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Leukemia
Immunotherapy

Dasatinib/Blinatumomab Produces High Rates of Molecular Response and Survival in Philadelphia Chromosome–Positive ALL

In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Robin Foà, MD, of Sapienza University of Rome, and colleagues, found that first-line induction and consolidation treatment with dasatinib and blinatumomab produced a high rates of molecular response as...

Multiple Myeloma
Immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

“Both KarMMa and CARTITUDE-1 trials presented during the ASCO20 Virtual Scientific Program showed exceptional results, not only in obtaining higher responses in the majority of patients but also in attaining high-quality responses,” said Ajay K. Nooka, MD, MPH, Associate Professor, Department of...

Multiple Myeloma
Immunotherapy

Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma

Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...

Lymphoma
Immunotherapy

Pembrolizumab in Adult and Pediatric Classical Hodgkin Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 14, 2020, the approval of pembrolizumab was...

Immunotherapy

Can Antihypertensives Improve Outcomes With Immunotherapy?

Angiotensin receptor blockers, commonly used to treat hypertension, may improve outcomes in patients treated with anti–PD-1/L1 agents, according to an observational study of almost 600 patients reported at the virtual 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.1 The...

Immunotherapy

Use of Pembrolizumab in Advanced Pleural Mesothelioma: Results From KEYNOTE-158

The largest single-arm trial evaluating pembrolizumab in relapsed malignant pleural mesothelioma has demonstrated an “impressive” duration of response, according to a presentation during the virtual edition of the International Association for the Study of Lung Cancer (IASLC) 2020 North America...

Lung Cancer
Immunotherapy

ESMO Asia 2020: Phase III GEMSTONE-302 Trial Finds CS1001 Plus Platinum Chemotherapy Prolongs Progression-Free Survival in NSCLC

The addition of CS1001, an anti–PD-L1 monoclonal antibody, to platinum-based chemotherapy significantly prolonged progression-free survival vs chemotherapy in treatment-naive patients with advanced non–small cell lung cancer (NSCLC), according to phase III findings presented by Zhou et al at the...

Hepatobiliary Cancer
Immunotherapy

ESMO Asia 2020: First-Line Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma

Sintilimab, an anti–PD-1 antibody, in combination with a bevacizumab biosimilar as first-line therapy significantly improved survival compared to sorafenib in patients with advanced hepatocellular carcinoma, according to findings presented by Ren et al at the ESMO Asia Virtual Congress 2020...

Lung Cancer
Immunotherapy

Nivolumab Plus Ipilimumab in First-Line NSCLC: Two New Indications, Many More Questions

In May 2020, the combination of nivolumab and ipilimumab was approved by the U.S. Food and Drug Administration (FDA) for two separate indications in the first-line setting of advanced non–small cell lung cancer (NSCLC). One was in metastatic NSCLC with tumors that have PD-L1 expression ≥ 1% with...

Solid Tumors
Immunotherapy

ESMO Asia 2020: Novel PD-L1 Antibody Shows Activity in Advanced MSI-H/dMMR Tumors

Envafolimab (also known as KN035), a novel PD-L1 antibody, demonstrated antitumor activity and was safe in patients with diverse, advanced microsatellite instability–high/mismatch repair–deficient (MSI-H/dMMR) tumors, according to findings presented by Shen et al at the ESMO Asia Virtual Congress...

Gynecologic Cancers
Immunotherapy

Pembrolizumab Plus Bevacizumab and Oral Metronomic Cyclophosphamide for Recurrent Ovarian Cancer

In a single-institution phase II trial reported in JAMA Oncology, Zsiros et al found that the combination of pembrolizumab with bevacizumab and oral metronomic cyclophosphamide produced objective response in approximately half of women with recurrent ovarian cancer taking part in the study....

Leukemia
Immunotherapy

4-Year Findings From MURANO Trial: Venetoclax Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia

As reported in the Journal of Clinical Oncology by Arnon P. Kater, MD, PhD, of Amsterdam University Medical Centers, and colleagues,1 the 4-year progression-free and overall survival rates were significantly higher with venetoclax plus rituximab vs bendamustine plus rituximab in the phase III...

Leukemia
Immunotherapy

Acalabrutinib Improves Progression-Free Survival vs Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory CLL

As reported in the Journal of Clinical Oncology by Paolo Ghia, MD, PhD, of the Università Vita-Salute San Raffaele, Milan, Italy, and colleagues, the phase III ASCEND trial showed significantly prolonged progression-free survival with acalabrutinib monotherapy vs investigator’s choice of either...

Multiple Myeloma
Immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

“Both KarMMa and CARTITUDE-1 trials presented during the ASCO20 Virtual Scientific Program showed exceptional results, not only in obtaining higher responses in the majority of patients but also in attaining high-quality responses,” said Ajay K. Nooka, MD, MPH, Associate Professor, Department of...

Multiple Myeloma
Immunotherapy

Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma

Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...

Multiple Myeloma
Immunotherapy

Expert Point of View: Philip McCarthy, MD

Philip McCarthy, MD, Professor of Oncology and Internal Medicine and Director of the Transplant and Cellular Therapy Center at Roswell Park Comprehensive Cancer Center, Buffalo, New York, found the results of the DREAMM-6 study to be “exciting and promising.” He commented: “The overall response...

Multiple Myeloma
Immunotherapy

Responses Achieved With Belantamab Mafodotin in Relapsed or Refractory Myeloma

The antibody-drug conjugate belantamab mafodotin yielded responses as a single agent and in combination with bortezomib and dexamethasone in the treatment of relapsed or refractory multiple myeloma, according to two reports from the DREAMM team at the ASCO20 Virtual Scientific Program.1,2 In the...

Leukemia
Lymphoma
Multiple Myeloma
Immunotherapy

Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies

Daratumumab and hyaluronidase-fihj: On May 1, 2020, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. Ibrutinib: On April 21, 2020, the FDA expanded the indication of ibrutinib (Imbruvica) to include...

Multiple Myeloma
Immunotherapy

Novel Treatment Approaches on the Horizon in Multiple Myeloma

Clinicians who treat multiple myeloma can anticipate a host of new treatments: melflufen, cereblon E3 ligase modulators (CELMoDs), antibody-drug conjugates, bispecific antibodies, and chimeric antigen receptor (CAR) T-cell therapies. Kenneth C. Anderson, MD, FASCO, Director of the Jerome Lipper...

Leukemia
Lymphoma
Multiple Myeloma
Immunotherapy

Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies

Venetoclax: On October 16, 2020, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older. See page 32 for more on this approval....

Hematologic Malignancies
Multiple Myeloma
Lymphoma
Leukemia
Immunotherapy

Hematologic Oncology Highlights 2019–2020 Almanac

The past year has seen remarkable advances in the treatment of leukemia, lymphoma, and multiple myeloma, which combined account for 9.9% of the estimated 1,806,590 new cases of cancer diagnosed in the United States and an estimated 56,840 cancer-related deaths.1 Novel therapies are providing...

Breast Cancer
Immunotherapy

Guideline Update Offers New Directions About Trastuzumab Emtansine for HER2-Positive Breast Cancer

About 10% to 20% of newly diagnosed breast cancers demonstrate overexpression of the HER2 protein.1 Since the introduction of trastuzumab, several new HER2-targeted therapies have been approved for use in the adjuvant and metastatic settings (eg, pertuzumab, lapatinib, and neratinib). However, for...

Lung Cancer
Immunotherapy

Combination of Nivolumab and Ipilimumab for Unresectable Malignant Pleural Mesothelioma

On October 2, 2020, the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) was approved for first-line treatment of adult patients with unresectable malignant pleural mesothelioma.1-3 Supporting Efficacy Data Approval was based on findings in the open-label phase III CheckMate 743 trial...

Bladder Cancer
Immunotherapy

DANUBE Trial Reports No Survival Benefit With First-Line Durvalumab in Metastatic Urothelial Carcinoma

As reported in The Lancet Oncology by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III DANUBE trial showed that durvalumab monotherapy did not prolong overall survival vs standard chemotherapy in previously untreated patients with...

Bladder Cancer
Immunotherapy

Expert Point of View: Kilian M. Gust, MD

Formal discussant Kilian M. Gust, MD, of the Medical University of Austria, Vienna, reminded listeners that JAVELIN Bladder 100 was designed at a time when no checkpoint inhibitor was approved for the treatment of metastatic urothelial cancer. In the past 5 years, five immune checkpoint inhibitors...

Bladder Cancer
Immunotherapy

Front-Line Avelumab Maintenance Improved Survival Across Subgroups With Advanced Urothelial Carcinoma

A strategy of front-line maintenance treatment with the PD-L1 inhibitor avelumab combined with best supportive care improved both progression-free and overall survival vs best supportive care alone across prespecified subgroups of patients with advanced or metastatic urothelial carcinoma that had...

Lymphoma
Immunotherapy

Do All Patients With Refractory Diffuse Large B-Cell Lymphoma Need CAR T-Cell Therapy?

Chimeric antigen receptor (CAR) T-cell therapy has made great strides in treating patients with relapsed or refractory diffuse large-B cell lymphoma (DLBCL) and refractory mantle cell lymphoma (MCL), but there may be newer strategies that can produce equivalent outcomes, and not all patients with...

Lung Cancer
Immunotherapy

Lung Cancer: Precision Therapies at the Forefront

What a difference 20 years have made! In the year 2000, the results of the ECOG 1594 trial were reported at the plenary session of the ASCO Annual Meeting. The study demonstrated comparable outcomes between four different platinum-based chemotherapy regimens for the treatment of metastatic...

Breast Cancer
Immunotherapy

First-Line Pembrolizumab Delays Disease Progression in PD-L1–Expressing Metastatic Triple-Negative Breast Cancer

In the phase III KEYNOTE-355 trial, pembrolizumab combined with several chemotherapy partners yielded a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with previously untreated locally advanced or metastatic...

Immunotherapy
Leukemia
Lymphoma

Bispecific Anti-CD20/Anti-CD19 CAR T Cells for Patients With Relapsed B-Cell Malignancies

In a single-institution phase I dose-escalation and -expansion trial reported as a letter in Nature Medicine, Shah et al found that treatment with tandem bispecific anti-CD20/anti-CD19 4-1BB–CD3ζ lentiviral (LV20.19) chimeric antigen receptor (CAR) T cells produced high response rates in adult...

Immunotherapy

Nivolumab Plus Ipilimumab for Metastatic Uveal Melanoma

In a single-institution phase II trial reported in the Journal of Clinical Oncology, Pelster et al found that nivolumab plus ipilimumab produced durable responses and improved survival outcomes in patients with metastatic uveal melanoma. Study Details The trial enrolled 35 patients at The...

Lung Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...

Immunotherapy
Supportive Care
Genomics/Genetics

Study Identifies Genetic Variants Linked to Bevacizumab-Induced Adverse Events

Researchers have found two common genetic variants that may be used to predict whether patients with cancer may have severe adverse events when treated with the anti-VEGF monoclonal antibody bevacizumab. A genome-wide association study—according to researchers, the largest such study in patients...

Kidney Cancer
Immunotherapy

Extended Follow-up of KEYNOTE-426: First-Line Pembrolizumab/Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma

As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, extended follow-up of the phase III KEYNOTE-426 trial shows continued progression-free and overall survival superiority with pembrolizumab/axitinib vs sunitinib in the first-line treatment of advanced renal cell...

Bladder Cancer
Immunotherapy

Expert Point of View: Richard Cathomas, MD

In his discussion of KEYNOTE-361 and the DANUBE trial, Richard Cathomas, MD, of Kantonsspital, Graubünden, Switzerland, said both studies yielded disappointing results. Overall, in these trials as well as current evidence from other trials, treatment of platinum-eligible (cisplatin or carboplatin)...

Bladder Cancer
Immunotherapy

Checkpoint Inhibitor and Chemotherapy Combinations Fail to Move Bar as First-Line Therapy for Advanced Urothelial Cancer

Two different phase III studies found that combining an anti–PD-1/PD-L1 checkpoint inhibitor (pembrolizumab in KEYNOTE-361) with platinum-based chemotherapy or with another checkpoint inhibitor (the anti–CTLA-4 antibody tremelimumab in DANUBE) failed to significantly improve overall or...

Lung Cancer
Immunotherapy

Multisystem Immune-Related Adverse Events and Disease Outcomes Among Patients With NSCLC Treated With Immunotherapy

In a retrospective cohort study reported in JAMA Oncology, Shankar et al found improved progression-free and overall survival among patients who experienced multisystem immune-related adverse events after anti–PD-1 or anti–PD-L1 immune checkpoint inhibitor therapy for stage III/IV non–small cell...

Kidney Cancer
Immunotherapy

Response-Based Management of Nivolumab and Ipilimumab Therapy in Metastatic Renal Cell Carcinoma

In the phase II OMNIVORE study reported in the Journal of Clinical Oncology, Rana R. McKay, MD, and colleagues did not find evidence supporting a strategy of discontinuing nivolumab monotherapy in responders and adding ipilimumab in nivolumab nonresponders among patients with metastatic renal cell...

Hepatobiliary Cancer
Immunotherapy

Systemic Therapy in the First- and Second-Line Treatment of Advanced Hepatocellular Carcinoma: Review and Meta-analysis

In a systematic review and network meta-analysis of 14 trials reported in JAMA Oncology, Sonbol et al found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma and identified preferred treatments in refractory disease. As...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Ana Oaknin, MD, PhD

The innovaTV 204 trial’s invited discussant, Ana Oaknin, MD, PhD, Head of the Gynecologic Cancer Program at Vall d’Hebron Institute of Oncology in Barcelona, was encouraged by the study’s findings. “Of note, the response rate was 24%, the time to response was short, and the median duration of...

Gynecologic Cancers
Immunotherapy

Novel Treatments Show Activity in Advanced Cervical Cancer

The treatment of recurrent or metastatic cervical cancer has not changed much in recent years, but according to preliminary trials presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, checkpoint inhibitors and antibody-drug conjugates may become new options. In the...

Immunotherapy

Effect of Angiotensin II Inhibition on Response to Immunotherapy

Researchers have found that a class of commonly used heart drugs may also improve patients’ responses to PD-L1 inhibitors, according to preliminary findings presented by Strauss et al at the 32th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (Abstract 7). Angiotensin...

Leukemia
Immunotherapy

First-Line Dasatinib Plus Blinatumomab for Adult Patients With Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia

In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Foà et al found that first-line induction and consolidation treatment with dasatinib plus blinatumomab produced a high rate of molecular response in adults with Philadelphia chromosome–positive acute...

Breast Cancer
Immunotherapy

Effect of Early Trastuzumab Interruption on Recurrence-Free Survival in HER2-Positive Breast Cancer

In a single-center analysis reported in a research letter in JAMA Oncology, Copeland-Halperin et al found that early trastuzumab interruption and interruption resulting in a cumulative trastuzumab dose ≤ 56 mg/kg were associated with significantly poorer recurrence-free survival in patients with...

Skin Cancer
Immunotherapy

Pretreatment ctDNA May Help Predict Outcomes With First-Line—but Not Second-Line—Immunotherapy for Patients With Melanoma

A study by Marsavela et al published in Clinical Cancer Research evaluating the predictive value of pretreatment circulating tumor DNA (ctDNA) to inform therapeutic outcomes in patients with advanced-stage melanoma relative to type and line of treatment has found that baseline levels of ctDNA...

Immunotherapy
Skin Cancer

Continued Benefit of First-Line Nivolumab vs Dacarbazine in Advanced BRAF Wild-Type Melanoma

The 5-year outcomes of the ­CheckMate 066 trial, reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, of Gustave Roussy, Villejuif, France,and colleagues, show continued benefit of first-line nivolumab vs dacarbazine in advanced BRAF wild-type melanoma and support evidence that ...

Immunotherapy
Skin Cancer

Advanced Melanoma: Lenvatinib Plus Pembrolizumab After Disease Progression on Anti–PD-1 Therapy

Checkpoint inhibitors can be lifesaving for many patients with advanced melanoma, but those who experience disease progression currently have few treatment options. The combination of a tyrosine kinase inhibitor and an anti–PD-1 agent may offer some hope in this setting, according to a study of...

Bladder Cancer
Immunotherapy

Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers

In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...

Breast Cancer
Immunotherapy

Sacituzumab Govitecan Yields Survival Benefit as Third-Line Treatment in Triple-Negative Breast Cancer: ASCENT Trial

Based on results from a phase I/II clinical trial, the antibody drug conjugate sacituzumab govitecan was recently granted accelerated approval in the treatment of patients with advanced triple-negative breast cancer, contingent on a larger study confirming its benefit. The confirmatory phase III...

Lung Cancer
Kidney Cancer
Leukemia
Solid Tumors
Gastroesophageal Cancer
Gastrointestinal Cancer
Pancreatic Cancer
Prostate Cancer
Genomics/Genetics
Immunotherapy

FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....

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