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402 results on '"Gadgeel, S"'

1. 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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2. Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189

Author

Rodríguez-Abreu, D., Powell, S.F., Hochmair, M.J., Gadgeel, S., Esteban, E., Felip, E., Speranza, G., De Angelis, F., Dómine, M., Cheng, S.Y., Bischoff, H.G., Peled, N., Reck, M., Hui, R., Garon, E.B., Boyer, M., Kurata, T., Yang, J., Pietanza, M.C., Souza, F., and Garassino, M.C.

Published
2021
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5. MA06.04 KRYSTAL-1: Two-Year Follow-Up of Adagrasib (MRTX849) Monotherapy in Patients with Advanced/Metastatic KRASG12C-Mutated NSCLC

Author

Gadgeel, S., primary, Jänne, P.A., additional, Spira, A.I., additional, Ou, S.-H.I., additional, Heist, R.S., additional, Pacheco, J.M., additional, Johnson, M.L., additional, Sabari, J.K., additional, Leventakos, K., additional, Mason, J.A., additional, Velastegui, K., additional, Yan, X., additional, Chao, R., additional, and Riely, G.J., additional

Published
2023
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7. Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies

Author

Gadgeel S, Shaw AT, Barlesi F, Crino L, Yang JCH, Dingemans AM, Kim DW, de Marinis F, Schulz M, Liu S, Gupta R, Smoljanovic V, and Ou SHI

Subjects
alectinib, non-small-cell lung cancer, np28673, np28761, time to response, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Shirish Gadgeel,1 Alice T Shaw,2 Fabrice Barlesi,3 Lucio Crino,4 James CH Yang,5 Anne-Marie Dingemans,6 Dong-Wan Kim,7 Filippo de Marinis,8 Mathias Schulz,8 Shiyao Liu,9 Ravindra Gupta,9 Vlatka Smoljanovic,10 Sai-Hong Ignatius Ou11 1Department of Internal Medicine, Division of Hematology and Oncology, The University of Michigan, Ann Arbor, MI 48109, USA; 2Center for Thoracic Cancers, Massachusetts General Hospital, Boston, MA, USA; 3Multidisciplinary Oncology and Therapeutic Innovations Department, Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille 13005, France; 4Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl I.R.C.C.S., Meldola, FC 47014, Italy; 5National Taiwan University Hospital and National Taiwan University Cancer Centre, Taipei City, Taiwan; 6Department of Pulmonology, Maastricht University Medical Centre, Maastricht 6229 HX, The Netherlands; 7Department of Internal Medicine, Seoul National University Hospital, Jongno-Gu, Seoul 03080, South Korea; 8Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan 20146, Italy; 9Genentech Inc., South San Francisco, CA, USA; 10F. Hoffmann-La Roche Ltd., Basel CH-4070, Switzerland; 11Division of Hematology-Medical Oncology, Department of Internal Medicine, University of California, Irvine School of Medicine, Orange, CA 92617, USACorrespondence: Sai-Hong Ignatius OuUniversity of California, Irvine School of Medicine, 1001 Health Sciences Road, Irvine, Orange, CA 92617, USATel +1 714 456 8104Email siou@uci.eduIntroduction: Alectinib is a highly selective and potent ALK inhibitor, approved for the treatment of patients with metastatic ALK+ NSCLC based on results from the Phase II global NP28673 (NCT01801111) and North American NP28761 (NCT01871805) studies.Methods: This exploratory analysis of two Phase II studies of alectinib (NP28673/NP28761) investigated time to systemic response (TTR) and time to central nervous system (CNS) response (TTCR) in patients with previously treated advanced anaplastic lymphoma kinase fusion gene-positive (ALK+) non-small-cell lung cancer. Patients (n=225) received 600 mg oral alectinib twice daily and had scans every 6/8 weeks (NP28673/NP28761).Results: For NP28673 and NP28761, respectively: median follow-up was 21.3 months/17.0 months; most responders (72.6%/82.9%) responded by the first disease assessment; median TTR was 8 weeks (95% confidence interval [CI]: 8.00–8.14)/6 weeks (95% CI: 5.86–6.14); median TTCR in responders with measurable baseline CNS disease was 8 weeks (95% CI: 7.86–10.29)/6 weeks (95% CI: 5.71–not evaluable). Similar results were observed regardless of measurable/non-measurable disease.Discussion: These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS.Keywords: alectinib, non-small-cell lung cancer, NP28673, NP28761, time to response

Published
2019

8. A retrospective study evaluating the pretreatment tumor volume (PTV) in non-small cell lung cancer (NSCLC) as a predictor of response to program death-1 (PD-1) inhibitors

Author

Nagasaka M, Abdallah N, Crosby M, Thummala N, Patel D, Wozniak AJ, Gadgeel S, Abrams J, and Sukari A

Subjects
non-small cell lung cancer, tumor volume, tumor burden, checkpoint inhibitors, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Misako Nagasaka,1,2 Nadine Abdallah,3 Marcus Crosby,4 Nithin Thummala,1 Dhaval Patel,1 Antoinette J Wozniak,5 Shirish Gadgeel,6 Judith Abrams,1 Ammar Sukari1 1Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA; 2Department of Advanced Medical Innovations, St. Marianna University Graduate School of Medicine, Kawasaki, Japan; 3Department of Internal Medicine, Wayne State University, Detroit, MI, USA; 4Department of Radiation Oncology, Gundersen Health System, La Crosse, WI, USA; 5Department of Oncology, University of Pittsburgh, Pittsburgh, PA, USA; 6Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI, USACorrespondence: Ammar SukariDepartment of Oncology, Karmanos Cancer Institute, Wayne State University, 4100 John R, Detroit, MI 48201, USATel +1 313 576 8753Fax +1 313 576 8699Email sukaria@karmanos.orgIntroduction of hypothesis: Little information is available regarding the imaging characteristics that assist in differentiating responders from non-responders. We hypothesized that patients with higher pretreatment tumor volume (PTV) would have lower response rates and shorter overall survival (OS).Methods: Data from patients who received at least one dose of program death-1 (PD-1) inhibitors before August 31, 2016 were captured from our institution’s pharmacy database. The primary objective was to determine the association of PTV with best response, evaluated utilizing RECIST v1.1 criteria. Secondary objectives were estimation of progression-free survival (PFS) and OS. PTV was measured using the Philips Intellispace Multi-Modality Tumor Tracking application.Results: 116 non-small cell lung cancer (NSCLC) patients were evaluated. 66% patients had adenocarcinoma, 28% had squamous cell carcinoma and 5% had poorly differentiated NSCLC. Median PTV was 53.7 cm3 (95% CI: 13.3–107.9). Only one individual had no metastases and the remainder had M1 disease; 38% M1a, 10% M1b, 51% M1c. Most (79%) were previously treated. There were no complete responses; among those followed for at least 6 weeks, 26% had a partial response, 39% stable disease and 34% PD; 4% had no recorded response. There were no strong associations of PTV with any of the demographic or clinical characteristics. There was no association between PTV and OS (HR 1.2, P=0.26) or PFS (HR 1.1, P=0.47). Liver metastasis was associated with shorter survival (HR=2.8, P=0.05).Conclusion: PTV in NSCLC did not prove to be a predictor of response to PD-1 inhibitors but having liver metastasis was associated with significantly shorter survival.Keywords: non-small cell lung cancer, tumor volume, tumor burden, checkpoint inhibitors

Published
2019

10. Combination pembrolizumab plus chemotherapy: a new standard of care for patients with advanced non-small-cell lung cancer

Author

Weinberg F and Gadgeel S

Subjects
NSCLC, immunotherapy, chemotherapy, clinical trials, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Frank Weinberg, Shirish GadgeelDivision of Hematology and Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI, USAAbstract: Until recently, the treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumors did not have a targetable genetic alteration was cytotoxic chemotherapy alone. This treatment provided only modest survival benefit. The introduction of immune checkpoint inhibitors targeting programmed cell death 1 protein (PD-1) signaling pathway in the treatment of patients with NSCLC has had significant effect on patient survival. Atezolizumab, nivolumab and pembrolizumab have been shown to be superior to chemotherapy in patients with recurrent NSCLC. Recently, pembrolizumab has been combined with chemotherapy in the front-line setting and has demonstrated an improvement in overall survival in NSCLC patients as compared to chemotherapy alone. In this review we will focus on the clinical trials that led to approval of combination pembrolizumab and chemotherapy as first-line treatment for patients with advanced NSCLC as well as discuss other combinations of immunotherapy and chemotherapy that have also been evaluated.Keywords: NSCLC, immunotherapy, chemotherapy, clinical trials

Published
2019

11. PP01.10 A Randomized, Open-Label Phase 2 Study of the TORC 1/2 Inhibitor Sapanisertib in Relapsed/Refractory (R/R) NFE2L2 (NRF2)-Mutated and Wild-Type (WT) Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Author

Riess, J.W., primary, Johnson, M.L., additional, Gadgeel, S., additional, Skoulidis, F., additional, Sumrow, B., additional, Kuriakose, E., additional, Albert, K., additional, Kittrell, N., additional, Akella, L., additional, Fiji, G., additional, and Paik, P., additional

Published
2023
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12. Mesothelioma in the United States: a Surveillance, Epidemiology, and End Results (SEER)–Medicare investigation of treatment patterns and overall survival

Author

Beebe-Dimmer JL, Fryzek JP, Yee CL, Dalvi TB, Garabrant DH, Schwartz AG, and Gadgeel S

Subjects
Mesothelioma, Chemotherapy, Epidemiology, Outcomes (incl mortality, morbidity, survival, etc.), Infectious and parasitic diseases, RC109-216
Abstract

Jennifer L Beebe-Dimmer,1,2 Jon P Fryzek,3 Cecilia L Yee,1,2 Tapashi B Dalvi,4 David H Garabrant,3 Ann G Schwartz,1,2 Shirish Gadgeel1,2 1Department of Oncology, Wayne State University School of Medicine, 2Barbara Ann Karmanos Cancer Institute, Detroit, 3EpidStat Institute, Ann Arbor, MI, 4AstraZeneca, Gaithersburg, MD, USA Introduction: Mesothelioma is a rare malignancy typically associated with exposure to asbestos and poor survival. The purpose of this investigation was to describe mesothelioma patient characteristics, treatment patterns, and overall survival (OS) utilizing the National Cancer Institute’s Surveillance, Epidemiology, and End Results–Medicare database. Materials and methods: Patients in this study were diagnosed with malignant mesothelioma of the pleura or peritoneum between January 1, 2005 and December 31, 2009 with follow-up for survival through December 31, 2010. We examined both patient and tumor characteristics at time of diagnosis and subsequent treatment patterns (surgery, radiation, and chemotherapy). Among patients treated with chemotherapy, we determined chemotherapy regimen and OS by line of therapy. Results: Of the 1,625 patients considered eligible for this investigation, the median age at diagnosis was 78 years. Nearly a third of patients (30%) had surgery as part of their treatment and 45% were given chemotherapy. The median OS was 8 months (range 1–69 months). Among chemotherapy patients, the most commonly (67%) prescribed regimen for first-line therapy was cisplatin or carboplatin (Ca/Ci) combined with pemetrexed (Pe). Among those prescribed Ca/Ci + Pe as first-line therapy, retreatment with Ca/Ci + Pe (28%) or treatment with gemcitabine (30%) were the most common second-line therapies. Median OS for those receiving first-line chemotherapy was 7 months, and among those receiving second-line therapy median OS was extended an additional 5 months. Conclusion: Irrespective of surgical resection, mesothelioma patients receiving some form of chemotherapy survived longer than patients who did not, with an additional survival benefit among those patients receiving multimodal treatment. Keywords: mesothelioma, chemotherapy, epidemiology, outcomes, mortality, morbidity, survival

Published
2016

13. LBA4 Preliminary safety and efficacy of adagrasib with pembrolizumab in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation

Author

Jänne, P.A., primary, Smit, E.F., additional, de Marinis, F., additional, Laskin, J., additional, Gomez, M. Domine, additional, Gadgeel, S., additional, Garassino, M.C., additional, Lu, S., additional, Spira, A.S., additional, Kang, V., additional, Roshan, S., additional, Yan, X., additional, and Felip, E., additional

Published
2022
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14. EP08.02-041 NVL-520, a Highly Selective ROS1 Inhibitor, in Patients with Advanced ROS1-Positive Solid Tumors: The Phase 1/2 ARROS-1 Study

Author

Drilon, A., primary, Ou, S.-H.I., additional, Gadgeel, S., additional, Johnson, M., additional, Spira, A., additional, Lopes, G., additional, Besse, B., additional, Felip, E., additional, van der Wekken, A.J., additional, Calles, A., additional, de Miguel, M.J., additional, Camidge, D.R., additional, Elamin, Y., additional, Liu, S., additional, Bauman, J., additional, Haggstrom, D., additional, Riley, G., additional, Pelish, H.E., additional, Zhu, V.W., additional, and Lin, J.J., additional

Published
2022
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15. EP08.02-019 Phase 1/2 Study of BLU-701, a Highly Selective EGFR Inhibitor, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

Author

Spira, A., primary, Spigel, D.R., additional, Camidge, R., additional, de Langen, A.J., additional, Kim, T.M., additional, Goto, K., additional, Elamin, Y., additional, Shum, E., additional, Reckamp, K.L., additional, Rotow, J., additional, Goldberg, S., additional, Gadgeel, S., additional, Leal, T.A., additional, Albayya, F., additional, Fitzpatrick, S., additional, Louie-Gao, M., additional, Parepally, J., additional, Zalutskaya, A., additional, and Yu, H., additional

Published
2022
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17. New options in the management of intractable ALK(+) metastatic non-small-cell lung cancer

Author

Weise AM and Gadgeel S

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Amy M Weise, Shirish Gadgeel Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA Abstract: Non-small-cell lung cancer (NSCLC) is a heterogeneous disease and a challenging malignancy to treat, as many patients have advanced disease at the time of diagnosis. Recent advances have led to the identification of molecularly defined subtypes of NSCLC, namely for patients with adenocarcinoma histology. The most recently identified molecular target is the anaplastic lymphoma kinase (ALK) gene rearrangement, and patient responses to the ALK inhibitor crizotinib have led to its approval in this selected patient population. Like other tyrosine kinase inhibitors, resistance to crizotinib ultimately develops by various mechanisms requiring alternative therapeutic options. This review article discusses the management of patients with the ALK gene rearrangement, mechanisms of crizotinib resistance, and future potential therapeutic options. Keywords: non-small-cell lung cancer, disease management, cancer therapy

Published
2014

18. 78TiP Clinical evaluation of NVL-520, a highly selective ROS1 inhibitor in patients with advanced ROS1-positive solid tumors: The phase I/II ARROS-1 study

Author

Besse, B., primary, Johnson, M., additional, Ou, S-H.I., additional, Gadgeel, S., additional, Spira, A., additional, Lin, J., additional, Felip, E., additional, van der Wekken, A.J., additional, Calles, A., additional, de Miguel, M.J., additional, Camidge, D.R., additional, Elamin, Y., additional, Lopes, G.D.L., additional, Liu, S., additional, Bauman, J., additional, Haggstrom, D., additional, Riley, G., additional, Pelish, H.E., additional, Zhu, V.W., additional, and Drilon, A., additional

Published
2022
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20. OA09.03 Pembrolizumab in Combination With Platinum-Based Chemotherapy in Recurrent EGFR/ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Author

Gadgeel, S., primary, Dziubek, K., additional, Nagasaka, M., additional, Braun, T., additional, Hassan, K., additional, Cheng, H., additional, Wozniak, A., additional, Halmos, B., additional, Stevenson, J., additional, Patil, P., additional, Pennell, N., additional, Fidler, M.J., additional, Bonomi, P., additional, Qin, A., additional, Niu, Z., additional, Nagrath, S., additional, and Kalemkerian, G., additional

Published
2021
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21. OA15.01 Mobocertinib in EGFR Exon 20 Insertion–Positive Metastatic NSCLC Patients With Disease Control on Prior EGFR TKI Therapy

Author

Spira, A., primary, Ramalingam, S., additional, Neal, J., additional, Piotrowska, Z., additional, Mekhail, T., additional, Tsao, A., additional, Gentzler, R., additional, Riely, G., additional, Bazhenova, L., additional, Gadgeel, S., additional, Nguyen, D., additional, Johnson, M., additional, Vincent, S., additional, Jin, S., additional, Griffin, C., additional, Bunn, V., additional, Lin, J., additional, Churchill, E., additional, Mehta, M., additional, and Janne, P., additional

Published
2021
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22. OA17.04 The Global Impact of COVID-19 on Telehealth and Care for Persons With Thoracic Cancers

Author

Smeltzer, M., primary, Bunn, B., additional, Choi, Y.S., additional, Coate, L., additional, Corona-Cruz, J., additional, Drilon, A., additional, Duma, N., additional, Edelman, M., additional, Fidler, M.J., additional, Gadgeel, S., additional, Goto, Y., additional, Herbst, R., additional, Hesdorffer, M., additional, Higgins, K., additional, Labdi, B., additional, Leal, T., additional, Liu, S., additional, Mazotti, J., additional, Novello, S., additional, Patel, S., additional, Popat, S., additional, Ramirez, R., additional, Reckamp, K., additional, Reguart, N., additional, Soo, R., additional, Tan, A., additional, Wolf, J., additional, Yano, S., additional, Stiles, B., additional, and Baird, A., additional

Published
2021
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23. P10.04 Immunotherapy-Treated Non-Small Cell Lung Cancer Patients With Sensitizing Gene Alterations: A Real World Survival Analysis

Author

Khaddour, L., primary, Zhang, C., additional, Ali, F., additional, Gadgeel, S., additional, Tadesse, E., additional, Thompson, M., additional, Reding, D., additional, Treisman, J., additional, Berry, A., additional, Izano, M., additional, Sweetnam, C., additional, Stafford, A., additional, Wolf, F., additional, Brown, T., additional, and Rybkin, I., additional

Published
2021
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25. Tribbles 2 confers enzalutamide resistance in prostate cancer by promoting lineage plasticity

Author

Adrianto I, Jagadananda Ghosh, Amina Zoubeidi, Himisha Beltran, Dhananjay Chitale, Monga J, Carl R. Rogers, Joshi J. Alumkal, and Gadgeel S

Subjects
Lineage (genetic), business.industry, Disease, medicine.disease, Neuroendocrine differentiation, Androgen receptor, Prostate cancer, chemistry.chemical_compound, chemistry, SOX2, Cancer research, medicine, Enzalutamide, business, Transcription factor
Abstract

Second-generation anti-androgen, such as enzalutamide (Xtandi), is commonly prescribed for prostate cancer therapy, but enzalutamide-resistant, lethally incurable disease invariably develops. To understand the molecular basis of enzalutamide resistance, we comprehensively analyzed prostate tumors and clinically relevant models. These studies revealed that enzalutamide resistant prostate cancer cells overexpress Tribbles 2 (Trib2), a pseudokinase. Expression of Trib2 is negatively regulated by androgen receptor signaling. Overexpression of Trib2 makes prostate cancer cells completely resistant to clinically relevant doses of enzalutamide. Trib2 downregulates expression of luminal markers but upregulates the neuronal transcription factor, BRN2, and the stemness factor, SOX2, to induce neuroendocrine differentiation. Our findings indicate that Trib2 confers resistance to enzalutamide therapy via a mechanism involving increased cellular plasticity and lineage switching.

Published
2021

26. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel

Author

Gandara, D., Reck, M., Moro-Sibilot, D., Mazieres, J., Gadgeel, S., Morris, S., Cardona, A., Mendus, D., Ballinger, M., Rittmeyer, A., and Peters, S.

Subjects
immunotherapy, lung neoplasms
Abstract

Treatment-induced accelerated tumor growth is a progression pattern reported with immune checkpoint inhibitors that has never been evaluated in randomized phase III studies because it requires two pretreatment scans. This study aimed to develop clinically relevant and applicable criteria for fast progression (FP), incorporating tumor growth kinetics and early death from disease progression to analyze data from the randomized phase III OAK study. The OAK study evaluated the efficacy and safety of atezolizumab versus docetaxel as second-line or third-line treatment for stage IIIb/IV non-small cell lung cancer. FP rates and associated baseline factors were analyzed. FP was defined as either a ≥50% increase in the sum of largest diameters (SLDs) within 6 weeks of treatment initiation or death due to cancer progression within 12 weeks (absent post-baseline scan). Forty-two of 421 patients (10%) receiving atezolizumab and 37 of 402 (9%) receiving docetaxel had FP. Twenty patients with FP (48%) receiving atezolizumab versus 12 (30%) receiving docetaxel had a ≥50% SLD increase within 6 weeks. FP was significantly associated with an ECOG (Eastern Cooperative Oncology Group) performance status of 1 (vs 0), ≥3 metastatic sites at baseline, and failure of preceding first-line treatment within 6 months, but not with epidermal growth factor receptor mutation, programmed cell death 1 ligand 1 or tumor mutational burden. Overall survival in patients with FP and a ≥50% SLD increase at week 6 was similar with atezolizumab and docetaxel (unstratified HR 0.89 (95% CI 0.41 to 1.92)). FP rates were similar with atezolizumab and docetaxel in the OAK study, suggesting that FP may not be unique to checkpoint inhibitors, although the underlying mechanisms may differ from those of chemotherapy. Applying the FP criteria to other phase III checkpoint inhibitor trials may further elucidate the risk factors for FP. NCT02008227.

Published
2021

28. Outcomes According to ALK Status Determined by Central Immunohistochemistry or Fluorescence In Situ Hybridization in Patients With ALK-Positive NSCLC Enrolled in the Phase 3 ALEX Study

Author

Mok, T., Peters, S., Camidge, D.R., Noé, J., Gadgeel, S., Ou, S.I., Kim, D.W., Konopa, K., Pozzi, E., Liu, T., Loftin, I.R., Williams, C., and Shaw, A.T.

Subjects
hemic and lymphatic diseases, ALK-positive, Alectinib, FISH, IHC, NSCLC
Abstract

We retrospectively examined progression-free survival (PFS) and response by ALK fluorescence in situ hybridization (FISH) status in patients with advanced ALK immunohistochemistry (IHC)-positive NSCLC in the ALEX study. A total of 303 treatment-naive patients were randomized to receive twice-daily alectinib 600 mg or crizotinib 250 mg. ALK status was assessed centrally using Ventana ALK (D5F3) CDx IHC and Vysis ALK Break Apart FISH Probe Kit. Primary end point is investigator-assessed PFS. Secondary end points of interest are objective response rate and duration. Investigator-assessed PFS was significantly prolonged with alectinib versus crizotinib in ALK IHC-positive and FISH-positive tumors (n = 203, 67%) (hazard ratio [HR] = 0.37, 95% confidence interval [CI]: 0.25-0.56; p < 0.0001) and ALK IHC-positive and FISH-uninformative tumors (n = 61, 20%) (HR = 0.39, 95% CI: 0.20-0.78) but not in ALK IHC-positive and FISH-negative tumors (n = 39, 13%) (HR = 1.33, 95% CI: 0.6-3.2). Objective response rates were higher with alectinib versus crizotinib in ALK IHC-positive and FISH-positive tumors (90.6% versus 81.4%; stratified OR = 2.22, 95% CI: 0.97-5.07) and ALK IHC-positive and FISH-uninformative tumors (96.0% versus 75.0%; OR = 9.29, 95% CI: 1.05-81.88) but not in ALK IHC-positive and FISH-negative tumors (28.6% versus 44.4%; OR = 0.45, 95% CI: 0.12-1.74). Next-generation sequencing was performed in 35 of 39 patients with ALK IHC-positive and FISH-negative tumors; no ALK fusion was identified in 20 of 35 patients (57.1%) by next-generation sequencing, but 10 of 20 (50.0%) had partial response or stable disease. Outcomes of patients with ALK IHC-positive and FISH-positive and ALK IHC-positive and FISH-uninformative NSCLC were similar to those of the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.

Published
2021

29. FP13.02 Pembrolizumab + Pemetrexed-Platinum vs Pemetrexed-Platinum for Metastatic NSCLC: 4-Year Follow-up From KEYNOTE-189

Author

Gray, J., primary, Rodríguez-Abreu, D., additional, Powell, S.F., additional, Hochmair, M.J., additional, Gadgeel, S., additional, Esteban, E., additional, Felip, E., additional, Speranza, G., additional, De Angelis, F., additional, Dómine, M., additional, Cheng, S.Y., additional, Bischoff, H.G., additional, Peled, N., additional, Reck, M., additional, Hui, R., additional, Garon, E.B., additional, Boyer, M., additional, Kurata, T., additional, Yang, J., additional, Jensen, E., additional, Souza, F., additional, and Garassino, M.C., additional

Published
2021
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31. OA04.05 Trastuzumab Deruxtecan in HER2-Overexpressing Metastatic Non-Small Cell Lung Cancer: Interim Results of DESTINY-Lung01

Author

Nakagawa, K., primary, Nagasaka, M., additional, Felip, E., additional, Pacheco, J., additional, Baik, C., additional, Goto, Y., additional, Saltos, A., additional, Li, B., additional, Udagawa, H., additional, Gadgeel, S., additional, Murakami, H., additional, Planchard, D., additional, Bazhenova, L., additional, Paz-Ares, L., additional, Perol, M., additional, Mazieres, J., additional, Barlesi, F., additional, Saxena, K., additional, Shiga, R., additional, Acharyya, S., additional, Cheng, Y., additional, Shahidi, J., additional, Jänne, P., additional, and Smit, E., additional

Published
2021
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32. P78.05 Patterns of irAE During First Line Pembrolizumab for NSCLC: Incidence, Risk Factors, and Impact on Clinical Outcome

Author

Wood, C., primary, Lopez, G., additional, Zhao, L., additional, Li, M., additional, Surya, N., additional, Patel, S., additional, Grogan, M., additional, Bertino, E., additional, Shields, P., additional, He, K., additional, Carbone, D., additional, Otterson, G., additional, Presley, C., additional, Pannecouk, B., additional, Kalemkerian, G., additional, Schneider, B., additional, Gadgeel, S., additional, Ramnath, N., additional, Owen, D., additional, and Qin, A., additional

Published
2021
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33. P77.04 PROPEL: A Phase 1/2 Trial of Bempegaldesleukin (NKTR-214) Plus Pembrolizumab in Lung Cancer and other Advanced Solid Tumors

Author

Spigel, D.R., primary, Rodríguez-Abreu, D., additional, Cappuzzo, F., additional, Velcheti, V., additional, Ganti, A.K., additional, Johnson, D., additional, Govindan, R., additional, Antonia, S., additional, Besse, B., additional, Altan, M., additional, Edelman, M., additional, Ramalingam, S., additional, Felip, E., additional, Gadgeel, S., additional, Juan-Vidal, O., additional, Gupta, A., additional, Currie, S., additional, Lin, W., additional, Tagliaferri, M., additional, and Reck, M., additional

Published
2021
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34. 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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35. Severe combined immunodeficiency disease

Author

Militsakh, O., Day, T., Hornig, J., Lentsch, E., Skoner, J., Gillespie, M., Sharma, A., Neville, B., Rumboldt, Z., James, R., Goddard, J., Shikata, K., Doi, Y., Rosen, E. M., Goldberg, I. D., Fan, S., Kong, L., Lu, J. J., Chlenski, A., Cohn, S. L., Hlubek, F., Qian, C.-N., Teh, B. T., Batistatou, A., Charalbopoulos, K., Christensen, C., Reddel, R., Ploeg, I. M. C., Kroon, B. B. R., Nieweg, O. E., Rijk, M. C., Winqvist, O., Thorn, M., Zwick, C., Pfreundschuh, M., Knudsen, B. S., Lucas, J., Nelson, P., Kashikar, N., Datta, P. K., Hottinger, A. F., Hormigo, A., Knobler, E., Knobler, R., McCarty, J. H., Bardia, A., Loprinzi, C., Buettner, R., Jove, R., Garcia, R., Frank, D. A., Nakatsura, T., Witt, O., Yoshida, K., Chou, P.-L., Tsay, G. J., Takeuchi, T., Furihata, M., Robertson, F. M., Werbowetski-Ogilvie, T. E., Maestro, R. F., Sadr, M. S., Dennler, S., Dijke, P., Gadgeel, S., Tierauch, K.-H., Yip, K. W., Liu, F.-F., Cano, A., Neto, M. A., Rünger, T. M., Frühwald, Michael C., Trakhtenbrot, L., Mi, J., Larner, J. M., Hamlin, J. L., Radin, N. S., Lo, T. L., Guy, G. R., Yeudall, W. A., Parsons, S. J., Fan, F., Platanias, L. C., Mcgahren-Murray, M., Keyomarsi, K., Kos, J., Seigel, G. M., Alison, M. R., Hiyama, E., Renehan, A. G., Potten, C. S., Tang, D. G., Foster, P., Lin, K., Bergelt, C., Ronai, Z., Cukierman, E., Aumercier, M., Hodson, M., Lolis, E., Mehta, A., Chung, F.-L., Glatt, H., Oberthür, A., Warnat, P., Aranda, S., Culig, Z., Chung, B. H., Shin, Y.-B., Kim, M., Grevenstein, W. M. U., van Eijck, C. H. J., Baker, S. G., Kramer, B. S., Mahotka, C., Carbone, M., Yang, H., Mueller, S. C., Coopman, P. J., Brujin, D., Kessel, A. D., and George, J. M.

Published
2020

36. Squamous cell carcinoma

Author

Yeudall, W. A., Militsakh, O., Day, T., Hornig, J., Lentsch, E., Skoner, J., Gillespie, M., Sharma, A., Neville, B., Rumboldt, Z., James, R., Goddard, J., Shikata, K., Doi, Y., Rosen, E. M., Goldberg, I. D., Fan, S., Kong, L., Lu, J. J., Chlenski, A., Cohn, S. L., Hlubek, F., Qian, C.-N., T., B. T., Batistatou, A., Charalbopoulos, K., Christensen, C., Reddel, R., Ploeg, I. M. C., Kroon, B. B. R., Nieweg, O. E., Rijk, M. C., Winqvist, O., Thorn, M., Zwick, C., Pfreundschuh, M., Knudsen, B. S., Lucas, J., Nelson, P., Kashikar, N., Datta, P. K., Hottinger, A. F., Hormigo, A., Knobler, E., Knobler, R., McCarty, J. H., Bardia, A., Loprinzi, C., Buettner, R., Jove, R., Garcia, R., Frank, D. A., Nakatsura, T., Witt, O., Yoshida, K., Chou, P.-L., Tsay, G. J., Takeuchi, T., Furihata, M., Robertson, F. M., Werbowetski-Ogilvie, T. E., Maestro, R. F., Sadr, M. S., Dennler, S., Dijke, P., Gadgeel, S., Tierauch, K.-H., Yip, K. W., Liu, F.-F., Cano, A., Neto, M. A., Rünger, T. M., Frühwald, Michael C., Trakhtenbrot, L., Mi, J., Larner, J. M., Hamlin, J. L., Radin, N. S., Lo, T. L., Guy, G. R., Parsons, S. J., Fan, F., Platanias, L. C., Mcgahren-Murray, M., Keyomarsi, K., Kos, J., Seigel, G. M., Alison, M. R., Hiyama, E., Renehan, A.G., Potten, C. S., Tang, D. G., Foster, P., Lin, K., Bergelt, C., Ronai, Z., Cukierman, E., Aumercier, M., Hodson, M., Lolis, E., Mehta, A., Chung, F.-L., Glatt, H., Oberthür, A., Warnat, P., Aranda, S., Culig, Z., Chung, B. H., Shin, Y.-B., Kim, M., Grevenstein, W. M. U., van Eijck, C. H. J., Baker, S. G., Kramer, B. S., Mahotka, C., Carbone, M., Yang, H., Mueller, S. C., Coopman, P. J., Brujin, D., Kessel, A. D., and George, J. M.

Published
2020

40. 1261MO Updated results from a phase I/II study of mobocertinib (TAK-788) in NSCLC with EGFR exon 20 insertions (exon20ins)

Author

Riely, G.J., primary, Neal, J.W., additional, Camidge, D.R., additional, Spira, A., additional, Piotrowska, Z., additional, Horn, L., additional, Costa, D.B., additional, Tsao, A., additional, Patel, J., additional, Gadgeel, S., additional, Bazhenova, L., additional, Zhu, V.W., additional, West, H., additional, Mekhail, T., additional, Gentzler, R., additional, Nguyen, D., additional, Bunn, V., additional, Jin, S., additional, Feng, Z., additional, and Jänne, P.A., additional

Published
2020
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41. KRAS mutational status and efficacy in KEYNOTE-189: Pembrolizumab (pembro) plus chemotherapy (chemo) vs placebo plus chemo as first-line therapy for metastatic non-squamous NSCLC

Author

Gadgeel, S., primary, Rodriguez-Abreu, D., additional, Felip, E., additional, Esteban, E., additional, Speranza, G., additional, Reck, M., additional, Hui, R., additional, Boyer, M., additional, Garon, E.B., additional, Horinouchi, H., additional, Cristescu, R., additional, Aurora-Garg, D., additional, Lunceford, J., additional, Kobie, J., additional, Ayers, M., additional, Piperdi, B., additional, Pietanza, M.C., additional, and Garassino, M.C., additional

Published
2019
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42. O.03 KEYNOTE-189: OS Update and Progression After the Next Line of Therapy (PFS2) with Pembrolizumab + Chemotherapy for Metastatic Nonsquamous NSCLC

Author

Gadgeel, S., primary, Garassino, M.C., additional, Esteban, E., additional, Speranza, G., additional, Felip, E., additional, Hochmair, M.J., additional, Powell, S., additional, Cheng, S.Y.-S., additional, Bischoff, H.G., additional, Peled, N., additional, Hui, R., additional, Reck, M., additional, Kurata, T., additional, Garon, E.B., additional, Boyer, M., additional, Yang, J., additional, Pietanza, M.C., additional, and Rodríguez-Abreu, D., additional

Published
2019
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43. OA01.01 Pembrolizumab Plus Chemotherapy for Advanced NSCLC without Tumor PD-L1 Expression: Pooled Analysis of KN021G, KN189 and KN407

Author

Borghaei, H., primary, Langer, C., additional, Paz-Ares, L., additional, Rodriguez-Abreu, D., additional, Papadimitrakopoulou, V., additional, Garassino, M., additional, Houghton, B., additional, Kurata, T., additional, Cheng, Y., additional, Lin, J., additional, Pietanza, C., additional, Piperdi, B., additional, and Gadgeel, S., additional

Published
2019
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44. PD2.02 Pembrolizumab plus Pemetrexed-Platinum for Patients with Metastatic Nonsquamous NSCLC and Liver or Brain Metastases: Results from KEYNOTE-189

Author

Garassino, M.C., primary, Gadgeel, S., additional, Esteban, E., additional, Felip, E., additional, Speranza, G., additional, De Angelis, F., additional, Domine, M., additional, Clingan, P., additional, Hochmair, M.J., additional, Powell, S.F., additional, Cheng, S.Y.-S., additional, Bischoff, H.G., additional, Peled, N., additional, Grossi, F., additional, Jennens, R.R., additional, Reck, M., additional, Hui, R., additional, Garon, E.B., additional, Boyer, M., additional, Rubio-Viqueira, B., additional, Novello, S., additional, Kurata, T., additional, Gray, J.E., additional, Cardellino, A., additional, Yang, J., additional, Pietanza, M.C., additional, and Rodríguez-Abreu, D., additional

Published
2019
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45. MA25.01 Pembrolizumab Plus Chemotherapy for Advanced NSCLC Without Tumor PD-L1 Expression: Pooled Analysis of KN021G, KN189 and KN407

Author

Borghaei, H., primary, Langer, C., additional, Paz-Ares, L., additional, Abreu, D. Rodriguez, additional, Halmos, B., additional, Papadimitrakopoulou, V., additional, Garassino, M., additional, Houghton, B., additional, Kurata, T., additional, Cheng, Y., additional, Lin, J., additional, Pietanza, M.C., additional, Piperdi, B., additional, and Gadgeel, S., additional

Published
2019
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46. P1.01-127 Antitumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 in NSCLC with EGFR Exon 20 Insertions

Author

Riely, G., primary, Neal, J., additional, Camidge, D.R., additional, Spira, A., additional, Piotrowska, Z., additional, Horn, L., additional, Costa, D., additional, Tsao, A., additional, Patel, J., additional, Gadgeel, S., additional, Bazhenova, L., additional, Zhu, V., additional, West, H., additional, Vincent, S., additional, Zhu, J., additional, Jin, S., additional, Zhang, S., additional, Li, S., additional, and Jänne, P., additional

Published
2019
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47. OA02.05 First-In-Human Phase 1/2 Trial of Anti-AXL Antibody–Drug Conjugate (ADC) Enapotamab Vedotin (EnaV) in Advanced NSCLC

Author

Ramalingam, S., primary, Lopez, J., additional, Mau-Sorensen, M., additional, Thistlethwaite, F., additional, Piha-Paul, S., additional, Gadgeel, S., additional, Drew, Y., additional, Jänne, P., additional, Mansfield, A., additional, Chen, G., additional, Forssmann, U., additional, Johannsdottir, H., additional, Pencheva, N., additional, Ervin-Haynes, A., additional, and Vergote, I., additional

Published
2019
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48. P1.01-71 Bone Metastases and Skeletal-Related Events in Patients with Metastatic NSCLC Treated with ICIs: A Multi-Institutional Study

Author

Qin, A., primary, Zhao, S., additional, Miah, A., additional, Wei, L., additional, Patel, S., additional, Johns, A., additional, Grogan, M., additional, Bertino, E., additional, He, K., additional, Olugbile, S., additional, Shields, P., additional, Kalemkerian, G., additional, Gadgeel, S., additional, Ramnath, N., additional, Schneider, B., additional, Hassan, K., additional, Carbone, D., additional, Presley, C., additional, Otterson, G., additional, and Owen, D., additional

Published
2019
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50. OA04.06 Evaluation of TMB in KEYNOTE-189: Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy for Nonsquamous NSCLC

Author

Garassino, M., primary, Rodriguez-Abreu, D., additional, Gadgeel, S., additional, Esteban, E., additional, Felip, E., additional, Speranza, G., additional, Reck, M., additional, Hui, R., additional, Boyer, M., additional, Cristescu, R., additional, Aurora-Garg, D., additional, Albright, A., additional, Loboda, A., additional, Kobie, J., additional, Lunceford, J., additional, Ayers, M., additional, Lubiniecki, G., additional, Piperdi, B., additional, Pietanza, M.C., additional, and Garon, E., additional

Published
2019
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