2024
Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.Peer-Reviewed Original ResearchBiliary tract cancerAdvanced biliary tract cancerAdverse eventsDose reduction due to adverse eventsBiliary tract cancer casesChemotherapy plus immunotherapyPhase Ia/Ib trialPD-1 inhibitorsSecond-line optionAnti-tumor activityStable diseasePartial responsePD-1Treatment discontinuationCase seriesSafety profilePatientsImprove outcomesMolecular heterogeneityCancerMDM2-p53DiseaseImmunotherapyDoseEfficacyThe HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results
Lewis G, Li G, Guo J, Yu S, Fields C, Lee G, Zhang D, Dragovich P, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee M, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung K, Hamilton E, LoRusso P, Krop I, Schutten M, Commerford R, Sliwkowski M, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nature Communications 2024, 15: 466. PMID: 38212321, PMCID: PMC10784567, DOI: 10.1038/s41467-023-44533-z.Peer-Reviewed Original ResearchConceptsHER2 antibody-drug conjugatesAntibody-drug conjugatesMetastatic breast cancerPhase 1 trialBreast cancerHER2-positive metastatic breast cancerHER2-positive breast cancerObjective response rateDose-escalation studyDuration of responseModel of HER2Anti-tumor activityMechanism of actionTrastuzumab deruxtecanPulmonary toxicityTrastuzumab emtansinePreclinical characterizationResponse rateHigh dosesVivo efficacySecondary objectiveEarly signsPotent cytotoxic agentCytotoxic agentsCancer
2023
126P Evaluation of myeloid targeting agents, PY159 and PY314, in two dose expansion phase Ib trials in platinum-resistant ovarian cancer
Yeku O, Barve M, Tan W, Wang J, Patnaik A, Lorusso P, Naqash A, Dowlati A, Fu S, Gordon M, Hubbard J, Kummar S, Kyriakopoulos C, Schenk E, Deegan D, Liang L, Li Y, Reyno L, Chamberlain M, Winer I. 126P Evaluation of myeloid targeting agents, PY159 and PY314, in two dose expansion phase Ib trials in platinum-resistant ovarian cancer. Immuno-Oncology Technology 2023, 20: 100598. DOI: 10.1016/j.iotech.2023.100598.Peer-Reviewed Original Research
2022
732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial
Champiat S, Wermke M, Vicier C, de Bono J, Jungels C, Vey N, Kotecki N, Wetzko K, Ruhnke L, Garralda E, de Aguiar V, Lorusso P, de Gassart A, Valentin E, Brune P, Iche M, Leparquier C, Olive D, Marabelle A, Frohna P. 732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial. Annals Of Oncology 2022, 33: s877-s878. DOI: 10.1016/j.annonc.2022.07.858.Peer-Reviewed Original ResearchOA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation
Sacher A, Patel M, Miller W, Desai J, Garralda E, Bowyer S, Kim T, De Miguel M, Falcon A, Krebs M, Lee J, Cheng M, Han S, Shacham-Shmueli E, Forster M, Jerusalem G, Massarelli E, Rodriguez L, Prenen H, Walpole I, Arbour K, Choi Y, Dharia N, Lin M, Mandlekar S, Joo S, Shi Z, Schutzman J, LoRusso P. OA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation. Journal Of Thoracic Oncology 2022, 17: s8-s9. DOI: 10.1016/j.jtho.2022.07.023.Peer-Reviewed Original Research362P Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutation
Desai J, Han S, Forster M, Kim T, Casal G, Shmueli E, Bowyer S, De Miguel M, Gonzalez A, Jones R, Krebs M, Miller W, Paz-Ares L, Lorusso P, Sacher A, Dharia N, Lin M, Schutzman J, Shi Z, Patel M. 362P Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutation. Annals Of Oncology 2022, 33: s701-s702. DOI: 10.1016/j.annonc.2022.07.500.Peer-Reviewed Original Research
2021
LBA-5 Phase Ib study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in patients with metastatic esophageal cancer
Wainberg Z, Matos I, Delord J, Cassier P, Gil-Martin M, Kim T, LoRusso P, Bahleda R, Italiano A, Mendus D, Hoang T, Xue C, Wen X, Carvalho O, Pham T, Patil N, Meng R, Bendell J, Cervantes A, Cho B. LBA-5 Phase Ib study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in patients with metastatic esophageal cancer. Annals Of Oncology 2021, 32: s227-s228. DOI: 10.1016/j.annonc.2021.06.012.Peer-Reviewed Original ResearchSO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancer
Chung H, Lee K, Kim W, Gainor J, Lakhani N, Chow L, Messersmith W, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, LoRusso P. SO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancer. Annals Of Oncology 2021, 32: s215-s216. DOI: 10.1016/j.annonc.2021.05.055.Peer-Reviewed Original Research
2020
395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy
Yap T, Wong D, Hu-Lieskovan S, Papadopoulos K, Morrow M, Grabowska U, Gliddon D, Holz J, LoRusso P. 395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy. 2020, a240-a240. DOI: 10.1136/jitc-2020-sitc2020.0395.Peer-Reviewed Original Research404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC)
Lee K, Chung H, Kim W, Chow L, Lakhani N, Messersmith W, Bang Y, LoRusso P, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC). 2020, a245.2-a246. DOI: 10.1136/jitc-2020-sitc2020.0404.Peer-Reviewed Original Research
2018
ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers.
Yap T, Burris H, Kummar S, Falchook G, Pachynski R, LoRusso P, Tykodi S, Gibney G, Gainor J, Rahma O, Seiwert T, Meric-Bernstam F, Blum Murphy M, Litton J, Hooper E, Hirsch H, Harvey C, Clancy M, McClure T, Callahan M. ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers. Journal Of Clinical Oncology 2018, 36: 3000-3000. DOI: 10.1200/jco.2018.36.15_suppl.3000.Peer-Reviewed Original ResearchSafety, efficacy and pharmacodynamics (PD) of MEDI9447 (oleclumab) alone or in combination with durvalumab in advanced colorectal cancer (CRC) or pancreatic cancer (panc).
Overman M, LoRusso P, Strickler J, Patel S, Clarke S, Noonan A, Prasanna T, Amin M, Nemunaitis J, Desai J, O'Byrne K, George T, Englert J, She D, Cooper Z, Wu Y, Khan A, Kumar R, Bendell J. Safety, efficacy and pharmacodynamics (PD) of MEDI9447 (oleclumab) alone or in combination with durvalumab in advanced colorectal cancer (CRC) or pancreatic cancer (panc). Journal Of Clinical Oncology 2018, 36: 4123-4123. DOI: 10.1200/jco.2018.36.15_suppl.4123.Peer-Reviewed Original Research
2017
90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC)
Yee D, Prat A, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Hua H, LoRusso P. 90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: x25. DOI: 10.1093/annonc/mdx656.001.Peer-Reviewed Original Research235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC)
Prat A, Yee D, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Stucke-Straub K, Russo P. 235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v72-v73. DOI: 10.1093/annonc/mdx364.017.Peer-Reviewed Original Research
2016
A phase I study of continuous (Con) and intermittent (Int) AZD2014 plus fulvestrant (F) in patients (pts) with estrogen receptor (ER+) metastatic breast cancer (BC).
Hamilton E, Patel M, Gluck W, Weise A, Pant S, Jones S, LoRusso P, Kittaneh M, Cosulich S, Harrington E, Littlewood G, Oelmann E, Burris H. A phase I study of continuous (Con) and intermittent (Int) AZD2014 plus fulvestrant (F) in patients (pts) with estrogen receptor (ER+) metastatic breast cancer (BC). Journal Of Clinical Oncology 2016, 34: 563-563. DOI: 10.1200/jco.2016.34.15_suppl.563.Peer-Reviewed Original Research
2015
Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC).
Curigliano G, Aftimos P, Dees E, LoRusso P, Pegram M, Awada A, Huang B, Cesari R, Jiang Y, Shaik M, Kern K, Locatelli M. Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2015, 33: 1068-1068. DOI: 10.1200/jco.2015.33.15_suppl.1068.Peer-Reviewed Original Research
2014
Enzalutamide plus exemestane: A pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer.
Schwartzberg L, Yardley D, Elias A, Patel M, Gucalp A, Burris H, Peterson A, Hannah A, Blaney M, Gibbons J, Tudor I, Steinberg J, LoRusso P, Infante J, Hudis C, Traina T. Enzalutamide plus exemestane: A pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer. Journal Of Clinical Oncology 2014, 32: 545-545. DOI: 10.1200/jco.2014.32.15_suppl.545.Peer-Reviewed Original ResearchRelationship of pharmacokinetics (PK), toxicity, and initial evidence of clinical activity with IMGN853, a folate receptor alpha (FRa) targeting antibody drug conjugate in patients (Pts) with epithelial ovarian cancer (EOC) and other FRa-positive solid tumors.
Moore K, Ponte J, LoRusso P, Birrer M, Bauer T, Borghaei H, O'Malley D, Ruiz-Soto R, Lutz R, Malik L. Relationship of pharmacokinetics (PK), toxicity, and initial evidence of clinical activity with IMGN853, a folate receptor alpha (FRa) targeting antibody drug conjugate in patients (Pts) with epithelial ovarian cancer (EOC) and other FRa-positive solid tumors. Journal Of Clinical Oncology 2014, 32: 5571-5571. DOI: 10.1200/jco.2014.32.15_suppl.5571.Peer-Reviewed Original Research10P A Phase 1 Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide Alone or Combined with an Aromatase Inhibitor in Women with Advanced Breast Cancer
Traina T, Yardley D, Patel M, Schwartzberg L, Elias A, Gucalp A, Blaney M, Gibbons J, Hudis C, LoRusso P. 10P A Phase 1 Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide Alone or Combined with an Aromatase Inhibitor in Women with Advanced Breast Cancer. Annals Of Oncology 2014, 25: i4. DOI: 10.1093/annonc/mdu064.1.Peer-Reviewed Original ResearchErratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer
Britten C, Adjei A, Millham R, Houk B, Borzillo G, Pierce K, Wainberg Z, LoRusso P. Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer. Investigational New Drugs 2014, 32: 575-575. DOI: 10.1007/s10637-014-0069-6.Peer-Reviewed Original Research