Checkpoint Inhibitors in Esophagogastric Cancer: Updates of Landmark Trials
Updates of landmark trials of immune checkpoint inhibitors as first-line therapy for advanced HER2-negative esophagogastric cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium. The studies upheld previous findings of an overall survival benefit when these agents are paired...
Expert Point of View: Christopher Willett, MD
Christopher Willett, MD, Professor and Chair of the Department of Radiation Oncology at Duke University in Durham, North Carolina, shared his thoughts on the findings of the study by Lumish et al1 with The ASCO Post. He first noted the shift in recent years toward total neoadjuvant therapy in the...
Small Study Reports Neoadjuvant PD-1 Blockade Yields 100% Clinical Complete Response Rate in Locally Advanced Mismatch Repair–Deficient Rectal Cancer
In a small study of patients with locally advanced mismatch repair–deficient (dMMR) rectal cancer, treatment with the anti–PD-1 agent dostarlimab-gxly alone led to a clinical complete response rate of 100%. The findings of this study from Memorial Sloan Kettering Cancer Center (MSK) were reported...
Expert Point of View: Samuel J. Klempner, MD
Samuel J. Klempner, MD, Associate Professor at Massachusetts General Hospital and Harvard Medical School, commented on the NEONIPIGA study for The ASCO Post. “This study was the first prospective data set to show what many have suspected—that neoadjuvant immune checkpoint blockade would lead to a...
Neoadjuvant Checkpoint Inhibitor Doublet Yields Complete Responses in Gastroesophageal Cancers
In patients with resectable microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) gastric and gastroesophageal junction adenocarcinoma, dual checkpoint inhibition with ipilimumab and nivolumab given as neoadjuvant therapy led to a pathologic complete response rate of 58.6%,...
Expert Point of View: Benoit Rousseau, MD, PhD
Benoit Rousseau, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, called the findings of the phase II GERCOR NIPICOL trial “interesting and convincing.” Long-term follow-up showed the 3-year progression-free survival rate to be 70% after just 1 total year of treatment with nivolumab...
NIPICOL Trial: Promising Outcomes With Shorter Duration of Checkpoint Inhibition in Metastatic Colorectal Cancer
The phase II GERCOR NIPICOL study evaluated 1 year of treatment with nivolumab plus ipilimumab in patients with chemotherapy-resistant metastatic colorectal cancer whose tumors were microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR). With this shortened treatment duration,...
Petros Grivas, MD, PhD, on Urothelial Cancer: New Data on Sacituzumab Govitecan-hziy and Pembrolizumab
Petros Grivas, MD, PhD, of the University of Washington and Fred Hutchinson Cancer Research Center, discusses results from Cohort 3 of the TROPHY-U-01 study, which assessed sacituzumab govitecan-hziy in combination with pembrolizumab in patients with metastatic urothelial cancer who experienced disease progression after platinum-based regimens (Abstract 434).
Toni K. Choueiri, MD, on Renal Cell Carcinoma: Follow-up Data on Pembrolizumab
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses a 30-month follow-up of results from the KEYNOTE-564 trial, which further support the use of adjuvant pembrolizumab when treating patients with renal cell carcinoma at intermediate-high or high risk of recurrence, or with an M1 NED (no evidence of disease) status after nephrectomy. The data show a disease-free survival benefit vs placebo (Abstract 290).
Updated Findings on T-DXd in Gastrointestinal Malignancies
Updates of phase II studies evaluating fam-trastuzumab deruxtecan-nxki (T-DXd) in gastrointestinal cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium, continuing to offer support for the antibody-drug conjugate in these malignancies. In HER2-expressing gastric cancer, T-DXd...
Jonathan E. Rosenberg, MD, on Urothelial Cancer: New Conclusions About Durvalumab Plus Olaparib
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses phase II findings from the BAYOU trial, which studied durvalumab in combination with olaparib for first-line treatment of platinum-ineligible patients with unresectable, stage IV urothelial carcinoma. Because secondary analyses indicated a potential progression-free survival benefit with this combination, there may be a role for PARP inhibitors in the treatment of advanced disease with homologous recombination repair mutation (Abstract 437).
Pathologic Response of Index Lymph Node and Concordance With Total Nodal Basin Pathologic Response in Stage III Melanoma
In a retrospective analysis reported in JAMA Surgery, Reijers et al found that pathologic response in largest lymph node metastasis (index lymph node [ILN]) was highly concordant with response in the total lymph node bed in patients with stage III melanoma receiving neoadjuvant...
FDA Approves Neoadjuvant Nivolumab and Platinum Doublet Chemotherapy for Early-Stage NSCLC
On March 4, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for...
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
Axicabtagene Ciloleucel vs Standard of Care as Second-Line Treatment for Large B-cell Lymphoma
As reported in The New England Journal of Medicine by Frederick L. Locke, MD, and colleagues, the phase III ZUMA-7 trial of patients with large B-cell lymphoma has shown improved event-free survival with second-line axicabtagene ciloleucel vs chemoimmunotherapy with high-dose chemotherapy and...
Interim Analysis of Overall Survival in ICARIA-MM: Addition of Isatuximab to Pomalidomide/Dexamethasone in Relapsed or Refractory Multiple Myeloma
As reported in The Lancet Oncology by Paul G. Richardson, MD, and colleagues, a prespecified interim overall survival analysis of the phase III ICARIA-MM trial showed that the addition of isatuximab to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma produced...
Axel Bex, MD, PhD, on Renal Cell Carcinoma: New Findings From the NeoAvAx Trial on Avelumab and Axitinib
Axel Bex, MD, PhD, of The Netherlands Cancer Institute, discusses an efficacy, safety, and biomarker analysis of neoadjuvant avelumab and axitinib in patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (Abstract 289).
Daniel P. Petrylak, MD, on Bladder Cancer: Study EV-103 Cohort H Findings on Enfortumab Vedotin-ejfv
Daniel P. Petrylak, MD, of Yale Cancer Center, discusses new data on the antitumor activity of neoadjuvant treatment with enfortumab vedotin-ejfv monotherapy in patients with muscle-invasive bladder cancer who are not eligible for cisplatin.
Hielke-Martijn de Vries, MD, on Penile Cancer: New Data on Atezolizumab and Radiotherapy
Hielke-Martijn de Vries, MD, of the Netherlands Cancer Institute, discusses phase II findings on the use of atezolizumab with or without radiotherapy for patients with advanced squamous cell carcinoma of the penis. The study was designed to address the poor prognosis for this disease by exploring whether a protracted schedule of radiotherapy for locoregional disease, in combination with immunotherapy, could improve outcomes (Abstract 3).
KEYNOTE-522: Event-Free Survival With Neoadjuvant and Adjuvant Pembrolizumab in Triple-Negative Breast Cancer
As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, and colleagues, a preplanned interim analysis of the phase III KEYNOTE-522 trial has shown improved event-free survival with the addition of pembrolizumab to neoadjuvant chemotherapy, followed by adjuvant pembrolizumab, in ...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Pembrolizumab to Identify Patients With MSI-H Solid Tumors
On February 21, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic to identify patients with microsatellite instability–high (MSI-H) status solid tumors who may be appropriate candidates for treatment with pembrolizumab. FoundationOne CDx is...
Expert Point of View: Joseph Mikhael, MD
The ASCO Post asked Joseph Mikhael, MD, Chief Medical Officer of the International Myeloma Foundation and Professor in the Applied Cancer Research and Drug Discovery Division at the Translational Genomics Research Institute (an affiliate of City of Hope Cancer Center), to comment on the GMMG-HD7...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Mosunetuzumab Meets Primary Endpoint of Phase II Trial in Relapsed or Refractory Follicular Lymphoma
The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma, according to the results of a pivotal phase II trial presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition.1 In ...
Expert Point of View: Laurie H. Sehn, MD, MPH, and Alex Herrera, MD
Laurie H. Sehn, MD, MPH, Clinical Professor with the BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, Canada, and Alex Herrera, MD, Associate Professor in Hematology and Hematopoietic Cell Transplantation at the Beckman Research Institute of City of Hope, Duarte,...
ZUMA-7: Axicabtagene Ciloleucel Quadruples Event-Free Survival in Large B-Cell Lymphoma
In the primary analysis of the phase III ZUMA-7 trial, examining second-line therapy for relapsed or refractory large B-cell lymphoma, the CAR T-cell therapy axicabtagene ciloleucel led to a fourfold increase in event-free survival over the standard of care. These findings were presented at the...
Expert Point of View: Laurie H. Sehn, MD, MPH
The moderator of the session, Laurie H. Sehn, MD, MPH, Clinical Professor at the BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, Canada, called the results of the TRANSFORM trial “quite remarkable” and said chimeric antigen receptor (CAR) T-cell therapy has the...
TRANSFORM: Lisocabtagene Maraleucel Improves Outcomes in Relapsed or Refractory Large B-Cell Lymphoma
Chimeric antigen receptor (CAR) T-cell therapy with lisocabtagene maraleucel could prove to be the new standard-of-care treatment for patients with relapsed or refractory large B-cell lymphoma in the second-line setting, according to data presented at the 2021 American Society of Hematology (ASH)...
Expert Point of View: Jane N. Winter, MD, and Christopher R. Flowers, MD, MS
Jane N. Winter, MD, Professor of Medicine at Northwestern University’s Feinberg School of Medicine and 2022 President of the American Society of Hematology (ASH), and Christopher R. Flowers, MD, MS, Chair of the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center,...
POLARIX: Addition of Polatuzumab Vedotin-piiq to Standard of Care Significantly Reduces Progression of Diffuse Large B-Cell Lymphoma
As a first-line treatment of intermediate- or high-risk diffuse large B-cell lymphoma, the addition of the antibody-drug conjugate polatuzumab vedotin-piiq to standard-of-care therapy resulted in a 27% reduction in the relative risk of disease progression, relapse, or death, with a similar safety...
Expert Point of View: Ajay K. Nooka, MD, MPH, FACP
Ajay K. Nooka, MD, MPH, FACP, Associate Professor in the Department of Hematology and Medical Oncology at Winship Cancer Institute, Emory University, Atlanta, commented on the promising emergence of bispecific T-cell engaging (bispecific) antibodies, as represented by studies presented at the 2021...
Bispecific Antibodies With Multiple Targets Moving Forward in Multiple Myeloma
Poor outcomes are observed in patients with myeloma who are refractory to multiple classes of therapies, with the average patient experiencing disease progression in up to 6 months and living no longer than 6 to 15 months. Patients often rapidly cycle through regimens that use less effective or...
Researchers Identify Biomarkers That May Help to Predict Response to Immunotherapy for Melanoma
Melanoma is often curable when detected and treated in its early stages. However, the disease can rapidly spread to other organs in the body and become deadly. Immune checkpoint inhibitors have transformed the treatment of certain cancers, including melanoma, and improved patient care. But despite...
Matthew R. Zibelman, MD, on Renal Cell Carcinoma: New Results on Combination of Nivolumab and Axitinib
Matthew R. Zibelman, MD, of Fox Chase Cancer Center, discusses phase I/II results from a study of treatment-naive patients with advanced renal cell carcinoma who received a combination of the immunotherapy (IO) nivolumab and the tyrosine kinase inhibitor (TKI) axitinib. The findings suggest that the efficacy of this regimen is comparable to that of currently available IO/TKI combinations for this population and has a similar safety profile (Abstract 291).
Neoadjuvant Enfortumab Vedotin-ejfv in Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer
The antibody-drug conjugate enfortumab vedotin-ejfv is effective in patients with muscle-invasive bladder cancer who are not eligible for cisplatin chemotherapy, according to data from cohort H of the phase IB/II EV-103 clinical trial being presented at the 2022 ASCO Genitourinary Cancers Symposium ...
Differences in Risk of Severe Adverse Events in Women vs Men Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials
In a study reported in the Journal of Clinical Oncology, Joseph M. Unger, PhD, and colleagues found that women in clinical trials of chemotherapy, immunotherapy, or targeted therapy had a significantly greater risk for severe adverse events overall—and, particularly, with immunotherapy. As stated...
Potential Use of FDG-PET Findings in Reducing Duration of Immunotherapy in Patients With Advanced Melanoma
In a Danish retrospective study reported in the International Journal of Cancer, Ellebaek et al found that patients with advanced melanoma responding to PD-1 inhibitor therapy who stopped treatment within 18 months had improved survival outcomes when fluorodeoxyglucose (F-18) positron-emission...
Cemiplimab-rwlc vs Single-Agent Chemotherapy in Recurrent Cervical Cancer After First-Line Platinum-Based Chemotherapy
As reported in The New England Journal of Medicine by Krishnansu S. Tewari, MD, and colleagues, the phase III EMPOWER-Cervical1/GOG-3016/ENGOT-cx9 trial has shown improved overall survival with cemiplimab-rwlc vs investigator’s choice of single-agent chemotherapy in patients with cervical cancer...
Updated Efficacy and Safety Data From CheckMate 743: First-Line Nivolumab/Ipilimumab vs Chemotherapy for Unresectable Malignant Pleural Mesothelioma
With a follow-up of at least 3 years, the results from the CheckMate 743 study represent the first long-term survival data in a phase III study evaluating first-line immune checkpoint inhibition in patients with unresectable malignant pleural mesothelioma. Overall, 23% of patients treated with...
Report Finds Cancer Immunotherapy Clinical Trials Continue to Grow Globally
The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, has announced the publication of a new analysis of the global landscape of clinical development of drugs that target the PD-1/PD-L1 immune...
Neoadjuvant Atezolizumab Plus Gemcitabine and Cisplatin in Muscle-Invasive Bladder Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Funt et al found that the combination of neoadjuvant atezolizumab with gemcitabine and cisplatin resulted in a high rate of tumor downstaging to < pT2N0 in patients with muscle-invasive bladder cancer. Study Details The U.S....
Sara A. Hurvitz, MD, on HER2-Positive Metastatic Breast Cancer: T-DXd vs T-DM1
Sara A. Hurvitz, MD, of the University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses phase III findings from the DESTINY-Breast03 trial, which compared ado-trastuzumab deruxtecan (T-DXd) with standard-of-care trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer. T-DXd showed superior progression-free survival across subgroups of patients previously treated with trastuzumab and a taxane, including those with brain metastases (Abstract GS3-01).
Concordance for Low HER2 Protein Expression in Breast Cancer Tissue Using Standard Immunohistochemistry Assays
In a study reported in JAMA Oncology, Fernandez et al found that scoring accuracy for low HER2 protein expression (0 or 1+) in breast cancer tissue on standard immunohistochemistry (IHC) assays was poor. As observed by the investigators, the findings pose issues for investigation of fam-trastuzumab ...
Expert Point of View: Angela DeMichele, MD, MSCE
Angela DeMichele, MD, MSCE, the Alan and Jill Miller Professor in Breast Cancer Excellence at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia, commented on NIMBUS1 for The ASCO Post. She said obtaining information on tumor mutational burden is simple, as it is part ...
Dual Checkpoint Inhibitor Therapy Elicits Responses in Highly Mutated Breast Cancer
Patients with advanced HER2-negative metastatic breast cancer and high tumor mutational burden achieved responses—often durable—from treatment with the immunotherapy doublet of nivolumab and ipilimumab, according to results of the phase II NIMBUS trial reported at the 2021 San Antonio Breast Cancer ...
Expert Point of View: Debu Tripathy, MD, and Hope S. Rugo, MD, FASCO
The ASCO Post asked Debu Tripathy, MD, Professor and Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, and Hope S. Rugo, MD, FASCO, Professor of Medicine, Director of Breast Oncology and Clinical Trials Education at the University of California San...
Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer
Datopotamab deruxtecan, an antibody-drug conjugate directed against trophoblast cell surface antigen-2 (Trop-2), is showing promise as a treatment for relapsed or refractory advanced triple-negative breast cancer, according to early findings from the phase I TROPION-PanTumor01 trial presented...
Expert Point of View: Hope S. Rugo, MD, FASCO
The discussant of KEYNOTE-522 at the 2021 San Antonio Breast Cancer Symposium, Hope S. Rugo, MD, FASCO, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, commented: “We are clearly making...
KEYNOTE-522: Sensitivity Analyses Confirm Value of Neoadjuvant Pembrolizumab in Triple-Negative Breast Cancer
Updated results from the pivotal KEYNOTE-522 trial have confirmed the benefit of neoadjuvant therapy with pembrolizumab plus chemotherapy in patients with early triple-negative breast cancer.1 The results were presented at the 2021 San Antonio Breast Cancer Symposium by Peter Schmid, MD, PhD,...
Expert Point of View: Anthony El-Khoueiry, MD
Anthony El-Khoueiry, MD, Member of the Section of Gastrointestinal Cancers, Director of the phase I program, and Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and USC Norris Comprehensive Cancer Center, said the findings of the...
