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Immunotherapy

Combination Therapies May Improve Outcomes Due to Independent, Rather Than Synergistic or Additive, Drug Action

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....

Hepatobiliary Cancer
Immunotherapy

Durvalumab/Tremelimumab Improves Overall Survival vs Sorafenib in Patients With Advanced Hepatocellular Carcinoma: HIMALAYA

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 ...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Addition of Nivolumab to Oxaliplatin-Based Chemotherapy for HER2-Negative, Unresectable, Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer

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, ...

immunotherapy

Yevgeniy R. Semenov, MD, on Cutaneous Immune-Related Adverse Events and Response to Immune Checkpoint Inhibitors

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).  

Hepatobiliary Cancer
Immunotherapy

Durvalumab Plus Gemcitabine/Cisplatin Improves Survival in Patients With Advanced Biliary Tract Cancer: TOPAZ-1

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...

Lung Cancer
Immunotherapy

Durvalumab/Tremelimumab With or Without Radiotherapy in Resistant NSCLC

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...

Kidney Cancer
Immunotherapy

First-Line Nivolumab/Cabozantinib vs Sunitinib for Advanced Renal Cell Carcinoma: Patient-Reported Outcomes

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...

immunotherapy
solid tumors
colorectal cancer
head and neck cancer

Mehmet Altan, MD, on Solid Tumors: Interim Safety and Efficacy Results on NKTR-255 Plus Cetuximab

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).

Immunotherapy

Is the Development of Cutaneous Immune-Related Adverse Events Correlated With Response to Immunotherapy?

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...

breast cancer
immunotherapy

Elizabeth A. Mittendorf, MD, PhD, on Making Strides in Managing Triple-Negative Breast Cancer

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.

Kidney Cancer
Immunotherapy

Atezolizumab/Bevacizumab vs Sunitinib in Previously Untreated Patients With Metastatic RCC: Final Overall Survival Analysis of IMmotion151

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...

multiple myeloma
immunotherapy

Romanos Sklavenitis-Pistofidis, MD, on Smoldering Myeloma: Identifying Biomarkers of Response to Immunotherapy

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).

lymphoma
immunotherapy

Manali Kamdar, MD, on Large B-Cell Lymphoma: Lisocabtagene Maraleucel vs the Standard of Care

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).

Immunotherapy

Effect of Recent Prior Radiotherapy on Adverse Events in Patients Receiving Immune Checkpoint Inhibitors

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...

Skin Cancer
Immunotherapy

Addition of Anti–LAG-3 Antibody Relatlimab to Nivolumab in Previously Untreated Patients With Advanced Melanoma

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...

Lymphoma
Immunotherapy

Bispecific Antibody Mosunetuzumab in Relapsed or Refractory B-Cell Lymphomas

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....

Skin Cancer
Immunotherapy

Interim Radiographic Assessment for Adaptive Dosing of Combination Immunotherapy in Advanced Melanoma

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...

Leukemia
Immunotherapy

Pretreatment Disease Burden and Outcomes With Commercial Tisagenlecleucel in Pediatric/Young Adult B-Cell Acute Lymphoblastic Leukemia

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...

immunotherapy

Patrick Hwu, MD, and Mary Dean, JD, CAE, on What’s Ahead for Cancer Immunology and SITC

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.

Genomics/Genetics
Immunotherapy

Association of HLA-A*03 With Outcomes of Immune Checkpoint Inhibition for Advanced Cancers

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...

Skin Cancer
Immunotherapy

Is a High-Fiber Diet Associated With Improved Survival and Treatment Response in Patients With Melanoma?

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...

Gynecologic Cancers
Immunotherapy

Balstilimab Plus Zalifrelimab for the Second-Line Treatment of Advanced Cervical Cancer

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...

Lymphoma
Immunotherapy

Polatuzumab Vedotin-piiq Plus R-CHP vs R-CHOP for Previously Untreated Patients With DLBCL

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, ...

Lymphoma
Immunotherapy

Second-Line Tisagenlecleucel vs Standard of Care in Aggressive B-Cell Lymphoma

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 ...

Multiple Myeloma
Immunotherapy
Genomics/Genetics

Molecular Analysis Advances Risk Profiling and Assessment of Immunotherapy Response in Smoldering Myeloma

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...

Multiple Myeloma
Immunotherapy

Daratumumab in Front-Line Treatment of Newly Diagnosed Transplant-Ineligible Multiple Myeloma: Questions Emerge From MAIA Trial

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...

Multiple Myeloma
Immunotherapy

MAIA Trial: Daratumumab Added to Lenalidomide Plus Dexamethasone Improves Overall Survival in Transplant-Ineligible Multiple Myeloma

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...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Ian Chau, MD

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...

Hepatobiliary Cancer
Immunotherapy

COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in 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...

Breast Cancer
Immunotherapy

Expert Point of View: Hope S. Rugo, MD, FASCO

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...

Breast Cancer
Immunotherapy

Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy

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...

Hepatobiliary Cancer
Immunotherapy

First-Line Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma: Effect on Overall Survival

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...

Breast Cancer
Immunotherapy

Adjuvant T-DM1/Pertuzumab vs Taxane/Trastuzumab/Pertuzumab in High-Risk HER2-Positive Breast Cancer

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...

Lymphoma
Genomics/Genetics
Immunotherapy

Effect of TP53 Alterations on Outcomes of CD19-Targeted CAR T-Cell Therapy for Patients With Large B-Cell Lymphoma

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...

lymphoma
immunotherapy

Roni Shouval, MD, PhD, on TP53-Mutant Large B-Cell Lymphoma and CAR T-Cell Therapy

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).

lymphoma
immunotherapy

Michael R. Bishop, MD, on Aggressive B-Cell NHL: Tisagenlecleucel vs Standard of Care as Second-Line Therapy

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).

Lymphoma
Immunotherapy

ZUMA-5 Trial: Axicabtagene Ciloleucel in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma

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...

Immunotherapy
Supportive Care
Hematologic Malignancies

Study Examines a Potential Approach to Mitigate CAR T-Cell Therapy Toxicity

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)...

Breast Cancer
Immunotherapy

Composite Biomarker Needed to Predict Benefit of Immunotherapy in Triple-Negative Breast Cancer

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....

Lymphoma
Immunotherapy

BELINDA Study: Second-Line Tisagenlecleucel Equivalent to Standard of Care for Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

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...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Study Suggests Lack of Benefit With the Addition of Immune Checkpoint Inhibition to Chemotherapy in Low PD-L1–Expressing Gastric or Esophageal Adenocarcinoma

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...

Skin Cancer
Immunotherapy

Immune Checkpoint Inhibitor Treatment in Patients Aged 65 and Older With Advanced Melanoma: Association Between Sex and Survival

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...

lymphoma
immunotherapy

L. Elizabeth Budde, MD, PhD, on Relapsed/Refractory Follicular Lymphoma: Early Results on Mosunetuzumab Monotherapy

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).

Multiple Myeloma
Immunotherapy

Isatuximab/RVd Meets Primary Endpoint of MRD Negativity for Newly Diagnosed, Transplant-Eligible Patients With Multiple Myeloma

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...

breast cancer
immunotherapy

Komal Jhaveri, MD, on Triple-Negative and Metastatic Breast Cancers: New Data on Neratinib, Fulvestrant, and Trastuzumab

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).

Lymphoma
Immunotherapy

TRANSFORM Trial: Lisocabtagene Maraleucel vs Standard of Care for Relapsed or Refractory Large B-Cell Lymphoma

An interim analysis of the TRANSFORM trial comparing the chimeric antigen receptor (CAR) T-cell immunotherapy lisocabtagene maraleucel to standard of care found that the CAR T-cell therapy significantly improved event-free survival for patients with large B-cell lymphoma that persisted or returned...

Lymphoma
Immunotherapy

Activity of Mosunetuzumab in Pretreated Patients With Relapsed or Refractory Follicular Lymphoma

The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma who had received two or more prior lines of therapy, according to pivotal results of a phase I/II trial presented at the 2021 American Society of...

breast cancer
immunotherapy

Javier Cortés, MD, PhD, on Previously Untreated Triple-Negative Breast Cancer: Pembrolizumab Plus Chemotherapy

Javier Cortés, MD, PhD, of Barcelona’s IOB Institute of Oncology, discusses the final phase III results of KEYNOTE-355, which showed that pembrolizumab and chemotherapy improved overall and progression-free survival, compared with placebo and chemotherapy, for patients with previously untreated, locally recurrent, inoperable or metastatic triple-negative breast cancer (Abstract GS1-02 ).

Skin Cancer
Immunotherapy

Long-Term Outcomes From CheckMate 067: Nivolumab/Ipilimumab, Nivolumab, or Ipilimumab in Advanced Melanoma

In a 6.5-year update of the phase III CheckMate 067 trial reported in the Journal of Clinical Oncology, Jedd D. Wolchok, MD, PhD, FASCO, and colleagues provided long-term overall survival as well as melanoma-specific survival findings among patients with advanced melanoma who received nivolumab...

Head and Neck Cancer
Immunotherapy

Adding Pembrolizumab to Chemotherapy Improves Overall and Progression-Free Survival in First-Line Treatment of Advanced Esophageal Cancer

As reported in The Lancet by Jong-Mu Sun, MD, of Samsung Medical Center, Sungkyunkwan University, Seoul, and colleagues, an interim analysis in the phase III KEYNOTE-590 trial has shown that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free...

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