2024
Trastuzumab Deruxtecan With Nivolumab in HER2-Expressing Metastatic Breast or Urothelial Cancer: Analysis of the Phase Ib DS8201-A-U105 Study
Hamilton E, Galsky M, Ochsenreither S, Del Conte G, Martín M, de Miguel M, Yu E, Williams A, Gion M, Tan A, Agrawal L, Rutten A, Machiels J, Cresta S, Debruyne P, Hennequin A, Moreno V, Minchom A, Valdes-Albini F, Petrylak D, Li L, Tsuchihashi Z, Suto F, Cheng F, Kandil M, Barrios D, Hurvitz S. Trastuzumab Deruxtecan With Nivolumab in HER2-Expressing Metastatic Breast or Urothelial Cancer: Analysis of the Phase Ib DS8201-A-U105 Study. Clinical Cancer Research 2024 PMID: 39405343, DOI: 10.1158/1078-0432.ccr-24-1513.Peer-Reviewed Original ResearchMetastatic urothelial cancerMetastatic breast cancerT-DXdHER2-lowTrastuzumab deruxtecanUrothelial cancerHER2-positive metastatic breast cancerCohort 1Treatment-emergent adverse eventsMedian treatment durationIndependent central reviewData cutoffMetastatic breastCentral reviewPrimary endpointNivolumabCohort 4Adverse eventsBreast cancerCohort 3Cohort 2Evaluate efficacyTreatment durationPrompt interventionPatients1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up
Aggarwal R, Tagawa S, Monk P, Zhu X, Jones R, Linch M, Costin D, de Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Zhang J. 1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up. Annals Of Oncology 2024, 35: s979. DOI: 10.1016/j.annonc.2024.08.1703.Peer-Reviewed Original Research
2023
1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations
Petrylak D, Garmezy B, Shen J, Kalebasty A, Sartor O, Dreicer R, Agarwal N, Hussain M, Percent I, Heath E, Gedrich R, Yu T, Healey D, Parameswaran J, Sternberg C, Gao X. 1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations. Annals Of Oncology 2023, 34: s973-s974. DOI: 10.1016/j.annonc.2023.09.2751.Peer-Reviewed Original ResearchTackling FGFR3-driven bladder cancer with a promising synergistic FGFR/HDAC targeted therapy
Wang Z, Muthusamy V, Petrylak D, Anderson K. Tackling FGFR3-driven bladder cancer with a promising synergistic FGFR/HDAC targeted therapy. Npj Precision Oncology 2023, 7: 70. PMID: 37479885, PMCID: PMC10362036, DOI: 10.1038/s41698-023-00417-5.Peer-Reviewed Original ResearchBladder cancerBC cellsEarly phase clinical trialsPhase clinical trialsDurable responsesMetastatic diseaseMost patientsFGFR3 alterationsPrevalent malignancyClinical trialsFGFR3 fusionsPreclinical studiesFGFR inhibitorsHDAC inhibitorsFGFR3 expressionEfficient therapyTherapyCancerQuisinostatFGFR3New mechanistic insightsInhibitorsCellsPatientsMalignancy
2022
Effect of Androgen–Androgen Receptor Directed Therapy on COVID-19 Outcome in Prostate Cancer Patients
Ünlü S, Shin J, Par-Young J, Simonov M, Vinetz J, Petrylak D, Kang I, Kim J. Effect of Androgen–Androgen Receptor Directed Therapy on COVID-19 Outcome in Prostate Cancer Patients. Cancer Investigation 2022, 41: 77-83. PMID: 36373994, DOI: 10.1080/07357907.2022.2139839.Peer-Reviewed Original ResearchConceptsProstate cancer patientsCOVID-19 outcomesCancer patientsPoor COVID-19 outcomesAndrogen-androgen receptorExpression of TMPRSS2COVID-19 infectionSARS-CoV-2Directed therapyMean hospitalizationPCa patientsHospitalization ratesPCa casesRetrospective analysisOutcome differencesPatientsDefinitive conclusionsStatistical significanceData generate hypothesesHospitalizationTherapyTMPRSS2Cellular entryOutcomesARDT1398P Overall survival (OS) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) who received prior androgen deprivation therapy (ADT) and reached low prostate-specific antigen (PSA) levels treated further with enzalutamide (ENZA): Post hoc analyses of ARCHES
Petrylak D, Azad A, Szmulewitz R, Iguchi T, Shore N, Holzbeierlein J, Alekseev B, El-Chaar N, Rosbrook B, Ma J, Zohren F, Haas G, Stenzl A, Armstrong A. 1398P Overall survival (OS) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) who received prior androgen deprivation therapy (ADT) and reached low prostate-specific antigen (PSA) levels treated further with enzalutamide (ENZA): Post hoc analyses of ARCHES. Annals Of Oncology 2022, 33: s1183-s1184. DOI: 10.1016/j.annonc.2022.07.1884.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyOverall survivalLow prostate-specific antigen levelsHormone-sensitive prostate cancerPrior androgen deprivation therapyProstate-specific antigen levelDeprivation therapyAntigen levelsProstate cancerEnzalutamidePatientsTherapyCancerLBA73 Study EV-103 Cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC)
Rosenberg J, Milowsky M, Ramamurthy C, Mar N, McKay R, Friedlander T, Ferrario C, Bracarda S, George S, Moon H, Geynisman D, Petrylak D, Borchiellini D, Burgess E, Rey J, Carret A, Yu Y, Guseva M, Moreno B, O'Donnell P. LBA73 Study EV-103 Cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC). Annals Of Oncology 2022, 33: s1441. DOI: 10.1016/j.annonc.2022.08.079.Peer-Reviewed Original ResearchCell-free DNA methylation as a predictive biomarker of response to neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer in SWOG S1314.
Lu Y, Plets M, Morrison G, Cunha A, Cen S, Rhie S, Siegmund K, Daneshmand S, Quinn D, Meeks J, Lerner S, Petrylak D, McConkey D, Flaig T, Thompson I, Goldkorn A. Cell-free DNA methylation as a predictive biomarker of response to neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer in SWOG S1314. Journal Of Clinical Oncology 2022, 40: 4506-4506. DOI: 10.1200/jco.2022.40.16_suppl.4506.Peer-Reviewed Original ResearchNeoadjuvant chemotherapyBladder cancer patientsPathologic responseTreatment responseCell-free DNA methylationCancer patientsMuscle-invasive bladder cancer patientsMuscle-invasive bladder cancerCycles of chemotherapyStandard neoadjuvant chemotherapyCooperative group trialsStandard of careProspective cooperative group trialsIndependent predictive abilityRadical cystectomyPredictive biomarkersPathologic respondersBladder cancerGroup trialsMR scoreBlood samplesChemotherapyPatientsPlasma samplesResponse scoresA0517 Clinical outcomes of patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC) with Prostate-Specific Antigen (PSA) decline to undetectable levels on enzalutamide (ENZA): Post hoc analysis of ARCHES
Stenzl A, Shore N, Villers A, Iguchi T, Gomez-Veiga F, Alcaraz A, Alekseev B, Azad A, Szmulewitz R, Petrylak D, Holzbeierlein J, Rosbrook B, Zohren F, Haas G, Gourgioti G, El-Chaar N, Armstrong A. A0517 Clinical outcomes of patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC) with Prostate-Specific Antigen (PSA) decline to undetectable levels on enzalutamide (ENZA): Post hoc analysis of ARCHES. European Urology 2022, 81: s776-s777. DOI: 10.1016/s0302-2838(22)00600-5.Peer-Reviewed Original Research
2021
PD34-07 ENZALUTAMIDE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER PATIENTS WHO RECEIVED PRIOR ANTIANDROGEN THERAPY: POST HOC ANALYSIS OF ARCHES
Shore N, Iguchi T, Villers A, Alcaraz A, Gomez-Veiga F, Stenzl A, Azad A, Alekseev B, Petrylak D, Szmulewitz R, Holzbeierlein J, Rosbrook B, Zohren F, Haas G, Gourgioti G, El-Chaar N, Armstrong A. PD34-07 ENZALUTAMIDE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER PATIENTS WHO RECEIVED PRIOR ANTIANDROGEN THERAPY: POST HOC ANALYSIS OF ARCHES. Journal Of Urology 2021, 206: e585-e585. DOI: 10.1097/ju.0000000000002038.07.Peer-Reviewed Original Research700P Efficacy of sacituzumab govitecan (SG) by trophoblast cell surface antigen 2 (Trop-2) expression in patients (Pts) with metastatic urothelial cancer (mUC)
Loriot Y, Balar A, Petrylak D, Rezazadeh A, Grivas P, Fléchon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Pan Y, Jürgensmeier J, Goswami T, Tagawa S. 700P Efficacy of sacituzumab govitecan (SG) by trophoblast cell surface antigen 2 (Trop-2) expression in patients (Pts) with metastatic urothelial cancer (mUC). Annals Of Oncology 2021, 32: s712-s713. DOI: 10.1016/j.annonc.2021.08.096.Peer-Reviewed Original Research
2020
A phase III, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE)
Powles T, van der Heijden M, Gauna D, Loriot Y, Galsky M, Petrylak D, Ogawa O, Park S, Necchi A, Lee J, De Giorgi U, Bögemann M, Bamias A, Fay A, Duran I, Angra N, Gupta A, He P, Levin W, Bellmunt J. A phase III, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE). Annals Of Oncology 2020, 31: s550-s551. DOI: 10.1016/j.annonc.2020.08.769.Peer-Reviewed Original ResearchTROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) and pembrolizumab (pembro) in patients (pts) with progression or recurrence of metastatic urothelial cancer (mUC) after platinum (PLT)-based therapy
Grivas P, Sternberg C, Agarwal N, Petrylak D, Tagawa S, Hong Q, Gladden A, Kanwal C, Goswami T, Loriot Y. TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) and pembrolizumab (pembro) in patients (pts) with progression or recurrence of metastatic urothelial cancer (mUC) after platinum (PLT)-based therapy. Annals Of Oncology 2020, 31: s604-s605. DOI: 10.1016/j.annonc.2020.08.2067.Peer-Reviewed Original ResearchBT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies
Mckean M, Bendell J, Petrylak D, Powles T, Sonpavde G, Dickson A, Dosunmu L, Hennessy M, Jeffrey P, Rigby M, West T. BT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies. Annals Of Oncology 2020, 31: s500-s501. DOI: 10.1016/j.annonc.2020.08.713.Peer-Reviewed Original ResearchAssociation of TMB with efficacy of pembrolizumab (pembro) in patients (pts) with advanced urothelial cancer (UC): Results from KEYNOTE-045 and KEYNOTE-052
Bellmunt J, de Wit R, Fradet Y, Climent M, Petrylak D, Lee J, Fong L, Necchi A, Sternberg C, Grivas P, O’Donnell P, Powles T, Plimack E, Cristescu R, Lunceford J, Ma J, Rajasagi M, Godwin J, Moreno B, Bajorin D. Association of TMB with efficacy of pembrolizumab (pembro) in patients (pts) with advanced urothelial cancer (UC): Results from KEYNOTE-045 and KEYNOTE-052. Annals Of Oncology 2020, 31: s580-s581. DOI: 10.1016/j.annonc.2020.08.819.Peer-Reviewed Original ResearchInfigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings.
Lyou Y, Grivas P, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris III H, Rearden J, Andresen C, Wang H, Daneshmand S, Bajorin D, Pal S. Infigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings. Journal Of Clinical Oncology 2020, 38: 5038-5038. DOI: 10.1200/jco.2020.38.15_suppl.5038.Peer-Reviewed Original ResearchUpper tract urothelial carcinomaMetastatic urothelial carcinomaTyrosine kinase inhibitorsPlatinum-based chemotherapyUrothelial bladder carcinomaUrothelial carcinomaTreatment responsePrior platinum-based chemotherapyDisease control rateObjective response rateMutations/fusionsConsistent treatment responseEligible patientsResected diseaseSalvage therapyPrimary endpointPrior linesFGFR3 alterationsLine treatmentControl rateBladder carcinomaSubgroup analysisOutcome measuresPatientsTreatment settingsPD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY
Shore* N, Crawford E, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Baron B, Haas G, Stenzl A, Armstrong A. PD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY. Journal Of Urology 2020, 203 DOI: 10.1097/ju.0000000000000844.010.Peer-Reviewed Original Research
2019
O1 Activity of the FGFR1–3 inhibitor infigratinib in patients with upper tract urothelial carcinoma and urothelial carcinoma of the bladder: Latest efficacy findings and comprehensive genomic profiling/cell-free DNA data
De Giorgi U, Pal S, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, Gupta S, Burris H, Soifer H, Li G, Dambkowski C, Moran S, Ye Y, Daneshmand S, Delord J, Bajorin D. O1 Activity of the FGFR1–3 inhibitor infigratinib in patients with upper tract urothelial carcinoma and urothelial carcinoma of the bladder: Latest efficacy findings and comprehensive genomic profiling/cell-free DNA data. European Urology Open Science 2019, 18: e3405-e3406. DOI: 10.1016/s1569-9056(19)34582-8.Peer-Reviewed Original ResearchDurability of complete response (CR) with atezolizumab (atezo) in locally advanced/metastatic urothelial carcinoma (mUC).
Loriot Y, Balar A, Dreicer R, Hoffman-Censits J, Perez-Gracia J, Petrylak D, Van Der Heijden M, Shen X, Zhu Q, Ding B, Kaiser C, Rosenberg J. Durability of complete response (CR) with atezolizumab (atezo) in locally advanced/metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2019, 37: 4527-4527. DOI: 10.1200/jco.2019.37.15_suppl.4527.Peer-Reviewed Original ResearchLong-term outcomes in elderly patients (pts) from IMvigor210: Atezolizumab (atezo) in metastatic urothelial cancer (mUC).
Balar A, Dreicer R, Loriot Y, Perez-Gracia J, Hoffman-Censits J, Petrylak D, Van Der Heijden M, Shen X, Ding B, Ramirez-Montagut T, Rosenberg J. Long-term outcomes in elderly patients (pts) from IMvigor210: Atezolizumab (atezo) in metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2019, 37: 394-394. DOI: 10.1200/jco.2019.37.7_suppl.394.Peer-Reviewed Original ResearchMetastatic urothelial cancerElderly ptsCR ratePD-L1 statusSingle-arm studyLong-term outcomesLong-term efficacyEvaluable ptsMedian OSEfficacy outcomesElderly patientsClinical outcomesUrothelial cancerClinical benefitPoor outcomeSubgroup analysisOverall populationChemotherapyOutcomesCisplatinAtezoAtezolizumabQ3wOSPatients