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Key Studies at ASCO 2019
An Expert’s Guide to ASCO 2019: A Preview of the Top Abstracts

Released: May 30, 2019

Tanios Bekaii-Saab
Tanios Bekaii-Saab, MD, FACP
John M. Burke
John M. Burke, MD
Sara Hurvitz
Sara Hurvitz, MD
Shaji K. Kumar
Shaji K. Kumar, MD
Daniel P. Petrylak
Daniel P. Petrylak, MD
Heather Wakelee
Heather Wakelee, MD
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At the 2019 ASCO 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 2019. As the ASCO 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 data.

Top Picks: Breast Cancer
Sara Hurvitz, MD, FACP, and Joyce O’Shaughnessy, MD: Clinical data from several phase III trials in both hormone receptor–positive/HER2-negative and HER2-positive metastatic breast cancer (MBC) will be presented. The OS results of a late-breaking abstract on the MONALEESA-7 trial will reveal whether the PFS benefit from adding the CDK4/6 inhibitor ribociclib to endocrine therapy translates into an OS benefit in premenopausal patients with hormone receptor–positive/HER2-negative MBC. In HER2-positive MBC, 2 studies will shed light on treatment options for patients who have received previous therapies for metastatic disease, a setting that currently lacks a defined standard of care. Data from the NALA trial will show whether capecitabine plus neratinib, an irreversible pan-HER inhibitor, is superior to capecitabine plus lapatinib in patients previously treated with ≥ 2 HER2-directed regimens. Also anticipated are the results from the SOPHIA trial comparing chemotherapy plus margetuximab, a novel anti-HER2 antibody, with chemotherapy plus trastuzumab in patients with HER2-positive MBC after pertuzumab and 1-3 lines of previous therapy for metastatic disease.

Top Picks: Lung Cancer
Heather Wakelee, MD: Results from early phase I trials with novel agents in select non-small-cell lung cancer (NSCLC) populations with genetic aberrations will be presented. The first study is the pivotal ARROW trial examining BLU-667, a selective RET inhibitor, in 79 patients with RET fusion–positive advanced NSCLC. Positive data from the expansion part of this trial could lead to FDA approval of BLU-667 in this patient population. The second study is evaluating AMG 510, a novel small molecule inhibitor of KRASG12C, in patients with advanced KRASG12C-mutated solid tumors including 6 with NSCLC, a setting that currently lacks effective treatments. Finally, a retrospective study using real-world data is evaluating treatment outcomes from immune checkpoint inhibitors in patients with advanced NSCLC and autoimmune disease, a population typically excluded from clinical trials.

Top Picks: Hematologic Malignancies
Several interesting and potentially practice-changing studies in hematologic malignancies are being reported at ASCO 2019. In chronic lymphocytic leukemia (CLL), John M. Burke, MD, highlights 2 of the most clinically relevant studies reporting. First, results from the phase III CLL14 trial comparing fixed-duration venetoclax/obinutuzumab with obinutuzumab/chlorambucil in newly diagnosed patients with comorbidities can establish venetoclax/obinutuzumab as another chemotherapy-free regimen in the frontline setting. Next, the ongoing phase I/II TRANSCEND CLL 004 trial is assessing minimal residual disease negativity after treatment with lisocabtagene maraleucel, a CD19-directed CAR T-cell therapy, in patients with relapsed/refractory CLL or small lymphocytic lymphoma who received ≥ 2 previous lines of therapy including ibrutinib unless contraindicated.

Shaji Kumar, MD, highlights several studies focused on treatment across the continuum of myeloma care, including data in smoldering multiple myeloma (MM) and relapsed/refractory (R/R) MM. Results from the phase III E3A06 trial of lenalidomide vs observation in patients with asymptomatic intermediate-risk or high-risk smoldering MM has the potential to change practice, at least for patients with high risk of progression, by demonstrating consistent benefit for lenalidomide as early intervention. In the R/R MM setting where new therapies are needed, a phase Ib/IIa trial is investigating iberdomide, a novel cereblon E3 ligase modulator, in combination with dexamethasone in patients who have received ≥ 2 previous regimens. Novel immunomodulatory drugs that can overcome the resistance to the current IMiDs will likely play an important role in the future of myeloma therapy. Updated results from the phase I trial of AMG 420, an anti-BCMA bispecific T-cell engager, in R/R MM will be presented at ASCO 2019.

Top Picks: Genitourinary Cancers
Daniel P. Petrylak, MD, has identified 2 genitourinary cancer studies of significant interest reporting at ASCO 2019. OS results from a late-breaking abstract to be presented at the plenary session on the ENZAMET trial have the potential to establish a role for enzalutamide in metastatic hormone-sensitive prostate cancer. In locally advanced/metastatic urothelial cancer, we will see efficacy and safety results from the pivotal phase II EV-201 trial of enfortumab vedotin, an antibody–drug conjugate to Nectin-4, in patients who have received both platinum-containing chemotherapy and an immune checkpoint inhibitor.

Top Picks: Gastrointestinal Cancers
Tanios Bekaii-Saab, MD, FACP: Several studies of interest on gastrointestinal cancers will be presented at ASCO 2019. Two presentations promise to shed light on potential strategic treatment approaches in key settings for patients with pancreatic cancer. In a plenary presentation, we will see results from the phase III POLO trial, in which patients with metastatic pancreatic cancer and a germline BRCA mutation who had not progressed after first-line platinum-based chemotherapy were treated with either maintenance olaparib, a PARP inhibitor, or placebo. We will also see results from the phase III APACT trial of adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine for patients with resected pancreatic cancer.

In hepatocellular carcinoma (HCC), results will be presented from the phase III KEYNOTE-240 trial of the anti–PD-1 antibody pembrolizumab vs best supportive care as second-line therapy in advanced HCC. Notably, accelerated FDA approval of pembrolizumab in second-line advanced HCC was based on the nonrandomized phase II KEYNOTE-224 study, and a February press release indicated that KEYNOTE-240 did not meet its coprimary endpoints of OS and PFS, making the first presentation of its data of great interest in determining how pembrolizumab with be used to treat HCC moving forward.

In addition, we will see updated results from the phase III TRIBE2 trial, in which patients with metastatic colorectal cancer were randomized to FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab after disease progression vs FOLFOXIRI plus bevacizumab followed by retreatment with the same regimen after disease progression. In an interim analysis, the FOLFOXIRI plus bevacizumab approach was associated with improved PFS; it will be interesting to see if this improvement is maintained.

Additional Studies
The CCO Conference Coverage of ASCO 2019 will also include slidesets of key presented studies in other tumor types, including ovarian cancer, that will likely have an impact on patient care. Among important studies covered in these settings will be:

  • Efficacy and safety data from the randomized phase II NSGO-AVANOVA2/ENGOT-OV24 trial of niraparib with or without bevacizumab in recurrent platinum-sensitive ovarian cancer
  • Results from the phase III SOLO3 trial of olaparib vs chemotherapy in germline BRCA-mutated platinum-sensitive relapsed ovarian cancer

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 2019. Downloadable slideset summaries of these studies and more will be available on our Web site as the data are presented at ASCO. 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 2019 meeting?
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