irinotecan vs Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed On/After Platinum-Based Therapy

Author

Paz-Ares, L., primary, Yang, J.C., additional, Zielinski, C., additional, Novello, S., additional, Schwartsmann, G., additional, Spigel, D., additional, Griesinger, F., additional, Dowlati, A., additional, Small, T., additional, De Jong, F., additional, Zhang, B., additional, Nazarenko, N., additional, and Bunn, P., additional

Published
2018
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46. PL02.01 Overall Survival with Durvalumab Versus Placebo After Chemoradiotherapy in Stage III NSCLC: Updated Results from PACIFIC

Author

Antonia, S., primary, Villegas, A., additional, Daniel, D., additional, Vicente, D., additional, Murakami, S., additional, Hui, R., additional, Kurata, T., additional, Chiappori, A., additional, Lee, K.H., additional, De Wit, M., additional, Cho, B.C., additional, Bourhaba, M., additional, Quantin, X., additional, Tokito, T., additional, Mekhail, T., additional, Planchard, D., additional, Kim, Y., additional, Karapetis, C., additional, Hiret, S., additional, Ostoros, G., additional, Kubota, K., additional, Gray, J., additional, Paz-Ares, L., additional, De Castro Carpeño, J., additional, Faivre-Finn, C., additional, Reck, M., additional, Vansteenkiste, J., additional, Spigel, D., additional, Wadsworth, C., additional, Taboada, M., additional, Dennis, P., additional, and Özgüroğlu, M., additional

Published
2018
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47. OA05.05 Avelumab vs Docetaxel for Previously Treated Advanced NSCLC: Primary Analysis of the Phase 3 JAVELIN Lung 200 Trial

Author

Barlesi, F., primary, Vansteenkiste, J., additional, Spigel, D., additional, Ishii, H., additional, Garassino, M., additional, De Marinis, F., additional, Özgüroğlu, M., additional, Szczesna, A., additional, Polychronis, A., additional, Uslu, R., additional, Krzakowski, M., additional, Lee, J., additional, Calabro, L., additional, Frontera, O., additional, Ellers-Lenz, B., additional, Bajars, M., additional, Ruisi, M., additional, and Park, K., additional

Published
2018
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48. P1.01-79 CheckMate 817: Safety of Flat-Dose Nivolumab Plus Weight-Based Ipilimumab for the First-line (1L) Treatment of Advanced NSCLC

Author

Paz-Ares, L., primary, Urban, L., additional, Audigier-Valette, C., additional, Grossi, F., additional, Jao, K., additional, Aucoin, J., additional, Linardou, H., additional, Vladimirovna Poddubskaya, E., additional, Fischer, J., additional, Curioni Fontecedro, A., additional, Groen, H., additional, Vermaelen, K., additional, Bourhaba, M., additional, Kowalski, D., additional, Pillai, R., additional, Spigel, D., additional, Ahmed, S., additional, Hu, W., additional, Vickery, D., additional, Fiore, J., additional, and Ready, N., additional

Published
2018
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49. P3.16-02 Phase III Study of Canakinumab (ACZ885) as Adjuvant Therapy in Patients with Surgically Resected NSCLC

Author

Garon, E., primary, Ardizzoni, A., additional, Barlesi, F., additional, Cho, B.C., additional, De Marchi, P., additional, Goto, Y., additional, Lu, S., additional, Paz-Ares, L., additional, Spigel, D., additional, Thomas, M., additional, Cazorla Arratia, P., additional, Baum, J., additional, Lau, Y., additional, Zheng, C., additional, and Yang, J.C., additional

Published
2018
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50. MA04.02 Responses and Durability in NSCLC Treated With Pegilodecakin and Anti-PD-1

Author

Garon, E., primary, Wong, D., additional, Schneider, J., additional, Aljumaily, R., additional, Korn, W., additional, Infante, J., additional, Patel, M., additional, Autio, K., additional, Papadopoulos, K., additional, Naing, A., additional, Gabrail, N., additional, Munster, P., additional, Goldman, J., additional, Hung, A., additional, Van Vlasselaer, P., additional, Leveque, J., additional, Oft, M., additional, and Spigel, D., additional

Published
2018
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