Navid Hafez, MD, MPH

• Abhijit Patel
• Adebowale Adeniran
• Daniel P. Petrylak
• David Rimm
• Joseph Kim
• Kurt Schalper
• Patricia LoRusso

Clinical Trial; Clinical Trial, Phase I

• Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Gounder M, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2023, 41: 543-543. DOI: 10.1200/jco.2023.41.4_suppl.543.
• Principles of Dose, Schedule, and Combination TherapyEder J, Hafez N. Principles of Dose, Schedule, and Combination Therapy. 2022, 1-13. DOI: 10.1002/9781119000822.hfcm055.pub3.
• Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors.Johnson M, Abdul-Karim R, Sommerhalder D, Hafez N, Wang S, Li C, Liu Y, Yang L, Collins S, Parot X, Strauss J. Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors. Journal Of Clinical Oncology 2022, 40: 2503-2503. DOI: 10.1200/jco.2022.40.16_suppl.2503.
• A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.Yamamoto N, Hafez N, Tolcher A, Teufel M, Geng J, Svensson L, Lahmar M, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3095-3095. DOI: 10.1200/jco.2022.40.16_suppl.3095.
• KRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation.Bekaii-Saab T, Spira A, Yaeger R, Buchschacher G, McRee A, Sabari J, Johnson M, Barve M, Hafez N, Velastegui K, Christensen J, Kheoh T, Der-Torossian H, Rybkin I. KRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation. Journal Of Clinical Oncology 2022, 40: 519-519. DOI: 10.1200/jco.2022.40.4_suppl.519.
• Analysis of homologous recombination DNA repair gene mutation status in patients with metastatic small cell lung cancer treated with cediranib and olaparib on NCI 9881 study.Kim J, Radke M, Hafez N, Soliman H, Fu S, Kato S, Lara P, Vaishampayan U, Razak A, Cardin D, Munster P, Eder J, Shyr Y, Ivy S, LoRusso P, Swisher E. Analysis of homologous recombination DNA repair gene mutation status in patients with metastatic small cell lung cancer treated with cediranib and olaparib on NCI 9881 study. Journal Of Clinical Oncology 2021, 39: 8563-8563. DOI: 10.1200/jco.2021.39.15_suppl.8563.
• P01.06 CX-2029, a Probody Drug Conjugate Targeting CD71 in Patients With Selected Tumor Types: PROCLAIM-CX-2029 Dose Expansion PhaseJohnson M, Ahnert J, Lakhani N, Sanborn R, El-Khoueiry A, Hafez N, Mamdani H, Boni V, Castro H, Hannah A, Spira A. P01.06 CX-2029, a Probody Drug Conjugate Targeting CD71 in Patients With Selected Tumor Types: PROCLAIM-CX-2029 Dose Expansion Phase. Journal Of Thoracic Oncology 2021, 16: s238. DOI: 10.1016/j.jtho.2021.01.330.
• Preliminary efficacy data of triple-negative breast cancer cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors.Hafez N, Soliman H, Fu S, Gelmon K, Abdul Razak A, Munster P, Vaishampayan U, Kato S, Lara P, Swisher E, Nixon A, Patel A, Shyr Y, Ivy S, LoRusso P, Kim J. Preliminary efficacy data of triple-negative breast cancer cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors. Journal Of Clinical Oncology 2020, 38: 1077-1077. DOI: 10.1200/jco.2020.38.15_suppl.1077.
• Preliminary efficacy data of platinum-pretreated small cell lung cancer (SCLC) cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors.Kim J, Hafez N, Soliman H, Fu S, Kato S, Lara P, Vaishampayan U, Abdul Razak A, Cardin D, Munster P, Eder J, Swisher E, Nixon A, Patel A, Shyr Y, Ivy S, LoRusso P. Preliminary efficacy data of platinum-pretreated small cell lung cancer (SCLC) cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors. Journal Of Clinical Oncology 2020, 38: 9065-9065. DOI: 10.1200/jco.2020.38.15_suppl.9065.
• CX-2029, a PROBODY drug conjugate targeting CD71 (transferrin receptor): Results from a first-in-human study (PROCLAIM-CX-2029) in patients (Pts) with advanced cancer.Johnson M, El-Khoueiry A, Hafez N, Lakhani N, Mamdani H, Rodon Ahnert J, Sanborn R, Ho T, Li R, Waldes J, Spira A. CX-2029, a PROBODY drug conjugate targeting CD71 (transferrin receptor): Results from a first-in-human study (PROCLAIM-CX-2029) in patients (Pts) with advanced cancer. Journal Of Clinical Oncology 2020, 38: 3502-3502. DOI: 10.1200/jco.2020.38.15_suppl.3502.
• A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors.Tolcher A, Hafez N, Yamamoto N, Park J, Grempler R, Lucarelli A, Lahmar M, Wang B, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3660-tps3660. DOI: 10.1200/jco.2020.38.15_suppl.tps3660.
• Abstract A080: Olaparib and the ATR inhibitor AZD6738 in relapsed, refractory cancer patients with homologous recombination (HR) repair mutations – OLAPCOEder J, Sohal D, Mahdi H, Do K, Keedy V, Hafez N, Doroshow D, Avedissian M, Mortimer P, Glover C, LoRusso P, Juergensmeier J, Shapiro G. Abstract A080: Olaparib and the ATR inhibitor AZD6738 in relapsed, refractory cancer patients with homologous recombination (HR) repair mutations – OLAPCO. Molecular Cancer Therapeutics 2019, 18: a080-a080. DOI: 10.1158/1535-7163.targ-19-a080.
• Abstract C047: A phase Ia/Ib, dose-escalation/expansion study of BI 907828, an MDM2-p53 antagonist, in combination with BI 754091, an anti-PD-1 antibody, and BI 754111, an anti-LAG-3 antibody, in patients with advanced solid tumorsTolcher A, Hafez N, Yamamoto N, Park J, Grempler R, Lucarelli A, Vallaster M, Wang B, Hyman D. Abstract C047: A phase Ia/Ib, dose-escalation/expansion study of BI 907828, an MDM2-p53 antagonist, in combination with BI 754091, an anti-PD-1 antibody, and BI 754111, an anti-LAG-3 antibody, in patients with advanced solid tumors. Molecular Cancer Therapeutics 2019, 18: c047-c047. DOI: 10.1158/1535-7163.targ-19-c047.
• OA05.01 Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 TherapyHellmann M, Jänne P, Opyrchal M, Hafez N, Raez L, Gabrilovich D, Wang F, Ordentlich P, Brouwer S, Sankoh S, Schmidt E, Meyers M, Ramalingam S. OA05.01 Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy. Journal Of Thoracic Oncology 2018, 13: s330. DOI: 10.1016/j.jtho.2018.08.257.
• A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma.Lakhani N, LoRusso P, Hafez N, Krishnamurthy A, O'Rourke T, Kamdar M, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma. Journal Of Clinical Oncology 2018, 36: 3068-3068. DOI: 10.1200/jco.2018.36.15_suppl.3068.
• Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with non-small cell lung cancer (NSCLC) previously treated with anti-PD-(L)1 therapy.Gandhi L, Janne P, Opyrchal M, Ramalingam S, Rybkin I, Hafez N, Raez L, Gabrilovich D, Wang F, Ordentlich P, Brouwer S, Sankoh S, Schmidt E, Meyers M, Hellmann M. Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with non-small cell lung cancer (NSCLC) previously treated with anti-PD-(L)1 therapy. Journal Of Clinical Oncology 2018, 36: 9036-9036. DOI: 10.1200/jco.2018.36.15_suppl.9036.
• Docetaxel in Advanced and Castration Resistant Prostate CancerPetrylak D, Hafez N. Docetaxel in Advanced and Castration Resistant Prostate Cancer. 2016, 77-92. DOI: 10.1007/978-3-319-31341-2_6.
• The impact of androgen deprivation and pelvic radiation on the development of bladder cancer.Hafez N, Wang R, Hurwitz M, Ma X, Petrylak D. The impact of androgen deprivation and pelvic radiation on the development of bladder cancer. Journal Of Clinical Oncology 2016, 34: 439-439. DOI: 10.1200/jco.2016.34.2_suppl.439.
• The effect of BCG intravesical therapy and recurrence on PDL1 expression in non-invasive bladder cancers.Hurwitz M, Adeniran A, Yao X, Hafez N, Schalper K, Rimm D, Petrylak D. The effect of BCG intravesical therapy and recurrence on PDL1 expression in non-invasive bladder cancers. Journal Of Clinical Oncology 2015, 33: e15504-e15504. DOI: 10.1200/jco.2015.33.15_suppl.e15504.
• Finding the Kool Mixx: how Brown & Williamson used music marketing to sell cigarettes.Hafez N, Ling PM. Finding the Kool Mixx: how Brown & Williamson used music marketing to sell cigarettes. Tobacco Control 2006, 15: 359-66. PMID: 16998169, PMCID: PMC2563654, DOI: 10.1136/tc.2005.014258.
• How Philip Morris built Marlboro into a global brand for young adults: implications for international tobacco control.Hafez N, Ling PM. How Philip Morris built Marlboro into a global brand for young adults: implications for international tobacco control. Tobacco Control 2005, 14: 262-71. PMID: 16046690, PMCID: PMC1748078, DOI: 10.1136/tc.2005.011189.