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Session Highlights from the 2021 Annual Meeting |
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| Real-World Utilization of Advanced Therapies by Metastatic Site and Age Among Patients With mCSPC: A Medicare Database Analysis
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| Daniel George, MD
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| Daniel George presented data assessing real-world utilization of advanced therapies by metastatic site and age among patients with metastatic castration-sensitive prostate cancer (mCSPC). In this large, nationally representative sample, mCSPC treatment intensification occurred more frequently among patients with bone and/or visceral metastases than those with node-only metastasis.
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| Real-World Treatment Patterns in Metastatic Hormone-Sensitive Prostate Cancer Patients in the United States
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| Peter Goebell, MD, Ph.D.
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| Peter Goebell discussed real-world treatment patterns among patients with metastatic hormone-sensitive prostate cancer (mHSPC). The objective of this study was to describe mHSPC patients’ current treatment patterns, contextualized by their demographic and clinical characteristics and treating physician characteristics.
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| Treatment Patterns and Overall Survival in Metastatic Castration-Sensitive Prostate Cancer from 2006 to 2019
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| Stephen Freedland, MD
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| Stephen Freedland presented real-world data assessing treatment patterns and survival among patients with mCSPC. OS improvement in men with mCSPC coincided with the introduction of novel hormonal therapies in mCRPC and docetaxel and novel hormonal therapies in mCSPC. However, only 20% of patients with mCSPC received treatment intensification with docetaxel or novel hormonal therapies in the most recent time period (2015-2019), suggesting there is room for significant survival improvement in this population.
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| Androgen Changes After Enzalutamide or Abiraterone plus Prednisone in Men with Castration-Resistant Prostate Cancer (HEAT): Results from a Randomised Clinical Trial
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| Klara Kvorning Ternov, MD
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| Klara Kvorning Ternov presented an analysis of treatment-related changes in serum androgens for patients treated with abiraterone or enzalutamide in the context of a randomized controlled trial. There is a rationale for a potential difference. These data support the different mechanisms of action of these two efficacious treatment approaches in advanced prostate cancer, given different androgen profiles.
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| The Role of Radiotherapy
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| Chris Parker, MD
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| In this presentation, Chris Parker discussed the role of radiotherapy for the management of patients with node-positive locally advanced prostate cancer. He began by emphasizing that there are no randomized controlled trials testing the role of radiotherapy in this disease setting. He goes on to give a summary of observational studies in patients with node-positive disease.
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| Pembrolizumab Monotherapy for Docetaxel-Pretreated mCRPC: Updated Analyses with 4 Years of Follow-up from Cohorts 1-3 of the KEYNOTE-199 Study |
| Emmanuel Antonarakis, MD |
| Emmanuel Antonarakis presented updated results of KEYNOTE-199 with four years of follow-up assessing pembrolizumab monotherapy for docetaxel-pretreated mCRPC. With 4 years of follow-up data, pembrolizumab monotherapy continued to show modest antitumor activity in patients with RECIST-measurable and bone-predominant mCRPC that was previously treated with novel hormonal agents and docetaxel. |
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| Pembrolizumab Plus Olaparib in Patients with Docetaxel-Pretreated mCRPC: Update of KEYNOTE-365 Cohort A with a Minimum of 11 Months of Follow-Up for all Patients
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| Evan Yu, MD
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| Evan Yu presented an updated follow-up of the KEYNOTE-365 Cohort A trial. Data from the phase I/II KEYNOTE-365 study previously showed antitumor activity and acceptable safety of pembrolizumab + olaparib in patients with molecularly unselected, docetaxel-pretreated mCRPC enrolled in cohort A. At the ESMO 2021 congress, Dr. Yu presented updated results for all patients after a minimum of 11.4 months of follow-up.
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| Apalutamide for Advanced Prostate Cancer in Older Patients: Combined Analysis of TITAN & SPARTAN
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| John Shen, MD
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| John Shen presented a discussion on apalutamide for advanced prostate cancer in older patients. In TITAN and SPARTAN, apalutamide added to continuous ADT improved PSA response, rPFS, MFS, and OS in patients with metastatic castration-sensitive prostate cancer and nonmetastatic castration-resistant prostate cancer. The objective of this analysis presented at the ESMO 2021 meeting was to assess the efficacy and safety of apalutamide in the TITAN and SPARTAN studies by patient age.
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| Estimation of Overall Survival With Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study |
| Nobuaki Matsubara, MD |
| In this presentation, Nobuaki Matsubara estimates overall survival with subsequent treatment effect by applying inverse probability of censoring weighting in the LATITUDE study. This is the first analysis to estimate the real treatment effect adjusting for patients without life-extending subsequent therapies. This post hoc analysis confirmed the importance of earlier intensive treatment for patients with high-risk mCSPC regardless of receiving life-extending subsequent therapy. |
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| Phase 2 Neoadjuvant Trial of the anti–B7-H3 Antibody, Enoblituzumab, in Men with Localized Prostate Cancer: Safety, Efficacy, and Immune Correlates |
| Eugene Shenderov, MD, Ph.D. |
| Eugene Shenderov presented results of a phase 2 trial of the anti–B7-H3 antibody, enoblituzumab, in men with localized prostate cancer. B7-H3, a member of the B7 superfamily, is highly expressed in prostate cancer. Further, its expression is prognostic as it is associated with rapid biochemical recurrence and early metastases. Enoblituzumab is an investigational humanized Fc-optimized B7-H3–targeting antibody that induces antibody-dependent cellular cytotoxicity. |
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| Time Course Profile of Adverse Events of Interest and Serious Adverse Events with Darolutamide in the ARAMIS Trial
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| Christian J. Gratzke, MD
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| Christian Gratzke presented results of the analysis of time to adverse events of interest associated with some androgen receptor inhibitors (fatigue, falls, fracture, hypertension, mental impairment, and rash) and the cumulative incidence of these adverse events, grade 3/4 adverse events, and serious adverse events from the ARAMIS trial.
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| SAABR: Single Arm Phase II Study of Abiraterone + Atezolizumab + GnRH Analog and SBRT to the Prostate in Men with Newly Diagnosed mHSPC
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| Dana Rathkopf, MD
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| Dana Rathkopf presented the trial concept and design of SAABR, a single arm phase 2 study of abiraterone + atezolizumab + GnRH analog with stereo body radiotherapy (SBRT) in men with metastatic hormone sensitive prostate cancer (mHSPC). Several phase 3 trials have demonstrated that adding the androgen synthesis inhibitor abiraterone acetate to androgen deprivation therapy (ADT) offers a survival benefit for men with mHSPC.
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| TALAPRO-3: A Phase 3, Double-blind, Randomized Study of Enzalutamide Plus Talazoparib versus Placebo Plus Enzalutamide in Patients with DDR Gene Mutated Metastatic Castration-Sensitive Prostate Cancer
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| Neeraj Agarwal, MD
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| Neeraj Agarwal discussed the TALAPRO-3 trial concept and design, a phase 3 trial assessing enzalutamide plus talazoparib versus placebo plus enzalutamide in men with DDR gene mutated metastatic castration-sensitive prostate cancer. The primary endpoint is radiographic progression-free survival. Secondary endpoints include overall survival, safety, and patient-reported outcomes.
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| Phase 3 CLEAR Trial in Advanced Renal Cell Carcinoma: Outcomes in Subgroups and Toxicity Update |
| Toni Choueiri, MD |
| Toni Choueiri presented the outcomes of a subgroup analyses and a toxicity update among patients in the phase 3 CLEAR trial for advanced renal cell carcinoma (RCC). The analysis reported explored efficacy outcomes in patients with or without adverse pathologic features (ie. sarcomatoid histology, bone metastases, liver metastases, and no prior nephrectomy) in the lenvatinib + pembrolizumab versus sunitinib arms. Additionally, the number of patients who received high-dose corticosteroids to manage immune-related adverse events is reported as well. |
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| Conditional Survival and 5-Year Follow-Up in CheckMate 214: First-Line Nivolumab + Ipilimumab Versus Sunitinib in Advanced RCC |
| Robert J. Motzer, MD |
| Robert Motzer presented updated data from the CheckMate 214 trial with 5-years of follow-up. These results highlight the durable clinical benefits observed with nivolumab + ipilimumab versus sunitinib in patients with advanced RCC after 5 years of follow-up and show that most patients alive or in response at the 3-year landmark will remain alive or in response at 5 years with nivolumab + ipilimumab. |
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| Role of Prior Nephrectomy for Synchronous Metastatic RCC on Efficacy in Patients Treated with Avelumab + Axitinib or Sunitinib: Results from JAVELIN Renal 101 |
| Marc-Oliver Grimm, MD |
| Marc-Oliver Grimm discussed the role of prior nephrectomy on outcomes of avelumab + axitinib versus sunitinib in the JAVELIN Renal 101 trial for metastatic renal cell carcinoma (RCC). Cytoreductive nephrectomy has been a standard of care in metastatic RCC for 20 years, although its role in patients receiving currently available therapies remains controversial. |
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| Pembrolizumab Monotherapy as First-Line Therapy in Advanced Clear Cell RCC: Results After a Minimum of 41 Months of Follow-up From KEYNOTE-427 Cohort A |
| David F. McDermott, MD |
| David McDermott presented the long-term outcomes in the KEYNOTE-427 Cohort A trial of pembrolizumab monotherapy for first-line treatment of advanced renal cell carcinoma (RCC). Specificaly, these were updated efficacy and safety results after a minimum of 41 months of follow-up for patients with clear cell RCC. |
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| A Discussion on Modified Delivery of RCC Therapy: Can We Maintain Efficacy and Improve Quality of Life?
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| Brian Rini, MD
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| The 2021 ESMO annual congress included a discussant presentation by Dr. Brian Rini in which he discussed, maintaining efficacy and improving quality of life in the delivery of RCC therapy. Dr. Rini discussed three abstracts: "Patient-reported outcomes in KEYNOTE-564” by Dr. Toni Choueiri, “Nivolumab in combination with alternatively scheduled ipilimumab in first-line treatment of patients with advanced RCC: A randomized phase II trial (PRISM)” by Dr. Naveen Vasudev, and “STAR: A Randomized Multi-Stage Phase II/III Trial of Standard first-line therapy (sunitinib or pazopanib) Comparing Temporary Cessation with Allowing Continuation, in the treatment of locally advanced and/or metastatic RCC” by Dr. Janet Brown.
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| Enhanced Androgen Signaling Inhibition Should Be the Treatment of Choice for Treatment of mCSPC Rather than Docetaxel - Yes
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| Karim Fizazi, MD, Ph.D.
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| Karim Fizazi and Ronald De Wit debate the question of whether enhanced androgen signaling inhibition should be the treatment of choice for treatment of metastatic castration sensitive prostate cancer (mCSPC) rather than docetaxel. Presenting first, Karim Fizazi took the position that androgen signaling inhibition should be the treatment of choice, though he emphasized that potentially these approaches should be considered in combination.
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| Enhanced Androgen Signaling Inhibition Should Be the Treatment of Choice for Treatment of mCSPC Rather than Docetaxel - No
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| Ronald De Wit, MD, Ph.D.
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| In this presentation, Ronald De Wit supported the use of docetaxel as the treatment of choice for patients with metastatic castration sensitive prostate cancer. Dr. De Wit, discussed the extent of benefit and quality of life during and after treatment with docetaxel. Highlighting data from both CHAARTED and STAMPEDE, he emphasized the robust and durable responses of docetaxel in both metastatic and non-metastatic castration-sensitive prostate cancer.
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| Are Adjuvant Immune Checkpoint Inhibitors a Standard of Care for Operable High-Risk Urothelial and Kidney Cancer? Yes
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| Thomas Powles, MD, MBBS, FRCP
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| The European Society of Medical Oncology (ESMO) 2021 annual congress included a controversial session highlighting ‘Are adjuvant immune checkpoint inhibitors a standard of care for operable high-risk urothelial and kidney cancer?’ Thomas Powles discussed that yes, adjuvant immune checkpoint inhibitors are standard of care.
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| Are Adjuvant Immune Checkpoint Inhibitors a Standard of Care for Operable High-Risk Urothelial and Kidney Cancer? No
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| Michiel S. Van der Heijden, MD
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| The ESMO 2021 annual congress included a controversial session highlighting ‘Are adjuvant immune checkpoint inhibitors a standard of care for operable high-risk urothelial and kidney cancer?’ Dr. Michiel van der Heijden discussed that no, adjuvant immune checkpoint inhibitors are not standard of care.
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