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1. Talazoparib in Patients With Solid Tumors With BRCA1/2 Mutation: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Srkalovic, Gordan, primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Ahn, Eugene R., additional, Brouse, Gregory, additional, Chan, John, additional, Mehmi, Inderjit, additional, Khalil, Maya, additional, Duvivier, Herbert L., additional, Gaba, Anu, additional, Leuva, Harshraj, additional, Thota, Ramya, additional, Yost, Kathleen J., additional, Grantham, Gina N., additional, Gregory, Abigail, additional, Hinshaw, Dominique C., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2024
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2. Pertuzumab Plus Trastuzumab in Patients With Biliary Tract Cancer With ERBB2/3 Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Cannon, Timothy L., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Chiu, Vi K., additional, Hwang, Jimmy, additional, Vijayvergia, Namrata, additional, Alese, Olatunji B., additional, Dib, Elie G., additional, Duvivier, Herbert L., additional, Klute, Kelsey A., additional, Sahai, Vaibhav, additional, Ahn, Eugene R., additional, Bedano, Pablo, additional, Behl, Deepti, additional, Sinclair, Sarah, additional, Thota, Ramya, additional, Urba, Walter J., additional, Yang, Eddy S., additional, Grantham, Gina N., additional, Hinshaw, Dominique C., additional, Gregory, Abigail, additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2024
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3. Olaparib in Patients With Pancreatic Cancer With BRCA1/2 Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Ahn, Eugene R., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Calfa, Carmen J., additional, Alva, Ajjai S., additional, Suhag, Vijay, additional, Alese, Olatunji B., additional, Dotan, Efrat, additional, Hamid, Omid, additional, Yang, Eddy S., additional, Marr, Alissa S., additional, Palmer, Martin C., additional, Thompson, Forrest L., additional, Yost, Kathleen J., additional, Gregory, Abigail, additional, Grantham, Gina N., additional, Hinshaw, Dominique C., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2024
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4. Talazoparib in Patients With Solid Tumors With BRCA1 / 2 Mutation: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Srkalovic, Gordan, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Ahn, Eugene R., Brouse, Gregory, Chan, John, Mehmi, Inderjit, Khalil, Maya, Duvivier, Herbert L., Gaba, Anu, Leuva, Harshraj, Thota, Ramya, Yost, Kathleen J., Grantham, Gina N., Gregory, Abigail, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Subjects
POLY(ADP-ribose) polymerase, EPIDERMAL growth factor receptors, CANCER patients, NON-small-cell lung carcinoma, BRCA genes, HORMONE receptor positive breast cancer, SKIN cancer
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with various solid tumors with germline or somatic BRCA1/2 mutations treated with talazoparib are reported. METHODS: Eligible patients had advanced solid tumors, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. Patients with germline BRCA -mutated human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer were not eligible for this study. Primary end point was disease control (DC) determined by investigator assessment of objective response (OR) or stable disease (SD) of at least 16 weeks duration (SD16+). The results were evaluated on the basis of a one-sided exact binomial test with a null DC rate of 15% versus 35% (power = 0.82; α =.10). Secondary end points were OR, progression-free survival, overall survival, duration of response, duration of SD, and safety. RESULTS: Twenty-eight patients (20 cancer types) with BRCA1/2 mutations were enrolled from December 2019 to September 2021 and collapsed into a single histology pooled cohort for analysis. All patients were evaluable for efficacy. One complete response, nine partial response, and six SD16+ were observed for DC and OR rates of 57% (one-sided 90% CI, 43 to 100) and 36% (95% CI, 19 to 56), respectively. The null hypothesis of a 15% DC rate was rejected (P <.001). Patients with OR had the following tumor types: breast (2), nonmelanoma skin, mesothelioma, stomach, uterus, non–small cell lung cancer, ovary, hepatocellular carcinoma, and pancreas. Thirteen patients had at least one grade 3-5 adverse event (AE) or serious AE at least possibly related to talazoparib. All were consistent with the drug label except bilirubin increase and hyponatremia (both grade 3 AEs). CONCLUSION: Talazoparib demonstrated antitumor activity in patients with advanced solid tumors and BRCA1/2 mutations, including cancer types for which poly ADP-ribose polymerase inhibitors are not yet US Food and Drug Administration–approved. Talazoparib showed activity in patients with BRCA-mutated tumors for which PARP inhibitors are not yet FDA-approved. @ASCO #TAPUR [ABSTRACT FROM AUTHOR]

Published
2024
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6. Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Klute, Kelsey A., Rothe, Michael, Garrett-Mayer, Elizabeth, Mangat, Pam K., Nazemzadeh, Reza, Yost, Kathleen J., Duvivier, Herbert L., Ahn, Eugene R., Cannon, Timothy L., Alese, Olatunji B., Krauss, John C., Thota, Ramya, Calfa, Carmen J., Denlinger, Crystal S., OʼLone, Raegan, Halabi, Susan, Grantham, Gina N., and Schilsky, Richard L.

Published
2022
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8. Sunitinib in Patients With Breast Cancer With FGFR1 or FGFR2 Amplifications or Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Calfa, Carmen J., Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Ahn, Eugene R., Burness, Monika L., Gogineni, Keerthi, Rohatgi, Nitin, Al Baghdadi, Tareq, Conlin, Alison, Gaba, Anu, Hamid, Omid, Krishnamurthy, Jairam, Gavini, Naga Jyothi, Gold, Philip J., Rodon, Jordi, Rueter, Jens, Thota, Ramya, Grantham, Gina N., and Hinshaw, Dominique C.

Subjects
SUNITINIB, CANCER patients, BREAST cancer, METASTATIC breast cancer, DRUG target
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results from cohorts of patients with metastatic breast cancer (BC) with FGFR1 and FGFR2 alterations treated with sunitinib are reported. METHODS: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) or stable disease of at least 16 weeks duration (SD16+) according to RECIST v1.1. Secondary end points included OR, progression-free survival, overall survival, duration of response, duration of stable disease, and safety. RESULTS: Forty patients with BC with FGFR1 (N = 30; amplification only n = 26, mutation only n = 1, both n = 3) or FGFR2 (N = 10; amplification only n = 2, mutation only n = 6, both n = 2) alterations were enrolled. Three patients in the FGFR1 cohort were not evaluable for efficacy; all patients in the FGFR2 cohort were evaluable. For the FGFR1 cohort, two patients with partial response and four with SD16+ were observed for DC and OR rates of 27% (90% CI, 13 to 100) and 7% (95% CI, 1 to 24), respectively. The null hypothesis of 15% DC rate was not rejected (P =.169). No patients achieved DC in the FGFR2 cohort (P = 1.00). Thirteen of the 40 total patients across both cohorts had at least one grade 3-4 adverse event or serious adverse event at least possibly related to sunitinib. CONCLUSION: Sunitinib did not meet prespecified criteria to declare a signal of antitumor activity in patients with BC with either FGFR1 or FGFR2 alterations. Other treatments and clinical trials should be considered for these patient populations. Sunitinib did not demonstrate antitumor activity in patients with FGFR1-/2-amplified or -mutated breast cancer. @ASCO #TAPUR [ABSTRACT FROM AUTHOR]

Published
2024
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9. Talazoparib (Tala) in patients (pts) with colorectal cancer (CRC) with BRCA1/2 mutations (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Yost, Kathleen J, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Duvivier, Herbert Leon, Ahn, Eugene R., Cannon, Timothy Lewis, Chiu, Vi Kien, Khalil, Maged F., Kim, Brian, Prinz, Allison Marie, Grantham, Gina N., Gregory, Abby, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Published
2024
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10. Pembrolizumab in Patients With Tumors With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Duvivier, Herbert L., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Ahn, Eugene R., additional, Al Baghdadi, Tareq, additional, Alva, Ajjai S., additional, Dublis, Stephanie A., additional, Cannon, Timothy L., additional, Calfa, Carmen J., additional, Li, Rui, additional, Behl, Deepti, additional, Chiu, Vi K., additional, Gold, Philip J., additional, Marr, Alissa S., additional, Mileham, Kathryn F., additional, Powell, Steven Francis, additional, Rodon, Jordi, additional, Thota, Ramya, additional, Grantham, Gina N., additional, Gregory, Abigail, additional, Hinshaw, Dominique C., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2023
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11. Talazoparib (Tala) in patients (pts) with solid tumors with BRCA1/2 mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Srkalovic, Gordan, primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Ahn, Eugene R, additional, Brouse, Gregory, additional, Chan, John K, additional, Mehmi, Inderjit, additional, Khalil, Maya, additional, Duvivier, Herbert Leon, additional, Gaba, Anu G., additional, Leuva, Harshraj, additional, Thota, Ramya, additional, Yost, Kathleen J, additional, Grantham, Gina N., additional, Gregory, Abigail, additional, Hinshaw, Dominique C., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2023
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12. Abstract CT226: Crizotinib (C) in patients (pts) with solid tumors with MET amplification (amp) or mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Mileham, Kathryn F., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Duvivier, Herbert L., additional, Calfa, Carmen J., additional, Dul, Carrie L., additional, Marr, Alissa S., additional, Ahn, Eugene R., additional, Behl, Deepti, additional, Hall, Michael J., additional, Mehmi, Inderjit, additional, Gaba, Anu, additional, Leidner, Rom, additional, Zalupski, Mark M., additional, Grantham, Gina N., additional, Gregory, Abigail, additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2023
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13. Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With ERBB2/3 Amplification, Overexpression, or Mutation: Results From the TAPUR Study

Author

Ahn, Eugene R., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Ali-Ahmad, Hussein M., additional, Chan, John, additional, Maitland, Michael L., additional, Patel, Sapna R., additional, Reese, Zachary, additional, Balmanoukian, Ani S., additional, Drescher, Charles W., additional, Li, Rui, additional, Tsimberidou, Apostolia M., additional, Leath, Charles A., additional, O'Lone, Raegan, additional, Grantham, Gina N., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2023
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14. Cobimetinib Plus Vemurafenib in Patients With Solid Tumors With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Meric-Bernstam, Funda, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Gutierrez, Rodolfo, Ahn, Eugene R., Cannon, Timothy L., Powell, Steven, Krauss, John C., Reynolds, Christopher M., von Mehren, Margaret, Behl, Deepti, Calfa, Carmen J., Duvivier, Herbert L., Kaplan, Henry G., Livingston, Michael B., Sharma, Manish R., Urba, Walter J., Grantham, Gina N., and Hinshaw, Dominique C.

Subjects
VEMURAFENIB, BRAF genes, CANCER patients, PATIENT experience, ANTINEOPLASTIC agents, OVARIAN cancer
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket study evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers with genomic alterations known to be drug targets. The results in a cohort of patients with solid tumors with BRAF mutations treated with cobimetinib plus vemurafenib are reported. METHODS: Eligible patients had measurable disease (RECIST v.1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as complete response (CR) or partial response (PR) or stable disease of at least 16-weeks duration (SD16+). Low-accruing histology-specific cohorts with BRAF mutations treated with cobimetinib plus vemurafenib were collapsed into a single histology-pooled cohort for this analysis. The results were evaluated on the basis of a one-sided exact binomial test with a null DC rate of 15% versus 35% (power,.82; α,.10). The secondary end points were objective response (OR), progression-free survival, overall survival, duration of response, duration of stable disease, and safety. RESULTS: Thirty-one patients with solid tumors with BRAF mutations were enrolled. Twenty-eight patients were evaluable for efficacy. Patients had tumors with BRAF V600E (n = 26), K601E (n = 2), or other (n = 3) mutations. Two patients with CR (breast and ovarian cancers; V600E), 14 with PR (13 V600E, one N581I), and three with SD16+ (two V600E, one T599_V600insT) were observed with a DC rate of 68% (P <.0001; one-sided 90% CI, 54 to 100) and an OR rate of 57% (95% CI, 37 to 76). Nineteen patients experienced ≥one drug-related grade 3-5 adverse event or serious adverse event including one death attributed to treatment-related kidney injury. CONCLUSION: Cobimetinib plus vemurafenib showed antitumor activity in patients with advanced solid tumors with BRAF V600E mutations; additional study is warranted to confirm the antitumor activity in tumors with non-V600E BRAF mutations. @ASCO #TAPUR results build upon efficacy of BRAF + MEK inhibitors in patients with advanced solid tumors and BRAF V600E mutations [ABSTRACT FROM AUTHOR]

Published
2023
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15. Pertuzumab plus trastuzumab (P+T) in patients (pts) with biliary tract cancer (BTC) with ERBB2/3 amplification (amp), overexpression (oe), or mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Cannon, Timothy Lewis, primary, Rothe, Michael, additional, Garrett-Mayer, Elizabeth, additional, Chiu, Vi Kien, additional, Hwang, Jimmy J., additional, Vijayvergia, Namrata, additional, Alese, Olatunji B., additional, Dib, Elie G., additional, Duvivier, Herbert Leon, additional, Klute, Kelsey, additional, Sahai, Vaibhav, additional, Ahn, Eugene R, additional, Behl, Deepti, additional, Sinclair, Sarah, additional, Thota, Ramya, additional, Urba, Walter John, additional, Yang, Eddy Shih-Hsin, additional, Grantham, Gina N., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2023
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17. Pertuzumab Plus Trastuzumab in Patients With Lung Cancer With ERBB2 Mutation or Amplification: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Ganti, Apar K., Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Dib, Elie G., Duvivier, Herbert L., Ahn, Eugene R., Behl, Deepti, Borghaei, Hossein, Balmanoukian, Ani S., Gaba, Anu, Li, Rui, Osei-Boateng, Kwabena, Thota, Ramya, Grantham, Gina N., Gregory, Abigail, Halabi, Susan, and Schilsky, Richard L.

Subjects
CANCER patients, LUNG cancer, TRASTUZUMAB, INSERTION mutation, NON-small-cell lung carcinoma
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with lung cancer and ERBB2 mutation or amplification treated with pertuzumab plus trastuzumab (P + T) are reported. METHODS: Eligible patients had advanced lung cancer of any histology, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with ERBB2 mutation or amplification. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) per RECIST v. 1.1 or stable disease (SD) of at least 16 weeks duration (SD16+). Secondary end points included safety, duration of response, duration of SD, progression-free survival, and overall survival. RESULTS: Twenty-eight patients with lung cancer (27 non–small-cell, 1 small-cell) and ERBB2 mutation (n = 15), ERBB2 amplification (n = 12), or both (n = 1) were enrolled from November 2016 to July 2020. All patients were evaluable for efficacy and toxicity. Three patients with partial response (two ERBB2 mutation; one both mutation and amplification) and seven patients with SD16+ (five ERBB2 mutation; two amplification) were observed for a DC rate of 37% (95% CI, 21 to 50; P =.005) and OR rate of 11% (95% CI, 2 to 28). Five patients had one or more grade 3 or 4 adverse or serious adverse events at least possibly related to P + T. CONCLUSION: Combination P + T showed evidence of antitumor activity in heavily pretreated patients with non–small-cell lung cancer and ERBB2 mutation or amplification, particularly those with ERBB2 exon 20 insertion mutations. Pertuzumab + trastuzumab had antitumor activity in pretreated patients with ERBB2-mutated NSCLC @ASCO #TAPUR. [ABSTRACT FROM AUTHOR]

Published
2023
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19. Abstract CT110: Olaparib (O) in patients (pts) with solid tumors with ATM mutation or deletion: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Mileham, Kathryn F., primary, Rothe, Michael, additional, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Yang, Eddy S., additional, Alese, Olatunji B., additional, Jain, Angela, additional, Duvivier, Herbert L., additional, Palmbos, Phillip, additional, Ahn, Eugene R., additional, Aragon-Ching, Jeanny B., additional, Beekman, Kathleen W., additional, Behl, Deepti, additional, Meric-Bernstam, Funda, additional, Gutierrez, Rodolfo, additional, Sanford, Amy, additional, Thota, Ramya, additional, Zakem, Michael, additional, Zhao, Song, additional, O'Lone, Raegan, additional, Grantham, Gina N., additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2022
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20. First-in-human dose escalation and expansion study of MT-6402, a novel engineered toxin body (ETB) targeting PD-L1, in patients with PD-L1 expressing relapsed/refractory advanced solid tumors: Interim data.

Author

Ahn, Eugene R, primary, Duvivier, Herbert Leon, additional, Rasco, Drew W., additional, Rethy, Agnes, additional, Moore, Chris, additional, Yuet, Amy, additional, Hankins, Sandra R., additional, Orlandella, Rachael, additional, Khanna, Swati, additional, Dekker, Joseph, additional, Georgy, Angela, additional, and Spigel, David R., additional

Published
2022
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21. Cobimetinib plus vemurafenib (C+V) in patients (Pts) with solid tumors with BRAF V600E/d/k/R mutation: Results from the targeted agent and profiling utilization registry (TAPUR) study.

Author

Meric-Bernstam, Funda, primary, Rothe, Michael, additional, Garrett-Mayer, Elizabeth, additional, Gutierrez, Rodolfo, additional, Ahn, Eugene R, additional, Cannon, Timothy Lewis, additional, Powell, Steven Francis, additional, Krauss, John C., additional, Reynolds, Christopher M., additional, von Mehren, Margaret, additional, Behl, Deepti, additional, Calfa, Carmen Julia, additional, Duvivier, Herbert Leon, additional, Kaplan, Henry G., additional, Livingston, Michael B., additional, Sharma, Manish, additional, Urba, Walter John, additional, O'Lone, Raegan, additional, Halabi, Susan, additional, and Schilsky, Richard L., additional

Published
2022
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22. Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Alva, Ajjai S., primary, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Hansra, Damien, additional, Calfa, Carmen J., additional, Khalil, Maged F., additional, Ahn, Eugene R., additional, Cannon, Timothy L., additional, Crilley, Pamela, additional, Fisher, Julie G., additional, Haslem, Derrick S., additional, Shrestha, Sagun, additional, Antonelli, Kaitlyn R., additional, Butler, Nicole L., additional, Warren, Sasha L., additional, Rygiel, Andrew L., additional, Ranasinghe, Shamika, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2021
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26. Palbociclib in Patients With Non–Small-Cell Lung Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Ahn, Eugene R., primary, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Dib, Elie G., additional, Haggstrom, Daniel E., additional, Alguire, Kathryn B., additional, Calfa, Carmen J., additional, Cannon, Timothy L., additional, Crilley, Pamela A., additional, Gaba, Anu G., additional, Marr, Alissa S., additional, Sangal, Ashish, additional, Thota, Ramya, additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Rygiel, Andrew L., additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2020
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27. Olaparib (O) in patients (pts) with pancreatic cancer with BRCA1/2 inactivating mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Ahn, Eugene R, primary, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Mangat, Pam K., additional, Calfa, Carmen Julia, additional, Alva, Ajjai Shivaram, additional, Suhag, Vijay S., additional, Hamid, Omid, additional, Dotan, Efrat, additional, Yang, Eddy Shih-Hsin, additional, Alese, Olatunji B., additional, Yost, Kathleen J, additional, Marr, Alissa S., additional, Palmer, Martin Clive, additional, Thompson, Forrest L., additional, Rygiel, Andrew Lawrence, additional, Anderson, Sarah T., additional, Islam, Samiha, additional, and Schilsky, Richard L., additional

Published
2020
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29. Pembrolizumab (P) in patients (Pts) with colorectal cancer (CRC) with high tumor mutational burden (HTMB): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Author

Meiri, Eyal, primary, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Mangat, Pam K., additional, Shrestha, Sagun, additional, Ahn, Eugene R., additional, Osayameh, Olufunlayo, additional, Perla, Venu, additional, and Schilsky, Richard L., additional

Published
2020
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30. Palbociclib in Patients With Pancreatic and Biliary Cancer WithCDKN2AAlterations: Results From the Targeted Agent and Profiling Utilization Registry Study

Author

Al Baghdadi, Tareq, primary, Halabi, Susan, additional, Garrett-Mayer, Elizabeth, additional, Mangat, Pam K., additional, Ahn, Eugene R., additional, Sahai, Vaibhav, additional, Alvarez, Ricardo H., additional, Kim, Edward S., additional, Yost, Kathleen J., additional, Rygiel, Andrew Lawrence, additional, Antonelli, Kaitlyn R., additional, Butler, Nicole L., additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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35. Abstract CT146: Sunitinib (S) in patients (Pts) with metastatic colorectal cancer (mCRC) with FLT-3 alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Alvarez, Ricardo H., primary, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Mangat, Pam K., additional, Baghdadi, Tareq Al, additional, Ahn, Eugene R., additional, Chai, Seungjean, additional, Rygiel, Andrew L., additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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36. Abstract CT146: Sunitinib (S) in patients (Pts) with metastatic colorectal cancer (mCRC) withFLT-3alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Alvarez, Ricardo H., primary, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Mangat, Pam K., additional, Baghdadi, Tareq Al, additional, Ahn, Eugene R., additional, Chai, Seungjean, additional, Rygiel, Andrew L., additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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37. Effects on histologic subgroup, race, and BMI in 2,110 breast cancer patient: Results from single institution in Georgia.

Author

Alvarez, Ricardo H., primary, Rollins, Rebecca, additional, Ensor, Joe, additional, Nixon, Daniel W., additional, Ramey, Jonathan, additional, Pannell, Rachel, additional, Rados, Karen, additional, Ahn, Eugene R, additional, Aithal, Sramila, additional, Lynch, Cynthia, additional, Pabbathi, Haritha, additional, Hansra, Damien, additional, McKnight, John Edward, additional, Kim, Elizabeth MH, additional, and Johnson, Anita, additional

Published
2019
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38. Pembrolizumab (P) in patients (pts) with metastatic breast cancer (MBC) with high tumor mutational burden (HTMB): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Author

Alva, Ajjai Shivaram, primary, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Alvarez, Ricardo H., additional, Calfa, Carmen Julia, additional, Khalil, Maged F., additional, Ahn, Eugene R, additional, Cannon, Timothy Lewis, additional, Crilley, Pamela A., additional, Fisher, Julie Gottlieb, additional, Haslem, Derrick S., additional, Shrestha, Sagun, additional, Antonelli, Kaitlyn R., additional, Butler, Nicole L., additional, Warren, Sasha L., additional, Rygiel, Andrew Lawrence, additional, Ranasinghe, Shamika, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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39. Evaluation of pathologic and genomic characteristics in male breast cancer (MBC) patients.

Author

Hansra, Damien Mikael, primary, Ahn, Eugene R, additional, McKnight, John Edward, additional, Pabbathi, Haritha, additional, Lynch, Cynthia, additional, Crilley, Pamela A., additional, Parikh, Ankur Rasik, additional, Aithal, Sramila, additional, Moran, Amber, additional, Rollins, Rebecca, additional, Nixon, Daniel W., additional, Markman, Maurie, additional, and Alvarez, Ricardo H., additional

Published
2019
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40. Palbociclib (P) in patients (pts) with non-small cell lung cancer (NSCLC) with CDKN2A alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Author

Ahn, Eugene R, primary, Mangat, Pam K., additional, Garrett-Mayer, Elizabeth, additional, Halabi, Susan, additional, Dib, Elie G., additional, Haggstrom, Daniel Ernest, additional, Alguire, Kathryn B., additional, Alvarez, Ricardo H., additional, Calfa, Carmen Julia, additional, Cannon, Timothy Lewis, additional, Crilley, Pamela A., additional, Gaba, Anu G., additional, Marr, Alissa S., additional, Sangal, Ashish, additional, Thota, Ramya, additional, Antonelli, Kaitlyn R., additional, Islam, Samiha, additional, Rygiel, Andrew Lawrence, additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2019
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41. Palbociclib (P) in patients (Pts) with pancreatic cancer (PC) and gallbladder or bile duct cancer (GBC) with CDKN2A alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Al Baghdadi, Tareq, primary, Halabi, Susan, additional, Garrett-Mayer, Elizabeth, additional, Mangat, Pam K., additional, Ahn, Eugene R, additional, Sahai, Vaibhav, additional, Alvarez, Ricardo H., additional, Kim, Edward S., additional, Yost, Kathleen J, additional, Guo, Kuo, additional, Rygiel, Andrew Lawrence, additional, Antonelli, Kaitlyn R., additional, Butler, Nicole L., additional, Bruinooge, Suanna S., additional, and Schilsky, Richard L., additional

Published
2018
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42. Efficacy of olaparib monotherapy in patients (pts) with HER2-negative metastatic breast cancer (MBC) with germline BRCA mutation (gBRCAm) or lesional BRCA mutation (lBRCAm).

Author

Meisner, Eleanor, primary, Rollins, Rebecca, additional, Ensor, Joe, additional, Moran, Amber, additional, Woodward, Amanda, additional, Ahn, Eugene R, additional, Lynch, Cynthia Anne, additional, Citrin, Dennis L., additional, Hansra, Damien, additional, Aithal, Sramila S., additional, Ninan, Mary, additional, Nixon, Daniel W., additional, Zook, Susan, additional, Ali, Siraj Mahamed, additional, Markman, Maurie, additional, and Alvarez, Ricardo H., additional

Published
2018
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43. Palbociclib in Patients With Pancreatic and Biliary Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Al Baghdadi, Tareq, Halabi, Susan, Garrett-Mayer, Elizabeth, Mangat, Pam K., Ahn, Eugene R., Sahai, Vaibhav, Alvarez, Ricardo H., Kim, Edward S., Yost, Kathleen J., Rygiel, Andrew Lawrence, Antonelli, Kaitlyn R., Butler, Nicole L., Bruinooge, Suanna S., and Schilsky, Richard L.

Subjects
PANCREATIC cancer, PROGRESSION-free survival, TARGETED drug delivery
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations known as drug targets. In this article, data from two cohorts of patients with pancreatic and biliary cancers with CDKN2A loss or mutation treated with palbociclib are reported. METHODS: Eligible patients age 12 years and older with advanced measurable or evaluable solid tumors are provided treatment according to protocol-specified genomic matching rules. The primary study end point is objective response or stable disease of at least 16 weeks duration. For each cohort, a Simon two-stage design was used with a futility evaluation after 10 patients. Secondary end points include safety, progression-free survival (PFS), and overall survival (OS). RESULTS: Between July 2016 and November 2017, 12 and 10 patients with pancreatic and biliary cancer, respectively, with CDKN2A loss or mutation were treated with palbociclib. Twenty evaluable patients (10 per cohort) were included in the analysis. No patients had objective response or stable disease at 16 weeks, and both cohorts were closed. Two patients, neither with response, were determined to be ineligible. All patients were evaluated for safety, PFS, and OS. A median PFS of 7.2 weeks (90% CI, 4.0 to 8.0 weeks) and median OS of 12.4 weeks (90% CI, 4.7 to 23.1 weeks) were observed in the pancreatic cohort. A median PFS of 7.3 weeks (90% CI, 3.9 to 7.9 weeks) and median OS of 11.1 weeks (90% CI, 5.1 to 14.0 weeks) were observed in the biliary cohort. No unexpected toxicities were observed. CONCLUSION: Palbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with CDKN2A loss or mutation. Toxicity is similar to reported experience with palbociclib in other tumor types. [ABSTRACT FROM AUTHOR]

Published
2019
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44. Nivolumab plus ipilimumab (N+I) in patients (pts) with ovarian cancer (OC) with BRCA1/2 mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Drescher, Charles, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Behl, Deepti, Ahn, Eugene R, Al Baghdadi, Tareq, Naumann, R. Wendel, Bell, Maria C, Leath, Charles A., Cannon, Timothy Lewis, Alese, Olatunji B., Grantham, Gina N., Gregory, Abigail, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Published
2023
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