Heinz-Josef Lenz, MD, of USC Norris Comprehensive Cancer Center, discusses phase II results from the CheckMate 9X8 study, which compared nivolumab plus fluorouracil/leucovorin/oxaliplatin (mFOLFOX6) and bevacizumab vs mFOLFOX6 and bevacizumab in the first-line treatment of metastatic colorectal cancer. A subgroup of patients may benefit from adding nivolumab to the standard of care in this setting (Abstract 8).
In the phase II DESTINY-Lung01 trial reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, and colleagues found that fam-trastuzumab deruxtecan-nxki (T-DXd) showed durable activity in patients with metastatic HER2-mutant non–small cell lung cancer (NSCLC) refractory to standard...
In an analysis from the phase II CALGB 40603/Alliance trial reported in the Journal of Clinical Oncology, Shepherd et al found that the addition of carboplatin or bevacizumab to neoadjuvant chemotherapy was not associated with improved long-term outcomes in patients with stage II or III...
As reported in the Journal of Clinical Oncology by David M. O’Malley, MD, and colleagues, pembrolizumab showed durable activity in a cohort of patients with microsatellite instability–high or mismatch repair–deficient (MSI-H/dMMR) advanced endometrial cancer enrolled in the multicohort KEYNOTE-158...
Kohei Shitara, MD, of Japan’s National Cancer Center Hospital East, discusses a long-term data follow-up from CheckMate 649, which support the continued use of nivolumab plus chemotherapy as first-line treatment in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinomas (Abstract 240).
Independent drug action—not synergy nor additivity—accounted for the clinical efficacy of nearly all examined combination therapies involving immune checkpoint inhibitors in clinical trials, according to results from a retrospective analysis published by Palmer et al in Clinical Cancer Research....
Results from the randomized international phase III HIMALAYA trial showed that a combination of the anti–PD-L1 immunotherapy durvalumab plus the anti–CTLA-4 immunotherapy tremelimumab reduced the risk of death by 22% in patients with stage III or IV unresectable hepatocellular carcinoma compared to ...
In an Asian phase II/III trial (ATTRACTION-4) reported in The Lancet Oncology, Yoon-Koo Kang, MD, and colleagues found that the addition of nivolumab to oxaliplatin-based chemotherapy improved progression-free survival—but not overall survival—as first-line treatment of HER2-negative, unresectable, ...
Yevgeniy R. Semenov, MD, of Massachusetts General Hospital and Harvard Medical School, discusses new findings suggesting cutaneous adverse events such as vitiligo, lichenoid dermatitis, and psoriasis—which often occur in patients with cancer who receive immune checkpoint inhibitors—may be strongly associated with response to therapy and a 22% reduction in mortality (Abstract 814).
Biliary tract cancer is a rare and often fatal disease comprised primarily of bile duct and gallbladder cancers; it is diagnosed in about 12,000 individuals each year in the United States. The cancer has a 5-year relative survival rate of 25% for localized intrahepatic bile duct cancers and just...
In a recent phase II clinical trial, the combination of the PD-L1 inhibitor durvalumab and the CTLA-4 inhibitor tremelimumab curtailed tumor growth in some patients with non–small cell lung cancer (NSCLC) that was resistant to a single immunotherapy agent. The addition of radiation therapy to the...
In an analysis from the phase III CheckMate 9ER trial reported in The Lancet Oncology, David Cella, PhD, FASCO, and colleagues found that nivolumab/cabozantinib was associated with maintained or improved patient-reported outcomes vs sunitinib in the first-line treatment of advanced renal cell...
Mehmet Altan, MD, of The University of Texas MD Anderson Cancer Center, discusses findings from a phase Ib dose-escalation study, which showed early evidence of activity for NKTR-255, an investigational IL-15 receptor agonist, plus cetuximab in patients with solid tumors. Treatment appeared to lead to expansion and proliferation of NK and CD8+ cells (Abstract 957).
Immune checkpoint inhibitors have become the standard of care for many patients with advanced cancers; however, these medications cause cutaneous adverse events in 20% to 40% of all patients who receive them. A study by Tang et al published in JAMA Dermatology indicated that these side effects may...
Elizabeth A. Mittendorf, MD, PhD, of Dana-Farber Brigham and Women’s Cancer Center, discusses the progress made in recent years treating patients with triple-negative breast cancer (TNBC), including approval of the immunotherapy agents pembrolizumab and sacituzumab govitecan-hziy, a new standard of care in the preoperative setting for early-stage disease, as well as a better understanding of the biology of TNBC and its heterogeneity.
As reported in JAMA Oncology by Robert J. Motzer, MD, and colleagues, the final overall survival analysis of the phase III IMmotion151 trial has shown no significant difference for atezolizumab plus bevacizumab vs sunitinib in previously untreated patients with metastatic renal cell carcinoma...
Romanos Sklavenitis-Pistofidis, MD, of Dana-Farber Cancer Institute, discusses study findings on a next generation of clinical assays to assess both tumor biology and immune state, as well as common clinical biomarkers in the marrow or blood. These biomarkers may accurately predict which patients with smoldering multiple myeloma might benefit from early treatment, monitor response to immunotherapy, and improve patient outcomes (Abstract 330).
Manali Kamdar, MD, of the University of Colorado Cancer Center, discusses phase III results from the TRANSFORM study, which suggest that lisocabtagene maraleucel, a CD19-directed CAR T-cell therapy, improved outcomes with a favorable safety profile and may be a potential new standard of care for second-line treatment of patients with relapsed or refractory large B-cell lymphoma (Abstract 91).
In a pooled analysis of individual patient data from trials in the U.S. Food and Drug Administration database reported in JAMA Oncology, Anscher et al found that patients with cancer receiving radiotherapy within 90 days prior to the start of immune checkpoint inhibitor treatment were not at...
In the phase II/III RELATIVITY-047 trial reported in The New England Journal of Medicine, Hussein A. Tawbi, MD, PhD, and colleagues found that the addition of relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, to nivolumab, a PD-1 inhibitor, significantly prolonged...
In a phase I study reported in the Journal of Clinical Oncology, L. Elizabeth Budde, MD, PhD, and colleagues found that the CD20-CD3 bispecific antibody mosunetuzumab produced durable responses in patients with relapsed or refractory aggressive and indolent B-cell non-Hodgkin lymphomas....
In the phase II ADAPT-IT trial reported in the Journal of Clinical Oncology, Michael A. Postow, MD, and colleagues showed that findings on interim computed tomography (CT) allowed patients to avoid the third and fourth doses of combination nivolumab/ipilimumab for the treatment of advanced...
In an analysis from the Pediatric Real-World Chimeric Antigen Receptor Consortium reported in the Journal of Clinical Oncology, Schultz et al found that pretreatment high disease burden was associated with poorer outcomes in pediatric and young adult patients who received commercial...
Patrick Hwu, MD, of Moffitt Cancer Center and President of the Society for Immunotherapy of Cancer (SITC), and Mary Dean, JD, CAE, SITC Executive Director, discuss the organization’s mission, strides made in cancer immunology, meeting the challenge of immunoresistance, and the new SITC app for clinical practice guidelines. This app places a useful tool in the hands of health-care providers, one that can be continually updated as the science evolves.
In a study reported in The Lancet Oncology, Naranbhai et al found that the presence of HLA-A*03 was associated with poorer outcomes in patients receiving immune checkpoint inhibitors for advanced cancers. As stated by the investigators, “Predictive biomarkers could allow more precise use of immune...
Patients with melanoma who reported eating more fiber-rich foods when they began treatment with immunotherapy survived longer without cancer growth than patients with insufficient dietary fiber intake, according to new research published by Spencer et al in Science. The benefit was most noticeable...
In a phase II trial reported in the Journal of Clinical Oncology, David M. O’Malley, MD, and colleagues found that the PD-1 inhibitor balstilimab and the CTLA-4 inhibitor zalifrelimab—both investigational agents—produced durable responses as second-line treatment for patients with recurrent or...
In the phase III POLARIX trial reported in The New England Journal of Medicine, Tilly et al found that polatuzumab vedotin-piiq plus R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) significantly improved progression-free survival vs R-CHOP (rituximab, cyclophosphamide, doxorubicin, ...
As reported in The New England Journal of Medicine by Bishop et al, the phase III BELINDA trial showed no improvement in event-free survival with second-line tisagenlecleucel vs standard of care including salvage chemotherapy and autologous hematopoietic stem cell transplantation (HSCT) in patients ...
Molecular and genetic research has advanced the categorization of different risk groups in patients with smoldering myeloma. Notable presentations at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition included reports on biomarkers to predict response to immunotherapy in...
In the past decade, use of immunotherapy has arisen as a novel adjunct to multiple myeloma therapy. Daratumumab is the first anti-CD38 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA), in November 2015, for use in treating relapsed or refractory multiple myeloma.1...
As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...
Invited discussant Ian Chau, MD, Consultant Medical Oncologist at The Royal Marsden Hospital in London and Surrey in the United Kingdom, said the findings from COSMIC-3121 are not mature enough to establish cabozantinib/atezolizumab as a new front-line option for advanced hepatocellular carcinoma...
The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...
Invited discussant of the KEYNOTE-355 trial, Hope S. Rugo, MD, FASCO, one of the coauthors of the study, had presented the survival data at the 2021 European Society of Medical Oncology (ESMO) Annual Congress.1 The San Antonio presentation was a more in-depth evaluation of survival by different...
Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...
As reported in The Lancet Oncology by Thomas Yau, MD, and colleagues, the phase III CheckMate 459 trial has shown no improvement in overall survival with first-line nivolumab vs sorafenib in patients with advanced hepatocellular carcinoma. Study Details In the open-label trial, 743 patients not...
In the phase III KAITLIN trial reported in the Journal of Clinical Oncology, Ian E. Krop, MD, and colleagues found that adjuvant ado-trastuzumab emtansine (T-DM1) plus pertuzumab did not improve invasive disease–free survival vs a taxane plus trastuzumab/pertuzumab, both following...
In a single-center retrospective study reported in the Journal of Clinical Oncology, Shouval et al found that the presence of TP53 alterations was associated with poorer outcomes in patients treated with CD19-targeted chimeric antigen receptor (CAR) T-cell therapy (CD19–CAR-T) for relapsed or...
Roni Shouval, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses his findings, which show, for the first time, that TP53 alterations are a valuable prognostic and potentially predictive marker in patients with large B-cell lymphoma who receive CD19–CAR T-cell therapy. Gene-expression profiling suggests that TP53 alterations result in an immunosuppressive tumor microenvironment and impaired apoptosis signaling, which could lead to decreased CAR T-cell therapy efficacy (Abstract 710).
Michael R. Bishop, MD, of the University of Chicago, discusses insights from findings of the phase III BELINDA study, which may inform the design of future CAR T-cell trials, as well as the use of second-line tisagenlecleucel therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (Abstract LBA-6).
As reported in The Lancet Oncology by Caron A. Jacobson, MD, and colleagues, the phase II ZUMA-5 trial showed that axicabtagene ciloleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, produced high rates of durable responses in patients with relapsed or refractory...
Research demonstrating a novel approach that may reduce cytokine-release syndrome associated with chimeric antigen receptor (CAR) T-cell therapy was presented by Marcela Maus, MD, PhD, and colleagues at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1723)...
Although there is a biomarker that predicts response to the one approved immunotherapy agent for metastatic triple-negative breast cancer, “it is important to note there are no biomarkers of response to neoadjuvant immunotherapy in early-stage triple-negative breast cancer,” Elizabeth A....
In an analysis of the phase III BELINDA trial presented by Bishop et al during the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-6), the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel was not found to improve event-free survival over the...
In an analysis reported in the Journal of Clinical Oncology, Zhao et al found that the addition of an immune checkpoint inhibitor to chemotherapy in trials of first-line treatment of advanced gastric or esophageal adenocarcinoma was not associated with benefit in low PD-L1–expressing subgroups not...
In a study reported in JAMA Network Open, Jang et al found that women with advanced melanoma receiving combination immune checkpoint inhibitor therapy with nivolumab/ipilimumab as their most recent immune checkpoint inhibitor therapy (all with prior ipilimumab treatment) had a poorer survival...
L. Elizabeth Budde, MD, PhD, of City of Hope, discusses phase I/II findings that showed mosunetuzumab monotherapy induces deep and durable remissions in patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of treatment, including those with double-refractory disease. Because follicular lymphoma is associated with frequent relapses and decreasing progression-free intervals with successive lines of conventional therapy, these data are encouraging (Abstract 127).
For the first-line treatment of newly diagnosed, transplant-eligible patients with multiple myeloma, the achievement of measurable residual disease (MRD) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to the standard three-drug induction regimen of...
Komal Jhaveri, MD, of Memorial Sloan Kettering Cancer Center, discusses the latest updates from the SUMMIT trial, which explored the combinations of neratinib/fulvestrant/trastuzumab and neratinib plus trastuzumab, as well as fulvestrant alone. The combination regimens appeared to benefit patients with hormone–receptor positive, HER2-mutated metastatic breast cancer who have had prior exposure to CDK4/6 inhibitors, and those with HER2-mutated triple-negative disease (Abstract GS4-10).