CME-MOC/NCPD-accredited LIVE Webinar
Saturday, October 24, 2020
8:30 AM – 4:30 PM (Eastern Time)

FINAL SCHEDULE

Lung Cancer | 8:30 AM – 9:30 AM

Case presentations and topics to be discussed

A patient with locally advanced non-small cell lung cancer (NSCLC)

• Long-term efficacy and safety findings from the Phase III PACIFIC trial evaluating the use of consolidation durvalumab after chemoradiation therapy for patients with unresectable Stage III NSCLC
• Role of durvalumab consolidation in patients with locally advanced NSCLC and low PD-L1 expression or targetable genomic alterations
• Spectrum, incidence, timing and severity of toxicities, including immune-related adverse events, with consolidation durvalumab in patients with locally advanced NSCLC
• Other ongoing and planned clinical trials of immune checkpoint inhibitors for patients with nonmetastatic NSCLC

A patient with newly diagnosed extensive-stage small cell lung cancer (SCLC)

• Designs, eligibility criteria and key efficacy and safety findings from the pivotal Phase III IMpower133 and CASPIAN trials evaluating atezolizumab or durvalumab, respectively, in combination with chemotherapy for patients with previously untreated extensive-stage SCLC
• Appropriate integration of first-line carboplatin/etoposide/atezolizumab and platinum/etoposide/durvalumab into current SCLC management
• Available clinical trial data with and current clinical role of anti-PD-1/PD-L1 antibodies alone or in combination with anti-CTLA-4 antibodies for progressive SCLC
• Design, eligibility criteria and major efficacy and safety findings of the Phase II basket trial assessing lurbinectedin for patients with SCLC that has progressed after prior platinum-based therapy; recent FDA approval and current clinical role

A patient with early-stage NSCLC with an EGFR exon 19 deletion mutation

• Design, eligibility criteria and primary and secondary endpoints of the Phase III ADAURA trial evaluating adjuvant osimertinib versus placebo in EGFR mutation-positive early-stage NSCLC after complete tumor resection
• Available efficacy and safety results from ADAURA; potential implications for biomarker testing and clinical care
• Optimal first-line treatment for patients with NSCLC with EGFR tumor mutations; overall and progression-free survival benefit observed with up-front osimertinib
• Incidence, clinical relevance and spectrum of resistance mechanisms in patients experiencing disease progression on osimertinib
• Key efficacy and safety findings from the Phase III RELAY study leading to the FDA approval of erlotinib in combination with ramucirumab for patients with previously untreated metastatic EGFR-mutant NSCLC
• Clinical trial findings with the use of anti-PD-1/PD-L1 antibodies in patients with EGFR mutation-positive NSCLC; impact of the prior use of immune checkpoint inhibitors on the tolerability of EGFR TKI therapy

A patient with metastatic NSCLC with an ALK rearrangement

• Optimal selection of first- and later-line therapy for patients with metastatic NSCLC with an ALK rearrangement
• Long-term efficacy and safety outcomes with first-line alectinib and brigatinib for patients with ALK-rearranged disease
• Emerging results from the Phase III CROWN and eXalt3 trials demonstrating a progression-free survival advantage with first-line lorlatinib and ensartinib, respectively, in ALK-positive NSCLC
• Similarities and differences in the clinicopathologic features of patients with ROS1-positive disease versus those with ALK rearrangements
• Pooled findings from the STARTRK-2, STARTRK-1 and ALKA-372-001 trials demonstrating the efficacy and safety of entrectinib in ROS1-positive NSCLC; FDA approval and appropriate integration into clinical practice
• Intracranial response rates observed with entrectinib in patients with ROS1-rearranged NSCLC and CNS involvement; implications for care

A patient with metastatic NSCLC who experiences disease progression on first-line carboplatin/pemetrexed/pembrolizumab and undergoes next-generation sequencing

• Frequency of other targetable mutations (eg, RET, MET exon 14, HER2) in metastatic NSCLC; optimal testing protocols
• Available safety and efficacy results from the LIBRETTO-001 trial leading to the FDA approval of selpercatinib for patients with RET fusion-driven NSCLC; optimal integration into clinical practice
• Reported clinical activity of pralsetinib in patients with advanced NSCLC and RET fusions; FDA breakthrough therapy designation and potential clinical role
• Design, eligibility criteria and key findings from the Phase II GEOMETRY mono-1 trial assessing capmatinib in patients with MET exon 14 mutation-positive NSCLC; recent FDA approval and role in current clinical practice
• Available safety and efficacy data contributing to the FDA breakthrough therapy designation for tepotinib in patients with MET exon 14-mutated metastatic NSCLC
• Key findings from the Phase II DESTINY-Lung01 study evaluating trastuzumab deruxtecan in HER2-mutated NSCLC; FDA breakthrough therapy designation and potential nonprotocol role in patients with HER2-mutant NSCLC

A patient with newly diagnosed metastatic NSCLC with no actionable tumor mutation

• Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab administered as monotherapy and combined with chemotherapy as first-line treatment for metastatic NSCLC
• Current clinical role of atezolizumab in combination with carboplatin/paclitaxel/bevacizumab as first-line therapy for patients with metastatic nonsquamous NSCLC
• Phase III clinical trial results (CheckMate 227, CheckMate 9LA) leading to the recent FDA approvals of first-line nivolumab/ipilimumab with and without chemotherapy; patient selection and optimal integration into practice
• Design, eligibility criteria and emerging safety and efficacy data from the Phase III POSEIDON trial evaluating durvalumab or durvalumab and tremelimumab in combination with platinum-based chemotherapy versus chemotherapy alone as first-line therapy for patients with metastatic NSCLC
• Management of disease that has progressed on anti-PD-1/PD-L1-based therapy in the first-line setting; current role of approved agents and regimens (eg, ramucirumab, afatinib, bevacizumab)

Case of a patient with newly diagnosed unresectable malignant pleural mesothelioma (MPM)

• Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab administered as monotherapy and combined with chemotherapy as first-line treatment for metastatic NSCLC
• Key factors guiding the selection and sequencing of therapy for patients with MPM
• Design, eligibility criteria and key efficacy and safety endpoints of the Phase III CheckMate743 trial comparing nivolumab in combination with ipilimumab versus pemetrexed with cisplatin or carboplatin as first-line therapy for MPM
• Overall survival advantage associated with nivolumab/ipilimumab in CheckMate743; implications for current clinical practice

Multiple Myeloma | 9:30 AM – 10:30 AM

Case presentations and topics to be discussed

A younger, transplant-eligible patient with newly diagnosed multiple myeloma (MM)
An older, transplant-ineligible patient with newly diagnosed MM

• Clinical and biologic factors to be considered in the selection of an optimal induction/consolidation regimen for patients with transplant-eligible or -ineligible MM
• Available efficacy and safety findings from and clinical implications of the Phase III ENDURANCE (E1A11) trial of carfilzomib, lenalidomide and dexamethasone (KRd) versus RVd as initial therapy for newly diagnosed MM
• Published research findings from Phase III trials evaluating daratumumab-containing front-line regimens for newly diagnosed MM; current clinical role in patients who are eligible and ineligible for transplant
• Correlation between minimal residual disease (MRD) negativity and long-term outcomes for patients with newly diagnosed MM undergoing active treatment; role of MRD assessment to inform decision-making in routine practice
• Selection of an optimal maintenance approach for transplant-eligible and -ineligible patients
• Available efficacy and safety outcomes with and current indications, if any, for the use of ixazomib as maintenance therapy

A patient who receives up-front RVD followed by transplant and lenalidomide maintenance but then experiences disease relapse
An older patient who received Rd/daratumumab and experienced disease progression
A patient with relapsed/refractory (R/R) MM who has experienced disease progression on multiple lines of conventional therapy

• Clinical, biologic and practical factors influencing the selection, sequencing and combining of carfilzomib, pomalidomide, daratumumab, elotuzumab and ixazomib for patients with R/R MM
• Available clinical research findings with and optimal therapeutic partner for daratumumab in patients with R/R MM; recent FDA approval of daratumumab/carfilzomib/dexamethasone
• Mechanism of action of isatuximab; structural and pharmacologic similarities and differences between isatuximab and daratumumab and implications, if any, for activity and tolerability
• Published Phase III research experience with isatuximab in R/R MM (eg, ICARIA-MM, IKEMA); optimal use in clinical practice and ongoing research
• Mechanism of action of and published research experience leading to the FDA approval of selinexor for multiagent/regimen-refractory MM; optimal incorporation into routine practice
• Available results and potential clinical implications of the Phase III BOSTON trial evaluating selinexor in combination with bortezomib/dexamethasone for patients with R/R MM who have received 1 to 3 prior lines of therapy
• Structural composition and mechanism of action of the BCMA-directed antibody-drug conjugate belantamab mafodotin
• Efficacy and safety results from the Phase II DREAMM-2 study evaluating belantamab mafodotin in patients with R/R MM who have received 3 or more prior lines of therapy
• FDA approval of belantamab mafodotin and incorporation in routine practice; monitoring for and management of ocular and other toxicities

A patient with R/R MM who has experienced disease progression on multiple lines of conventional therapy and is interested in participating in a clinical research study

• Compositional and mechanistic similarities and differences among various BCMA-targeted chimeric antigen receptor (CAR) T-cell platforms under investigation in MM
• Design, eligibility criteria and available efficacy and safety results from the pivotal Phase II KarMMa trial evaluating idecabtagene vicleucel in patients with R/R MM; developmental timeline and potential clinical role
• Safety and efficacy findings from the Phase Ib/II CARTITUDE-1 study leading to the FDA breakthrough therapy designation for JNJ-4528 in R/R disease
• Early data with and ongoing clinical research efforts evaluating other CAR T-cell platforms (eg, orvacabtagene autoleucel, bb21217) in MM
• Optimal timing and selection of patients for enrollment in clinical trials assessing CAR T-cell therapy in MM
• Incidence and severity of class-effect toxicities observed with BCMA-targeted CAR T-cell therapy
• Biologic rationale, available data and favorable risk-benefit ratio associated with venetoclax-based therapy in patients with t(11;14) or Bcl-2 overexpression and current nonprotocol role in these populations
• Anticipated completion date of the Phase III CANOVA trial evaluating venetoclax/dexamethasone versus pomalidomide/dexamethasone in patients with R/R MM positive for t(11;14); other ongoing studies assessing venetoclax-based combination therapy
• Other promising novel agents and strategies under investigation

SHORT PROGRAM BREAK | 10:30 AM – 10:45 AM

Chronic Lymphocytic Leukemia and Lymphomas | 10:45 AM – 11:45 AM

Case presentations and topics to be discussed

A younger patient with newly diagnosed IGHV-mutated chronic lymphocytic leukemia (CLL)
An older patient with newly diagnosed IGHV-unmutated CLL

• Clinical and biologic factors influencing the selection of a first-line treatment regimen for patients with newly diagnosed CLL
• Phase III data sets comparing ibrutinib-based therapy to standard chemoimmunotherapy for younger (ECOG-E1912) and older (Alliance A041202, iLLUMINATE) patients with treatment-naïve CLL
• Design of, eligibility criteria for and key efficacy and safety findings from the Phase III ELEVATE-TN trial leading to the FDA approval of acalabrutinib for patients with previously untreated CLL
• Efficacy and safety findings from the Phase III CLL14 trial evaluating venetoclax/obinutuzumab versus chlorambucil/obinutuzumab for patients with treatment-naïve CLL and coexisting medical conditions; clinical implications of the FDA approval of this regimen
• Spectrum, frequency and severity of toxicities associated with BTK inhibitors and venetoclax-based treatment; optimal management strategies and implications for treatment selection

A patient with CLL who experiences disease progression on first-line therapy

• Long-term outcomes with venetoclax with or without rituximab for patients with relapsed/refractory (R/R) CLL
• Key efficacy and safety findings from the Phase III ASCEND trial comparing acalabrutinib to rituximab in combination with either idelalisib or bendamustine for patients with R/R CLL
• Current clinical roles of the PI3K inhibitors idelalisib and duvelisib in the CLL treatment paradigm
• Biologic rationale for the evaluation of CD19-directed chimeric antigen receptor (CAR) T-cell therapy for patients with R/R CLL; key findings from the Phase I/II TRANSCEND CLL 004 trial assessing lisocabtagene maraleucel in R/R CLL

A patient with newly diagnosed follicular lymphoma (FL)

• Integration of obinutuzumab into current algorithms for treatment-naïve and R/R FL; potential benefit in preventing early disease progression
• Clinical and research implications of the Phase III RELEVANCE trial evaluating the R-squared regimen of lenalidomide/rituximab in newly diagnosed FL
• Available results from the Phase III trials evaluating R-squared in patients with R/R FL; recent FDA approval of R-squared in this setting and patient selection for this approach
• Current clinical role of and patient selection for PI3 kinase inhibition in FL
• Mechanism of action, efficacy and tolerability of tazemetostat in patients with previously treated FL
• Recent FDA approval and current clinical role of tazemetostat in patients with and without EZH2 mutations
• Available data with the use of CD19-directed CAR T-cell therapy (eg, tisagenlecleucel, axicabtagene ciloleucel) in patients with R/R FL; clinical and research implications of the FDA regenerative medicine advanced therapy designation for tisagenlecleucel

A patient with relapsed diffuse large B-cell lymphoma (DLBCL)

• Available efficacy and safety data with polatuzumab vedotin in combination with BR for patients with R/R DLBCL; optimal incorporation into current management algorithms
• Long-term data with axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel in patients with R/R DLBCL
• Patient identification and appropriate referral for consideration of CAR T-cell therapy
• Biologic rationale for the investigation of selinexor in patients with R/R DLBCL
• Design, eligibility criteria and key efficacy and safety findings from the Phase IIb SADAL trial evaluating selinexor in patients with R/R DLBCL who have had at least 2 prior multidrug therapies and who are ineligible for stem cell transplantation or CAR T-cell therapy; FDA approval and optimal sequencing
• Mechanism of action of tafasitamab and biologic rationale for combining it with lenalidomide in patients with DLBCL
• Key efficacy and safety findings leading to the FDA approval of tafasitamab/lenalidomide for patients with R/R DLBCL; patient selection for treatment with this regimen

A patient with relapsed mantle cell lymphoma (MCL)

• Research database supporting the FDA approvals of ibrutinib, acalabrutinib and zanubrutinib in R/R MCL; patient selection for their routine use
• Activity and safety data with and ongoing Phase III investigations of BTK inhibitors in previously untreated MCL
• Available data with, current clinical role of and ongoing trials assessing venetoclax alone or combined with other agents in patients with MCL
• Designs of, eligibility criteria for and available safety and efficacy findings from studies evaluating CAR T-cell therapy for R/R MCL
• FDA approval of brexucabtagene autoleucel and optimal integration into current MCL treatment algorithms

A patient with newly diagnosed Hodgkin lymphoma (HL)

• Role of brentuximab vedotin (BV) in combination with AVD as first-line therapy for advanced classical HL
• Available data with and current role of BV in elderly patients with newly diagnosed HL
• Potential role of BV alone or in combination with immune checkpoint inhibition as a bridge to transplant in patients experiencing disease progression on up-front treatment
• Results from the Phase III KEYNOTE-204 trial evaluating pembrolizumab versus BV for patients with R/R HL; potential implications for clinical practice
• Available activity and safety data with and ongoing evaluation of anti-PD-1/PD-L1 antibodies alone or in combination with other systemic approaches (eg, BV, chemotherapy) for patients with HL

Gastrointestinal Cancers | 11:45 AM – 12:45 PM

Case presentations and topics to be discussed

A patient with newly diagnosed metastatic colorectal cancer (mCRC)

• Indications for molecular testing in patients with mCRC
• Available data linking tumor sidedness to response to specific therapeutic interventions in mCRC
• Published research findings from the Phase III BEACON CRC trial comparing encorafenib/cetuximab with or without binimetinib to irinotecan/cetuximab or FOLFIRI/cetuximab for patients with mCRC with a BRAF V600E mutation
• FDA approval of encorafenib/cetuximab for patients with BRAF-mutant mCRC; appropriate integration into practice
• Available results from the Phase II DESTINY-CRC01 study of trastuzumab deruxtecan for patients with HER2-expressing mCRC; potential nonprotocol role
• Rational incorporation of regorafenib and TAS-102 into current treatment algorithms for patients with multiply relapsed mCRC
• Available data with and potential role of TAS-102 in combination with other systemic agents in mCRC and/or in earlier disease stages

A patient with MSI-high (MSI-H) mCRC

• Key efficacy and safety results from the Phase III KEYNOTE-177 study of front-line pembrolizumab versus chemotherapy for MSI-high/mismatch repair-deficient (dMMR) mCRC
• Rational incorporation of pembrolizumab, nivolumab and nivolumab/ipilimumab into the treatment of MSI-H/dMMR mCRC
• Early responses observed with anti-PD-1/PD-L1 antibody-based therapies in individuals with microsatellite-stable (MSS) mCRC
• Ongoing investigation of immune checkpoint inhibitors in combination with other systemic approaches (eg, chemotherapy, targeted therapy) in MSI-H/dMMR and MSS mCRC

A patient with newly diagnosed metastatic gastric cancer (mGC)

• Design, eligibility criteria and key efficacy and safety data from Phase III studies (eg, KEYNOTE-062, KEYNOTE-181, ATTRACTION-3) evaluating anti-PD-1/PD-L1 antibodies in advanced gastroesophageal cancers
• Emerging findings from the Phase III CheckMate 649 study demonstrating an overall and progression-free survival advantage with first-line nivolumab in combination with chemotherapy in patients with metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma
• Emerging efficacy and safety data from KEYNOTE-590 demonstrating an overall and progression-free survival advantage with first-line pembrolizumab in combination with chemotherapy in patients with metastatic esophageal cancer
• Current role of checkpoint inhibition for patients with metastatic gastric, GEJ and esophageal cancers

A patient with HER2-positive mGC who experiences disease progression on first-line FOLFOX/trastuzumab

• Current management of relapsed/refractory HER2-positive GC
• Integration of ramucirumab into current clinical algorithms for patients with HER2-positive and -negative mGC/GEJ cancer
• Efficacy and safety findings from the randomized Phase II DESTINY-Gastric01 study of trastuzumab deruxtecan in patients with HER2-positive advanced gastric or GEJ adenocarcinoma
• FDA breakthrough therapy designation, ongoing evaluation and potential clinical role of trastuzumab deruxtecan in patients with progressive HER2-positive disease
• FDA approval of and patient selection for TAS-102 in mGC

A patient with newly diagnosed advanced hepatocellular carcinoma (HCC)

• Clinical and biologic factors affecting the selection of first-line treatment for advanced HCC (eg, age, symptomatology, liver function)
• Available data with and current clinical role of lenvatinib as first-line therapy for unresectable HCC
• Design, entry criteria and key efficacy and safety findings of the Phase III IMbrave150 trial comparing first-line atezolizumab/bevacizumab to sorafenib for unresectable HCC
• FDA approval and optimal integration of atezolizumab/bevacizumab as first-line therapy for unresectable HCC
• Available data with and ongoing evaluation of other novel combination strategies (eg, lenvatinib/pembrolizumab, cabozantinib/atezolizumab, durvalumab/tremelimumab) for advanced HCC

A patient with HCC who experiences disease progression on first-line atezolizumab/bevacizumab

• Key factors influencing the selection and sequence of approved regimens for patients whose disease has progressed on first-line therapy
• Long-term outcomes with approved anti-angiogenic agents (eg, regorafenib, cabozantinib, ramucirumab) for patients with progressive HCC
• Published efficacy and safety data with the use of single-agent immune checkpoint inhibitor therapy in patients with relapsed HCC
• Efficacy and safety findings from the CheckMate 040 trial leading to the FDA approval of nivolumab/ipilimumab in patients with progressive HCC; current clinical role

A patient with advanced cholangiocarcinoma and an activating FGFR2 rearrangement

• Efficacy and safety findings contributing to the FDA approval of the selective FGFR inhibitor pemigatinib for patients with pretreated cholangiocarcinoma with an FGFR2 translocation; ongoing Phase III evaluation in treatment-naïve disease
• Available evidence with other FGFR-targeted agents (eg, futibatinib, infigratinib, erdafitinib) in advanced or unresectable cholangiocarcinoma
• Outcomes from the Phase III ClarIDHy study evaluating the IDH1 inhibitor ivosidenib for patients with previously treated cholangiocarcinoma with an IDH1 mutation; potential implications for future research and current practice

A patient with localized pancreatic adenocarcinoma (PAD)

• Available clinical trial efforts evaluating the utility of contemporary cytotoxic regimens (mFOLFIRINOX, nab paclitaxel/gemcitabine) as preoperative therapy in patients with resectable or borderline resectable PAD
• Selection of adjuvant systemic therapy for individuals with resected PAD
• Key efficacy results from the Phase III APACT trial evaluating adjuvant nab paclitaxel/gemcitabine versus gemcitabine alone; clinical applicability of the results, if any

A patient with metastatic PAD

• Optimal selection of first- and later-line treatment for patients with metastatic PAD; impact of age, comorbidities and prior therapy
• Early front-line activity observed with the combination of nanoliposomal irinotecan (nal-IRI), 5-FU/leucovorin and oxaliplatin (NALIRIFOX) in patients with metastatic PAD
• Patient selection for and practical integration of nal-IRI for relapsed metastatic PAD
• Design, entry criteria and key efficacy and safety findings from the Phase III POLO trial evaluating olaparib as maintenance therapy for patients with metastatic PAD and a germline BRCA mutation after first-line chemotherapy
• FDA approval of maintenance olaparib and implications for genetic testing and current nonprotocol care of patients with metastatic BRCA-mutated PAD

PROGRAM BREAK | 12:45 PM – 1:15 PM

Genitourinary Cancers | 1:15 PM – 2:15 PM

Case presentations and topics to be discussed

A patient with nonmetastatic prostate cancer (PC) and a rising PSA on androgen deprivation therapy

• Design, eligibility criteria and key primary and secondary endpoints evaluated in the Phase III PROSPER, SPARTAN and ARAMIS trials assessing enzalutamide, apalutamide and darolutamide, respectively, for patients with nonmetastatic CRPC
• Key efficacy outcomes observed in PROSPER, SPARTAN and ARAMIS; metastasis-free survival and overall survival benefits associated with the addition of the antiandrogen
• FDA approvals of enzalutamide, apalutamide and darolutamide for patients with nonmetastatic CRPC; patient selection for and practical integration based on patient- and disease-specific factors
• Spectrum, frequency and severity of toxicities associated with the use of enzalutamide, apalutamide and/or darolutamide in the PROSPER, SPARTAN and ARAMIS trials; implications for therapeutic selection

A patient with newly diagnosed metastatic PC who has received no prior systemic therapy

• Key clinical and practical factors guiding the selection of docetaxel, abiraterone, enzalutamide or apalutamide in combination with ADT for patients with metastatic hormone-sensitive PC (HSPC)
• Available efficacy and safety findings with the use of chemotherapy and secondary hormonal agents in combination with ADT for men with mHSPC
• Design, entry criteria and primary and secondary endpoints of the Phase III ARCHES and TITAN trials assessing enzalutamide or apalutamide in combination with ADT compared to ADT alone for patients with mHSPC; key efficacy and safety outcomes
• Results from the Phase III ENZAMET study of enzalutamide in combination with ADT versus other nonsteroidal antiandrogens (eg, bicalutamide, nilutamide or flutamide) with ADT for patients with mHSPC
• FDA approval of enzalutamide and apalutamide for patients with mHSPC and optimal integration into current clinical practice

A patient with metastatic castration-resistant PC (mCRPC)

• Key considerations influencing the selection and sequencing of therapy for patients with mCRPC; impact of earlier use of chemotherapy and secondary hormonal therapy
• Major efficacy and safety findings from the CARD trial comparing cabazitaxel to an androgen receptor (AR)-targeted agent in patients with mCRPC progressing after docetaxel and an alternative AR-targeted agent; implications for therapeutic sequencing
• Clinical trial data with the use of PARP inhibitors (eg, olaparib, rucaparib, niraparib, talazoparib) for patients with progressive mCRPC
• Recent FDA approvals of rucaparib and olaparib for men with mCRPC; indications for genetic testing and the use of PARP inhibitors in clinical practice
• Frequency of PTEN loss in mCRPC; emerging data from the Phase III IPATential150 trial showing improved radiographic progression-free survival with ipatasertib in combination with abiraterone/prednisone in this population
• Preliminary findings from the mCRPC cohort of the Phase Ib COSMIC-021 trial evaluating cabozantinib in combination with atezolizumab; design and key endpoints of Phase III CONTACT-02 trial

A patient with newly diagnosed advanced renal cell carcinoma (RCC)

• Key considerations influencing the selection of nivolumab/ipilimumab, TKI/anti-PD-1/PD-L1 combinations and TKI monotherapy for patients with newly diagnosed RCC
• Major efficacy and safety findings with the utilization of nivolumab/ipilimumab for treatment-naïve advanced RCC
• Available data from the Phase III KEYNOTE-426 and JAVELIN Renal 101 trials assessing pembrolizumab/axitinib and avelumab/axitinib, respectively, in the front-line setting
• Emerging results from the Phase III CheckMate-9ER trial evaluating nivolumab in combination with cabozantinib in previously untreated advanced RCC; potential role in clinical practice
• Available research findings leading to the FDA breakthrough therapy designation for pembrolizumab/lenvatinib; potential clinical role

A patient with advanced RCC that has progressed on first-line checkpoint inhibitor-based therapy

• Clinical and biologic factors influencing the selection of therapy for patients relapsing on first-line treatment
• Published research database with cabozantinib for patients with relapsed/refractory (R/R) RCC; current role in patients progressing on checkpoint inhibitor-based therapies
• Role of rechallenge with alternative checkpoint inhibitor-based approaches in patients who have previously progressed on immunotherapy
• Published research data with and optimal clinical utilization of lenvatinib for progressive RCC
• Available clinical trial data with and ongoing evaluation of other novel agents/strategies in treatment-naïve and R/R metastatic RCC

A patient with newly diagnosed metastatic urothelial bladder carcinoma (mUBC)

• Defining platinum eligibility in patients with newly diagnosed mUBC; current role of single-agent anti-PD-1/PD-L1 antibodies as first-line therapy in patients not eligible for chemotherapy
• Key efficacy and safety results from the Phase III JAVELIN Bladder 100 trial evaluating first-line maintenance therapy with avelumab; recent FDA approval and current clinical role
• Design, eligibility criteria and available efficacy and safety findings from the Phase III IMvigor130 trial assessing atezolizumab in combination with chemotherapy in patients with untreated locally advanced or mUBC
• Published efficacy findings with and FDA breakthrough therapy designation for enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or mUBC
• Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating anti-PD-1/PD-L1 antibodies in combination with other systemic therapies

A patient with mUBC that has progressed on checkpoint inhibitor-based therapy

• Spectrum and frequency of FGFR alterations in patients with mUBC; indications for molecular assessment
• Efficacy and safety data supporting the FDA approval of erdafitinib for patients with locally advanced or mUBC with susceptible FGFR3 or FGFR2 genetic alterations who have experienced disease progression on or after chemotherapy
• Published efficacy and safety findings from the pivotal Phase II EV-201 trial evaluating enfortumab vedotin in patients with locally advanced or metastatic UBC
• FDA approval of enfortumab vedotin in progressive UBC based on EV-201 and optimal integration into current management algorithms
• Incidence and severity of adverse events with enfortumab vedotin and erdafitinib; optimal monitoring and management strategies
• Published research findings and ongoing evaluation of other promising agents and strategies in UBC (eg, sacituzumab govitecan, cabozantinib)

Gynecologic Cancers | 2:15 PM – 3:15 PM

Case presentations and topics to be discussed

A patient with newly diagnosed advanced ovarian cancer (OC) and a germline BRCA mutation
A patient with newly diagnosed homologous recombination deficiency (HRD)-positive advanced OC
A patient with newly diagnosed BRCA-negative, HRD-negative advanced OC

• Clinical and biologic factors impacting the selection and sequencing of therapies for patients with newly diagnosed advanced OC; indications for first-line maintenance therapy
• Outcomes from the Phase III SOLO-1 trial evaluating maintenance olaparib after first-line platinum-based chemotherapy for patients with advanced OC and a BRCA mutation
• FDA approval of maintenance olaparib in the front-line OC setting; current role and optimal duration of therapy
• Design of, entry criteria for and key efficacy and safety findings from the Phase III PRIMA study evaluating maintenance niraparib after first-line platinum-based chemotherapy for patients with advanced OC; benefit of niraparib maintenance therapy in various patient subgroups
• FDA approval of niraparib maintenance for patients with newly diagnosed OC; patient selection and optimal dosing
• Available efficacy and safety data from the Phase III PAOLA-1 trial comparing olaparib/bevacizumab to bevacizumab alone as maintenance therapy for patients with advanced OC who responded to first-line platinum-based chemotherapy and bevacizumab
• FDA approval and optimal integration of maintenance treatment with olaparib/bevacizumab
• Mechanistic similarities and differences between veliparib and other approved PARP inhibitors; rationale for the investigation of veliparib in combination with chemotherapy in OC
• Principal efficacy and safety findings from the Phase III VELIA trial evaluating veliparib with carboplatin and paclitaxel and as continuation maintenance therapy in newly diagnosed OC; potential future role
• Biologic rationale for ongoing clinical trials evaluating novel agents and strategies in the management of OC

A patient with newly diagnosed microsatellite instability high (MSI-H)/DNA mismatch repair deficient (dMMR) endometrial cancer (EC)
A patient with relapsed/refractory (R/R) microsatellite stable (MSS) EC

• Incidence of MSI-H or dMMR in patients with advanced EC; current indications for MSI/MMR testing
• Efficacy and safety outcomes with anti-PD-1/PD-L1 monotherapy in patients with MSI-H/dMMR advanced EC
• Mechanism of action of dostarlimab; design of the Phase I/II GARNET trial evaluating dostarlimab in patients with advanced EC
• Available safety and efficacy data from GARNET; response rates and duration of response with dostarlimab in patients with MSI-H/dMMR and MSS tumors
• Biologic rationale for combining immune checkpoint inhibitors with chemotherapy in EC; current Phase III trials (eg, RUBY, AtTEND, DUO-E) in patients with recurrent or primary advanced disease
• Key efficacy and safety findings from the Phase II KEYNOTE-146 study assessing lenvatinib in combination with pembrolizumab in patients with R/R EC
• FDA approval of lenvatinib/pembrolizumab for patients with advanced EC that is not MSI-high/dMMR and who have disease progression after prior systemic therapy but are not candidates for curative surgery or radiation
• Ongoing Phase III trials comparing lenvatinib/pembrolizumab to standard chemotherapy in newly diagnosed or recurrent advanced EC (KEYNOTE-775, LEAP-001)

A patient with R/R cervical cancer (CC)

• Current management of metastatic CC; optimal selection and sequencing of available therapies
• Available data with and indications for use of pembrolizumab in CC; current role and optimal integration into the care of patients with metastatic disease
• Ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies in combination with chemotherapy or chemoradiation therapy for the management of localized and metastatic CC
• Mechanism of action and early data with tisotumab vedotin in patients with R/R CC
• Design, eligibility criteria and topline results of the pivotal Phase II INNOVA TV 204 trial evaluating tisotumab vedotin monotherapy for recurrent and/or metastatic CC; potential future role in clinical practice
• Ongoing clinical development of tisotumab vedotin in combination with other anti-cancer agents in CC

PROGRAM BREAK | 3:15 PM – 3:30 PM

Breast Cancer | 3:30 PM – 4:30 PM

Case presentations and topics to be discussed

A patient with localized HER2-positive breast cancer (BC)

• Key clinical factors affecting the decision to administer neoadjuvant treatment for patients with HER2-positive localized BC
• Clinical implications of the FDA approval of adjuvant T-DM1 for patients with residual disease after neoadjuvant therapy
• Available efficacy and safety results from the Phase II ATEMPT study comparing adjuvant T-DM1 to paclitaxel/trastuzumab for Stage I HER2-positive BC; current role, if any, in clinical practice
• Long-term efficacy and safety findings with pertuzumab as a component of adjuvant treatment for HER2-positive localized BC
• Current role of neratinib as extended-adjuvant therapy; patient selection and clinical factors guiding its use in practice
• FDA approval of a fixed-dose subcutaneous formulation of pertuzumab, trastuzumab and hyaluronidase-zzxf; optimal integration into current clinical management

A patient with high-risk ER-positive, HER2-negative localized BC

• Biologic rationale for the evaluation of CDK4/6 inhibitors in localized ER-positive, HER2-negative BC
• Improvement in invasive disease-free survival observed with the addition of abemaciclib to standard adjuvant hormonal therapy for patients with ER-positive, HER2-negative BC at high risk for recurrence in the Phase III monarchE trial
• Spectrum, frequency and severity of toxicities reported with abemaciclib in monarchE; rates of treatment discontinuation before 2 years
• Clinical and research implications of monarchE and potential role of adjuvant abemaciclib
• Key efficacy and safety findings from the Phase III PALLAS trial evaluating palbociclib in combination with standard adjuvant endocrine therapy for patients with localized ER-positive BC
• Other ongoing clinical research studies evaluating CDK4/6 inhibitors as neoadjuvant or adjuvant therapy

A patient with localized triple-negative BC (TNBC)

• Available results from the Phase III KEYNOTE-522 trial documenting the benefit of neoadjuvant pembrolizumab with chemotherapy versus chemotherapy alone for TNBC
• Emerging findings from the Phase III IMpassion031 study evaluating atezolizumab in combination with chemotherapy as neoadjuvant treatment for patients with early TNBC
• Current nonprotocol role, if any, of neoadjuvant checkpoint inhibition for patients with TNBC
• Ongoing randomized Phase III clinical trials evaluating the use of anti-PD-1/PD-L1 antibodies in combination with chemotherapy for patients with localized TNBC (eg, IMpassion030, SWOG-S1418)

A patient with HER2-positive metastatic BC (mBC)

• Clinical factors (eg, prior HER2-directed therapy, symptomatology, disease-free interval, sites of metastases) affecting the selection of therapy for patients with HER2-positive mBC
• Available efficacy and safety data from the pivotal Phase II HER2CLIMB trial of tucatinib in combination with trastuzumab/capecitabine for patients with HER2-positive mBC
• Outcomes from the Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan for previously treated advanced HER2-positive BC
• Key findings from the Phase III NALA study of neratinib/capecitabine versus lapatinib/capecitabine for patients with HER2-positive mBC
• Recent FDA approvals of tucatinib/trastuzumab/capecitabine, trastuzumab deruxtecan and neratinib/capecitabine and optional integration into practice for patients with and without brain metastases
• Comparative adverse event profiles of the newer anti-HER2 therapies; strategies to monitor for, prevent and manage complications

A patient with ER-positive, HER2-negative mBC

• Long-term follow-up data with and factors affecting the selection of a CDK4/6 inhibitor and an endocrine partner for patients with ER-positive mBC
• Incidence, monitoring and management of commonly occurring class- and agent-specific toxicities associated with CDK4/6 inhibition
• Published research findings leading to the FDA approval of alpelisib/fulvestrant in patients with ER-positive mBC with a PIK3CA mutation; Phase II BYLieve study affirming the utility of this combination after disease progression on a CDK4/6 inhibitor
• Spectrum, frequency and severity of alpelisib-related toxicities; optimal prevention and management strategies (eg, prophylactic antihistamines)

A patient with metastatic TNBC

• Current indications for and optimal testing platforms to assess PD-L1 expression in patients with metastatic TNBC
• Optimal integration of first-line atezolizumab/nab paclitaxel for patients with PD-L1-positive metastatic TNBC
• Key efficacy and safety findings from the Phase III KEYNOTE-355 trial evaluating the addition of pembrolizumab to chemotherapy for patients with previously untreated metastatic TNBC; potential clinical role
• Incidence of BRCA1/2 alterations and other relevant genetic abnormalities predictive of sensitivity to PARP inhibition in patients with BC; optimal integration of olaparib and talazoparib
• Key findings from the Phase II TBCRC 048 study of olaparib monotherapy in patients with mBC with germline or somatic mutations in DDR pathway genes beyond germline BRCA1/2
• Mechanism of action, available data with and FDA approval of sacituzumab govitecan

PROGRAM ADJOURNS