Opening Remarks | 9:00 AM – 9:05 AM PT (12:00 PM – 12:05 PM ET)
Module 1
Breast Cancer | 9:05 AM – 10:05 AM PT (12:05 PM – 1:05 PM ET)
- Feasibility of chemotherapy de-escalation with dual HER2 blockade for patients with localized breast cancer
- Adjuvant T-DM1 for patients with residual disease after neoadjuvant therapy
- Neratinib as extended-adjuvant therapy; improvement in rates of CNS recurrence after long-term follow-up in the Phase III ExteNET study
- Optimizing the use of postadjuvant neratinib; available data with and rationale for a dose-escalation strategy
- Ongoing clinical trials investigating novel HER2-targeted therapy for HER2-positive localized breast cancer (eg, DESTINY-Breast05, CompassHER2 RD, MARGOT)
- Published data from the pivotal HER2CLIMB, DESTINY-Breast01 and NALA studies of tucatinib/trastuzumab/capecitabine, trastuzumab deruxtecan (T-DXd) and neratinib/capecitabine, respectively, for HER2-positive metastatic breast cancer (mBC)
- Integration of tucatinib/trastuzumab/capecitabine, T-DXd and neratinib/capecitabine into therapy for patients with and without brain metastases
- Updated results from the Phase III DESTINY-Breast03 trial evaluating T-DXd versus T-DM1 for previously treated HER2-positive mBC
- Findings from the Phase III DESTINY-Breast04 trial evaluating T-DXd versus treatment of physician’s choice for patients with previously treated HER2-low unresectable and/or metastatic breast cancer
- Ongoing clinical studies evaluating novel HER2-targeted combination strategies for HER2-positive mBC (eg, HER2CLIMB-02, DESTINY-Breast07)
- Major findings from the Phase III RxPONDER trial evaluating the role of chemotherapy for patients with ER-positive, HER2-negative localized breast cancer with 1 to 3 positive lymph nodes and a 21-gene Recurrence Score® of ≤25
- Key outcomes observed with abemaciclib added to standard adjuvant hormonal therapy for patients with ER-positive, HER2-negative breast cancer in the Phase III monarchE trial; FDA approval and current role of adjuvant abemaciclib
- Other ongoing studies evaluating CDK4/6 inhibitors as neoadjuvant or adjuvant therapy
- Long-term follow-up data with CDK4/6 inhibitors for patients with ER-positive mBC
- Major research findings with alpelisib/fulvestrant for patients with ER-positive mBC and a PIK3CA mutation
- Optimal prevention and management strategies for alpelisib-related toxicities
- Findings from the FAKTION trial evaluating fulvestrant with capivasertib versus fulvestrant with placebo after relapse or progression on an aromatase inhibitor for ER-positive mBC
- Key outcomes of the Phase III OlympiA trial assessing adjuvant olaparib for patients with germline BRCA1/2 mutations and high-risk, HER2-negative breast cancer; current and potential role of adjuvant olaparib
- Available data from the Phase III KEYNOTE-522 study of neoadjuvant pembrolizumab combined with chemotherapy and continued as a single agent after surgery for high-risk localized triple-negative breast cancer (TNBC)
- Phase III data sets evaluating anti-PD-1/PD-L1 antibodies with chemotherapy for patients with previously untreated PD-L1-positive metastatic TNBC (mTNBC)
- Key research findings guiding the optimal use of PARP inhibitors for patients with mBC
- Primary results from the Phase III TROPiCS-02 study evaluating sacituzumab govitecan versus treatment of physician’s choice for patients with ER-positive advanced breast cancer
- Other novel agents under investigation for mTNBC (eg, T-DXd, ladiratuzumab vedotin, datopotamab deruxtecan)
Module 2
Genitourinary Cancers | 10:05 AM – 11:05 AM PT (1:05 PM – 2:05 PM ET)
- Major efficacy and safety findings with and current clinical role of the oral GnRH antagonist relugolix for men with advanced prostate cancer
- Key findings from the STAMPEDE platform assessing the addition of abiraterone and prednisolone with or without enzalutamide to androgen deprivation therapy (ADT) for men with high-risk nonmetastatic prostate cancer
- Long-term efficacy outcomes with enzalutamide, apalutamide or darolutamide for nonmetastatic castration-resistant prostate cancer; implications of differential toxicity profiles for therapeutic selection
- PEACE-1 trial: Docetaxel with or without abiraterone with or without local radiation therapy for men with de novo metastatic hormone-sensitive prostate cancer (mHSPC); implications for clinical practice
- Long-term follow-up from Phase III studies supporting the use of enzalutamide and apalutamide for mHSPC
- Results from the Phase III ARASENS trial demonstrating improved overall survival with darolutamide in combination with docetaxel and ADT for mHSPC; potential clinical significance
- Efficacy and safety of approved PARP inhibitors (olaparib and rucaparib) in men with metastatic castration-resistant prostate cancer (mCRPC); optimal integration of these agents into management algorithms
- Efficacy and safety findings from the Phase III PROpel trial comparing olaparib in combination with abiraterone to abiraterone alone as first-line therapy for patients with mCRPC with and without homologous recombination repair (HRR) gene mutations
- First results of the Phase III MAGNITUDE study of niraparib with abiraterone/prednisone as first-line therapy for patients with mCRPC with and without HRR gene mutations
- Other ongoing Phase III clinical research evaluating the role of PARP inhibitors with secondary hormonal agents for patients with mCRPC (eg, TALAPRO-2, CASPAR) and mHSPC (eg, TALAPRO-3, AMPLITUDE)
- Available results from studies investigating the optimal sequencing of cabazitaxel in therapy for mCRPC
- Impact of the addition of bone-protecting agents during treatment with radium-223 chloride and enzalutamide in the Phase III EORTC-1333-GUCG/PEACE III trial
- Findings from the Phase III VISION study evaluating 177Lu-PSMA-617 for progressive PSMA-positive mCRPC; recent FDA approval and appropriate integration into clinical practice
- Three-year follow-up results from the TheraP trial evaluating 177Lu-PSMA-617 versus cabazitaxel for mCRPC progressing after docetaxel
- Findings from the Phase III KEYNOTE-564 study of adjuvant pembrolizumab for high-risk clear-cell renal cell carcinoma (RCC); recent FDA approval and patient selection
- Use of nivolumab/ipilimumab, pembrolizumab/axitinib and avelumab/axitinib for treatment-naïve metastatic RCC (mRCC)
- FDA approval for lenvatinib/pembrolizumab as first-line therapy for mRCC
- Results of the Phase III CheckMate 9ER trial of nivolumab/cabozantinib for previously untreated mRCC; FDA approval and optimal integration into current first-line treatment algorithms
- Rational sequencing of available therapies for RCC that progresses on front-line treatment; patient-specific factors in decision-making in this setting
- FDA approval and optimal clinical role of tivozanib for patients with mRCC
- FDA approval, ongoing evaluation and efficacy of belzutifan in patients with von Hippel-Lindau disease-associated RCC
- Selection of appropriate patients with high-risk non-muscle-invasive urothelial bladder cancer (UBC) for pembrolizumab therapy
- Results of the Phase III CheckMate 274 trial comparing nivolumab to placebo after surgery for patients with high-risk muscle-invasive UBC; recent FDA approval and optimal integration into practice
- Efficacy, tolerability and ongoing investigation of TAR-200 (intravesical gemcitabine drug delivery system) for muscle-invasive UBC
- Findings from the Phase II TRUCE-02 trial of tislelizumab combined with nab paclitaxel for high-risk non-muscle-invasive UBC
- Current clinical role of atezolizumab and pembrolizumab as first-line treatment for metastatic UBC (mUBC); importance of chemotherapy eligibility and PD-L1 status in patient selection for this strategy
- Appropriate incorporation of first-line maintenance avelumab into clinical care
- Activity of enfortumab vedotin in patients with progressive mUBC; FDA-approved indication and optimal integration into the treatment paradigm
- Efficacy and potential clinical role of enfortumab vedotin/pembrolizumab for patients with previously untreated mUBC
- Clinical role of erdafitinib for patients with mUBC and FGFR3 or FGFR2 genetic alterations
- Findings from the Phase II TROPHY U-01 trial leading to the FDA approval of sacituzumab govitecan for patients with progressive mUBC; optimal integration into clinical management
- FDA breakthrough therapy designation for disitamab vedotin for progressive HER2-overexpressing mUBC
Break | 11:05 AM – 11:20 AM PT (2:05 PM – 2:20 PM ET)
Module 3
Multiple Myeloma (MM) | 11:20 AM – 12:20 PM PT (2:20 PM – 3:20 PM ET)
- Current utility of carfilzomib as a component of up-front therapy
- Published research findings with daratumumab-containing front-line regimens for newly diagnosed MM; role for patients who are eligible and ineligible for transplant
- Recently presented findings from the Phase III DETERMINATION trial of RVD (lenalidomide/bortezomib/dexamethasone), with or without autologous stem cell transplant, and maintenance lenalidomide to disease progression for patients with newly diagnosed MM; implications for clinical practice
- Current role of minimal residual disease (MRD) assessment in MM decision-making; optimal platforms
- Approach to maintenance therapy for transplant-eligible and ineligible patients, including those who have received daratumumab-based induction therapy
- Available data with and current indications, if any, for ixazomib in the induction and maintenance settings
- FDA approval of idecabtagene vicleucel and updated results from the pivotal Phase II KarMMa trial evaluating this agent for patients with relapsed/refractory (R/R) MM
- Available data from the CARTITUDE-1 and CARTITUDE-2 studies of ciltacabtagene autoleucel for pretreated MM; recent FDA approval and clinical role
- Early data with and ongoing research evaluating other chimeric antigen receptor (CAR) T-cell platforms and strategies for MM
- Incidence, severity and management of class-effect toxicities observed with B-cell maturation antigen (BCMA)-targeted CAR T-cell therapies
- Published Phase III research with isatuximab for R/R MM (eg, ICARIA-MM, IKEMA trials)
- Results from the Phase III BOSTON trial evaluating selinexor in combination with bortezomib/dexamethasone for R/R MM; FDA approval and patient selection
- Ongoing studies of selinexor in combination with other agents and in earlier lines of therapy
- Efficacy and safety results from the Phase II DREAMM-2 study leading to the FDA approval of belantamab mafodotin monotherapy for patients with R/R MM; incorporation into routine practice
- Monitoring for and management of ocular and other toxicities with belantamab mafodotin
- Available data with and ongoing evaluation of belantamab mafodotin in combination with other systemic therapies
- Mechanism of action of and available safety and efficacy data with BCMA-directed (eg, teclistamab, elranatamab) and non-BCMA-directed (eg, talquetamab, cevostamab) bispecific antibodies for R/R MM
- Biologic rationale for targeting Bcl-2 in MM; published data with and ongoing investigation of venetoclax-based therapy for patients with t(11;14) MM or Bcl-2 overexpression
- Activity and safety observed with the cereblon E3 ligase modulators iberdomide and CC-92480 in patients with heavily pretreated MM
- Other promising novel agents and strategies under investigation for MM
Lunch Break | 12:20 PM – 12:55 PM PT (3:20 PM – 3:55 PM ET)
Module 4
Chronic Lymphocytic Leukemia (CLL) and Lymphomas | 12:55 PM – 1:55 PM PT (3:55 PM – 4:55 PM ET)
- Pivotal data sets with Bruton tyrosine kinase (BTK) inhibitor-based therapy for treatment-naïve CLL
- Implications for therapeutic decision-making of results from the Phase III ELEVATE-RR study evaluating acalabrutinib versus ibrutinib for previously treated high-risk CLL
- Results from the Phase III ALPINE and SEQUOIA trials evaluating zanubrutinib for CLL
- Key data sets informing the optimal use of venetoclax for newly diagnosed CLL
- Current role and optimal platforms for MRD assessment for patients with CLL
- Results from the Phase III GLOW trial evaluating first-line ibrutinib/venetoclax versus chlorambucil/obinutuzumab
- Key factors guiding the selection of therapy for patients with disease progression on first-line treatment
- Current and future role of PI3 kinase (PI3K) inhibition in the CLL treatment paradigm
- Efficacy and safety of pirtobrutinib in the Phase I/II BRUIN study; ongoing investigation and potential clinical role of CD19-directed CAR T-cell therapy for patients with R/R CLL
- Integration of obinutuzumab into current therapeutic algorithms for treatment-naïve and R/R follicular lymphoma (FL)
- Lenalidomide/rituximab in the management of newly diagnosed and R/R FL
- Key findings from the Phase III CHRONOS-3 trial of copanlisib in combination with rituximab for patients with R/R FL
- Available data from the Phase IIb UNITY-NHL trial evaluating umbralisib for patients with R/R FL; FDA approval of umbralisib
- Results from the Phase II CITADEL-203 study evaluating the next-generation PI3K inhibitor parsaclisib for R/R FL
- Optimal integration of tazemetostat into the management of previously treated FL with and without EZH2 mutations
- Available data with and FDA approvals of axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel) for R/R FL
- Early-phase data with and potential clinical role of investigational bispecific antibodies (eg, mosunetuzumab, glofitamab, epcoritamab) for R/R FL
- Key results from the Phase III POLARIX study comparing polatuzumab vedotin in combination with chemotherapy to R-CHOP for previously untreated diffuse large B-cell lymphoma (DLBCL); implications for clinical practice
- Published research findings with polatuzumab vedotin in combination with bendamustine/rituximab (BR) for R/R DLBCL
- Available data with and FDA approval of loncastuximab tesirine
- Key data leading to the FDA approval of tafasitamab/lenalidomide for R/R DLBCL
- Long-term data with axi-cel, tis-cel and lisocabtagene maraleucel (liso-cel) for R/R DLBCL
- Phase III data with CAR T-cell therapy as second-line treatment for DLBCL
- Research database supporting the FDA approvals of ibrutinib, acalabrutinib and zanubrutinib for R/R mantle cell lymphoma (MCL); key factors in the choice of BTK inhibitor and practical use of these agents
- Primary results from the Phase III SHINE study of ibrutinib/BR and maintenance rituximab as first-line treatment for older patients with MCL
- Activity and safety data with and ongoing Phase III investigations of novel agents (eg, lenalidomide, BTK inhibitors) for previously untreated MCL
- Venetoclax alone or combined with other agents (eg, BTK inhibitors) for MCL
- Key efficacy and safety data with approved (brexucabtagene autoleucel) and investigational (liso-cel) CAR T-cell platforms in therapy for MCL
- Efficacy and safety observed with pirtobrutinib in patients with MCL in the Phase I/II BRUIN trial
- Long-term progression-free survival follow-up and prespecified overall survival analysis from the Phase III ECHELON-1 trial of first-line brentuximab vedotin (BV) and AVD (doxorubicin/vinblastine/dacarbazine) for advanced classical Hodgkin lymphoma
- Early findings with BV combined with chemotherapy for early-stage unfavorable-risk Hodgkin lymphoma
- Current role of BV for older patients with newly diagnosed Hodgkin lymphoma
- Potential role of BV alone or in combination with immune checkpoint inhibition as a bridge to transplant
- Key outcomes from the Phase III KEYNOTE-204 trial evaluating pembrolizumab versus BV for patients with R/R Hodgkin lymphoma; implications for clinical practice
Module 5
Gastrointestinal Cancers | 1:55 PM – 2:55 PM PT (4:55 PM – 5:55 PM ET)
- Appropriate use of encorafenib/cetuximab for patients with metastatic colorectal cancer (mCRC) with BRAF V600E mutations; available results and ongoing investigation with earlier use of BRAF-targeted therapy
- Immune checkpoint inhibitors for microsatellite instability-high/mismatch repair-deficient mCRC
- Incorporation of regorafenib and TAS-102 in the treatment of multiregimen-refractory mCRC
- Available data with and potential role of TAS-102 in combination with other systemic agents or in earlier disease stages; NCCN guideline inclusion of TAS-102/bevacizumab
- Updated results from the DESTINY-CRC01 study of T-DXd for HER2-expressing mCRC
- Early results with and ongoing evaluation of the KRAS G12C inhibitor sotorasib for mCRC with a KRAS G12C mutation
- Phase III data (eg, from the CheckMate 649, CheckMate 648 and KEYNOTE-590 trials) demonstrating the efficacy and safety of first-line checkpoint inhibitor-containing regimens for advanced gastric, gastroesophageal junction (GEJ) and esophageal cancer
- Available Phase III research findings (eg, from the ORIENT-16, ORIENT-15 and JUPITER-06 trials) with investigational anti-PD-1 antibodies in combination with chemotherapy as first-line treatment for advanced gastroesophageal tumors; potential clinical role
- Available data from the Phase III CheckMate 577 study of adjuvant nivolumab for resected esophageal or GEJ cancer
- Optimal placement of ramucirumab in current clinical algorithms for metastatic gastric/GEJ cancer; ongoing investigation of ramucirumab-containing combination regimens
- Use of TAS-102 in the management of heavily pretreated metastatic gastric/GEJ cancer
- Principal outcomes in the Phase III KEYNOTE-811 trial evaluating first-line pembrolizumab/ trastuzumab/chemotherapy for metastatic HER2-positive gastric/GEJ adenocarcinoma
- DESTINY-Gastric01 and DESTINY-Gastric02 trials of T-DXd for progressive HER2-positive gastric/GEJ cancer
- Key findings from the Phase II FIGHT trial of first-line bemarituzumab/chemotherapy for FGFR2b-positive metastatic gastric/GEJ cancer
- Key data with first-line atezolizumab/bevacizumab for unresectable hepatocellular carcinoma (HCC)
- Recently presented findings from the Phase III HIMALAYA trial evaluating first-line durvalumab/tremelimumab for unresectable HCC
- Results from the Phase III COSMIC-312 study evaluating first-line cabozantinib/atezolizumab versus sorafenib for metastatic HCC
- Roles of sorafenib and lenvatinib in first-line therapy for advanced HCC
- Long-term outcomes with anti-angiogenic agents (eg, regorafenib, cabozantinib, ramucirumab) for progressive HCC
- Results from the TOPAZ-1 trial of first-line durvalumab with chemotherapy for advanced biliary tract cancers
- Outcomes from the Phase II HERB study of T-DXd for patients with HER2-expressing unresectable or recurrent biliary tract cancer
- FDA approvals of pemigatinib and infigratinib for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement
- Results with futibatinib for intrahepatic cholangiocarcinoma with an FGFR2 fusion/rearrangement from the FOENIX-CCA2 trial
- FDA approval of ivosidenib for patients with previously treated cholangiocarcinoma with an IDH1 mutation; implications for current practice
- Selection of neoadjuvant and adjuvant systemic therapy for patients with localized pancreatic adenocarcinoma (PAD)
- Optimal selection of first- and later-line treatment for patients with metastatic PAD
- Patient selection for and practical integration of nal-IRI for relapsed metastatic PAD; early front-line activity observed with NALIRIFOX, the combination of nal-IRI, 5-FU/leucovorin and oxaliplatin
- Key efficacy and safety findings with and optimal integration of olaparib as maintenance therapy after first-line chemotherapy for patients with metastatic PAD with a germline BRCA mutation
Break | 2:55 PM – 3:10 PM PT (5:55 PM – 6:10 PM ET)
Module 6
Lung Cancer | 3:10 PM – 4:10 PM PT (6:10 PM – 7:10 PM ET)
- FDA approval of adjuvant osimertinib; patient selection and optimal incorporation into clinical care
- Optimal first-line treatment for metastatic non-small cell lung cancer (NSCLC) with EGFR tumor mutations
- Available data with and ongoing evaluation of the novel HER3-directed antibody-drug conjugate patritumab deruxtecan for metastatic EGFR tyrosine kinase inhibitor-resistant NSCLC
- Key data informing the FDA approvals of mobocertinib and amivantamab for patients with EGFR exon 20 insertion mutations who have experienced disease progression on first-line chemotherapy
- Activity and tolerability of lazertinib and amivantamab in the CHRYSALIS-2 trial for patients with NSCLC with EGFR mutations after disease progression on osimertinib and platinum-based chemotherapy
- Available data informing the use of alectinib, brigatinib or lorlatinib as first-line therapy for patients with NSCLC and ALK rearrangements
- Principal efficacy and safety results with entrectinib for NSCLC with a ROS1 rearrangement; appropriate integration into clinical practice
- Published data with and ongoing trials of other “next-generation” ROS1 inhibitors (eg, repotrectinib, larotrectinib, lorlatinib, ceritinib)
- Available data with selpercatinib and with pralsetinib for patients with advanced NSCLC and RET alterations; optimal integration into clinical practice
- Current clinical roles of capmatinib and tepotinib for NSCLC with a MET exon 14 mutation
- Principal efficacy and safety findings with sotorasib for pretreated NSCLC with a KRAS G12C mutation
- Key outcomes from the Phase II DESTINY-Lung01 study evaluating T-DXd in NSCLC with a HER2 mutation; FDA priority review designation and potential nonresearch role
- Results from the Phase III CheckMate 816 trial evaluating neoadjuvant nivolumab in combination with chemotherapy for resectable NSCLC
- FDA approval and current clinical role of adjuvant atezolizumab; principal findings from the Phase III IMpower010 trial evaluating atezolizumab after adjuvant chemotherapy for patients with completely resected NSCLC
- Long-term data from the Phase III PACIFIC trial of consolidation durvalumab after chemoradiation therapy for unresectable Stage III NSCLC
- Other ongoing and planned clinical trials of immune checkpoint inhibitors for patients with nonmetastatic NSCLC
- Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab as monotherapy and combined with chemotherapy as first-line treatment
- Available efficacy and safety data with cemiplimab as monotherapy and in combination with platinum-based chemotherapy as first-line treatment for NSCLC
- Phase III clinical trial results with first-line nivolumab/ipilimumab with and without chemotherapy (CheckMate 227, CheckMate 9LA); patient selection and optimal integration into practice
- POSEIDON: A Phase III trial evaluating durvalumab or durvalumab/tremelimumab in combination with platinum-based chemotherapy versus chemotherapy alone as first-line therapy
- Efficacy and safety observed with the anti-PD-1 monoclonal antibody tislelizumab in patients with advanced NSCLC; ongoing evaluation
- Ongoing investigation of the TROP2-directed antibody-drug conjugate datopotamab deruxtecan for patients with progressive metastatic NSCLC
- Key efficacy and safety findings with chemotherapy in combination with atezolizumab or durvalumab for previously untreated extensive-stage small cell lung cancer (SCLC)
- Available data with and current clinical role of lurbinectedin for patients with SCLC who experience disease progression after platinum-based therapy
- FDA approval of trilaciclib; optimal incorporation into routine practice as a means to preserve bone marrow function during chemotherapy in patients with extensive-stage SCLC
Closing Remarks | 4:10 PM – 4:30 PM PT (7:10 PM – 7:30 PM ET)
MEETING ADJOURNS | 4:30 PM PT (7:30 PM ET)
