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Key Studies at ASCO 2020
An Expert’s Guide to ASCO 2020: A Preview of the Top Abstracts

Released: May 27, 2020

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During the 2020 ASCO virtual annual meeting, important results from many clinical trials in both solid tumors and hematologic malignancies will be reported. Below, oncology experts have highlighted their most anticipated abstracts, which we will cover online as a part of CCO’s Independent Conference Coverage of ASCO 2020. As the ASCO virtual annual meeting unfolds, remember to check the CCO Web site often for downloadable slidesets summarizing the data from these studies and more and then again after the meeting for CME-certified online activities, featuring expert analyses and perspectives on the clinical implications of the new data.

Top Picks: Hematologic Malignancies
Several interesting and potentially practice-changing studies in hematologic malignancies are being reported at ASCO 2020.

Shaji Kumar, MD: In multiple myeloma (MM), my colleagues and I will present data in the Plenary Session from the phase III ENDURANCE (E1A11) trial evaluating treatment with carfilzomib/lenalidomide/dexamethasone compared with bortezomib/lenalidomide/dexamethasone (VRd) in patients with newly diagnosed MM. Another interesting study being reported by Usmani and colleagues is the phase II SWOG-1211 trial of VRd with or without elotuzumab for patients with newly diagnosed, high-risk MM, supporting a role of combination proteasome inhibitor and IMiD maintenance therapy in this disease setting. In the relapsed/refractory (R/R) setting, Dimopoulus and colleagues will report results from the phase III BOSTON trial comparing weekly selinexor plus bortezomib and dexamethasone vs twice-weekly bortezomib and dexamethasone, showing that this trial met its primary endpoint of significantly improved PFS with less peripheral neuropathy. In addition, some interesting studies will be presented on novel agents targeting BCMA. Nooka and colleagues will present the findings of the DREAMM-6 trial, exploring the safety and efficacy of the antibody–drug conjugate belantamab mafodotin in combination with bortezomib/dexamethasone for patients with R/R MM previously treated with at least 1 previous line of therapy. Other presentations will report on the BCMA-directed CAR T-cell therapies idecabtagene vicleucel and orvacabtagene autoleucel and their safety and efficacy potential in patients with heavily pretreated R/R MM. My colleagues and I will also present updated data from the phase III BELLINI trial of venetoclax plus bortezomib/dexamethasone showing a favorable risk-benefit profile for patients with R/R MM and t(11:14) or high BCL2 gene expression.

Farhad Ravandi, MD: In acute myeloid leukemia (AML), Lachowiez and colleagues highlight the potential of ivosidenib in combination with venetoclax and azacitidine for the treatment of patients with IDH1-mutated hematologic malignancies. In addition, DiNardo and colleagues will present the response rates and durations observed with the combination of enasidenib and azacitidine in mutant-IDH2 newly diagnosed AML patients and evaluate the impact of subsequent treatment on OS/event-free survival and new translational data.

Ian W. Flinn, MD, PhD: For patients with R/R classic Hodgkin lymphoma, Kuruvilla and colleagues will present findings from the phase III KEYNOTE-204 trial comparing pembrolizumab monotherapy with treatment with brentuximab vedotin.  The results of this study are practice changing and will guide treatment recommendations for these patients. Tam and colleagues will report findings from the phase III ASPEN trial comparing zanubrutinib with ibrutinib in patients with Waldenström macroglobulinemia. This is the first randomized trial of 2 BTK inhibitors to be reported with potential implications for many patient populations treated with these agents.

Top Picks: Lung Cancer

Stephen V. Liu, MD, and Zofia Piotrowska, MD, MHS: In the Plenary Session, Herbst and colleagues will present results from the much-anticipated phase III ADAURA trial, revealing the potential role of adjuvant osimertinib in patients with stage IB to IIIA EGFR-mutant non-small-cell lung cancer (NSCLC) following previous resection. Outcomes of this study promise to be telling, as this study was unblinded early due to observed efficacy in the experimental arm. Further insight on the clinical safety and efficacy of the tyrosine kinase inhibitor in this space may serve to change practice in the treatment of this patient population. Reck and colleagues will report positive data from the CheckMate 9LA trial that identified a survival benefit with the combination of nivolumab plus ipilimumab plus 2 cycles of platinum-based chemotherapy when compared with 4 cycles of chemotherapy. Promising results from this study may pave the way for another treatment option in the frontline setting. In addition, Rodriguez-Abreu and colleagues report on the primary analysis of the phase II CITYSCAPE trial evaluating the safety and efficacy of the novel anti-TIGIT antibody tiragolumab in combination with atezolizumab as first-line treatment for patients with PD-L1–selected NSCLC. Smit and colleagues will report new interim data from the phase II DESTINY-Lung01 trial showing promising activity with the antibody–drug conjugate trastuzumab deruxtecan for patients with HER2-mutated nonsquamous NSCLC.

Finally, new data reported from the phase III KEYNOTE-604 trial and the phase III CASPIAN trial will shed more light on the impact of the addition of immune checkpoint inhibitors to etoposide and platinum therapy in the first-line setting for patients with extensive-stage small-cell lung cancer.

Top Picks: Breast Cancer

Sara Hurvitz, MD, FACP: Clinical data from several trials in both the frontline and recurrent treatment settings will be presented. First, in effort to define whether early surgery is more effective than palliative therapy for advanced breast cancer, Khan and colleagues will present the results of the phase III E2108 trial in the Plenary Session examining the use of surgery after initial systemic therapy in patients with newly diagnosed metastatic breast cancer. This important study will hopefully help us to better understand whether proactively addressing the primary tumor with surgery and radiation improves survival compared with saving these locoregional approaches for patients who only require it for palliation. Following up on the HER2CLIMB trial, crucial data specifically examining the subset of patients with brain metastases will be presented. This triplet regimen (tucatinib plus trastuzumab plus capecitabine) for patients with advanced unresectable or metastatic HER2-positive breast cancer has demonstrated substantially improved intracranial response rates with the data strongly supporting the use of tucatinib in patients with history of treated or active/progressing brain metastases. Also anticipated are the results of the BYLieve study, as this is the first trial to evaluate alpelisib in combination with endocrine therapy in patients with hormone receptor–positive, HER2–PIK3CA-mutated advanced breast cancer following progression on cyclin-dependent kinase 4/6 inhibitor therapy. Finally, in triple-negative breast cancer, Cortes and colleagues share their findings on the phase III KEYNOTE-355 study that evaluated the addition of pembrolizumab to chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer.

Top Picks: Gynecologic Cancer

Bradley J. Monk, MD, FACS, FACOG: Several studies throughout the gynecologic malignancy space will be presented and include the final analysis of the AGO DESKTOP III/ENGOT-ov20 study that examined the OS impact of cytoreductive surgery in patients with recurrent ovarian cancer. With a great need for survival benefit in this disease setting, findings of this investigation are greatly anticipated.

In addition, final results of the KEYNOTE-100 trial will be presented, examining the potential for pembrolizumab to demonstrate antitumor activity and survival benefits in patients with advanced recurrent ovarian cancer. Finally, final survival analyses from both SOLO2/ENGOT-ov21 and NSGO-AVANOVA2/ENGOT-OV24 evaluating PARP inhibitors in relapsed platinum-sensitive ovarian cancer will be reported.

Top Picks: Genitourinary Cancers

Daniel P. Petrylak, MD, and Elizabeth R. Plimack, MD, MS: A much anticipated late-breaking abstract on the JAVELIN Bladder 100 trial of maintenance avelumab in addition to best supportive care in patients with advanced urothelial carcinoma (UC) who previously received platinum-based chemotherapy in the first-line setting, will be presented by Powles and colleagues. The novelty of this regimen holds the potential to significantly improve patient survival outcomes in this setting so more information is of great interest. Additional analysis of immunotherapy in UC with be explored through the IMvigor010 trial. Here, Hussain and colleagues will report their primary findings on the use of adjuvant atezolizumab vs observation in patients with high-risk muscle-invasive UC. Further data will be presented on the role of immunotherapy in patients with UC, such as durability results for the combination of pembrolizumab and enfortumab vedotin in patients with locally advanced or metastatic UC (Study EV-103), and the impact of antibiotic timing for UC patients on immunotherapy. In renal cell carcinoma, data will be presented from FRACTION-RCC by Choueiri and colleagues that suggest that combination therapy with nivolumab plus ipilimumab may be useful for some patients who previously progressed on immune checkpoint therapy including some heavily pretreated patients. Finally, updated results on the efficacy and safety of pembrolizumab in combination with axitinib as a frontline treatment option for patients with advanced renal cell carcinoma will be presented.

Top Picks: Gastrointestinal Cancers

Axel Grothey, MD, and Manish A. Shah, MD: Various studies will serve to further define the role of targeted therapies in gastrointestinal malignancies. In the Plenary Session, Andre and colleagues will report results from the phase III KEYNOTE-177 trial comparing pembrolizumab vs chemotherapy in the first-line setting for patients with microsatellite instability-high metastatic colorectal cancer. In addition, results from the phase II DESTINY-CRC01 trial evaluating the clinical safety and efficacy of trastuzumab deruxtecan in HER2-expressing patients will be presented. Similarly, Shitara and colleagues explore the utility of trastuzumab deruxtecan in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma

Additional Studies to Watch

The CCO Conference Coverage of ASCO 2020 will also include slidesets of other important studies including:

  • 3 studies presenting new data on CC-486 (oral azacytidine) for patients with AML (Abstracts 7513, 7530, and 7533)
  • 3 studies presenting the latest data on acalabrutinib in hematologic malignancies (Abstracts 8015, 8024, and 8064)
  • A 3-year update from the CheckMate 227 trial of nivolumab plus ipilimumab as first-line therapy for NSCLC (Abstract 9500)
  • A pooled analysis of circulating tumor DNA for biomarkers of response and resistance to the CDK4/6 inhibitor ribociclib in phase III advanced breast cancer trials (Abstract 1009)
  • 3 studies presenting new pharmacokinetic data for niraparib in advanced ovarian cancer (Abstracts 6050, 6051, and 6054)
  • Phase III SAVOIR trial of savolitinib versus sunitinib in MET-driven papillary RCC (Abstract 5002)
  • OS results from the phase III ARAMIS trial of darolutamide + ADT for nonmetastatic prostate cancer (Abstract 5514)

Remember to Check the CCO Web Site Often During and After ASCO!
These are just a few of the interesting and important abstracts selected by our expert faculty from ASCO 2020. Downloadable slideset summaries  of these studies and more will be available on our Web site as the data are released. After the meeting, comprehensive analyses by our expert faculty members will explore the clinical implications of the data in CME-certified text-based modules.

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Which of the following clinical trials are you most looking forward to seeing presented at the ASCO 2020 virtual meeting?
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